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Sabervel (irbesartan) – Package leaflet - C09CA04

Updated on site: 10-Oct-2017

Medication nameSabervel
ATC CodeC09CA04
Substanceirbesartan
ManufacturerPharmathen S.A.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sabervel 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.

authorised

In this leaflet:

1.

What Sabervel is and what it is used for

 

2.

Before you take Sabervel

 

3.

How to take Sabervel

 

4.

Possible side effects

 

5.

How to store Sabervel

 

6.

Further information

 

1.

longer

 

WHAT SABERVEL IS AND WHAT IT IS USED FOR

 

Sabervel belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to recept rs in blood vessels causing them to tighten.

This results in an increase in blood pressure. Sabervelprevents the binding of angiotensin-II to these

receptors, causing the blood vessels to relax and the b ood pressure to lower. Sabervel slows the

decrease of kidney function in patients with high bl d pressure and type 2 diabetes.

Sabervel is used in adult patients

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.

2.BEFORE YOU TAKE SABERVELproduct

Do not take Sabervel

if you are allergic (hypersensitive) to irbesartan or any other ingredients of Sabervel

if you are more than 3 months pregnant. (It is also better to avoid Sabervel in early pregnancy

– see pregnancy section)

if you have diabetes or impaired kidney function and you are treated with a blood pressure low ring medicine containing aliskiren.Medicinal

Warnings and precautions 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 Sabervel 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.

if you are taking any of the following medicines used to treat high blood pressure:

 

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have

 

diabetes-related kidney problems.

- aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Sabervel”.

You must tell your doctor if you think you are (or might become) pregnant. Sabervel 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).

Use in Children

authorised

This medicine should not be used in children and adolescents (under 18 years) because the safety and

efficacy have not yet been fully established.

 

Other medicines and Sabervel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any ther medicines.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Sabervel” and “Warnings and precautions”).

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

 

longer

 

 

 

 

If you take certain painkillers, called non-steroidal a ti-inflammatory drugs, the effect of irbesartan

may be reduced.

 

no

 

 

 

 

 

Taking Sabervel with food and drink

 

 

Sabervel can be taken with or witho t food.

 

 

 

 

product

 

 

Pregnancy and breast-feeding

 

 

Pregnancy

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

Medicinal

advise you to stop t king Sabervel before you become pregnant or as soon as you know you are

pregnant and will

dvise you to take another medicine instead of Sabervel. Sabervel is not

recommended

early pregnancy, and must not be taken when more than 3 months pregnant, as it may

cause ser ous harm to your baby if used after the third month of pregnancy.

Br ast-f ing

Tell your doctor if you are breast-feeding or about to start breast-feeding. Sabervel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Sabervel 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 doctor before attempting to drive or use machines.

Important information about some of the ingredients of Sabervel

Sabervel contains 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 SABERVEL

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

Method of administration

Sabervel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Sabervel 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 Sabervel until your doctor tells you otherwise.

Patients with high blood pressure

authorised

 

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 t e 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 w ks after beginning treatment.

If you take more Sabervel than you should:

 

If you accidentally take too many tablets, contact your d ct r immediately.

Children should not take Sabervel

longer

Sabervel should not be given to children under 18 years of age. If a child swallows some tablets,

contact your doctor immediately.

no

If you forget to take Sabervel:product

If you accidentally miss a daily ose, j st take the next dose as normal. Do not 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.

Like all med nes, Sabervel can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

4.MedicinalPOSSIBLE SIDE EFFECTS

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

The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more

Common: at least 1 in 100 and less than 1 in 10 patients

Uncommon: at least 1 in 1000 and less than 1 in 100 patientsSide effects reported in clinical studies for patients treated with Irbesartan were:

Very common : if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests 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 side effects have been reported since marketing of Irbesartan Side effects where the frequency is

not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassiumauthorisedlevels, impaired ki ney

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

Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

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

5.HOW TO STORE SABERVEL

Keep out of the sight and reach of children.

Do not use Sabervel after the expiry date which is stated n the carton and on the blister after EXP.

The expiry date refers to the last day of that month.

longer

 

 

 

 

This medicinal product does not require any special storage conditions.

 

 

 

no

 

Medicines should not be disposed of via was ewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

 

 

What Sabervel contains

 

 

 

 

product

 

 

The active subst nce is irbesartan. Each tablet of Sabervel 75 mg contains 75 mg irbesartan.

The other gredients are:

 

 

 

Tablet ore: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica

 

collo al anhydrous, hypromellose, magnesium stearate,

 

Film-coating: hypromellose, titanium dioxide (E171), macrogol 400

Medicinal

 

 

 

What Sabervel looks like and contents of the pack

Sabervel 75 mg film-coated tablets are white, concave, round, film-coated tablets with 7 mm diameter.

Sabervel 75mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Pharmathen S.A,

6 Dervenakion Str.,

15351 Pallini, Attiki, Greece

Manufacturer:
J. Uriach y Compañía, S.A. Av. Camí Reial, 51-57
08184 – Palau-solità i Plegamans, Barcelona, Spain
Pharmathen S.A,
6 Dervenakion Str.,
15351 Pallini, Attiki, Greece

Pharmathen International S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5, Rodopi 69300, Greece

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

België/Belgique/Belgien

 

Lietuva

authorised

Pharmathen S.A.

 

Portfarma ehf.

Tél/Tel: +30 210 66 65 067

Tel: +354 534 4030

България

 

 

 

 

Luxembourg/Lux mbu g

Pharmathen S.A.

 

Portfarma ehf.

 

Teл.: +30 210 66 65 067

 

Tel: +354 534 4030

 

Česká republika

 

Magyar rszág

 

Pharmathen S.A.

 

Pharmathen S.A.

 

Tel: +30 210 66 65 067

 

 

longer

 

 

Tel.: +30 210 66 65 067

 

Danmark

 

Malta

 

 

Portfarma ehf.

 

no

 

 

 

Pharmathen S.A.

 

Tlf: +354 534 4030

 

Tel: +30 210 66 65 067

 

Deutschland

 

Nederland

 

Glenmark Arzneimittel GmbH

Glenmark Generics B.V.

Tel: +49 8142 44392 0

product

Tel: 0031 20 5226030

 

Eesti (Estonia)

Norge

 

 

Portfarma ehf.

 

Pharmathen S.A.

 

Tel: +354 534 4030

 

Tlf: +30 210 66 65 067

 

Ελλάδα

 

Österreich

 

Pharmathen Hellas S.A.

 

Pharmathen S.A.

 

Τηλ: +30 210 66 04 300

 

Tel: +30 210 66 65 067

 

España

 

Polska

 

PharmathenMedicinalS.A.

 

Pharmathen S.A.

 

Tel: +30 210 66 65 067

 

Tel.: +30 210 66 65 067

 

France

 

Portugal

 

Pharmathen S.A.

 

Pharmathen S.A.

 

Tél: +30 210 66 65 067

 

Tel: +30 210 66 65 067

 

Hrvatska

 

România

 

Pharmathen S.A.

 

Pharmathen S.A.

 

Tel: +30 210 66 65 067

 

Tel: +30 210 66 65 067

 

 

 

 

 

Ireland

Slovenija

 

Aspire Pharma Limited

Pharmathen S.A.

 

Tel: +44(0)1730 234527

Tel: +30 210 66 65 067

 

Ísland

Slovenská republika

 

Portfarma ehf.

Pharmathen S.A.

 

Tel: +354 534 4030

Tel: +30 210 66 65 067

 

Italia

Suomi/Finland

 

Pharmathen S.A.

Pharmathen S.A.

 

Tel: +30 210 66 65 067

Puh/Tel: +30 210 66 65 067

Κύπρος

Sverige

authorised

C.V. MEDILINE LTD

Pharmathen S.A.

Τηλ: +357 25761699

Tel: +30 210 66 65 067

Latvija

United Kingdom

Portfarma ehf.

Aspire Pharma Limited

Tel: +354 534 4030

Tel: +44(0)1730 234527

This leaflet was last approved in

 

 

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

 

 

no

longer

 

product

 

Medicinal

 

 

 

 

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sabervel 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.

authorised

In this leaflet:

1.

What Sabervel is and what it is used for

 

2.

Before you take Sabervel

 

3.

How to take Sabervel

 

4.

Possible side effects

 

5.

How to store Sabervel

 

6.

Further information

 

1.

longer

 

WHAT SABERVEL IS AND WHAT IT IS USED FOR

 

Sabervel belongs to a group of medicines known as angiote sin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to recept rs in blood vessels causing them to tighten.

This results in an increase in blood pressure. Sabervelprevents the binding of angiotensin-II to these

receptors, causing the blood vessels to relax and the b ood pressure to lower. Sabervel slows the

decrease of kidney function in patients with high bl d pressure and type 2 diabetes.

Sabervel is used in adult patients

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.

2.BEFORE YOU TAKE SABERVELproduct

Do not take Sabervel

if you are allergic (hypersensitive) to irbesartan or any other ingredients of Sabervel

if you are more than 3 months pregnant. (It is also better to avoid Sabervel in early pregnancy

– see pregnancy section)

if you have diabetes or impaired kidney function and you are treated with a blood pressure low ring medicine containing aliskiren.Medicinal

Warning and precautions

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 Sabervel 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.

if you are taking any of the following medicines used to treat high blood pressure:

 

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have

diabetes-related kidney problems. - aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Sabervel’’.

You must tell your doctor if you think you are (or might become) pregnant. Sabervel 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).

Use in Children

authorised

This medicine should not be used in children and adolescents (under 18 years) because the safety and

efficacy have not yet been fully established.

 

Other medicines and Sabervel

Tell your doctor or pharmacist if you are taking , have recently taken or might take any ther medicines.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Sabervel” and “Warnings and precautions”).

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

 

longer

 

 

 

 

If you take certain painkillers, called non-steroidal a ti-inflammatory drugs, the effect of irbesartan

may be reduced.

 

no

 

 

 

 

 

Taking Sabervel with food and drink

 

 

Sabervel can be taken with or witho t food.

 

 

 

 

product

 

 

Pregnancy and breast-feeding

 

 

Pregnancy

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

Medicinal

advise you to stop t king Sabervel before you become pregnant or as soon as you know you are

pregnant and will

dvise you to take another medicine instead of Sabervel. Sabervel is not

recommended

early pregnancy, and must not be taken when more than 3 months pregnant, as it may

cause ser ous harm to your baby if used after the third month of pregnancy.

Br ast-f ing

Tell your doctor if you are breast-feeding or about to start breast-feeding. Sabervel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Sabervel 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 doctor before attempting to drive or use machines.

Important information about some of the ingredients of Sabervel

Sabervel contains 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 SABERVEL

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

Method of administration

Sabervel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Sabervel 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 Sabervel until your doctor tells you otherwise.

Patients with high blood pressure

authorised

 

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 t e 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 w ks after beginning treatment.

If you take more Sabervel than you should:

 

If you accidentally take too many tablets, contact your d ct r immediately.

Children should not take Sabervel

longer

Sabervel should not be given to children under 18 years of age. If a child swallows some tablets,

contact your doctor immediately.

no

If you forget to take Sabervel:product

If you accidentally miss a daily ose, j st take the next dose as normal. Do not 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.

Like all med nes, Sabervel can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

4.MedicinalPOSSIBLE SIDE EFFECTS

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

The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more

Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients

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

Very common : if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests 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 side effects have been reported since marketing of Irbesartan Side effects where the frequency is

not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassiumauthorisedlevels, impaired ki ney

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

Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

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

5. HOW TO STORE SABERVEL

Keep out of the sight and reach of children.

Do not use Sabervel after the expiry date which is stated n the carton and on the blister after EXP.

The expiry date refers to the last day of that month.

longer

 

 

 

 

This medicinal product does not require any special storage conditions.

 

 

 

no

 

Medicines should not be disposed of via was ewater or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

 

 

What Sabervel contains

 

 

 

 

product

 

 

The active subst nce is irbesartan. Each tablet of Sabervel 150 mg contains 150 mg irbesartan.

The other gredients are:

 

 

 

Tablet ore: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica

 

collo al anhydrous, hypromellose, magnesium stearate,

 

Film-coating: hypromellose, titanium dioxide (E171), macrogol 400

Medicinal

 

 

 

What Sabervel looks like and contents of the pack

Sabervel 150 mg film-coated tablets are white, concave, round, film-coated tablets with 9 mm diameter.

Sabervel 150mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Pharmathen S.A,

6 Dervenakion Str.,

France
Pharmathen S.A.
Tél: +30 210 66 65 067
Hrvatska
Pharmathen S.A.
Danmark
Portfarma ehf. Tlf: +354 534 4030
Deutschland product
Glenmark Arzneimittel GmbH
Tel: +49 8142 44392 0
EestiMedicinal(Estonia)
Portfarma ehf. Tel: +354 534 4030
Ελλάδα
Pharmath n Hellas S.A. Τηλ: +30 210 66 04 300
España
Pharmathen S.A.
Tel: +30 210 66 65 067
15351 Pallini, Attiki, Greece
Manufacturer:
J. Uriach y Compañía, S.A. Av. Camí Reial, 51-57
08184 – Palau-solità i Plegamans, Barcelona, Spain
Pharmathen S.A,
6 Dervenakion Str.,
15351 Pallini, Attiki, Greece

Pharmathen International S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5, Rodopi 69300, Greece

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

België/Belgique/Belgien

Lietuva

authorised

Pharmathen S.A.

Portfarma ehf.

Tél/Tel: +30 210 66 65 067

Tel: +354 534 4030

 

 

България

Luxembour /Lux mburg

Pharmathen S.A.

Portfarma ehf.

 

Teл.: +30 210 66 65 067

Tel: +354 534 4030

 

Česká republika

Magyarország

 

Pharmathen S.A.

PharmathenlongerS.A.

 

Tel: +30 210 66 65 067

Tel.: +30 210 66 65 067

 

 

no

 

Malta

Pharmathen S.A.

Tel: +30 210 66 65 067

Nederland

Glenmark Generics B.V.

Tel: 0031 20 5226030

Norge

Pharmathen S.A.

Tlf: +30 210 66 65 067

Österreich

Pharmathen S.A.

Tel: +30 210 66 65 067

Polska

Pharmathen S.A.

Tel.: +30 210 66 65 067

Portugal

Pharmathen S.A.

Tel: +30 210 66 65 067

România

Pharmathen S.A.

Tel: +30 210 66 65 067

Tel: +30 210 66 65 067

 

Ireland

Slovenija

 

Aspire Pharma Limited

Pharmathen S.A.

 

Tel: +44(0)1730 234527

Tel: +30 210 66 65 067

 

Ísland

Slovenská republika

 

Portfarma ehf.

Pharmathen S.A.

 

Tel: +354 534 4030

Tel: +30 210 66 65 067

 

Italia

Suomi/Finland

 

Pharmathen S.A.

Pharmathen S.A.

 

Tel: +30 210 66 65 067

Puh/Tel: +30 210 66 65 067

Κύπρος

Sverige

authorised

C.V. MEDILINE LTD

Pharmathen S.A.

Τηλ: +357 25761699

Tel: +30 210 66 65 067

Latvija

United Kingdom

Portfarma ehf.

Aspire Pharma Limited

Tel: +354 534 4030

Tel: +44(0)1730 234527

This leaflet was last approved

in

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

 

 

no

longer

 

product

 

Medicinal

 

 

 

 

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sabervel 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.

authorised

In this leaflet:

1.

What Sabervel is and what it is used for

 

2.

Before you take Sabervel

 

3.

How to take Sabervel

 

4.

Possible side effects

 

5.

How to store Sabervel

 

6.

Further information

 

1.

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WHAT SABERVEL IS AND WHAT IT IS USED FOR

 

Sabervel belongs to a group of medicines known as angiote sin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to recept rs in blood vessels causing them to tighten.

This results in an increase in blood pressure. Sabervelprevents the binding of angiotensin-II to these

receptors, causing the blood vessels to relax and the b ood pressure to lower. Sabervel slows the

decrease of kidney function in patients with high bl d pressure and type 2 diabetes.

Sabervel is used in adult patients

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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.

2.BEFORE YOU TAKE SABERVELproduct

Do not take Sabervel

if you are allergic (hypersensitive) to irbesartan or any other ingredients of Sabervel

if you are more than 3 months pregnant. (It is also better to avoid Sabervel in early pregnancy

– see pregnancy section)

if you have diabetes or impaired kidney function and you are treated with a blood pressure low ring medicine containing aliskiren.Medicinal

Warning and precautions

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 Sabervel 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.

if you are taking any of the following medicines used to treat high blood pressure:

 

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have

diabetes-related kidney problems. - aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Sabervel”.

You must tell your doctor if you think you are (or might become) pregnant. Sabervel 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).

Use in Children

authorised

This medicine should not be used in children and adolescents (under 18 years) because the safety and efficacy have not yet been fully established.

Other medicines and Sabervel

Tell your doctor or pharmacist if you are taking , have recently taken or might take any ther medicines.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take

Sabervel” and “Warnings and precautions”).

You may need to have blood checks if you take:

potassium supplements

salt substitutes containing potassium

potassium-sparing medicines (such as certain diuretics)longer

medicines containing lithium

advise you to stop t ki g Sabervel before you become pregnant or as soon as you know you are pregnant and w ll advise you to take another medicine instead of Sabervel. Sabervel is not

If you take certain painkillers, called non-s eroidal anti-inflammatory drugs, the effect of irbesartan

may be reduced.

 

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Taking Sabervel with food and rink

 

Sabervel can be taken with or with ut food.

 

Pregnancy and breast-feeding

 

Pregnancy

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

Medicinal

 

 

recommended n early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause ser ous harm to your baby if used after the third month of pregnancy.

Br ast-f ding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Sabervel is not

recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Sabervel 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 doctor before attempting to drive or use machines.

Important information about some of the ingredients of Sabervel

Sabervel contains 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 SABERVEL

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

Method of administration

Sabervel is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).

You can take Sabervel 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 Sabervel until your doctor tells you otherwise.

Patients with high blood pressure

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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 t e 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 Sabervel than you should:

 

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

 

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Children should not take Sabervel

Sabervel should not be given to children under 18 years of age. If a child swallows some tablets,

contact your doctor immediately.

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product

 

If you forget to take Sabervel:

If you accidentally miss a daily se, just take the next dose as normal. Do not 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.

ofMedicinalthese symptoms or get short of breath, stop taking Sabervel and contact your doctor

4.

POSSIBLE SIDE EFFECTS

Like all me c nes, Sabervel can cause side effects, although not everybody gets them. Some of these eff cts may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any

immediately.

The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more

Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients

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

Very common : if you suffer from high blood pressure and type 2 diabetes with kidney disease,

 

blood tests 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.

authorised

 

 

Some side effects have been reported since marketing of Irbesartan Side effects where the fr qu ncy is

not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impa ed kidney

function, and inflammation of small blood vessels mainly affecting the skin (a conditi n known as leukocytoclastic vasculitis).

Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) ave also been reported.

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 SABERVEL

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Keep out of the sight and reach of children.

 

Do not use Sabervel 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.

 

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This medicinal product does not req ire any special storage conditions.

product

 

Medicines should not be disp sed f via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer equired. These measures will help to protect the environment.

6. FURTHER INFORMATION What Sabervel co tains

The act ve substance is irbesartan. Each tablet of Sabervel 300 mg contains 300 mg irbesartan.

The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica

colloidal anhydrous, hypromellose, magnesium stearate, Film-coating: hypromellose, titanium dioxide (E171), macrogol 400Medicinal

What Sabervel looks like and contents of the pack

Sabervel 300 mg film-coated tablets are white, concave, round, film-coated tablets with 11 mm diameter.

Sabervel 300mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Pharmathen S.A,
6 Dervenakion Str.,
15351 Pallini, Attiki, Greece
Manufacturer:
J. Uriach y Compañía, S.A.
Av. Camí Reial, 51-57
08184 – Palau-solità i Plegamans, Barcelona, Spain

Pharmathen S.A,

6 Dervenakion Str.,

 

 

 

 

 

 

 

 

authorised

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

België/Belgique/Belgien

 

 

 

Lietuva

Pharmathen S.A.

 

 

 

Portfarma ehf.

 

Tél/Tel: +30 210 66 65 067

Tel: +354 534 4030

 

България

 

 

 

Luxemb urg/Luxemburg

Pharmathen S.A.

 

 

 

Portfarma ehf.

 

Teл.: +30 210 66 65 067

 

 

 

Tel: +354longer534 4030

 

Česká republika

 

 

 

Magyarország

 

Pharmathen S.A.

product

no

 

Pharmathen S.A.

 

Tel: +30 210 66 65 067

Tel.: +30 210 66 65 067

 

Danmark

Malta

 

Portfarma ehf.

Pharmathen S.A.

 

Tlf: +354 534 4030

Tel: +30 210 66 65 067

 

Deutschland

Nederland

 

Glenmark Arz eimittel GmbH

Glenmark Generics B.V.

Tel: +49 8142 44392 0

 

 

 

Tel: 0031 20 5226030

 

Eesti (Eston a)

 

 

 

Norge

 

Portfarma ehf.

 

 

 

Pharmathen S.A.

 

Tel: +354 534 4030

 

 

 

Tlf: +30 210 66 65 067

 

Ελλάδα

 

 

 

Österreich

 

PharmathenMedicinalHellas S.A.

 

 

 

Pharmathen S.A.

 

Τηλ: +30 210 66 04 300

 

 

 

Tel: +30 210 66 65 067

 

España

 

 

 

Polska

 

Pharmathen S.A.

 

 

 

Pharmathen S.A.

 

Tel: +30 210 66 65 067

 

 

 

Tel.: +30 210 66 65 067

 

France

 

 

 

Portugal

 

Pharmathen S.A.

 

 

 

Pharmathen S.A.

 

Tél: +30 210 66 65 067

 

 

 

Tel: +30 210 66 65 067

 

 

 

 

 

 

 

 

 

15351 Pallini, Attiki, Greece

Pharmathen International S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5, Rodopi 69300, Greece

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

This leaflet was last approved in

Hrvatska

România

 

Pharmathen S.A.

Pharmathen S.A.

 

Tel: +30 210 66 65 067

Tel: +30 210 66 65 067

 

Ireland

Slovenija

 

Aspire Pharma Limited

Pharmathen S.A.

 

Tel: +44(0)1730 234527

Tel: +30 210 66 65 067

 

Ísland

Slovenská republika

 

Portfarma ehf.

Pharmathen S.A.

 

Tel: +354 534 4030

Tel: +30 210 66 65 067

authorised

Italia

Suomi/Finland

Pharmathen S.A.

Pharmathen S.A.

 

Tel: +30 210 66 65 067

Puh/Tel: +30 210 66 65 067

Κύπρος

Sverige

 

C.V. MEDILINE LTD

Pharmathen S.A.

 

Τηλ: +357 25761699

Tel: +30 210 66 65 067

 

Latvija

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United Kingdom

 

Portfarma ehf.

Aspire Pharma Limit d

 

Tel: +354 534 4030

Tel: +44(0)1730 234527

 

 

 

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Detailed information on this medicine is available n the European Medicines Agency web site:

http://www.ema.europa.eu/

 

Medicinal

product

 

 

 

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