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Paglitaz (pioglitazone hydrochloride) – Labelling - A10BG03

Updated on site: 09-Oct-2017

Medication namePaglitaz
ATC CodeA10BG03
Substancepioglitazone hydrochloride
ManufacturerKrka, d.d., Novo mesto

PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Paglitaz 15 mg tablets

Pioglitazone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 15 mg of pioglitazone (as hydrochloride).

3. LIST OF EXCIPIENTS

Contains also lactose monohydrate.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTSlongerTablet.

14 tablets

 

product

no

 

 

28 tablets

 

 

 

 

 

30 tablets

 

 

 

56 tablets

 

 

 

60 tablets

 

 

 

90 tablets

 

 

 

98 tablets

Medicinal

 

 

 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package l aflet before use.

Oral use

authorised

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

14 tablets:

EU/1/11/721/001

 

28 tablets:

EU/1/11/721/002

 

 

30 tablets: EU/1/11/721/003

 

 

56 tablets: EU/1/11/721/004

 

 

60 tablets: EU/1/11/721/005

 

longer

90 tablets: EU/1/11/721/006

 

 

 

98 tablets: EU/1/11/721/007

 

 

13.

BATCH NUMBER

 

no

Batch

 

product

 

 

14.

 

 

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.

Medicinal

 

 

INSTRUCTIONS ON USE

 

16.

INFORMATION IN BRAILLE

 

Paglitaz 15 mg

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Paglitaz 15 mg tablets

Pioglitazone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

 

 

 

authorised

4.

BATCH NUMBER

 

 

 

3.

EXPIRY DATE

 

 

 

 

 

EXP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Batch

 

 

 

longer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5.

OTHER

 

no

 

 

 

 

 

 

 

 

 

Medicinal

product

 

 

 

 

 

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Paglitaz 30 mg tablets

Pioglitazone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 30 mg of pioglitazone (as hydrochloride).

3. LIST OF EXCIPIENTS

Contains also lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTSlongerTablet.

14 tablets

 

product

no

 

 

28 tablets

 

 

 

 

 

30 tablets

 

 

 

56 tablets

 

 

 

60 tablets

 

 

 

90 tablets

 

 

 

98 tablets

Medicinal

 

 

 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package l aflet before use.

Oral use

authorised

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

14 tablets:

EU/1/11/721/008

 

28 tablets:

EU/1/11/721/009

 

 

30 tablets: EU/1/11/721/010

 

 

56 tablets: EU/1/11/721/011

 

 

60 tablets: EU/1/11/721/012

 

longer

90 tablets: EU/1/11/721/013

 

 

 

98 tablets: EU/1/11/721/014

 

 

13.

BATCH NUMBER

 

no

Batch

 

product

 

 

14.

 

 

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.

Medicinal

 

 

INSTRUCTIONS ON USE

 

16.

INFORMATION IN BRAILLE

 

Paglitaz 30 mg

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Paglitaz 30 mg tablets

Pioglitazone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

 

 

 

authorised

4.

BATCH NUMBER

 

 

 

3.

EXPIRY DATE

 

 

 

 

 

EXP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Batch

 

 

 

longer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5.

OTHER

 

no

 

 

 

 

 

 

 

 

 

Medicinal

product

 

 

 

 

 

 

 

 

 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOLDING BOX

1. NAME OF THE MEDICINAL PRODUCT

Paglitaz 45 mg tablets

Pioglitazone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 45 mg of pioglitazone (as hydrochloride).

3. LIST OF EXCIPIENTS

Contains also lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTSlongerTablet.

14 tablets

 

product

no

 

 

28 tablets

 

 

 

 

 

30 tablets

 

 

 

56 tablets

 

 

 

60 tablets

 

 

 

90 tablets

 

 

 

98 tablets

Medicinal

 

 

 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package l aflet before use.

Oral use

authorised

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

14 tablets:

EU/1/11/721/015

 

28 tablets:

EU/1/11/721/016

 

 

30 tablets: EU/1/11/721/017

 

 

56 tablets: EU/1/11/721/018

 

 

60 tablets: EU/1/11/721/019

 

longer

90 tablets: EU/1/11/721/020

 

 

 

98 tablets: EU/1/11/721/021

 

 

13.

BATCH NUMBER

 

no

Batch

 

product

 

 

14.

 

 

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.

Medicinal

 

 

INSTRUCTIONS ON USE

 

16.

INFORMATION IN BRAILLE

 

Paglitaz 45 mg

 

 

authorised

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Paglitaz 45 mg tablets

Pioglitazone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

 

 

 

authorised

4.

BATCH NUMBER

 

 

 

3.

EXPIRY DATE

 

 

 

 

 

EXP

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Batch

 

 

 

longer

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5.

OTHER

 

no

 

 

 

 

 

 

 

 

 

Medicinal

product

 

 

 

 

 

 

 

 

 

 

B. PACKAGE

 

product

no

Medicinal

 

 

 

LEAFLETlonger

authorised

Package leaflet: Information for the user

Paglitaz 15 mg tablets

Pioglitazone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

 

1.

What Paglitaz is and what it is used for

authorised

1.

What Paglitaz is and what it is used for

2.

What you need to know before you take Paglitaz

 

3.

How to take Paglitaz

 

4.

Possible side effects

 

5.

How to store Paglitaz

 

6.

Contents of the pack and other information

 

Paglitaz contains pioglitazone. It is an anti-diabetic medicilongere used to treat type 2 (non-insulin

dependent) diabetes mellitus, when metformin is not suitable or has failed to work adequately. This is the diabetes that usually develops in adulthood.

Paglitaz may be used on its own in atients who are unable to take metformin, and where treatment

Paglitaz helps control the level of sugar in your bloodno when you have type 2 diabetes by helping your body make better use of the insulinproductit produ es. Your doctor will check whether Paglitaz is working 3 to 6 months after you start taking it.

-if youMedicinalare hypersensitive (allergic) to pioglitazone or any of the other ingredients of this medicine (listed in section 6).

-if you have heart failure or have had heart failure in the past.

-if you have liver disease.

-if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting).

-if you have or ever had bladder cancer.

-if you have blood in your urine that your doctor has not checked.assugar.

Warnings and precautions

Talk to your doctor before taking Paglitaz:

-if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old. If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor.

-if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).

-if you have cysts on your ovaries (polycystic ovary syndrome). There may be an increased possibility of your becoming pregnant because you may ovulate again when you take Paglitaz. If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.

-if you have a problem with your liver or heart. Before you start taking Paglitaz you will have a blood sample taken to check your liver function. This check may be repeated at intervals. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Paglitaz and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

If you take Paglitaz with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).

Use in children under 18 years is not recommended.

authorised

You may also experience a reduction in blood count (anaemia).

 

Broken bones

A higher number of bone fractures was seen in patients, particularly women taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and adolescents

Other medicines and Paglitaz

Tell your doctor or pharmacist if you are taking , have rece tly taken or might take any other

Tell your doctor or pharmacist if y u are taking any of these. Your blood sugar will be checked, and your dose of Paglitaz may need to be changed.

medicines.

 

longer

 

 

 

You can usually continue to take other medici

es whilst you are being treated with Paglitaz. However,

certain medicines are especially likely to affe

 

henoamount of sugar in your blood:

-

gemfibrozil (used to lower cholesterol)

 

 

-

rifampicin (used to treat tuberculosis and other infections)

 

product

 

Paglitaz withMedicinalfood and drink

You may take your tablets with or without food. You should swallow the tablets with a glass of water.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.Your doctor will advise you to discontinue this medicine.

Driving and using machines

Pioglitazone will not affect your ability to drive or use machines but take care if you experience abnormal vision.

Paglitaz contains lactose monohydrate

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Paglitaz.

3.How to take Paglitaz

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

One tablet should be taken once daily. If necessary your doctor may tell you to take a different dose. If you have the impression that the effect of Paglitaz is too weak, talk to your doctor.

When Paglitaz is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.

Your doctor will ask you to have blood tests periodically during treatment with Paglitaz. This is to check that your liver is working normally.

If you are following a diabetic diet, you should continue with this while you are taking Paglitaz. Your weight should be checked at regular intervals; if your weight increases, inform your doctor.

Use in children and adolescents

 

Use in children under 18 years is not recommended.

authorised

If you forget to take Paglitaz

If you take more Paglitaz than you should

 

If you accidentally take too many Paglitaz tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. Your blood sugar could fall bel w the normal level and can be increased by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.

 

 

 

longer

Take Paglitaz tablets daily as prescribed. However if you miss a dose, just carry on with the next dose

as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Paglitaz

 

no

 

Paglitaz tablets should be used every day to work pr perly. If you stop using Paglitaz tablets, your

blood sugar may go up. Talk to your doctor before stopping this treatment.

 

product

 

 

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

4.Possible side effects

Like all medicines,Medicinalthis medicine can cause side effects, although not everybody gets them. In particular, patients have experienced the following serious side effects:

Heart failure has b n experienced commonly (may affect up to 1 in 10 people) in patients taking Paglitaz in combination with insulin. Symptoms are unusual shortness of breath or rapid increase in weight or localised swelling (oedema). If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.

Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Paglitaz. Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate. If you experience any of these, talk to your doctor as soon as possible.

Localised swelling (oedema) has also been experienced very commonly in patients taking Paglitaz in combination with insulin. If you experience this side effect, talk to your doctor as soon as possible.

Broken bones have been reported commonly (may affect up to 1 in 10 people) in women patients taking Paglitaz. If you experience this side effect, talk to your doctor as soon as possible.

Blurred vision due to swelling (or fluid) at the back of the eye (frequency not known) has also been reported in patients taking Paglitaz. If you experience this symptom for the first time, talk to your

doctor as soon as possible. Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.

Allergic reactions have been reported (frequency not known) in patients taking Paglitaz. If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing stop taking this medicine and talk to your doctor as soon as possible.

The other side effects that have been experienced by some patients taking Paglitaz are:

common (may affect up to 1 in 10 people)

-respiratory infection

-abnormal vision

-weight gain

-numbness

uncommon (may affect up to 1 in 100 people)

-inflammation of the sinuses (sinusitis)

-difficulty sleeping (insomnia)

not known (frequency cannot be estimated from the available data)

-increase in liver enzymes

-allergic reactions

very common (may affect more than 1 in 10 people)

longer

The other side effects that have been experienced by some pati nts

antidiabetic medicines are:

 

 

 

-

decreased blood sugar (hypoglycaemia)

no

 

 

 

product

 

common (may affect up to 1 in 10 people)

 

-

headache

 

 

 

-

dizziness

 

 

 

-

joint pain

 

 

 

-

impotence

 

 

 

-

back pain

 

 

 

-

Medicinal

 

 

 

shortness of breath

 

 

 

-

small reduction red blood cell count

 

 

-

flatulence

 

 

 

uncommon (may affect up to 1 in 100 people)

 

 

-

sugar in urine, proteins in urine

 

 

-

increase in enzymes

 

 

 

-

spinning sensation (vertigo)

 

 

-sweating

-tiredness

-increased appetite

authorised

when Paglitaz is taken with other

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Paglitaz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Paglitaz contains

 

-

The active substance is pioglitazone. Each tablet contains 15 mg of pioglitazone (as

 

hydrochloride).

authorised

 

 

-

The other ingredients are lactose monohydrate, hydroxypropylcellulose (E463), croscarmellose

 

sodium, magnesium stearate (E572).

 

What Paglitaz looks like and contents of the pack

White to almost white round tablets with bevelled edges and with engraved "15" on one side of tablet (diameter 7.0 mm).

The tablets are available in boxes of 14, 28, 30, 56, 60, 90 and 98 tablets in blisters.

Not all pack sizes may be marketed.

 

longer

Marketing Authorisation Holder

 

 

 

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

 

no

 

 

 

 

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

 

product

 

 

For any information about this medicine, please contact the local representative of the Marketing

Medicinal

 

 

 

Authorisation Holder:

 

 

 

België/Belgique/Belg en

 

Lietuva

KRKA, d.d., Novo mesto

 

UAB KRKA Lietuva

Tél/Tel: + 32 (0)3 321 63 52

 

Tel: + 370 5 236 27 40

България

 

Luxembourg/Luxemburg

Представителство на KRKA в България

KRKA, d.d., Novo mesto

Teл.: + 359 (02) 962 34 50

 

Tél/Tel: + 32 (0)3 321 63 52

Česká republika

 

Magyarország

KRKA ČR, s.r.o.

 

KRKA Magyarország Kereskedelmi Kft.

Tel: + 420 (0) 221 115 150

 

Tel.: + 361 (0) 355 8490

Danmark

 

Malta

KRKA Sverige AB

 

KRKA Pharma Dublin, Ltd.

Tlf: + 46 (0)8 643 67 66 (SE)

 

Tel: + 353 1 293 91 80

Deutschland

 

Nederland

TAD Pharma GmbH

 

Focus Care Pharmaceuticals B.V.

 

Tel: +31 (0)75 61 20 511

Eesti

KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658

Ελλάδα

QUALIA PHARMA S.A. Τηλ: +30 (0)210 2832941

España

KRKA Farmacéutica, S.L.

Tel: + 34 911 61 03 81

France

KRKA France Eurl

Tél: + 33 (0)1 57 40 82 25

Hrvatska

Krka – farma d.o.o.

Tel: + 385 1 6312 100

Ireland

KRKA Pharma Dublin, Ltd.

Tel: + 353 1 293 91 80

Ísland

KRKA Sverige AB

Sími: + 46 (0)8 643 67 66 (SE)

Italia

product

KRKA Farmaceutici Milano S.r.l.

Tel: + 39 02 3300 8841

 

Κύπρος

 

Kipa Pharmacal Ltd.

 

Τηλ: + 357 24 651 882

 

Medicinal

 

Latvija

KRKA Latvija SIA

Tel: + 371 6 733 86 10

Norge

KRKA Sverige AB

Tlf: + 46 (0)8 643 67 66 (SE)

Österreich

KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300

Polska

KRKA-POLSKA Sp. z o.o.

Tel.: + 48 (0)22 573 7500

Portugal

KRKA Farmacêutica, Sociedade Unipessoal Lda.

Tel: + 351 (0)21 46 43 650

KRKA Romania S.R.L., Bucharest

Tel: + 4 021 310 66 05

România authorised

Slovenija

Slove ská republika

KRKA, d.d., Novo mesto

Tel:longer+ 386 (0) 1 47 51 100

KRKA Slovensko, s.r.o.,

Te : + 421 (0) 2 571 04 501

noSuomi/Finland

KRKA Sverige AB

Puh/Tel: + 46 (0)8 643 67 66 (SE)

Sverige

KRKA Sverige AB

Tel: + 46 (0)8 643 67 66 (SE)

United Kingdom

Consilient Health (UK) Ltd.

Tel: + 44 (0)2089562310

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

Package leaflet: Information for the user

Paglitaz 30 mg tablets

Pioglitazone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

 

1.

What Paglitaz is and what it is used for

authorised

1.

What Paglitaz is and what it is used for

2.

What you need to know before you take Paglitaz

 

3.

How to take Paglitaz

 

4.

Possible side effects

 

5.

How to store Paglitaz

 

6.

Contents of the pack and other information

 

Paglitaz contains pioglitazone. It is an anti-diabetic medicilongere used to treat type 2 (non-insulin

dependent) diabetes mellitus, when metformin is not suitable or has failed to work adequately. This is the diabetes that usually develops in adulthood.

Paglitaz may be used on its own in atients who are unable to take metformin, and where treatment

Paglitaz helps control the level of sugar in your bloodno when you have type 2 diabetes by helping your body make better use of the insulinproductit produ es. Your doctor will check whether Paglitaz is working 3 to 6 months after you start taking it.

-if youMedicinalare hypersensitive (allergic) to pioglitazone or any of the other ingredients of this medicine (listed in section 6).

-if you have heart failure or have had heart failure in the past.

-if you have liver disease.

-if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting).

-if you have or ever had bladder cancer.

-if you have blood in your urine that your doctor has not checked.assugar.

Warnings and precautions

Talk to your doctor before taking Paglitaz:

-if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old. If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor.

-if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).

-if you have cysts on your ovaries (polycystic ovary syndrome). There may be an increased possibility of your becoming pregnant because you may ovulate again when you take Paglitaz. If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.

-if you have a problem with your liver or heart. Before you start taking Paglitaz you will have a blood sample taken to check your liver function. This check may be repeated at intervals. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Paglitaz and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

If you take Paglitaz with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).

Use in children under 18 years is not recommended.

authorised

You may also experience a reduction in blood count (anaemia).

 

Broken bones

A higher number of bone fractures was seen in patients, particularly women taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and adolescents

Other medicines and Paglitaz

Tell your doctor or pharmacist if you are taking , have rece tly taken or might take any other

Tell your doctor or pharmacist if y u are taking any of these. Your blood sugar will be checked, and your dose of Paglitaz may need to be changed.

medicines.

 

longer

 

 

 

You can usually continue to take other medici

es whilst you are being treated with Paglitaz. However,

certain medicines are especially likely to affe

 

henoamount of sugar in your blood:

-

gemfibrozil (used to lower cholesterol)

 

 

-

rifampicin (used to treat tuberculosis and other infections)

 

product

 

Paglitaz withMedicinalfood and drink

You may take your tablets with or without food. You should swallow the tablets with a glass of water.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.Your doctor will advise you to discontinue this medicine.

Driving and using machines

Pioglitazone will not affect your ability to drive or use machines but take care if you experience abnormal vision.

Paglitaz contains lactose monohydrate

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Paglitaz.

3.How to take Paglitaz

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

One tablet should be taken once daily. If necessary your doctor may tell you to take a different dose. If you have the impression that the effect of Paglitaz is too weak, talk to your doctor.

When Paglitaz is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.

Your doctor will ask you to have blood tests periodically during treatment with Paglitaz. This is to check that your liver is working normally.

If you are following a diabetic diet, you should continue with this while you are taking Paglitaz. Your weight should be checked at regular intervals; if your weight increases, inform your doctor.

Use in children and adolescents

 

Use in children under 18 years is not recommended.

authorised

If you forget to take Paglitaz

If you take more Paglitaz than you should

 

If you accidentally take too many Paglitaz tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. Your blood sugar could fall bel w the normal level and can be increased by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.

 

 

 

longer

Take Paglitaz tablets daily as prescribed. However if you miss a dose, just carry on with the next dose

as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Paglitaz

 

no

 

Paglitaz tablets should be used every day to work pr perly. If you stop using Paglitaz tablets, your

blood sugar may go up. Talk to your doctor before stopping this treatment.

 

product

 

 

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

4.Possible side effects

Like all medicines,Medicinalthis medicine can cause side effects, although not everybody gets them. In particular, patients have experienced the following serious side effects:

Heart failure has b n experienced commonly (may affect up to 1 in 10 people) in patients taking Paglitaz in combination with insulin. Symptoms are unusual shortness of breath or rapid increase in weight or localised swelling (oedema). If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.

Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Paglitaz. Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate. If you experience any of these, talk to your doctor as soon as possible.

Localised swelling (oedema) has also been experienced very commonly in patients taking Paglitaz in combination with insulin. If you experience this side effect, talk to your doctor as soon as possible.

Broken bones have been reported commonly (may affect up to 1 in 10 people) in women patients taking Paglitaz. If you experience this side effect, talk to your doctor as soon as possible.

Blurred vision due to swelling (or fluid) at the back of the eye (frequency not known) has also been reported in patients taking Paglitaz. If you experience this symptom for the first time, talk to your

doctor as soon as possible. Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.

Allergic reactions have been reported (frequency not known) in patients taking Paglitaz. If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing stop taking this medicine and talk to your doctor as soon as possible.

The other side effects that have been experienced by some patients taking Paglitaz are:

common (may affect up to 1 in 10 people)

-respiratory infection

-abnormal vision

-weight gain

-numbness

uncommon (may affect up to 1 in 100 people)

-inflammation of the sinuses (sinusitis)

-difficulty sleeping (insomnia)

not known (frequency cannot be estimated from the available data)

-increase in liver enzymes

-allergic reactions

very common (may affect more than 1 in 10 people)

longer

The other side effects that have been experienced by some pati nts

antidiabetic medicines are:

 

 

 

-

decreased blood sugar (hypoglycaemia)

no

 

 

 

product

 

common (may affect up to 1 in 10 people)

 

-

headache

 

 

 

-

dizziness

 

 

 

-

joint pain

 

 

 

-

impotence

 

 

 

-

back pain

 

 

 

-

Medicinal

 

 

 

shortness of breath

 

 

 

-

small reduction red blood cell count

 

 

-

flatulence

 

 

 

uncommon (may affect up to 1 in 100 people)

 

 

-

sugar in urine, proteins in urine

 

 

-

increase in enzymes

 

 

 

-

spinning sensation (vertigo)

 

 

-sweating

-tiredness

-increased appetite

authorised

when Paglitaz is taken with other

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Paglitaz

Luxembourg/Luxemburg
KRKA, d.d., Novo mesto Tél/Tel: + 32 (0)3 321 63 52
Magyarország
KRKA Magyarország Kereskedelmi Kft. Tel.: + 361 (0) 355 8490
Malta
KRKA Pharma Dublin, Ltd. Tel: + 353 1 293 91 80
Nederland
Focus Care Pharmaceuticals B.V. Tel: +31 (0)75 61 20 511
Norge
Lietuva
UAB KRKA Lietuva Tel: + 370 5 236 27 40

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Paglitaz contains

-

The active substance is pioglitazone. Each tablet contains 30 mg of pioglitazone (as

The tablets are available in boxes of 14, 28, 30, 56, 60, 90 and 98 tabletsauthorisedin blisters.

 

hydrochloride).

-

The other ingredients are lactose monohydrate, hydroxypropylcellulose (E463), croscarmellose

 

sodium, magnesium stearate (E572).

What Paglitaz looks like and contents of the pack

White to almost white round tablets with bevelled edges (diameter 8.0 mm).

Not all pack sizes may be marketed.

longer

 

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturerno

KRKA, d.d., Novo mesto, Šmarješkaproductcesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/BelgienMedicinal

KRKA, d.d., Novo mesto

Tél/Tel: + 32 (0)3 321 63 52

България

Представителство на KRKA в България

Teл.: + 359 (02) 962 34 50

Česká republika

KRKA ČR, s.r.o.

Tel: + 420 (0) 221 115 150

Danmark

KRKA Sverige AB

Tlf: + 46 (0)8 643 67 66 (SE)

Deutschland

TAD Pharma GmbH

Eesti

KRKA, d.d., Novo mesto Eesti filiaal

KRKA Sverige AB

Tel: + 372 (0) 6 671 658

Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα

Österreich

QUALIA PHARMA S.A.

KRKA Pharma GmbH, Wien

Τηλ: +30 (0)210 2832941

Tel: + 43 (0)1 66 24 300

España

Polska

KRKA Farmacéutica, S.L.

KRKA-POLSKA Sp. z o.o.

Tel: + 34 911 61 03 81

Tel.: + 48 (0)22 573 7500

France

Portugal

KRKA France Eurl

KRKA Farmacêutica, Sociedade Unipessoal Lda.

Tél: + 33 (0)1 57 40 82 25

Tel: + 351 (0)21 46 43 650

Hrvatska

Krka – farma d.o.o.

Tel: + 385 1 6312 100

Ireland

KRKA Pharma Dublin, Ltd.

Tel: + 353 1 293 91 80

Ísland

KRKA Sverige AB

Sími: + 46 (0)8 643 67 66 (SE)

Italia

KRKA Farmaceutici Milano S.r.l.

Tel: + 39 02 3300 8841

Κύπρος

 

product

 

 

Kipa Pharmacal Ltd.

 

Τηλ: + 357 24 651 882

 

Latvija

Medicinal

 

KRKA Latvija SIA

 

Tel: + 371 6 733 86 10

România

Slovenija

KRKA RomaniaauthorisedS.R.L., Buchar st Tel: + 4 021 310 66 05

KRKA, d.d., Novo mes o

Tel: + 386 (0) 1 47 51 100

Slovenskálongerepublika

KRKA Slov nsko, s.r.o.,

Tel: + 421 (0) 2 571 04 501

Su mi/Finland noKRKA Sverige AB

Puh/Tel: + 46 (0)8 643 67 66 (SE)

Sverige

KRKA Sverige AB

Tel: + 46 (0)8 643 67 66 (SE)

United Kingdom

Consilient Health (UK) Ltd.

Tel: + 44 (0)2089562310

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

Package leaflet: Information for the user

Paglitaz 45 mg tablets

Pioglitazone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

authorised

 

1.

What Paglitaz is and what it is used for

 

2.

What you need to know before you take Paglitaz

 

3.

How to take Paglitaz

 

4.

Possible side effects

 

5.

How to store Paglitaz

 

6.

Contents of the pack and other information

 

1. What Paglitaz is and what it is used for

Paglitaz contains pioglitazone. It is an anti-diabetic medicilongere used to treat type 2 (non-insulin dependent) diabetes mellitus, when metformin is not suitable or has failed to work adequately. This is

the diabetes that usually develops in adulthood. no

to 6 months after you start taking it.

Paglitaz helps control the level ofproductsugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it prod es. Your doctor will check whether Paglitaz is working 3

Paglitaz may be used on its own in atients who are unable to take metformin, and where treatment

-if youMedicinalare hypersensitive (allergic) to pioglitazone or any of the other ingredients of this medicine (listed in section 6).

-if you have heart failure or have had heart failure in the past.

-if you have liver disease.

-if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting).

-if you have or ever had bladder cancer.

-if you have blood in your urine that your doctor has not checked.assugar.

Warnings and precautions

Talk to your doctor before taking Paglitaz:

-if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old. If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor.

-if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).

-if you have cysts on your ovaries (polycystic ovary syndrome). There may be an increased possibility of your becoming pregnant because you may ovulate again when you take Paglitaz. If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.

-if you have a problem with your liver or heart. Before you start taking Paglitaz you will have a blood sample taken to check your liver function. This check may be repeated at intervals. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Paglitaz and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

If you take Paglitaz with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).

Use in children under 18 years is not recommended.

authorised

You may also experience a reduction in blood count (anaemia).

 

Broken bones

A higher number of bone fractures was seen in patients, particularly women taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and adolescents

Other medicines and Paglitaz

Tell your doctor or pharmacist if you are taking , have rece tly taken or might take any other

Tell your doctor or pharmacist if y u are taking any of these. Your blood sugar will be checked, and your dose of Paglitaz may need to be changed.

medicines.

 

longer

 

 

 

You can usually continue to take other medici

es whilst you are being treated with Paglitaz. However,

certain medicines are especially likely to affe

 

henoamount of sugar in your blood:

-

gemfibrozil (used to lower cholesterol)

 

 

-

rifampicin (used to treat tuberculosis and other infections)

 

product

 

Paglitaz withMedicinalfood and drink

You may take your tablets with or without food. You should swallow the tablets with a glass of water.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.Your doctor will advise you to discontinue this medicine.

Driving and using machines

Pioglitazone will not affect your ability to drive or use machines but take care if you experience abnormal vision.

Paglitaz contains lactose monohydrate

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Paglitaz.

3.How to take Paglitaz

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

One tablet should be taken once daily. If necessary your doctor may tell you to take a different dose. If you have the impression that the effect of Paglitaz is too weak, talk to your doctor.

When Paglitaz is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.

Your doctor will ask you to have blood tests periodically during treatment with Paglitaz. This is to check that your liver is working normally.

If you are following a diabetic diet, you should continue with this while you are taking Paglitaz. Your weight should be checked at regular intervals; if your weight increases, inform your doctor.

Use in children and adolescents

 

Use in children under 18 years is not recommended.

authorised

If you forget to take Paglitaz

If you take more Paglitaz than you should

 

If you accidentally take too many Paglitaz tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. Your blood sugar could fall bel w the normal level and can be increased by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.

 

 

 

longer

Take Paglitaz tablets daily as prescribed. However if you miss a dose, just carry on with the next dose

as normal. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Paglitaz

 

no

 

Paglitaz tablets should be used every day to work pr perly. If you stop using Paglitaz tablets, your

blood sugar may go up. Talk to your doctor before stopping this treatment.

 

product

 

 

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

4.Possible side effects

Like all medicines,Medicinalthis medicine can cause side effects, although not everybody gets them. In particular, patients have experienced the following serious side effects:

Heart failure has b n experienced commonly (may affect up to 1 in 10 people) in patients taking Paglitaz in combination with insulin. Symptoms are unusual shortness of breath or rapid increase in weight or localised swelling (oedema). If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.

Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Paglitaz. Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate. If you experience any of these, talk to your doctor as soon as possible.

Localised swelling (oedema) has also been experienced very commonly in patients taking Paglitaz in combination with insulin. If you experience this side effect, talk to your doctor as soon as possible.

Broken bones have been reported commonly (may affect up to 1 in 10 people) in women patients taking Paglitaz. If you experience this side effect, talk to your doctor as soon as possible.

Blurred vision due to swelling (or fluid) at the back of the eye (frequency not known) has also been reported in patients taking Paglitaz. If you experience this symptom for the first time, talk to your

doctor as soon as possible. Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.

Allergic reactions have been reported (frequency not known) in patients taking Paglitaz. If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing stop taking this medicine and talk to your doctor as soon as possible.

The other side effects that have been experienced by some patients taking Paglitaz are:

common (may affect up to 1 in 10 people)

-respiratory infection

-abnormal vision

-weight gain

-numbness

uncommon (may affect up to 1 in 100 people)

-inflammation of the sinuses (sinusitis)

-difficulty sleeping (insomnia)

not known (frequency cannot be estimated from the available data)

-increase in liver enzymes

-allergic reactions

very common (may affect more than 1 in 10 people)

longer

The other side effects that have been experienced by some pati nts

antidiabetic medicines are:

 

 

 

-

decreased blood sugar (hypoglycaemia)

no

 

 

 

product

 

common (may affect up to 1 in 10 people)

 

-

headache

 

 

 

-

dizziness

 

 

 

-

joint pain

 

 

 

-

impotence

 

 

 

-

back pain

 

 

 

-

Medicinal

 

 

 

shortness of breath

 

 

 

-

small reduction red blood cell count

 

 

-

flatulence

 

 

 

uncommon (may affect up to 1 in 100 people)

 

 

-

sugar in urine, proteins in urine

 

 

-

increase in enzymes

 

 

 

-

spinning sensation (vertigo)

 

 

-sweating

-tiredness

-increased appetite

authorised

when Paglitaz is taken with other

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Paglitaz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Paglitaz contains

 

-

The active substance is pioglitazone. Each tablet contains 45 mg of pioglitazone (as

 

hydrochloride).

authorised

 

 

-

The other ingredients are lactose monohydrate, hydroxypropylcellulose (E463), croscarmellose

 

sodium, magnesium stearate (E572).

 

What Paglitaz looks like and contents of the pack

White to almost white round tablets with bevelled edges and with engraved "45" on one side of tablet (diameter 10.0 mm).

The tablets are available in boxes of 14, 28, 30, 56, 60, 90 and 98 tablets in blisters.

Not all pack sizes may be marketed.

 

longer

Marketing Authorisation Holder

 

 

 

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

 

no

 

 

 

 

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

 

product

 

 

For any information about this medicine, please contact the local representative of the Marketing

Medicinal

 

 

 

Authorisation Holder:

 

 

 

België/Belgique/Belg en

 

Lietuva

KRKA, d.d., Novo mesto

 

UAB KRKA Lietuva

Tél/Tel: + 32 (0)3 321 63 52

 

Tel: + 370 5 236 27 40

България

 

Luxembourg/Luxemburg

Представителство на KRKA в България

KRKA, d.d., Novo mesto

Teл.: + 359 (02) 962 34 50

 

Tél/Tel: + 32 (0)3 321 63 52

Česká republika

 

Magyarország

KRKA ČR, s.r.o.

 

KRKA Magyarország Kereskedelmi Kft.

Tel: + 420 (0) 221 115 150

 

Tel.: + 361 (0) 355 8490

Danmark

 

Malta

KRKA Sverige AB

 

KRKA Pharma Dublin, Ltd.

Tlf: + 46 (0)8 643 67 66 (SE)

 

Tel: + 353 1 293 91 80

Deutschland

 

Nederland

TAD Pharma GmbH

 

Focus Care Pharmaceuticals B.V.

 

Tel: +31 (0)75 61 20 511

Eesti

KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658

Ελλάδα

QUALIA PHARMA S.A. Τηλ: +30 (0)210 2832941

España

KRKA Farmacéutica, S.L.

Tel: + 34 911 61 03 81

France

KRKA France Eurl

Tél: + 33 (0)1 57 40 82 25

Hrvatska

Krka – farma d.o.o.

Tel: + 385 1 6312 100

Ireland

KRKA Pharma Dublin, Ltd.

Tel: + 353 1 293 91 80

Ísland

KRKA Sverige AB

Sími: + 46 (0)8 643 67 66 (SE)

Italia

product

KRKA Farmaceutici Milano S.r.l.

Tel: + 39 02 3300 8841

 

Κύπρος

 

Kipa Pharmacal Ltd.

 

Τηλ: + 357 24 651 882

 

Medicinal

 

Latvija

KRKA Latvija SIA

Tel: + 371 6 733 86 10

Norge

KRKA Sverige AB

Tlf: + 46 (0)8 643 67 66 (SE)

Österreich

KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300

Polska

KRKA-POLSKA Sp. z o.o.

Tel.: + 48 (0)22 573 7500

Portugal

KRKA Farmacêutica, Sociedade Unipessoal Lda.

Tel: + 351 (0)21 46 43 650

KRKA Romania S.R.L., Bucharest

Tel: + 4 021 310 66 05

România authorised

Slovenija

Slove ská republika

KRKA, d.d., Novo mesto

Tel:longer+ 386 (0) 1 47 51 100

KRKA Slovensko, s.r.o.,

Te : + 421 (0) 2 571 04 501

noSuomi/Finland

KRKA Sverige AB

Puh/Tel: + 46 (0)8 643 67 66 (SE)

Sverige

KRKA Sverige AB

Tel: + 46 (0)8 643 67 66 (SE)

United Kingdom

Consilient Health (UK) Ltd.

Tel: + 44 (0)2089562310

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

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