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Irbesartan BMS (irbesartan) – Labelling - C09CA04

Updated on site: 08-Oct-2017

Medication nameIrbesartan BMS
ATC CodeC09CA04
Substanceirbesartan
ManufacturerBristol-Myers Squibb Pharma EEIG

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 75 mg tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 75 mg

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

authorised

 

 

 

Excipients: also contains lactose monohydrate.

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

14 tablets

 

longer

 

 

 

 

28 tablets

 

 

 

56 tablets

 

 

 

56 x 1 tablets

no

 

 

98 tablets

 

 

 

 

 

5. METHOD AND ROUTE(S)

productOF ADMINISTRATION

6.SPECIALMedicinalWARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/375/001 - 14 tablets

EU/1/06/375/002 - 28 tablets

EU/1/06/375/003 - 56 tablets

EU/1/06/375/004 - 56 x 1 tablets

EU/1/06/375/005 - 98 tablets

13. BATCH NUMBER

Lot

 

 

longer

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

product

 

Medicinal product subject to medical pres rip ion.no

 

15.

INSTRUCTIONS ON USE

 

16.

Medicinal

 

 

INFORMATION IN BRAILLE

 

Irbesartan BMS 75 mg

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 75 mg tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

14 - 28 - 56 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

56 x 1 tablets:Medicinal

 

 

longer

authorised

 

no

 

product

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 150 mg tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 150 mg

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

authorised

 

 

 

Excipients: also contains lactose monohydrate.

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

14 tablets

 

longer

 

 

 

 

28 tablets

 

 

 

56 tablets

 

 

 

56 x 1 tablets

no

 

 

98 tablets

 

 

 

 

 

5. METHOD AND ROUTE(S)productOF ADMINISTRATION

6. SPECIALMedicinalWARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/375/006 - 14 tablets

EU/1/06/375/007 - 28 tablets

EU/1/06/375/008 - 56 tablets

EU/1/06/375/009 - 56 x 1 tablets

EU/1/06/375/010 - 98 tablets

13. BATCH NUMBER

Lot

 

 

longer

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

product

 

Medicinal product subject to medical pres rip ion.no

 

15.

INSTRUCTIONS ON USE

 

16.

Medicinal

 

 

INFORMATION IN BRAILLE

 

Irbesartan BMS 150 mg

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 150 mg tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

14 - 28 - 56 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

56 x 1 tablets:Medicinal

 

 

longer

authorised

 

no

 

product

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 300 mg tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 300 mg

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

authorised

 

 

 

Excipients: also contains lactose monohydrate.

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

14 tablets

 

longer

 

 

 

 

28 tablets

 

 

 

56 tablets

 

 

 

56 x 1 tablets

no

 

 

98 tablets

 

 

 

 

 

5. METHOD AND ROUTE(S)productOF ADMINISTRATION

6. SPECIALMedicinalWARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/375/011 - 14 tablets

EU/1/06/375/012 - 28 tablets

EU/1/06/375/013 - 56 tablets

EU/1/06/375/014 - 56 x 1 tablets

EU/1/06/375/015 - 98 tablets

13. BATCH NUMBER

Lot

 

 

longer

 

 

 

14.

GENERAL CLASSIFICATION FOR SUPPLY

 

 

product

 

Medicinal product subject to medical pres rip ion.no

 

15.

INSTRUCTIONS ON USE

 

16.

Medicinal

 

 

INFORMATION IN BRAILLE

 

Irbesartan BMS 300 mg

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 300 mg tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

14 - 28 - 56 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

56 x 1 tablets:Medicinal

 

 

longer

authorised

 

no

 

product

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 75 mg film-coated tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 75 mg

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

authorised

 

 

 

Excipients: also contains lactose monohydrate.

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

14 tablets

 

longer

 

 

 

 

28 tablets

 

 

 

56 tablets

 

 

 

56 x 1 tablets

no

 

 

84 tablets

 

 

 

 

 

98 tablets

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

product

 

 

 

Oral use. Read the package leaflet before use.

 

 

 

6. SPECIALMedicinalWARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/375/016 - 14 tablets

EU/1/06/375/017 - 28 tablets

EU/1/06/375/018 - 56 tablets

EU/1/06/375/019 - 56 x 1 tablets

EU/1/06/375/020 - 84 tablets

EU/1/06/375/021 - 98 tablets

13.

BATCH NUMBER

 

 

longer

 

 

 

Lot

 

 

no

 

14.

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

 

 

product

 

 

Medicinal product subject to medical pres ription.

 

15.

INSTRUCTIONS ON USE

 

 

16.

Medicinal

 

 

 

INFORMATION IN BRAILLE

 

 

Irbesartan BMS 75 mg

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 75 mg tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

14 - 28 - 56 - 84 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

56 x 1 tablets:Medicinal

 

 

longer

authorised

 

no

 

product

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 150 mg film-coated tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 150 mg

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

authorised

 

 

 

Excipients: also contains lactose monohydrate.

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

14 tablets

 

longer

 

 

 

 

28 tablets

 

 

 

56 tablets

 

 

 

56 x 1 tablets

no

 

 

84 tablets

 

 

 

 

 

98 tablets

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

product

 

 

 

Oral use. Read the package leaflet before use.

 

 

 

6. SPECIALMedicinalWARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/375/022 - 14 tablets

EU/1/06/375/023 - 28 tablets

EU/1/06/375/024 - 56 tablets

EU/1/06/375/025 - 56 x 1 tablets

EU/1/06/375/026 - 84 tablets

EU/1/06/375/027 - 98 tablets

13.

BATCH NUMBER

 

 

longer

 

 

 

Lot

 

 

no

 

14.

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

 

 

product

 

 

Medicinal product subject to medical pres ription.

 

15.

INSTRUCTIONS ON USE

 

 

16.

Medicinal

 

 

 

INFORMATION IN BRAILLE

 

 

Irbesartan BMS 150 mg

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 150 mg tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

14 - 28 - 56 - 84 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

56 x 1 tablets:Medicinal

 

 

longer

authorised

 

no

 

product

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 300 mg film-coated tablets irbesartan

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains: irbesartan 300 mg

 

 

 

 

 

 

 

 

3.

LIST OF EXCIPIENTS

 

 

authorised

 

 

 

Excipients: also contains lactose monohydrate.

 

 

 

 

 

 

4.

PHARMACEUTICAL FORM AND CONTENTS

 

14 tablets

 

longer

 

 

 

 

28 tablets

 

 

 

56 tablets

 

 

 

56 x 1 tablets

no

 

 

84 tablets

 

 

 

 

 

98 tablets

 

 

 

 

 

 

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

 

 

product

 

 

 

Oral use. Read the package leaflet before use.

 

 

 

6. SPECIALMedicinalWARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/06/375/028 - 14 tablets

EU/1/06/375/029 - 28 tablets

EU/1/06/375/030 - 56 tablets

EU/1/06/375/031 - 56 x 1 tablets

EU/1/06/375/032 - 84 tablets

EU/1/06/375/033 - 98 tablets

13.

BATCH NUMBER

 

 

longer

 

 

 

Lot

 

 

no

 

14.

 

 

 

GENERAL CLASSIFICATION FOR SUPPLY

 

 

product

 

 

Medicinal product subject to medical pres ription.

 

15.

INSTRUCTIONS ON USE

 

 

16.

Medicinal

 

 

 

INFORMATION IN BRAILLE

 

 

Irbesartan BMS 300 mg

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

Irbesartan BMS 300 mg tablets irbesartan

2. NAME OF THE MARKETING AUTHORISATION HOLDER

BRISTOL-MYERS SQUIBB PHARMA EEIG

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

14 - 28 - 56 - 84 - 98 tablets: Mon

Tue

Wed

Thu

Fri

Sat

Sun

56 x 1 tablets:Medicinal

 

 

longer

authorised

 

no

 

product

 

 

 

 

 

B. PACKAGE

 

product

no

Medicinal

 

 

 

LEAFLETlonger

authorised

PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 75 mg tablets

irbesartan

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.What Irbesartan BMS is and what it is used for

2.Before you take Irbesartan BMS

3.How to take Irbesartan BMS

4.Possible side effects

5.How to store Irbesartan BMS

6.Further information

 

 

authorised

1. WHAT IRBESARTAN BMS IS AND WHAT IT IS USED FOR

diabetes.

longer

 

Irbesartan BMS belongs to a group of medicines known as angiot nsin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to ceptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan BMS prevents the binding of angiotensin-II to these receptors, causing the blood vesse s to relax and the blood pressure to lower. Irbesartan BMS slows the decrease of kidney function in patients with high blood pressure and type 2

2. BEFORE YOU TAKE productIRBESARTAN BMS

Irbesartan BMS is used

no

to treat high blood pressure (essential hypertension)

to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory

evidence of impaired kidney function.

 

Medicinal

 

Do not take Irbesartan BMS

if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS if you are more than 3 months pregnant. (It is also better to avoid Irbesartan BMS in early pregnancy – see pregnancy section)

Irbesartan B S should not be given to children and adolescents (under 18 years).

Take special care with Irbesartan BMS

Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea

if you suffer from kidney problems if you suffer from heart problems

if you receive Irbesartan BMS for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function

if you are going to have an operation (surgery) or be given anaesthetics

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan BMS is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Irbesartan BMS does not usually interact with other medicines.

You may need to have blood checks if you take: potassium supplements

salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Taking Irbesartan BMS with food and drink

Irbesartan BMS can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregn nt. Your doctor will normally

advise you to stop taking Irbesartan BMS before you become pregn nt soon as you know you are

authorised

not recommended in early pregnancy, and must not be longertaken wh more than 3 months pregnant, as it may cause serious harm to your baby if used after the third mo th of pregnancy.

pregnant and will advise you to take another medicine instead of I b sartan BMS. Irbesartan BMS is

Breast-feeding

no you if you wish to breast-feed, productespecially if your baby is newborn, or was born prematurely. doctor before attempting to drive or use machines.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan BMS is not recommended for mothers who are breast-feedi g, a d your doctor may choose another treatment for

Driving and using machines

No studies on the effects on the ability to rive and use machines have been performed. Irbesartan BMS is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your

ImportantMedicinalinformat on about some of the ingredients of Irbesartan BMS

Irbesartan BMS ontains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

3. HOW TO TAKE IRBESARTAN BMS

Always take Irbesartan BMS exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan BMS is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan BMS with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan BMS until your doctor tells you otherwise.

Patients with high blood pressure

The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

Patients with high blood pressure and type 2 diabetes with kidney disease

In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

If you take more Irbesartan BMS than you should

If you accidentally take too many tablets, contact your doctor immediately.

Children should not take Irbesartan BMS

Irbesartan BMS should not be given to children under 18 years of age. If a child swallows some

tablets, contact your doctor immediately.

authorised

 

If you forget to take Irbesartan BMS

If you accidentally miss a daily dose, just take the next dose as normal. Do n take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Irbesartan BMS can cause side effects,longeralthough not everybody gets them. Some of these effects may be serious and may require medical attention.

immediately.

As with similar medicines, rare cases of allergic noskin reactions (rash, urticaria), as well as localised swelling of the face, lips and/orproducttongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan BMS and contact your doctor

The frequency of the side effects listed below is defined using the following convention:

Very common: at least 1 in 10 atients or more

Common:Medicinalat least 1 100 and ess than 1 in 10 patients

Uncommon: at least 1 in 1000 and less than 1 in 100 patients

Side effects reported clinical studies for patients treated with Irbesartan BMS were:

Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood t sts may show an increased level of potassium.

Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium

Do not store above 30°C.

levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.HOW TO STORE IRBESARTAN BMS

Keep out of the reach and sight of children.

Do not use Irbesartan BMS after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste.authorisedAsk your pharmacist how to dispose of medicines no longer required. These measures will help to protect the env ronment.

6. FURTHER INFORMATION

What Irbesartan BMS contains

longer

The active substance is irbesartan. Each tablet of Irbesartan BMS 75 mg contains 75 mg irbesartan.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.

What Irbesartan BMS looks like and conte tsnoof the pack

Irbesartan BMS 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delive y in h spitals are also available.

Irbesartan BMS 75 mg tablets areproductwhite to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

Marketing Author sat on Holder:

Not all packMedicinalsizes may be marketed.

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

Manufacturer:

SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge

Ambarès & Lagrave

F-33565 Carbon Blanc Cedex - France

SANOFI SYNTHELABO LIMITED

Edgefield Avenue - Fawdon

Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom

SANOFI WINTHROP INDUSTRIE

30-36 Avenue Gustave Eiffel, BP 7166

F-37071 Tours Cedex 2 - France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

 

Luxembourg/Luxemburg

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

Tél/Tel: + 32 2 352 74 60

 

Tél/Tel: + 32 2 352 74 60

България

 

Magyarország

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB

GYÓGYSZERKERESKEDELMI KFT.

GYÓGYSZERKERESKEDELMI KFT.

Teл.: + 359 800 12 400

 

Tel.: + 36 1 301 9700

Česká republika

 

Malta

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

BRISTOL-MYERS SQUIBB S.R.L.

Tel: + 420 221 016 111

 

Tel: + 39 06 50 39 61

Danmark

 

Nederland

authorised

 

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB BV

Tlf: + 45 45 93 05 06

 

Tel: + 31 34 857 42 22

Deutschland

 

Norge

 

BRISTOL-MYERS SQUIBB GMBH & CO. KGAA

BRISTOL-MYERS SQUIBB NORWAY LTD

 

Tlf: + 47 67 55 53 50

Eesti

 

 

longer

 

 

 

Österreich

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB GESMBH

GYÓGYSZERKERESKEDELMI KFT.

Te : + 43 1 60 14 30

Tel: + 372 640 1301

 

 

 

Ελλάδα

 

product

Polska

 

 

 

Tel: + 351 21 440 70 00

BRISTOL-MYERS SQUIBB A.E.

 

noBRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Τηλ: + 30 210 6074300

 

Tel.: + 48 22 5796666

España

 

 

Portugal

 

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB FARMACÊUTICA

Tel: + 34 91 456 53 00

 

PORTUGUESA, S.A.

Ireland

Medicinal

 

Slovenija

 

France

 

 

România

 

BRISTOL- YERS SQUIBB SARL

BRISTOL-MYERS SQUIBB

Tél: + 33 (0)810 410 500

 

GYÓGYSZERKERESKEDELMI KFT.

 

 

 

Tel: + 40 (0)21 272 16 00

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD BRISTOL-MYERS SQUIBB SPOL. S R.O.

Tel: + 353 (1 800) 749 749

 

Tel: + 386 1 236 47 00

Ísland

 

 

Slovenská republika

VISTOR HF

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

Sími: + 354 535 7000

 

Tel: + 421 2 59298411

Italia

 

 

Suomi/Finland

 

BRISTOL-MYERS SQUIBB S.R.L.

OY BRISTOL-MYERS SQUIBB (FINLAND) AB

Tel: + 39 06 50 39 61

 

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε.Π.Ε.

BRISTOL-MYERS SQUIBB AB

Τηλ: + 357 22 677038

Tel: + 46 8 704 71 00

Latvija

United Kingdom

BRISTOL-MYERS SQUIBB

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD

GYÓGYSZERKERESKEDELMI KFT.

Tel: + 44 (0800) 731 1736

Tel: + 371 67 50 21 85

 

Lietuva

 

BRISTOL-MYERS SQUIBB

 

GYÓGYSZERKERESKEDELMI KFT.

 

Tel: + 370 5 2790 762

 

This leaflet was last approved in

Detailed information on this medicine is available on site: http://www.emea.europa.eu/

 

product

no

Medicinal

 

 

 

 

authorised

the European Medicines Agency (EMEA) web

longer

 

PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 150 mg tablets

irbesartan

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.What Irbesartan BMS is and what it is used for

2.Before you take Irbesartan BMS

3.How to take Irbesartan BMS

4.Possible side effects

5.How to store Irbesartan BMS

6.Further information

 

 

authorised

1. WHAT IRBESARTAN BMS IS AND WHAT IT IS USED FOR

diabetes.

longer

 

Irbesartan BMS belongs to a group of medicines known as angiot nsin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to ceptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan BMS prevents the binding of angiotensin-II to these receptors, causing the blood vesse s to relax and the blood pressure to lower. Irbesartan BMS slows the decrease of kidney function in patients with high blood pressure and type 2

2. BEFORE YOU TAKE productIRBESARTAN BMS

Irbesartan BMS is used

no

to treat high blood pressure (essential hypertension)

to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory

evidence of impaired kidney function.

 

Medicinal

 

Do not take Irbesartan BMS

if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS if you are more than 3 months pregnant. (It is also better to avoid Irbesartan BMS in early pregnancy – see pregnancy section)

Irbesartan B S should not be given to children and adolescents (under 18 years).

Take special care with Irbesartan BMS

Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea

if you suffer from kidney problems if you suffer from heart problems

if you receive Irbesartan BMS for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function

if you are going to have an operation (surgery) or be given anaesthetics

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan BMS is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Irbesartan BMS does not usually interact with other medicines.

You may need to have blood checks if you take: potassium supplements

salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Taking Irbesartan BMS with food and drink

Irbesartan BMS can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregn nt. Your doctor will normally

advise you to stop taking Irbesartan BMS before you become pregn nt soon as you know you are

authorised

not recommended in early pregnancy, and must not be longertaken wh more than 3 months pregnant, as it may cause serious harm to your baby if used after the third mo th of pregnancy.

pregnant and will advise you to take another medicine instead of I b sartan BMS. Irbesartan BMS is

Breast-feeding

no you if you wish to breast-feed, productespecially if your baby is newborn, or was born prematurely. doctor before attempting to drive or use machines.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan BMS is not recommended for mothers who are breast-feedi g, a d your doctor may choose another treatment for

Driving and using machines

No studies on the effects on the ability to rive and use machines have been performed. Irbesartan BMS is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your

ImportantMedicinalinformat on about some of the ingredients of Irbesartan BMS

Irbesartan BMS ontains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

3. HOW TO TAKE IRBESARTAN BMS

Always take Irbesartan BMS exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan BMS is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan BMS with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan BMS until your doctor tells you otherwise.

Patients with high blood pressure

The usual dose is 150 mg once a day. The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.

Patients with high blood pressure and type 2 diabetes with kidney disease

In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

If you take more Irbesartan BMS than you should

If you accidentally take too many tablets, contact your doctor immediately.

Children should not take Irbesartan BMS

Irbesartan BMS should not be given to children under 18 years of age. If a child swallows some

tablets, contact your doctor immediately.

authorised

 

If you forget to take Irbesartan BMS

If you accidentally miss a daily dose, just take the next dose as normal. Do n take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Irbesartan BMS can cause side effects,longeralthough not everybody gets them. Some of these effects may be serious and may require medical attention.

immediately.

As with similar medicines, rare cases of allergic noskin reactions (rash, urticaria), as well as localised swelling of the face, lips and/orproducttongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan BMS and contact your doctor

The frequency of the side effects listed below is defined using the following convention:

Very common: at least 1 in 10 atients or more

Common:Medicinalat least 1 100 and ess than 1 in 10 patients

Uncommon: at least 1 in 1000 and less than 1 in 100 patients

Side effects reported clinical studies for patients treated with Irbesartan BMS were:

Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood t sts may show an increased level of potassium.

Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium

Do not store above 30°C.

levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE IRBESARTAN BMS

Keep out of the reach and sight of children.

Do not use Irbesartan BMS after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste.authorisedAsk your pharmacist how to dispose of medicines no longer required. These measures will help to protect the env ronment.

6. FURTHER INFORMATION

What Irbesartan BMS contains

longer

The active substance is irbesartan. Each tablet of Irbesartan BMS 150 mg contains 150 mg irbesartan.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.

What Irbesartan BMS looks like and conte tsnoof the pack

Irbesartan BMS 150 mg tabletsproductare white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2772 engraved on the other side.

Irbesartan BMS 150 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delive y in h spitals are also available.

Marketing Author sat on Holder:

Not all packMedicinalsizes may be marketed.

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

Manufacturer:

SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge

Ambarès & Lagrave

F-33565 Carbon Blanc Cedex - France

SANOFI SYNTHELABO LIMITED

Edgefield Avenue - Fawdon

Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom

SANOFI WINTHROP INDUSTRIE

30-36 Avenue Gustave Eiffel, BP 7166

F-37071 Tours Cedex 2 - France

CHINOIN PRIVATE CO. LTD.

Lévai u.5.

2112 Veresegyház - Hungary

 

 

 

longer

authorised

 

 

no

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

 

Luxembourg/Luxemburg

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

Tél/Tel: + 32 2 352 74 60

 

Tél/Tel: + 32 2 352 74 60

България

 

Magyarország

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB

GYÓGYSZERKERESKEDELMI KFT.

GYÓGYSZERKERESKEDELMI KFT.

Teл.: + 359 800 12 400

 

Tel.: + 36 1 301 9700

Česká republika

 

Malta

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

BRISTOL-MYERS SQUIBB S.R.L.

Tel: + 420 221 016 111

 

Tel: + 39 06 50 39 61

Danmark

 

Nederland

authorised

 

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB BV

Tlf: + 45 45 93 05 06

 

Tel: + 31 34 857 42 22

Deutschland

 

Norge

 

BRISTOL-MYERS SQUIBB GMBH & CO. KGAA

BRISTOL-MYERS SQUIBB NORWAY LTD

 

Tlf: + 47 67 55 53 50

Eesti

 

 

longer

 

 

 

Österreich

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB GESMBH

GYÓGYSZERKERESKEDELMI KFT.

Te : + 43 1 60 14 30

Tel: + 372 640 1301

 

 

 

Ελλάδα

 

product

Polska

 

 

 

Tel: + 351 21 440 70 00

BRISTOL-MYERS SQUIBB A.E.

 

noBRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Τηλ: + 30 210 6074300

 

Tel.: + 48 22 5796666

España

 

 

Portugal

 

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB FARMACÊUTICA

Tel: + 34 91 456 53 00

 

PORTUGUESA, S.A.

Ireland

Medicinal

 

Slovenija

 

France

 

 

România

 

BRISTOL- YERS SQUIBB SARL

BRISTOL-MYERS SQUIBB

Tél: + 33 (0)810 410 500

 

GYÓGYSZERKERESKEDELMI KFT.

 

 

 

Tel: + 40 (0)21 272 16 00

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD BRISTOL-MYERS SQUIBB SPOL. S R.O.

Tel: + 353 (1 800) 749 749

 

Tel: + 386 1 236 47 00

Ísland

 

 

Slovenská republika

VISTOR HF

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

Sími: + 354 535 7000

 

Tel: + 421 2 59298411

Italia

 

 

Suomi/Finland

 

BRISTOL-MYERS SQUIBB S.R.L.

OY BRISTOL-MYERS SQUIBB (FINLAND) AB

Tel: + 39 06 50 39 61

 

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε.Π.Ε.

BRISTOL-MYERS SQUIBB AB

Τηλ: + 357 22 677038

Tel: + 46 8 704 71 00

Latvija

United Kingdom

BRISTOL-MYERS SQUIBB

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD

GYÓGYSZERKERESKEDELMI KFT.

Tel: + 44 (0800) 731 1736

Tel: + 371 67 50 21 85

 

Lietuva

 

BRISTOL-MYERS SQUIBB

 

GYÓGYSZERKERESKEDELMI KFT.

 

Tel: + 370 5 2790 762

 

This leaflet was last approved in

Detailed information on this medicine is available on site: http://www.emea.europa.eu/

 

product

no

Medicinal

 

 

 

 

authorised

the European Medicines Agency (EMEA) web

longer

 

PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 300 mg tablets

irbesartan

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.What Irbesartan BMS is and what it is used for

2.Before you take Irbesartan BMS

3.How to take Irbesartan BMS

4.Possible side effects

5.How to store Irbesartan BMS

6.Further information

 

 

authorised

1. WHAT IRBESARTAN BMS IS AND WHAT IT IS USED FOR

diabetes.

longer

 

Irbesartan BMS belongs to a group of medicines known as angiot nsin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to ceptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan BMS prevents the binding of angiotensin-II to these receptors, causing the blood vesse s to relax and the blood pressure to lower. Irbesartan BMS slows the decrease of kidney function in patients with high blood pressure and type 2

2. BEFORE YOU TAKE productIRBESARTAN BMS

Irbesartan BMS is used

no

to treat high blood pressure (essential hypertension)

to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory

evidence of impaired kidney function.

 

Medicinal

 

Do not take Irbesartan BMS

if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS if you are more than 3 months pregnant. (It is also better to avoid Irbesartan BMS in early pregnancy – see pregnancy section)

Irbesartan B S should not be given to children and adolescents (under 18 years).

Take special care with Irbesartan BMS

Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea

if you suffer from kidney problems if you suffer from heart problems

if you receive Irbesartan BMS for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function

if you are going to have an operation (surgery) or be given anaesthetics

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan BMS is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Irbesartan BMS does not usually interact with other medicines.

You may need to have blood checks if you take: potassium supplements

salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Taking Irbesartan BMS with food and drink

Irbesartan BMS can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregn nt. Your doctor will normally

advise you to stop taking Irbesartan BMS before you become pregn nt soon as you know you are

authorised

not recommended in early pregnancy, and must not be longertaken wh more than 3 months pregnant, as it may cause serious harm to your baby if used after the third mo th of pregnancy.

pregnant and will advise you to take another medicine instead of I b sartan BMS. Irbesartan BMS is

Breast-feeding

no you if you wish to breast-feed, productespecially if your baby is newborn, or was born prematurely. doctor before attempting to drive or use machines.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan BMS is not recommended for mothers who are breast-feedi g, a d your doctor may choose another treatment for

Driving and using machines

No studies on the effects on the ability to rive and use machines have been performed. Irbesartan BMS is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your

ImportantMedicinalinformat on about some of the ingredients of Irbesartan BMS

Irbesartan BMS ontains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

3. HOW TO TAKE IRBESARTAN BMS

Always take Irbesartan BMS exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan BMS is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan BMS with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan BMS until your doctor tells you otherwise.

Patients with high blood pressure

The usual dose is 150 mg once a day. The dose may later be increased to 300 mg once daily depending on blood pressure response.

Patients with high blood pressure and type 2 diabetes with kidney disease

In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

If you take more Irbesartan BMS than you should

If you accidentally take too many tablets, contact your doctor immediately.

Children should not take Irbesartan BMS

Irbesartan BMS should not be given to children under 18 years of age. If a child swallows some

tablets, contact your doctor immediately.

authorised

 

If you forget to take Irbesartan BMS

If you accidentally miss a daily dose, just take the next dose as normal. Do n take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Irbesartan BMS can cause side effects,longeralthough not everybody gets them. Some of these effects may be serious and may require medical attention.

immediately.

As with similar medicines, rare cases of allergic noskin reactions (rash, urticaria), as well as localised swelling of the face, lips and/orproducttongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan BMS and contact your doctor

The frequency of the side effects listed below is defined using the following convention:

Very common: at least 1 in 10 atients or more

Common:Medicinalat least 1 100 and ess than 1 in 10 patients

Uncommon: at least 1 in 1000 and less than 1 in 100 patients

Side effects reported clinical studies for patients treated with Irbesartan BMS were:

Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood t sts may show an increased level of potassium.

Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium

Do not store above 30°C.

levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE IRBESARTAN BMS

Keep out of the reach and sight of children.

Do not use Irbesartan BMS after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste.authorisedAsk your pharmacist how to dispose of medicines no longer required. These measures will help to protect the env ronment.

6. FURTHER INFORMATION

What Irbesartan BMS contains

longer

The active substance is irbesartan. Each tablet of Irbesartan BMS 300 mg contains 300 mg irbesartan.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.

What Irbesartan BMS looks like and conte tsnoof the pack

Irbesartan BMS 300 mg tabletsproductare white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2773 engraved on the other side.

Irbesartan BMS 300 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delive y in h spitals are also available.

Marketing Author sat on Holder:

Not all packMedicinalsizes may be marketed.

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

Manufacturer:

SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge

Ambarès & Lagrave

F-33565 Carbon Blanc Cedex - France

SANOFI SYNTHELABO LIMITED

Edgefield Avenue - Fawdon

Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom

SANOFI WINTHROP INDUSTRIE

30-36 Avenue Gustave Eiffel, BP 7166

F-37071 Tours Cedex 2 - France

CHINOIN PRIVATE CO. LTD.

Lévai u.5.

2112 Veresegyház - Hungary

 

 

 

longer

authorised

 

 

no

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

 

Luxembourg/Luxemburg

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

Tél/Tel: + 32 2 352 74 60

 

Tél/Tel: + 32 2 352 74 60

България

 

Magyarország

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB

GYÓGYSZERKERESKEDELMI KFT.

GYÓGYSZERKERESKEDELMI KFT.

Teл.: + 359 800 12 400

 

Tel.: + 36 1 301 9700

Česká republika

 

Malta

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

BRISTOL-MYERS SQUIBB S.R.L.

Tel: + 420 221 016 111

 

Tel: + 39 06 50 39 61

Danmark

 

Nederland

authorised

 

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB BV

Tlf: + 45 45 93 05 06

 

Tel: + 31 34 857 42 22

Deutschland

 

Norge

 

BRISTOL-MYERS SQUIBB GMBH & CO. KGAA

BRISTOL-MYERS SQUIBB NORWAY LTD

 

Tlf: + 47 67 55 53 50

Eesti

 

 

longer

 

 

 

Österreich

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB GESMBH

GYÓGYSZERKERESKEDELMI KFT.

Te : + 43 1 60 14 30

Tel: + 372 640 1301

 

 

 

Ελλάδα

 

product

Polska

 

 

 

Tel: + 351 21 440 70 00

BRISTOL-MYERS SQUIBB A.E.

 

noBRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Τηλ: + 30 210 6074300

 

Tel.: + 48 22 5796666

España

 

 

Portugal

 

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB FARMACÊUTICA

Tel: + 34 91 456 53 00

 

PORTUGUESA, S.A.

Ireland

Medicinal

 

Slovenija

 

France

 

 

România

 

BRISTOL- YERS SQUIBB SARL

BRISTOL-MYERS SQUIBB

Tél: + 33 (0)810 410 500

 

GYÓGYSZERKERESKEDELMI KFT.

 

 

 

Tel: + 40 (0)21 272 16 00

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD BRISTOL-MYERS SQUIBB SPOL. S R.O.

Tel: + 353 (1 800) 749 749

 

Tel: + 386 1 236 47 00

Ísland

 

 

Slovenská republika

VISTOR HF

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

Sími: + 354 535 7000

 

Tel: + 421 2 59298411

Italia

 

 

Suomi/Finland

 

BRISTOL-MYERS SQUIBB S.R.L.

OY BRISTOL-MYERS SQUIBB (FINLAND) AB

Tel: + 39 06 50 39 61

 

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε.Π.Ε.

BRISTOL-MYERS SQUIBB AB

Τηλ: + 357 22 677038

Tel: + 46 8 704 71 00

Latvija

United Kingdom

BRISTOL-MYERS SQUIBB

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD

GYÓGYSZERKERESKEDELMI KFT.

Tel: + 44 (0800) 731 1736

Tel: + 371 67 50 21 85

 

Lietuva

 

BRISTOL-MYERS SQUIBB

 

GYÓGYSZERKERESKEDELMI KFT.

 

Tel: + 370 5 2790 762

 

This leaflet was last approved in

Detailed information on this medicine is available on site: http://www.emea.europa.eu/

 

product

no

Medicinal

 

 

 

 

authorised

the European Medicines Agency (EMEA) web

longer

 

PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 75 mg film-coated tablets

irbesartan

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.What Irbesartan BMS is and what it is used for

2.Before you take Irbesartan BMS

3.How to take Irbesartan BMS

4.Possible side effects

5.How to store Irbesartan BMS

6.Further information

 

 

authorised

1. WHAT IRBESARTAN BMS IS AND WHAT IT IS USED FOR

diabetes.

longer

 

Irbesartan BMS belongs to a group of medicines known as angiot nsin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to ceptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan BMS prevents the binding of angiotensin-II to these receptors, causing the blood vesse s to relax and the blood pressure to lower. Irbesartan BMS slows the decrease of kidney function in patients with high blood pressure and type 2

2. BEFORE YOU TAKE productIRBESARTAN BMS

Irbesartan BMS is used

no

to treat high blood pressure (essential hypertension)

to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory

evidence of impaired kidney function.

 

Medicinal

 

Do not take Irbesartan BMS

if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS if you are more than 3 months pregnant. (It is also better to avoid Irbesartan BMS in early pregnancy – see pregnancy section)

Irbesartan B S should not be given to children and adolescents (under 18 years).

Take special care with Irbesartan BMS

Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea

if you suffer from kidney problems if you suffer from heart problems

if you receive Irbesartan BMS for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function

if you are going to have an operation (surgery) or be given anaesthetics

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan BMS is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Irbesartan BMS does not usually interact with other medicines.

You may need to have blood checks if you take: potassium supplements

salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Taking Irbesartan BMS with food and drink

Irbesartan BMS can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregn nt. Your doctor will normally

advise you to stop taking Irbesartan BMS before you become pregn nt soon as you know you are

authorised

not recommended in early pregnancy, and must not be longertaken wh more than 3 months pregnant, as it may cause serious harm to your baby if used after the third mo th of pregnancy.

pregnant and will advise you to take another medicine instead of I b sartan BMS. Irbesartan BMS is

Breast-feeding

no you if you wish to breast-feed, productespecially if your baby is newborn, or was born prematurely. doctor before attempting to drive or use machines.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan BMS is not recommended for mothers who are breast-feedi g, a d your doctor may choose another treatment for

Driving and using machines

No studies on the effects on the ability to rive and use machines have been performed. Irbesartan BMS is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your

ImportantMedicinalinformat on about some of the ingredients of Irbesartan BMS

Irbesartan BMS ontains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

3. HOW TO TAKE IRBESARTAN BMS

Always take Irbesartan BMS exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan BMS is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan BMS with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan BMS until your doctor tells you otherwise.

Patients with high blood pressure

The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

Patients with high blood pressure and type 2 diabetes with kidney disease

In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

If you take more Irbesartan BMS than you should:

If you accidentally take too many tablets, contact your doctor immediately.

Children should not take Irbesartan BMS

Irbesartan BMS should not be given to children under 18 years of age. If a child swallows some

tablets, contact your doctor immediately.

authorised

 

If you forget to take Irbesartan BMS:

If you accidentally miss a daily dose, just take the next dose as normal. Do n take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Irbesartan BMS can cause side effects,longeralthough not everybody gets them. Some of these effects may be serious and may require medical attention.

immediately.

As with similar medicines, rare cases of allergic noskin reactions (rash, urticaria), as well as localised swelling of the face, lips and/orproducttongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan BMS and contact your doctor

The frequency of the side effects listed below is defined using the following convention:

Very common: at least 1 in 10 atients or more

Common:Medicinalat least 1 100 and ess than 1 in 10 patients

Uncommon: at least 1 in 1000 and less than 1 in 100 patients

Side effects reported clinical studies for patients treated with Irbesartan BMS were:

Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood t sts may show an increased level of potassium.

Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium

Do not store above 30°C.

levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE IRBESARTAN BMS

Keep out of the reach and sight of children.

Do not use Irbesartan BMS after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste.authorisedAsk your pharmacist how to dispose of medicines no longer required. These measures will help to protect the env ronment.

6. FURTHER INFORMATION

What Irbesartan BMS contains

longer

The active substance is irbesartan. Each tablet of Irbesartan BMS 75 mg contains 75 mg irbesartan.

The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.

no Irbesartan BMS 75 mg film-coatedproducttablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2871 engraved on the other side.

What Irbesartan BMS looks like and conte ts of the pack

Irbesartan BMS 75 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film- coated tablets. Unidose blister packs f 56 x 1 film-coated tablet for delivery in hospitals are also

available.

Marketing Author sation Holder:

Not all packMedicinalsizes may be m rketed.

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Busin ss Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

Manufacturer:

SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge

Ambarès & Lagrave

F-33565 Carbon Blanc Cedex - France

SANOFI SYNTHELABO LIMITED

Edgefield Avenue - Fawdon

Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom

SANOFI WINTHROP INDUSTRIE

30-36 Avenue Gustave Eiffel, BP 7166

F-37071 Tours Cedex 2 - France

 

 

 

longer

authorised

 

 

no

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

 

Luxembourg/Luxemburg

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

Tél/Tel: + 32 2 352 74 60

 

Tél/Tel: + 32 2 352 74 60

България

 

Magyarország

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB

GYÓGYSZERKERESKEDELMI KFT.

GYÓGYSZERKERESKEDELMI KFT.

Teл.: + 359 800 12 400

 

Tel.: + 36 1 301 9700

Česká republika

 

Malta

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

BRISTOL-MYERS SQUIBB S.R.L.

Tel: + 420 221 016 111

 

Tel: + 39 06 50 39 61

Danmark

 

Nederland

authorised

 

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB BV

Tlf: + 45 45 93 05 06

 

Tel: + 31 34 857 42 22

Deutschland

 

Norge

 

BRISTOL-MYERS SQUIBB GMBH & CO. KGAA

BRISTOL-MYERS SQUIBB NORWAY LTD

 

Tlf: + 47 67 55 53 50

Eesti

 

 

longer

 

 

 

Österreich

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB GESMBH

GYÓGYSZERKERESKEDELMI KFT.

Te : + 43 1 60 14 30

Tel: + 372 640 1301

 

 

 

Ελλάδα

 

product

Polska

 

 

 

Tel: + 351 21 440 70 00

BRISTOL-MYERS SQUIBB A.E.

 

noBRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Τηλ: + 30 210 6074300

 

Tel.: + 48 22 5796666

España

 

 

Portugal

 

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB FARMACÊUTICA

Tel: + 34 91 456 53 00

 

PORTUGUESA, S.A.

Ireland

Medicinal

 

Slovenija

 

France

 

 

România

 

BRISTOL- YERS SQUIBB SARL

BRISTOL-MYERS SQUIBB

Tél: + 33 (0)810 410 500

 

GYÓGYSZERKERESKEDELMI KFT.

 

 

 

Tel: + 40 (0)21 272 16 00

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD BRISTOL-MYERS SQUIBB SPOL. S R.O.

Tel: + 353 (1 800) 749 749

 

Tel: + 386 1 236 47 00

Ísland

 

 

Slovenská republika

VISTOR HF

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

Sími: + 354 535 7000

 

Tel: + 421 2 59298411

Italia

 

 

Suomi/Finland

 

BRISTOL-MYERS SQUIBB S.R.L.

OY BRISTOL-MYERS SQUIBB (FINLAND) AB

Tel: + 39 06 50 39 61

 

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε.Π.Ε.

BRISTOL-MYERS SQUIBB AB

Τηλ: + 357 22 677038

Tel: + 46 8 704 71 00

Latvija

United Kingdom

BRISTOL-MYERS SQUIBB

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD

GYÓGYSZERKERESKEDELMI KFT.

Tel: + 44 (0800) 731 1736

Tel: + 371 67 50 21 85

 

Lietuva

 

BRISTOL-MYERS SQUIBB

 

GYÓGYSZERKERESKEDELMI KFT.

 

Tel: + 370 5 2790 762

 

This leaflet was last approved in

Detailed information on this medicine is available on site: http://www.emea.europa.eu/

 

product

no

Medicinal

 

 

 

 

authorised

the European Medicines Agency (EMEA) web

longer

 

PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 150 mg film-coated tablets

irbesartan

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.What Irbesartan BMS is and what it is used for

2.Before you take Irbesartan BMS

3.How to take Irbesartan BMS

4.Possible side effects

5.How to store Irbesartan BMS

6.Further information

 

 

authorised

1. WHAT IRBESARTAN BMS IS AND WHAT IT IS USED FOR

diabetes.

longer

 

Irbesartan BMS belongs to a group of medicines known as angiot nsin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to ceptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan BMS prevents the binding of angiotensin-II to these receptors, causing the blood vesse s to relax and the blood pressure to lower. Irbesartan BMS slows the decrease of kidney function in patients with high blood pressure and type 2

2. BEFORE YOU TAKE productIRBESARTAN BMS

Irbesartan BMS is used

no

to treat high blood pressure (essential hypertension)

to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory

evidence of impaired kidney function.

 

Medicinal

 

Do not take Irbesartan BMS

if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS if you are more than 3 months pregnant. (It is also better to avoid Irbesartan BMS in early pregnancy – see pregnancy section)

Irbesartan B S should not be given to children and adolescents (under 18 years).

Take special care with Irbesartan BMS

Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea

if you suffer from kidney problems if you suffer from heart problems

if you receive Irbesartan BMS for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function

if you are going to have an operation (surgery) or be given anaesthetics

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan BMS is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Irbesartan BMS does not usually interact with other medicines.

You may need to have blood checks if you take: potassium supplements

salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Taking Irbesartan BMS with food and drink

Irbesartan BMS can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregn nt. Your doctor will normally

advise you to stop taking Irbesartan BMS before you become pregn nt soon as you know you are

authorised

not recommended in early pregnancy, and must not be longertaken wh more than 3 months pregnant, as it may cause serious harm to your baby if used after the third mo th of pregnancy.

pregnant and will advise you to take another medicine instead of I b sartan BMS. Irbesartan BMS is

Breast-feeding

no you if you wish to breast-feed, productespecially if your baby is newborn, or was born prematurely. doctor before attempting to drive or use machines.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan BMS is not recommended for mothers who are breast-feedi g, a d your doctor may choose another treatment for

Driving and using machines

No studies on the effects on the ability to rive and use machines have been performed. Irbesartan BMS is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your

ImportantMedicinalinformat on about some of the ingredients of Irbesartan BMS

Irbesartan BMS ontains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

3. HOW TO TAKE IRBESARTAN BMS

Always take Irbesartan BMS exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan BMS is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan BMS with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan BMS until your doctor tells you otherwise.

Patients with high blood pressure

The usual dose is 150 mg once a day. The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response.

Patients with high blood pressure and type 2 diabetes with kidney disease

In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

If you take more Irbesartan BMS than you should:

If you accidentally take too many tablets, contact your doctor immediately.

Children should not take Irbesartan BMS

Irbesartan BMS should not be given to children under 18 years of age. If a child swallows some

tablets, contact your doctor immediately.

authorised

 

If you forget to take Irbesartan BMS:

If you accidentally miss a daily dose, just take the next dose as normal. Do n take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Irbesartan BMS can cause side effects,longeralthough not everybody gets them. Some of these effects may be serious and may require medical attention.

immediately.

As with similar medicines, rare cases of allergic noskin reactions (rash, urticaria), as well as localised swelling of the face, lips and/orproducttongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan BMS and contact your doctor

The frequency of the side effects listed below is defined using the following convention:

Very common: at least 1 in 10 atients or more

Common:Medicinalat least 1 100 and ess than 1 in 10 patients

Uncommon: at least 1 in 1000 and less than 1 in 100 patients

Side effects reported clinical studies for patients treated with Irbesartan BMS were:

Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood t sts may show an increased level of potassium.

Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium

Do not store above 30°C.

levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE IRBESARTAN BMS

Keep out of the reach and sight of children.

Do not use Irbesartan BMS after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste.authorisedAsk your pharmacist how to dispose of medicines no longer required. These measures will help to protect the env ronment.

6. FURTHER INFORMATION

What Irbesartan BMS contains

longer

The active substance is irbesartan. Each tablet of Irbesartan BMS 150 mg contains 150 mg irbesartan.

The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.

no Irbesartan BMS 150 mg film-coatedproducttablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2872 engraved on the other side.

What Irbesartan BMS looks like and conte ts of the pack

Irbesartan BMS 150 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film- coated tablets. Unidose blister packs f 56 x 1 film-coated tablet for delivery in hospitals are also

available.

Marketing Author sation Holder:

Not all packMedicinalsizes may be m rketed.

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Busin ss Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

Manufacturer:

SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge

Ambarès & Lagrave

F-33565 Carbon Blanc Cedex - France

SANOFI SYNTHELABO LIMITED

Edgefield Avenue - Fawdon

Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom

SANOFI WINTHROP INDUSTRIE

30-36 Avenue Gustave Eiffel, BP 7166

F-37071 Tours Cedex 2 - France

CHINOIN PRIVATE CO. LTD.

Lévai u.5.

2112 Veresegyház - Hungary

 

 

 

longer

authorised

 

 

no

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

 

Luxembourg/Luxemburg

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

Tél/Tel: + 32 2 352 74 60

 

Tél/Tel: + 32 2 352 74 60

България

 

Magyarország

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB

GYÓGYSZERKERESKEDELMI KFT.

GYÓGYSZERKERESKEDELMI KFT.

Teл.: + 359 800 12 400

 

Tel.: + 36 1 301 9700

Česká republika

 

Malta

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

BRISTOL-MYERS SQUIBB S.R.L.

Tel: + 420 221 016 111

 

Tel: + 39 06 50 39 61

Danmark

 

Nederland

authorised

 

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB BV

Tlf: + 45 45 93 05 06

 

Tel: + 31 34 857 42 22

Deutschland

 

Norge

 

BRISTOL-MYERS SQUIBB GMBH & CO. KGAA

BRISTOL-MYERS SQUIBB NORWAY LTD

 

Tlf: + 47 67 55 53 50

Eesti

 

 

longer

 

 

 

Österreich

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB GESMBH

GYÓGYSZERKERESKEDELMI KFT.

Te : + 43 1 60 14 30

Tel: + 372 640 1301

 

 

 

Ελλάδα

 

product

Polska

 

 

 

Tel: + 351 21 440 70 00

BRISTOL-MYERS SQUIBB A.E.

 

noBRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Τηλ: + 30 210 6074300

 

Tel.: + 48 22 5796666

España

 

 

Portugal

 

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB FARMACÊUTICA

Tel: + 34 91 456 53 00

 

PORTUGUESA, S.A.

Ireland

Medicinal

 

Slovenija

 

France

 

 

România

 

BRISTOL- YERS SQUIBB SARL

BRISTOL-MYERS SQUIBB

Tél: + 33 (0)810 410 500

 

GYÓGYSZERKERESKEDELMI KFT.

 

 

 

Tel: + 40 (0)21 272 16 00

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD BRISTOL-MYERS SQUIBB SPOL. S R.O.

Tel: + 353 (1 800) 749 749

 

Tel: + 386 1 236 47 00

Ísland

 

 

Slovenská republika

VISTOR HF

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

Sími: + 354 535 7000

 

Tel: + 421 2 59298411

Italia

 

 

Suomi/Finland

 

BRISTOL-MYERS SQUIBB S.R.L.

OY BRISTOL-MYERS SQUIBB (FINLAND) AB

Tel: + 39 06 50 39 61

 

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε.Π.Ε.

BRISTOL-MYERS SQUIBB AB

Τηλ: + 357 22 677038

Tel: + 46 8 704 71 00

Latvija

United Kingdom

BRISTOL-MYERS SQUIBB

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD

GYÓGYSZERKERESKEDELMI KFT.

Tel: + 44 (0800) 731 1736

Tel: + 371 67 50 21 85

 

Lietuva

 

BRISTOL-MYERS SQUIBB

 

GYÓGYSZERKERESKEDELMI KFT.

 

Tel: + 370 5 2790 762

 

This leaflet was last approved in

Detailed information on this medicine is available on site: http://www.emea.europa.eu/

 

product

no

Medicinal

 

 

 

 

authorised

the European Medicines Agency (EMEA) web

longer

 

PACKAGE LEAFLET: INFORMATION FOR THE USER Irbesartan BMS 300 mg film-coated tablets

irbesartan

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.What Irbesartan BMS is and what it is used for

2.Before you take Irbesartan BMS

3.How to take Irbesartan BMS

4.Possible side effects

5.How to store Irbesartan BMS

6.Further information

 

 

authorised

1. WHAT IRBESARTAN BMS IS AND WHAT IT IS USED FOR

diabetes.

longer

 

Irbesartan BMS belongs to a group of medicines known as angiot nsin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to ceptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Irbesartan BMS prevents the binding of angiotensin-II to these receptors, causing the blood vesse s to relax and the blood pressure to lower. Irbesartan BMS slows the decrease of kidney function in patients with high blood pressure and type 2

2. BEFORE YOU TAKE productIRBESARTAN BMS

Irbesartan BMS is used

no

to treat high blood pressure (essential hypertension)

to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory

evidence of impaired kidney function.

 

Medicinal

 

Do not take Irbesartan BMS

if you are allergic (hypersensitive) to irbesartan or any other ingredients of Irbesartan BMS if you are more than 3 months pregnant. (It is also better to avoid Irbesartan BMS in early pregnancy – see pregnancy section)

Irbesartan B S should not be given to children and adolescents (under 18 years).

Take special care with Irbesartan BMS

Tell your doctor if any of the following apply to you: if you get excessive vomiting or diarrhoea

if you suffer from kidney problems if you suffer from heart problems

if you receive Irbesartan BMS for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function

if you are going to have an operation (surgery) or be given anaesthetics

You must tell your doctor if you think you are (or might become) pregnant. Irbesartan BMS is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Irbesartan BMS does not usually interact with other medicines.

You may need to have blood checks if you take: potassium supplements

salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Taking Irbesartan BMS with food and drink

Irbesartan BMS can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregn nt. Your doctor will normally

advise you to stop taking Irbesartan BMS before you become pregn nt soon as you know you are

authorised

not recommended in early pregnancy, and must not be longertaken wh more than 3 months pregnant, as it may cause serious harm to your baby if used after the third mo th of pregnancy.

pregnant and will advise you to take another medicine instead of I b sartan BMS. Irbesartan BMS is

Breast-feeding

no you if you wish to breast-feed, productespecially if your baby is newborn, or was born prematurely. doctor before attempting to drive or use machines.

Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan BMS is not recommended for mothers who are breast-feedi g, a d your doctor may choose another treatment for

Driving and using machines

No studies on the effects on the ability to rive and use machines have been performed. Irbesartan BMS is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your

ImportantMedicinalinformat on about some of the ingredients of Irbesartan BMS

Irbesartan BMS ontains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

3. HOW TO TAKE IRBESARTAN BMS

Always take Irbesartan BMS exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan BMS is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan BMS with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan BMS until your doctor tells you otherwise.

Patients with high blood pressure

The usual dose is 150 mg once a day. The dose may later be increased to 300 mg once daily depending on blood pressure response.

Patients with high blood pressure and type 2 diabetes with kidney disease

In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

If you take more Irbesartan BMS than you should:

If you accidentally take too many tablets, contact your doctor immediately.

Children should not take Irbesartan BMS

Irbesartan BMS should not be given to children under 18 years of age. If a child swallows some

tablets, contact your doctor immediately.

authorised

 

If you forget to take Irbesartan BMS:

If you accidentally miss a daily dose, just take the next dose as normal. Do n take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Irbesartan BMS can cause side effects,longeralthough not everybody gets them. Some of these effects may be serious and may require medical attention.

immediately.

As with similar medicines, rare cases of allergic noskin reactions (rash, urticaria), as well as localised swelling of the face, lips and/orproducttongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan BMS and contact your doctor

The frequency of the side effects listed below is defined using the following convention:

Very common: at least 1 in 10 atients or more

Common:Medicinalat least 1 100 and ess than 1 in 10 patients

Uncommon: at least 1 in 1000 and less than 1 in 100 patients

Side effects reported clinical studies for patients treated with Irbesartan BMS were:

Very common: if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood t sts may show an increased level of potassium.

Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

Uncommon: heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of Irbesartan BMS but the frequency for them to occur is not known. These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium

Do not store above 30°C.

levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE IRBESARTAN BMS

Keep out of the reach and sight of children.

Do not use Irbesartan BMS after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste.authorisedAsk your pharmacist how to dispose of medicines no longer required. These measures will help to protect the env ronment.

6. FURTHER INFORMATION

What Irbesartan BMS contains

longer

The active substance is irbesartan. Each tablet of Irbesartan BMS 300 mg contains 300 mg irbesartan.

The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.

no Irbesartan BMS 300 mg film-coatedproducttablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2873 engraved on the other side.

What Irbesartan BMS looks like and conte ts of the pack

Irbesartan BMS 300 mg film-coated tablets are supplied in blister packs of 14, 28, 56, 84 or 98 film- coated tablets. Unidose blister packs f 56 x 1 film-coated tablet for delivery in hospitals are also

available.

Marketing Author sation Holder:

Not all packMedicinalsizes may be m rketed.

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Busin ss Park

Sanderson Road

Uxbridge UB8 1DH - United Kingdom

Manufacturer:

SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge

Ambarès & Lagrave

F-33565 Carbon Blanc Cedex - France

SANOFI SYNTHELABO LIMITED

Edgefield Avenue - Fawdon

Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom

SANOFI WINTHROP INDUSTRIE

30-36 Avenue Gustave Eiffel, BP 7166

F-37071 Tours Cedex 2 - France

CHINOIN PRIVATE CO. LTD.

Lévai u.5.

2112 Veresegyház - Hungary

 

 

 

longer

authorised

 

 

no

 

 

product

 

 

Medicinal

 

 

 

 

 

 

 

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

 

Luxembourg/Luxemburg

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V.

Tél/Tel: + 32 2 352 74 60

 

Tél/Tel: + 32 2 352 74 60

България

 

Magyarország

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB

GYÓGYSZERKERESKEDELMI KFT.

GYÓGYSZERKERESKEDELMI KFT.

Teл.: + 359 800 12 400

 

Tel.: + 36 1 301 9700

Česká republika

 

Malta

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

BRISTOL-MYERS SQUIBB S.R.L.

Tel: + 420 221 016 111

 

Tel: + 39 06 50 39 61

Danmark

 

Nederland

authorised

 

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB BV

Tlf: + 45 45 93 05 06

 

Tel: + 31 34 857 42 22

Deutschland

 

Norge

 

BRISTOL-MYERS SQUIBB GMBH & CO. KGAA

BRISTOL-MYERS SQUIBB NORWAY LTD

 

Tlf: + 47 67 55 53 50

Eesti

 

 

longer

 

 

 

Österreich

 

BRISTOL-MYERS SQUIBB

 

BRISTOL-MYERS SQUIBB GESMBH

GYÓGYSZERKERESKEDELMI KFT.

Te : + 43 1 60 14 30

Tel: + 372 640 1301

 

 

 

Ελλάδα

 

product

Polska

 

 

 

Tel: + 351 21 440 70 00

BRISTOL-MYERS SQUIBB A.E.

 

noBRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Τηλ: + 30 210 6074300

 

Tel.: + 48 22 5796666

España

 

 

Portugal

 

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB FARMACÊUTICA

Tel: + 34 91 456 53 00

 

PORTUGUESA, S.A.

Ireland

Medicinal

 

Slovenija

 

France

 

 

România

 

BRISTOL- YERS SQUIBB SARL

BRISTOL-MYERS SQUIBB

Tél: + 33 (0)810 410 500

 

GYÓGYSZERKERESKEDELMI KFT.

 

 

 

Tel: + 40 (0)21 272 16 00

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD BRISTOL-MYERS SQUIBB SPOL. S R.O.

Tel: + 353 (1 800) 749 749

 

Tel: + 386 1 236 47 00

Ísland

 

 

Slovenská republika

VISTOR HF

 

BRISTOL-MYERS SQUIBB SPOL. S R.O.

Sími: + 354 535 7000

 

Tel: + 421 2 59298411

Italia

 

 

Suomi/Finland

 

BRISTOL-MYERS SQUIBB S.R.L.

OY BRISTOL-MYERS SQUIBB (FINLAND) AB

Tel: + 39 06 50 39 61

 

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε.Π.Ε.

BRISTOL-MYERS SQUIBB AB

Τηλ: + 357 22 677038

Tel: + 46 8 704 71 00

Latvija

United Kingdom

BRISTOL-MYERS SQUIBB

BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD

GYÓGYSZERKERESKEDELMI KFT.

Tel: + 44 (0800) 731 1736

Tel: + 371 67 50 21 85

 

Lietuva

 

BRISTOL-MYERS SQUIBB

 

GYÓGYSZERKERESKEDELMI KFT.

 

Tel: + 370 5 2790 762

 

This leaflet was last approved in

Detailed information on this medicine is available on site: http://www.emea.europa.eu/

 

product

no

Medicinal

 

 

 

 

authorised

the European Medicines Agency (EMEA) web

longer

 

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