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Clopidogrel Teva Generics B.V.
clopidogrel

PACKAGE LEAFLET: INFORMATION FOR THE USER


Clopidogrel Teva Generics B.V. 75 mg film-coated tablets

Clopidogrel


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


In this leaflet:

  1. What Clopidogrel Teva Generics B.V. is and what it is used for

  2. Before you take Clopidogrel Teva Generics B.V.

  3. How to take Clopidogrel Teva Generics B.V.

  4. Possible side effects

  5. How to store Clopidogrel Teva Generics B.V.

  6. Further information


  1. WHAT CLOPIDOGREL TEVA GENERICS B.V. IS AND WHAT IT IS USED FOR


    Medicinal product no longer authorised

    Clopidogrel Teva Generics B.V. belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).


    Clopidogrel Teva Generics B.V. is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).


    You have been prescribed Clopidogrel Teva Generics B.V. to help prevent blood clots and reduce the risk of these severe events because:

    - You have a condition of hardening of arteries (also known as atherosclerosis), and

    - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or

    - You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial infarction’ (heart attack). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.


  2. BEFORE YOU TAKE CLOPIDOGREL TEVA GENERICS B.V.


    Do not take Clopidogrel Teva Generics B.V.

    • if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Teva Generics B.V.

    • if you have a medical condition that is currently causing bleeding such as a stomach ulcer or

      bleeding within the brain

    • if you suffer from severe liver disease.

      If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva Generics B.V..


      Take special care with Clopidogrel Teva Generics B.V.

      If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva Generics B.V.:

    • if you have a risk of bleeding such as

      • a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer)

      • a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body)

      • a recent serious injury

      • a recent surgery (including dental)

      • a planned surgery (including dental) in the next seven days

    • if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days

    • if you have kidney or liver disease.


      While you are taking Clopidogrel Teva Generics B.V.:

    • You should tell your doctor if a surgery (including dental) is planned

    • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects’)

    • If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to

      Medicinal product no longer authorised

      the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects’)

    • Your doctor may order blood tests


    Clopidogrel Teva Generics B.V. is not intended for use in children or adolescents.


    Taking other medicines

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

    Some other medicines may influence the use of Clopidogrel Teva Generics B.V. or vice versa.


    You should specifically tell your doctor if you take

    • oral anticoagulants, medicines used to reduce blood clotting,

    • a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints,

    • heparin, or any other medicine used to reduce blood clotting.

    - a proton pump inhibitor (e.g, omeprazole) for upset stomach,

    - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections,

    • cimetidine, medicine to treat upset stomach,

    • fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression,

    • carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy,

    • ticlopidine, other antiplatelet agent.


    If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed clopidogrel in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

    Taking Clopidogrel Teva Generics B.V. with food and drink

    Clopidogrel Teva Generics B.V. may be taken with or without food.


    Pregnancy and breast-feeding

    It is preferable not to use this product during pregnancy and breast-feeding.


    If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Teva Generics B.V.. If you become pregnant while taking Clopidogrel Teva Generics B.V., consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.


    While taking Clopidogrel Teva Generics B.V., consult your doctor about the breast-feeding of a baby. Ask your doctor or pharmacist for advice before taking any medicine.

    Driving and using machines

    Clopidogrel Teva Generics B.V. is unlikely to affect your ability to drive or to use machines.


    Important information about some of the ingredients of Clopidogrel Teva Generics B.V. Clopidogrel Teva Generics B.V. contains hydrogenated castor oil which may cause stomach upset and diarrhoea.


  3. HOW TO TAKE CLOPIDOGREL TEVA GENERICS B.V.


    Medicinal product no longer authorised

    Always take Clopidogrel Teva Generics B.V. exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


    If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Generics B.V. (4 tablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75 mg tablet of Clopidogrel Teva Generics B.V. per day to be taken orally with or without food, and at the same time each day.


    You should take Clopidogrel Teva Generics B.V. for as long as your doctor continues to prescribe it.


    If you take more Clopidogrel Teva Generics B.V. than you should

    Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.


    If you forget to take Clopidogrel Teva Generics B.V.

    If you forget to take a dose of Clopidogrel Teva Generics B.V., but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.


    If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet dose.


    For the 28x1 tablets pack size, you can check the day on which you last took the tablet by referring to the calendar printed on the blister.


    If you stop taking Clopidogrel Teva Generics B.V.

    Do not stop the treatment. Contact your doctor or pharmacist before stopping.


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


  4. POSSIBLE SIDE EFFECTS

    Like all medicines, Clopidogrel Teva Generics B.V. can cause side effects, although not everybody gets them.


    Contact your doctor immediately if you experience:

    • fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood cells.

    • signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Take special care with Clopidogrel Teva Generics B.V.’).

    • swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be the signs of an allergic reaction.


    The most common side effect (affects 1 to 10 patients in 100) reported with Clopidogrel Teva Generics B.V. is bleeding.

    Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or

    bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.


    If you experience prolonged bleeding when taking Clopidogrel Teva Generics B.V.

    If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Take special care with Clopidogrel Teva Generics B.V.’).


    Medicinal product no longer authorised

    Other side effects reported with Clopidogrel Teva Generics B.V. are:


    Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or heartburn.


    Uncommon side effects (affects 1 to 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.


    Rare side effect (affects 1 to 10 patients in 10,000): Vertigo.


    Very rare side effects (affects less than 1 patient in 10,000): Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste.


    In addition, your doctor may identify changes in your blood or urine test results.


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


  5. HOW TO STORE CLOPIDOGREL TEVA GENERICS B.V.


    Keep out of the reach and sight of children.

    Do not use Clopidogrel Teva Generics B.V. 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.


    Store in the original package in order to protect from moisture and light.

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


  6. FURTHER INFORMATION


What Clopidogrel Teva Generics B.V. contains


What Clopidogrel Teva Generics B.V. looks like and contents of the pack

The film-coated tablets are pink, round and slightly convex.

Boxes of 28, 30, 50, 56, 84, 90 or 100 film-coated tablets in blisters or boxes of 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in perforated unit dose blisters are available.


Not all pack sizes may be marketed.


Marketing Authorisation Holder

Teva Generics B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands


Medicinal product no longer authorised

Manufacturer

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

Teva Pharma Belgium N.V./S.A. Tél/Tél: +32 3 820 73 73

Luxembourg/Luxemburg Teva Pharma Belgium S.A. Tél/Tel: +32 3 820 73 73


България

Тева Фармасютикълс България ЕООД

Teл: +359 2 489 95 82

Magyarország

Teva Magyarország Zrt Tel.: +36 1 288 64 00


Česká republika

Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111

Malta

Teva Ελλάς Α.Ε.

Τel: +30 210 72 79 099


Danmark

Teva Denmark A.S. Tlf: +45 44 98 55 11

Nederland

Teva Nederland B.V. Tel: +31 (0) 800 0228400


Deutschland

Teva Generics GmbH Tel: (49) 351 834 0

Norge

Teva Sweden AB Tlf: (46) 42 12 11 00


Eesti

Teva Eesti esindus UAB Sicor Biotech Eesti filiaal

Österreich

Teva Generics GmbH Tel: (49) 351 834 0

Tel: +372 611 2409


Ελλάδα

Teva Ελλάς Α.Ε.

Τηλ: +30 210 72 79 099

Polska

Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +(48) 22 345 93 00


España

TEVA PHARMA, S.L.U. Tél: +(34) 91 387 32 80

Portugal

Teva Pharma - Produtos Farmacêuticos Lda Tel: (351) 214 235 910


France

Teva Santé

Tél: +(33) 1 55 91 7800

România

Teva Pharmaceuticals S.R.L Tel: +4021 230 65 24


Ireland

Teva Pharmaceuticals Ireland Tel: +353 (0)42 9395 892

Slovenija

Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390


Ísland

Teva UK Limited

Sími: +(44) 1323 501 111.

Slovenská republika

Teva Pharmaceuticals Slovakia s.r.o. Tel: +(421) 2 5726 7911


Italia

Teva Italia S.r.l.

Tel: +(39) 0289179805

Suomi/Finland

Teva Sweden AB

Puh/Tel: +(46) 42 12 11 00


Κύπρος

Medicinal product no longer authorised

Teva Ελλάς Α.Ε.

Τηλ: +30 210 72 79 099

Sverige

Teva Sweden AB

Tel: +(46) 42 12 11 00


Latvija

UAB Sicor Biotech filiāle Latvijā Tel: +371 67 784 980

United Kingdom

Teva UK Limited

Tel: +(44) 1323 501 111


Lietuva

UAB “Sicor Biotech” Tel: +370 5 266 02 03


This leaflet was last approved in {MM/YYYY}.