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

Clopidogrel Teva Pharma B.V contains the active substance clopidogrel which belongs to a group of medicines called ?platelet aggregation inhibitors.? It works by stopping certain particles in your blood (?platelets?) from sticking together to form blood clots which can block blood flow to important parts of your body including your heart and your brain.

If you suffer from hardening of the arteries (?atherosclerosis?) there is an increased risk of a blood clot forming in your blood vessels. Clopidogrel Teva Pharma B.V. reduces the risk of blood clots forming which in turn reduces the risk of serious conditions such as heart attack and stroke from occurring.

You have been prescribed Clopidogrel Teva Pharma B.V. because:

• You have hardening of the arteries and have recently suffered from a heart attack, a stroke or have a condition known as ?peripheral arterial disease? (diseases of the blood vessels except those in the brain and heart).
• 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 used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.

Do not take Clopidogrel Teva Pharma B.V.

• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Teva Pharma B.V.
• If you have severe liver disease
• If you are suffering from another condition which is currently causing bleeding such as a stomach ulcer or bleeding within the brain.

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 Pharma B.V.

Take special care with Clopidogrel Teva Pharma B.V.

Tell your doctor before you start to take this medicine if:

• You are at increased risk of bleeding. For example:
• If you have recently suffered from a serious injury
• If you have recently undergone surgery or are due to have surgery (including dental surgery)
• If you have any blood disorder which makes internal bleeding (bleeding inside your body) more likely
• If you suffer from any other illness which makes internal bleeding more likely (e.g. stomach ulcers or wounds inside the eye)
• You have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
• You have liver or kidney disease.

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

• You should tell your doctor if surgery (including dental) is planned
• You should also tell your doctor immediately if you develop a medical condition (known as Thrombotic Thrombocytopenic Purpura) that includes altered behaviour, headaches, coma, visual disturbances, seizures (fitting), kidney failure, fever, extreme tiredness, weakness or bleeding into the stomach, bowels or skin (including small red spots or large bruised areas) (see ?POSSIBLE SIDE EFFECTS? section)
• 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 ?POSSIBLE SIDE EFFECTS? section)
• Your doctor may order blood tests

Use in children

Clopidogrel Teva Pharma B.V. is not recommended for use in children or adolescents under 18 years of age.

Using 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.

Talk to your doctor if you are using or have recently used any of the following medicines:

• Oral anticoagulants (oral medicines used to stop blood clotting) such as warfarin. Their use with Clopidogrel Teva Pharma B.V. is not recommended.
• Glycoprotein IIb/IIIa inhibitors (medicines used to stop blood clotting). E.g. abciximab, eptifibatide or tirofiban.
• Heparin (medicine used to prevent blood clotting).
• Medicines used to break down blood clots (e.g. alteplase and streptokinase).
• Non-steroidal anti-inflammatory medicines (used to treat painful inflammatory conditions of the joints or muscles). E.g. ibuprofen, diclofenac and meloxicam.
• 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.

Taking these medicines in combination with Clopidogrel Teva Pharma B.V. could result in an increased risk of bleeding.

If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed clopidogrel in combination with acetylsalicylic acid, a substance 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 Pharma B.V. with food and drink
You can take Clopidogrel Teva Pharma B.V. with or without food.

Pregnancy and breast-feeding

It is preferable not to use this medicine 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 Pharma B.V. If you become pregnant while taking Clopidogrel Teva Pharma B.V., consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

While taking Clopidogrel Teva Pharma B.V., consult your doctor about the breastfeeding of a baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Clopidogrel Teva Pharma B.V. is unlikely to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Clopidogrel Teva Pharma B.V. Your medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Your medicine also contains an ingredient called hydrogenated castor oil. This ingredient may cause stomach upset and diarrhoea.

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

The usual dose is one 75 mg tablet per day which should be swallowed with water or another liquid. You should take your medicine regularly at the same time each day. You can take it with or without food.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Pharma B.V. once at the start of treatment. Then, the usual dose is one 75-mg tablet of Clopidogrel Teva Pharma B.V. per day

You should continue taking Clopidogrel Teva Pharma B.V. for as long as your doctor has told you to take it.

If you take more Clopidogrel Teva Pharma B.V. than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause an increased risk of bleeding. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

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

If you forget to take a dose of Clopidogrel Teva Pharma B.V., but don?t remember within 12 hours of the missed dose, skip the missed dose and take the next tablet at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clopidogrel Teva Pharma B.V.

Do not stop taking Clopidogrel Teva Pharma B.V. without discussing it with your doctor first.

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

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

Some of the side effects may be serious. If you suffer from any of the following symptoms you should contact your doctor immediately:

• Fever, signs of infection (e.g. sore throat), pale skin or extreme tiredness. These may be due to a decrease of some blood cells
• Altered behaviour, headaches, coma, visual disturbances, seizures (fitting), kidney failure, fever, extreme tiredness, weakness or bleeding into the stomach, bowels or skin (including small red spots or large bruised areas). This could indicate that you are suffering from a serious condition called thrombotic thrombocytic purpura (rare disorder of the blood clotting system which causes multiple blood clots to form around the body)
• Signs of liver problems such as yellowing of the skin and whites of the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion
• Swelling in the mouth or skin disorders such as rashes, itching and blistering of the skin. These may be the signs of an allergic reaction.

Bleeding
The most common side effect (affects 1 to 10 users in 100) reported for medicines containing clopidogrel is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleeds or blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the abdomen, the lung and the joints have also been reported.

If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. This is linked to the way that your medicine works. For minor cuts and injuries (e.g. shaving cuts) you should not worry. However, if you are in any doubt, bleeding becomes serious or you experience unexpected bleeding from unusual parts of your body you should contact your doctor straight away.

The following side effects have been reported. They are listed according to frequency as follows:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very rare affects less than 1 user in 10,000 Not known Frequency cannot be estimated from the available data

Common side effects:

• Bruising, haematoma (unusual bleeding under the skin), nose bleeds, bleeding in the stomach or bowels, increased bleeding at the site of a puncture wound
• Diarrhoea, abdominal pain, indigestion or heartburn

Uncommon side effects:

• Headache and dizziness
• Prolonged bleeding, bleeding inside the head, bleeding in the eye, blood in the urine and/or purpura (red spots on the skin caused by bleeding underneath the skin)
• Rashes, itching, abnormal touch sensation
• Ulcers in the stomach and small intestine, nausea, vomiting, constipation, flatulence (wind) and inflammation of the stomach leading to sickness, loss of appetite and discomfort after eating
• Reduction in blood platelets which makes bleeding or bruising more likely
• Blood disorders including a reduction in the number of white blood cells which makes infections more likely.

Rare side effects:

• Reduced levels of certain white blood cells which increases the risk of infection (neutropenia)
• Vertigo (dizziness accompanied by a whirling sensation)
• Bleeding inside the abdomen

Very rare side effects:

• A serious condition called thrombotic thrombocytic purpura (rare disorder of the blood clotting system which causes multiple blood clots to form around the body). Symptoms may include altered behaviour, headaches, coma, visual disturbances, seizures (fitting), kidney failure, fever, extreme tiredness, weakness, or bleeding into the stomach, bowels or skin (including small red spots or large bruised areas)
• Severe reduction in certain blood cells leading to increased risk of bleeding or bruising, increased risk of infections, pale skin and extreme tiredness
• Generalised allergic reactions, breathing difficulties, swelling or inflammation of the mouth, skin allergy, blisters on the skin
• Confusion or hallucinations
• Taste disorders
• Inflammation of the blood vessels, decrease in blood pressure
• Yellowing of the skin and whites of the eyes (jaundice)
• Bleeding in the lungs, throat, stomach or bowels, abdomen or joints
• Bleeding of post-operative wounds or other serious bleeds
• Severe abdominal pain with or without back pain, pain in the joints and muscular pain
• Diarrhoea
• Fever
• Changes in levels of certain substances in your blood or urine. This may be detectable via blood or urine tests.

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

Keep out of the reach and sight of children.
Do not use Clopidogrel Teva Pharma B.V. after the expiry date that is stated on the outer carton, bottle or blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package to protect from light.

30 tablets HDPE bottles:

Discard any remaining tablets 30 days after first opening of the bottle.

100 tablets HDPE bottles:

Discard any remaining tablets 100 days after first opening of the bottle.

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.

What Clopidogrel Teva Pharma B.V. contains

• The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrobromide).
• The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated castor oil and sodium laurilsulfate, and in the film-coating are lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).

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

• The film-coated tablets are light pink to pink, film coated, capsule shaped tablets. One side of the tablet is debossed with ?C75?. The other side of the tablet is plain.
• Clopidogrel Teva Pharma B.V. is supplied in peelable perforated blisters of aluminium/ aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablet; perforated blisters of aluminium/ aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablet or HDPE bottles with polypropylene closures or child resistant polypropylene closures and silica gel desiccant containing 30 or 100 tablets.

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.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

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

Manufacturer:

TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen,
Hungary

TEVA Pharmaceutical Works Private Limited Company

Táncsics Mihály út 82,

2100 Gödöll-,

Hungary

TEVA UK Ltd

Brampton Road,

Hampden Park,Eastbourne,East Sussex,
BN22 9AG,

United Kingdom

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem,

The Netherlands

TEVA Santé SA,

Rue Bellocier,

89107 Sens,

France

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

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. TélTel 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark AS 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 Österreich Teva Generics GmbH 37

Tel 49 351 834 0 Eesti filiaal Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Genéricos Española, 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 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111. Italia Teva Italia S.r.l. Tel 39 0289179805 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij 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

Detailed information is available on the European Medicines Agency website: http://www.ema.europa.eu.