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Telmisartan Teva Pharma (telmisartan) – Package leaflet - C09CA07

Updated on site: 10-Oct-2017

Medication nameTelmisartan Teva Pharma
ATC CodeC09CA07
Substancetelmisartan
ManufacturerTeva B.V.

Package leaflet: Information for the user

Telmisartan Teva Pharma 20 mg Tablets

Telmisartan

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 Telmisartan Teva Pharma is and what it is used for

2.What you need to know before you take Telmisartan Teva Pharma

3.How to take Telmisartan Teva Pharma

4.Possible side effects

5.How to store Telmisartan Teva Pharma

6.Contents of the pack and other information

1.What Telmisartan Teva Pharma is and what it is used for

Telmisartan Teva Pharma belongs to a class of medicines known as angiotensin-II receptor antagonists. Angiotensin II is a substance occurring in the body, which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan Teva Pharma blocks this effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Telmisartan Teva Pharma is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition.

High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attacks, heart or kidney failure, strokes or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Telmisartan Teva Pharma is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

2. What you need to know before you take Telmisartan Teva Pharma

Do not take Telmisartan Teva Pharma

-if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).

-if you are more than 3 months pregnant (It is also better to avoid Telmisartan Teva Pharma in early pregnancy – see pregnancy section).

-if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.

-if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Teva

Pharma.

Warnings and precautions

Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:

-Kidney disease or kidney transplant

-Renal artery stenosis (narrowing of the blood vessels to one or both kidneys)

-Liver disease

-Heart trouble

-Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals)

-Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, or vomiting.

-Elevated potassium levels in your blood

-Diabetes

Talk to your doctor before taking Telmisartan Teva Pharma:

-if you are taking digoxin.

-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 Telmisartan Teva Pharma”.

You must tell your doctor if you think that you are (or might become) pregnant. Telmisartan Teva Pharma 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).

In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan Teva Pharma.

Telmisartan Teva Pharma may be less effective in lowering the blood pressure in black patients.

Children and adolescents

The use of Telmisartan Teva Pharma in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Telmisartan Teva Pharma

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

Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Telmisartan Teva Pharma.

Lithium containing medicines to treat some types of depression.

Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.

Diuretics (‘water tablets’), especially if taken in high doses together with Telmisartan Teva Pharma, may lead to excessive loss of body water and low blood pressure (hypotension).

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

Digoxin.

The effect of Telmisartan Teva Pharma may be reduced when you take NSAIDs (non steroidal anti- inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartan Teva Pharma may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.

If you suffer from a condition called “orthostatic hypotension” (a drop in blood pressure on standing up from a sitting or lying position resulting in dizziness or faintness) your condition may worsen if you take Telmisartan Teva Pharma in combination with:

Other medicines used to treat high blood pressure

Baclofen (a muscle relaxant)

Amifostine (a protective medicine during radiotherapy for cancer treatment)

Alcohol

Barbiturates (strong sleeping tablets)

Narcotics (strong pain killers)

Antidepressants

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Telmisartan Teva Pharma before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Teva Pharma. Telmisartan Teva Pharma is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Telmisartan Teva Pharma 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

Some people feel dizzy or tired when taking Telmisartan Teva Pharma.If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan Teva Pharma contains sorbitol.

If you are intolerant to some sugars, contact your doctor before taking Telmisartan Teva Pharma.

3.How to take Telmisartan Teva Pharma

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

The recommended dose of Telmisartan Teva Pharma is one tablet a day. Try to take the tablet at the same time each day. You can take Telmisartan Teva Pharma with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Telmisartan Teva Pharma every day until your doctor tells you otherwise. If you have the impression that the effect of Telmisartan Teva Pharma is too strong or too weak, talk to your doctor or pharmacist.

For treatment of high blood pressure the usual dose of Telmisartan Teva Pharma for most patients is 40 mg once a day to control your blood pressure over the 24-hour period. Your doctor has recommended a lower dose of one 20 mg tablet daily. Alternatively, Telmisartan Teva Pharma may be used in combination with diuretics (“water” tablets) which have been shown to have an additive blood pressure lowering effect with Telmisartan Teva Pharma.

For reduction of cardiovascular events, the usual dose of Telmisartan Teva Pharma is one 80 mg tablet once a day. At the beginning of the preventive therapy with Telmisartan Teva Pharma 80 mg, blood pressure should be frequently monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once a day.

If you take more Telmisartan Teva Pharma than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Telmisartan Teva Pharma

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

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

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and need immediate medical attention:

You should see your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal.

Possible side effects of telmisartan:

Common side effects (may affect up to 1 in10 people):

Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

Uncommon side effects (may affect up to 1 in 100 people):

Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

Rare side effects (may affect up to 1 in 1,000 people):

Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a

blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.

Very rare side effects (may affect up to 1 in 10,000 people):

Progressive scarring of lung tissue (interstitial lung disease)**.

* The event may have happened by chance or could be related to a mechanism currently not known.

**Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.

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 Telmisartan Teva

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 carton and blister after “EXP”. The expiry date refers to the last day of that month.

This medicinal product 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 Telmisartan Teva Pharma contains

-The active substance is telmisartan. Each Telmisartan Teva Pharma tablet contains 20 mg telmisartan.

-The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420), magnesium stearate

What Telmisartan Teva Pharma looks like and contents of the pack

Telmisartan Teva Pharma 20 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93". The other side of the tablet is debossed with the number "7458".

Telmisartan Teva Pharma is provided in peelable perforated unit-dose aluminium-aluminium blisters and perforated unit-dose aluminium-aluminium blisters containing 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for each type of blister presentation, although not all pack sizes may be marketed. Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.

Telmisartan Teva Pharma is also provided in aluminium-aluminium blister packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

The manufacturer is:

TEVA Pharmaceutical Works Private Limited Company

H-4042 Debrecen,

Pallagi út 13,

Hungary

Or:

TEVA Pharmaceutical Works Private Limited Company

H-2100 Gödöllő,

Táncsics Mihály út 82

Hungary

Or:

TEVA UK Ltd

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex,

BN22 9AG

United Kingdom

Or:

Pharmachemie B.V.

Swensweg 5,

2031 GA, Haarlem,

The Netherlands

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

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A.

UAB “Sicor Biotech”

Tel/Tél: +32 3 820 73 73

Tel: +370 5 266 02 03

България

Luxembourg/Luxemburg

Тева Фармасютикълс България ЕООД

Teva Pharma Belgium S.A.

Teл: +359 2 489 95 82

Belgien/Belgique

 

Tél/Tel: +32 3 820 73 73

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt. (TPW)

Tel: +420 251 007 111

Tel.: +36 1 288 64 00

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland

Tlf: +45 44 98 55 11

L-Irlanda

 

Tel: +353 51 321740

Deutschland

Nederland

Teva GmbH

Teva Nederland B.V.

Tel: (49) 731 40208

Tel: +31 (0) 800 0228400

Eesti

Norge

Teva Eesti esindus UAB Sicor Biotech

Teva Norway AS

Eesti filiaal

Tlf: +47 66 77 55 90

Tel: +372 661 0801

 

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

Tel: +43 1 97 00 7

España

Polska

Teva Pharma, S.L.U

Teva Pharmaceuticals Polska Sp. z o.o.

Tél: +(34) 91 387 32 80

Tel.: +(48) 22 345 93 00

France

Portugal

Teva Santé

Teva Pharma - Produtos Farmacêuticos Lda

Tél: +(33) 1 55 91 7800

Tel: (351) 214 235 910

Hrvatska

România

Pliva Hrvatska d.o.o

Teva Pharmaceuticals S.R.L

Tel: + 385 1 37 20 000

Tel: +4021 230 65 24

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Tel: +353 (0)51 321 740

Tel: +386 1 58 90 390

Ísland

Slovenská republika

ratiopharm Oy

Teva Pharmaceuticals Slovakia s.r.o.

Finnland

Tel: +(421) 2 5726 7911

Sími: +358 9 180 452 5900

 

Italia

Suomi/Finland

Teva Italia S.r.l.

ratiopharm Oy

Tel: +(39) 028917981

Puh/Tel: +358 20 180 5900

Κύπρος

Sverige

Teva Ελλάς Α.Ε.

Teva Sweden AB

Ελλάδα

Tel: +(46) 42 12 11 00

Τηλ: +30 210 72 79 099

 

Latvija

United Kingdom

UAB Sicor Biotech filiāle Latvijā

Teva UK Limited

Tel: +371 67 784 980

Tel: +(44) 1977 628 500

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

Telmisartan Teva Pharma 40 mg Tablets

Telmisartan

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 Telmisartan Teva Pharma is and what it is used for

2.What you need to know before you take Telmisartan Teva Pharma

3.How to take Telmisartan Teva Pharma

4.Possible side effects

5.How to store Telmisartan Teva Pharma

6.Contents of the pack and other information

1. What Telmisartan Teva Pharma is and what it is used for

Telmisartan Teva Pharma belongs to a class of medicines known as angiotensin-II receptor antagonists. Angiotensin II is a substance occurring in the body, which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan Teva Pharma blocks this effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Telmisartan Teva Pharma is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition.

High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attacks, heart or kidney failure, strokes or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Telmisartan Teva Pharma is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

2. What you need to know before you take Telmisartan Teva Pharma

Do not take Telmisartan Teva Pharma

-if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).

-if you are more than 3 months pregnant (It is also better to avoid Telmisartan Teva Pharma in early pregnancy – see pregnancy section).

-if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.

-if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Teva

Pharma.

Warnings and precautions

Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:

-Kidney disease or kidney transplant

-Renal artery stenosis (narrowing of the blood vessels to one or both kidneys)

-Liver disease

-Heart trouble

-Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals)

-Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, or vomiting.

-Elevated potassium levels in your blood

-Diabetes

Talk to your doctor before taking Telmisartan Teva Pharma:

-if you are taking digoxin.

-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 Telmisartan Teva Pharma”.

You must tell your doctor if you think that you are (or might become) pregnant. Telmisartan Teva Pharma 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).

In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan Teva Pharma.

Telmisartan Teva Pharma may be less effective in lowering the blood pressure in black patients.

Children and adolescents

The use of Telmisartan Teva Pharma in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Telmisartan Teva Pharma

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

Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Telmisartan Teva Pharma.

Lithium containing medicines to treat some types of depression.

Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.

Diuretics (‘water tablets’), especially if taken in high doses together with Telmisartan Teva Pharma, may lead to excessive loss of body water and low blood pressure (hypotension).

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

The effect of Telmisartan Teva Pharma may be reduced when you take NSAIDs (non steroidal anti- inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartan Teva Pharma may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.

If you suffer from a condition called “orthostatic hypotension” (a drop in blood pressure on standing up from a sitting or lying position resulting in dizziness or faintness) your condition may worsen if you take Telmisartan Teva Pharma in combination with:

Other medicines used to treat high blood pressure

Baclofen (a muscle relaxant)

Amifostine (a protective medicine during radiotherapy for cancer treatment)

Alcohol

Barbiturates (strong sleeping tablets)

Narcotics (strong pain killers)

Antidepressants

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Telmisartan Teva Pharma before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Teva Pharma. Telmisartan Teva Pharma is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Telmisartan Teva Pharma 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

Some people feel dizzy or tired when they taking Telmisartan Teva Pharma. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan Teva Pharma contains sorbitol.

If you are intolerant to some sugars, contact your doctor before taking Telmisartan Teva Pharma.

3. How to take Telmisartan Teva Pharma

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

The recommended dose of Telmisartan Teva Pharma is one tablet a day. Try to take the tablet at the same time each day. You can take Telmisartan Teva Pharma with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Telmisartan Teva Pharma every day until your doctor tells you otherwise. If you have the impression that the effect of Telmisartan Teva Pharma is too strong or too weak, talk to your doctor or pharmacist.

For treatment of high blood pressure, the usual dose of Telmisartan Teva Pharma for most patients is 40 mg once a day to control your blood pressure over the 24-hour period. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Telmisartan Teva Pharma may be used in combination with diuretics (“water” tablets) which have been shown to have an additive blood pressure lowering effect with Telmisartan Teva Pharma.

For reduction of cardiovascular events, the usual dose of Telmisartan Teva Pharma is one 80 mg tablet once a day. At the beginning of the preventive therapy with Telmisartan Teva 80 mg, blood pressure should be frequently monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once a day.

If you take more Telmisartan Teva Pharma than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Telmisartan Teva Pharma

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and need immediate medical attention:

You should see your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal.

Possible side effects of telmisartan:

Common side effects (may affect up to 1 in 10 people):

Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

Uncommon side effects(may affect up to 1 in 100 people):

Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

Rare side effects (may affect up to 1 in 1,000 people):

Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.

Very rare side effects (may affect up to 1 in 10,000 people):

Progressive scarring of lung tissue (interstitial lung disease)**.

* The event may have happened by chance or could be related to a mechanism currently not known.

** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.

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 Telmisartan Teva Pharma

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 carton and blister after “EXP”. The expiry date refers to the last day of that month.

This medicinal product 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 Telmisartan Teva Pharma contains

-The active substance is telmisartan. Each Telmisartan Teva Pharma tablet contains 40 mg telmisartan.

-The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420), magnesium stearate

What Telmisartan Teva Pharma looks like and contents of the pack

Telmisartan Teva Pharma 40 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93". The other side of the tablet is debossed with the number "7459".

Telmisartan Teva Pharma is provided in peelable perforated unit-dose aluminium-aluminium blisters and perforated unit-dose aluminium-aluminium blisters containing 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for each type of blister presentation, although not all pack sizes may be marketed. Telmisartan Teva Pharma is also provided in aluminium-aluminium blister packs of 28 and 30 tablets.

Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

The manufacturer is:

TEVA Pharmaceutical Works Private Limited Company

H-4042 Debrecen,

Pallagi út 13,

Hungary

Or:

TEVA Pharmaceutical Works Private Limited Company

H-2100 Gödöllő,

Táncsics Mihály út 82

Hungary

Or:

TEVA UK Ltd

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex,

BN22 9AG

United Kingdom

Or:

Pharmachemie B.V.

Swensweg 5,

2031 GA, Haarlem,

The Netherlands

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

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A.

UAB “Sicor Biotech”

Tel/Tél: +32 3 820 73 73

Tel: +370 5 266 02 03

България

Luxembourg/Luxemburg

Тева Фармасютикълс България ЕООД

Teva Pharma Belgium S.A.

Teл: +359 2 489 95 82

Belgien/Belgique

 

Tél/Tel: +32 3 820 73 73

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt. (TPW)

Tel: +420 251 007 111

Tel.: +36 1 288 64 00

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland

Tlf: +45 44 98 55 11

L-Irlanda

 

Tel: +353 51 321740

Deutschland

Nederland

Teva GmbH

Teva Nederland B.V.

Tel: (49) 731 40208

Tel: +31 (0) 800 0228400

 

Eesti

Norge

Teva Eesti esindus UAB Sicor Biotech

Teva Norway AS

Eesti filiaal

Tlf: +47 66 77 55 90

Tel: +372 661 0801

 

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

Tel: +43 1 97 00 7

España

Polska

Teva Pharma, S.L.U

Teva Pharmaceuticals Polska Sp. z o.o.

Tél: +(34) 91 387 32 80

Tel.: +(48) 22 345 93 00

France

Portugal

Teva Santé

Teva Pharma - Produtos Farmacêuticos Lda

Tél: +(33) 1 55 91 7800

Tel: (351) 214 235 910

Hrvatska

România

Pliva Hrvatska d.o.o

Teva Pharmaceuticals S.R.L

Tel: + 385 1 37 20 000

Tel: +4021 230 65 24

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Tel: +353 (0)51 321 740

Tel: +386 1 58 90 390

Ísland

Slovenská republika

ratiopharm Oy

Teva Pharmaceuticals Slovakia s.r.o.

Finnland

Tel: +(421) 2 5726 7911

Sími: +358 9 180 452 5900

 

Italia

Suomi/Finland

Teva Italia S.r.l.

ratiopharm Oy

Tel: +(39) 028917981

Puh/Tel: +358 20 180 5900

Κύπρος

Sverige

Teva Ελλάς Α.Ε.

Teva Sweden AB

Ελλάδα

Tel: +(46) 42 12 11 00

Τηλ: +30 210 72 79 099

 

Latvija

United Kingdom

UAB Sicor Biotech filiāle Latvijā

Teva UK Limited

Tel: +371 67 784 980

Tel: +(44) 1977 628 500

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

Telmisartan Teva Pharma 80 mg Tablets

Telmisartan

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 Telmisartan Teva Pharma is and what it is used for

2.What you need to know before you take Telmisartan Teva Pharma

3.How to take Telmisartan Teva Pharma

4.Possible side effects

5.How to store Telmisartan Teva Pharma

6.Contents of the pack and other information

1. What Telmisartan Teva Pharma is and what it is used for

Telmisartan Teva Pharma belongs to a class of medicines known as angiotensin-II receptor antagonists. Angiotensin II is a substance occurring in the body, which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan Teva Pharma blocks this effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Telmisartan Teva Pharma is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that the high blood pressure is not caused by any other condition.

High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attacks, heart or kidney failure, strokes or blindness. There are usually no symptoms of high blood pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is within the normal range.

Telmisartan Teva Pharma is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.

2. What you need to know before you take Telmisartan Teva Pharma

Do not take Telmisartan Teva Pharma

-if you are allergic to telmisartan or any other ingredients of medicine (listed in section 6).

-if you are more than 3 months pregnant (It is also better to avoid Telmisartan Teva Pharma in early pregnancy – see pregnancy section).

-if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.

-if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Teva Pharma.

Warnings and precautions

Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or illnesses:

-Kidney disease or kidney transplant

-Renal artery stenosis (narrowing of the blood vessels to one or both kidneys)

-Liver disease

-Heart trouble

-Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals)

-Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (‘water tablets’), low-salt diet, diarrhoea, or vomiting.

-Elevated potassium levels in your blood

-Diabetes

Talk to your doctor before taking Telmisartan Teva Pharma:

-if you are taking digoxin.

-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 Telmisartan Teva Pharma”.

You must tell your doctor if you think that you are (or might become) pregnant. Telmisartan Teva Pharma 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).

In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan Teva Pharma.

Telmisartan Teva Pharma may be less effective in lowering the blood pressure in black patients.

Children and adolescents

The use of Telmisartan Teva Pharma in children and adolescents up to the age of 18 years is not recommended.

Other medicines and Telmisartan Teva Pharma

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

Your doctor may need to change the dose of these other medicines or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Telmisartan Teva Pharma.

Lithium containing medicines to treat some types of depression.

Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets’), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.

Diuretics (‘water tablets’), especially if taken in high doses together with Telmisartan Teva Pharma, may lead to excessive loss of body water and low blood pressure (hypotension).

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

Digoxin.

The effect of Telmisartan Teva Pharma may be reduced when you take NSAIDs (non steroidal anti- inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartan Teva Pharma may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.

If you suffer from a condition called “orthostatic hypotension” (a drop in blood pressure on standing up from a sitting or lying position resulting in dizziness or faintness) your condition may worsen if you take Telmisartan Teva Pharma in combination with:

Other medicines used to treat high blood pressure

Baclofen (a muscle relaxant)

Amifostine (a protective medicine during radiotherapy for cancer treatment)

Alcohol

Barbiturates (strong sleeping tablets)

Narcotics (strong pain killers)

Antidepressants

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Telmisartan Teva Pharma before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Teva Pharma. Telmisartan Teva Pharma is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Telmisartan Teva Pharma 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

Some people feel dizzy or tired when taking Telmisartan Teva Pharma. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan Teva Pharma contains sorbitol.

If you are intolerant to some sugars, contact your doctor before taking Telmisartan Teva Pharma.

3. How to take Telmisartan Teva Pharma

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

The recommended dose of Telmisartan Teva Pharma is one tablet a day. Try to take the tablet at the same time each day. You can take Telmisartan Teva Pharma with or without food. The tablets should be swallowed with some water or other non-alcoholic drink. It is important that you take Telmisartan Teva Pharma every day until your doctor tells you otherwise. If you have the impression that the effect of Telmisartan Teva Pharma is too strong or too weak, talk to your doctor or pharmacist.

For treatment of high blood pressure, the usual dose of Telmisartan Teva Pharma for most patients is 40 mg once a day to control your blood pressure over the 24-hour period. Your doctor has recommended a higher dose of one 80 mg tablet daily. Alternatively, Telmisartan Teva Pharma may be used in combination with diuretics (“water” tablets) which have been shown to have an additive blood pressure lowering effect with Telmisartan Teva Pharma.

For reduction of cardiovascular events, the usual dose of Telmisartan Teva Pharma is one 80 mg tablet once a day. At the beginning of the preventive therapy with Telmisartan Teva Pharma 80 mg, blood pressure should be frequently monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once a day.

If you take more Telmisartan Teva Pharma than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.

If you forget to take Telmisartan Teva Pharma

If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and need immediate medical attention:

You should see your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these effects are not treated they could be fatal.

Possible side effects of telmisartan:

Common side effects (may affect up to 1 in10 people):

Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.

Uncommon side effects (may affect up to 1 in 100 people):

Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.

Rare side effects (may affect up to 1 in 1,000 people):

Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain,, flu-like-illness, decreased haemoglobin (a

blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.

Very rare side effects (may affect up to 1 in 10,000 people):

Progressive scarring of lung tissue (interstitial lung disease)**.

* The event may have happened by chance or could be related to a mechanism currently not known.

** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects

If you get any side effects, takl 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 Telmisartan Teva Pharma

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 carton and blister after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away 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 Telmisartan Teva Pharma contains

-The active substance is telmisartan. Each Telmisartan Teva Pharma tablet contains 80 mg telmisartan.

-The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium starch glycolate (Type A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420), magnesium stearate

What Telmisartan Teva Pharma looks like and contents of the pack

Telmisartan Teva Pharma 80 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93". The other side of the tablet is debossed with the number "7460".

Telmisartan Teva Pharma is provided in peelable perforated unit-dose aluminium-aluminium blisters and perforated unit-dose aluminium-aluminium blisters containing 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for each type of blister presentation, although not all pack sizes may be marketed. Telmisartan Teva Pharma is also provided in aluminium-aluminium blister packs of 28 and 30 tablets.

Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

The manufacturer is:

TEVA Pharmaceutical Works Private Limited Company

H-4042 Debrecen,

Pallagi út 13,

Hungary

Or:

TEVA Pharmaceutical Works Private Limited Company

H-2100 Gödöllő,

Táncsics Mihály út 82

Hungary

Or:

TEVA UK Ltd

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex,

BN22 9AG

United Kingdom

Or:

Pharmachemie B.V.

Swensweg 5,

2031 GA, Haarlem,

The Netherlands

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

België/Belgique/Belgien

Lietuva

Teva Pharma Belgium N.V./S.A.

UAB “Sicor Biotech”

Tel/Tél: +32 3 820 73 73

Tel: +370 5 266 02 03

България

Luxembourg/Luxemburg

Тева Фармасютикълс България ЕООД

Teva Pharma Belgium S.A.

Teл: +359 2 489 95 82

Belgien/Belgique

 

Tél/Tel: +32 3 820 73 73

Česká republika

Magyarország

Teva Pharmaceuticals CR, s.r.o.

Teva Gyógyszergyár Zrt. (TPW)

Tel: +420 251 007 111

Tel.: +36 1 288 64 00

Danmark

Malta

Teva Denmark A/S

Teva Pharmaceuticals Ireland

Tlf: +45 44 98 55 11

L-Irlanda

 

Tel: +353 51 321740

Deutschland

Nederland

Teva GmbH

Teva Nederland B.V.

Tel: (49) 731 40208

Tel: +31 (0) 800 0228400

Eesti

Norge

Teva Eesti esindus UAB Sicor Biotech

Teva Norway AS

Eesti filiaal

Tlf: +47 66 77 55 90

Tel: +372 661 0801

 

Ελλάδα

Österreich

Teva Ελλάς Α.Ε.

ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 210 72 79 099

Tel: +43 1 97 00 7

España

Polska

Teva Pharma, S.L.U

Teva Pharmaceuticals Polska Sp. z o.o.

Tél: +(34) 91 387 32 80

Tel.: +(48) 22 345 93 00

France

Portugal

Teva Santé

Teva Pharma - Produtos Farmacêuticos Lda

Tél: +(33) 1 55 91 7800

Tel: (351) 214 235 910

Hrvatska

România

Pliva Hrvatska d.o.o

Teva Pharmaceuticals S.R.L

Tel: + 385 1 37 20 000

Tel: +4021 230 65 24

Ireland

Slovenija

Teva Pharmaceuticals Ireland

Pliva Ljubljana d.o.o.

Tel: +353 (0)51 321 740

Tel: +386 1 58 90 390

Ísland

Slovenská republika

ratiopharm Oy

Teva Pharmaceuticals Slovakia s.r.o.

Finnland

Tel: +(421) 2 5726 7911

Sími: +358 9 180 452 5900

 

Italia

Suomi/Finland

Teva Italia S.r.l.

ratiopharm Oy

Tel: +(39) 028917981

Puh/Tel: +358 20 180 5900

Κύπρος

Sverige

Teva Ελλάς Α.Ε.

Teva Sweden AB

Ελλάδα

Tel: +(46) 42 12 11 00

Τηλ: +30 210 72 79 099

 

Latvija

United Kingdom

UAB Sicor Biotech filiāle Latvijā

Teva UK Limited

Tel: +371 67 784 980

Tel: +(44) 1977 628 500

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

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