Clopidogrel Teva Generics B.V. - patient leaflet, side effects, dosage

WHAT IT IS USED FOR

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 take vessels (arteries), a process known as at (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 medi Thrombotic Thrombocytopenic Purpura or TTP) that includes feve

that may appear as red pinpoint dots, with or without unexplai

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 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

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 GENERIoctor has told you. You should check

Always take Clopidogrel Teva Generics B.V. exactly as 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.

Teva Generics B.V. than you should

est hospital emergency department because of the increased risk of

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 28×1 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

If you cut or injure yourself, it may take slightly longer than usual for bl to the way your medicine works as it prevents the ability of blood clo

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.’).

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.

ts less than 1 patient in 10,000): Jaundice; severe abdominal pain with or , breathing difficulties sometimes associated with cough; generalised allergic the mouth; blisters of the skin; skin allergy; inflammation of the mouth

se in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes

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

• – The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).

• – The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil in the tablet core and hydroxypropyl­cellulose (E463), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol in the filmcoating.

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 28×1, 28×1 (calendar pack), 30×1, 50×1, 56×1, 84×1, 90×1 and 100×1 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

Manufacturer

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

Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

For anv information about this medicinal 4.- ct „lease contact the focal rcnrcscntativc of the

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

Belgie/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A. Tél/Tél: +32 3 820 73 73 Efcnrapua TeBa OapMacroTUKs.ic Etnrapua EOOfl Ten: +359 2 489 95 82 Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111 Danmark Teva Denmark A.S. Tlf: +45 44 98 55 11 Deutschland Teva Generics GmbH Tel: (49) 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal

Luxembourg/Lu­xemburg Teva Pharma Belgium S.A. Tel/Tel: +32 3 820 73 73 Magyarorszag Teva Magyarorszag Zrt Tel.: +36 1 288 64 00 Malta Teva EXXag A.E. Tel: +30 210 72 79 099 Nederland Teva Nederland B.V. Tel: +31 (0) 800 0228400 Norge Teva Sweden AB Tlf: (46) 42 12 11 00 Österreich Teva Generics GmbH Tel: (49) 351 834 0

Latvija United Kingdom

UAB Sicor Biotech filiäle Latvijä Teva UK Limited

Tel: +371 67 784 980 Tel: +(44) 1323 501 111

Lietuva

UAB “Sicor Biotech”

Tel: +370 5 266 02 03

Detailed information on this medicine is available on the European Medicines Agency website:.

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