Clopidogrel Teva 75 mg film-coated tablets

Clopidogrel 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 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 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).

Or:

• You have hardening of the arteries and have experienced severe chest pains known as ?unstable angina?, have symptoms that indicate that a heart attack is developing or are suffering from a heart attack. Your doctor should also give you another medicine called ?acetyl salicylic acid? to use together with Clopidogrel Teva.

If you have unstable angina or symptoms of a developing heart attack your doctor may also have inserted a device called a ?stent? into the blocked or narrowed blood vessel to hold it open and to restore blood flow.

Do not take Clopidogrel Teva

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

Take special care with Clopidogrel Teva

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:

• You should tell your doctor if 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 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 section 4 ?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 section 4 ?POSSIBLE SIDE EFFECTS? section)
• Your doctor may order blood tests

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

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

• Oral anticoagulants (medicines used to stop blood clotting) such as warfarin.
• Glycoprotein IIb/IIIa inhibitors (medicines used to stop blood clotting). E.g. abciximab, eptifibatide or tirofiban.
• Acetylsalicylic acid (active substance present in many medicines used to relieve pain and reduce fever as well as to prevent blood clotting). Your doctor may have told you to take acetylsalicylic acid together with Clopidogrel Teva. If not, occasional use (e.g. to relieve pain) of doses not exceeding 1000 mg in any 24 hour period should not be associated with any significant complications. Prolonged use however should be discussed with your doctor first.
• 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.
• Omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach.
• Fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections.
• 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 could result in an increased risk of bleeding.

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

Taking Clopidogrel Teva with food and drink
You can take Clopidogrel Teva with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

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

You should not breastfeed while taking this medicine.
If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine..

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

Driving and using machines

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

Important information about some of the ingredients of Clopidogrel Teva

Your medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Always take Clopidogrel Teva 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.

In addition, if you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva (4 tablets of 75 mg) once at the start of treatment.

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

If you take more Clopidogrel Teva 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
If you forget to take a dose of Clopidogrel Teva, 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, 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

Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping.

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

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

The frequency of possible side effects listed below is defined using the following convention:

• 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)

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.

The most common side effect 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.

Other side effects reported with clopidogrel are:

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, sensation of tingling and numbness
• 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
• Changes in the way things taste
• 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 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.

This medicinal product does not require any special storage conditions.

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 contains

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

What Clopidogrel Teva 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 the number ?93?. The other side of the tablet is debossed with the number ?7314?.
• Clopidogrel Teva is supplied in:
• Peelable perforated blisters of aluminium/aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablets
• Perforated blisters of aluminium/aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablets
• 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

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. Malta Teva ..

Tel 420 251 007 111 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 GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich Teva GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech 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 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 353 042 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 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.