Clopidogrel Apotex 75 mg film-coated tablets

Clopidogrel Apotex contains the active substance clopidogrel, a platelet aggregation blocker. Platelets are very small structures which clump together (aggregate) during blood clotting. By preventing formation of blood clots (thrombi) in hardened blood vessels, clopidogrel reduces the risk of stroke or heart attack.

Clopidogrel Apotex is used if you have hardening of the arteries (atherosclerosis), and you have either:

• had a recent heart attack (myocardial infarction) or previous stroke, or
• you have a condition which causes disturbed blood flow in arms or legs due to blockade of the blood vessels (peripheral arterial disease)

Do not take Clopidogrel Apotex

• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Apotex (listed in section 6 ?What Clopidogrel Apotex contains?)
• if you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain
• if you have severe liver disease

Take special care with Clopidogrel Apotex

Tell your doctor before you start taking this medicine:

• if you are at increased risk of bleeding (haemorrhage), such as:
• any condition (e.g. stomach ulcer) or blood disorder that makes you prone to internalbleeding (inside tissues, organs or joints of your body)
• recent serious injury
• surgery (including dental), recent or due in the next 7 days
• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days

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• if you have kidney or liver disease

While you are taking Clopidogrel Apotex:

• 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 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 is not intended for use in children or adolescents.

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Some other medicines may influence the use of Clopidogrel Apotex or vice versa.

This applies specially to medicines containing any of the following active substances:

• oral anticoagulants, medicines used to reduce blood clotting
• non-steroidal anti-inflammatory medicines, used to treat fever, pain and inflammation of muscles 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.

Acetylsalicylic acid (an NSAID) may be used if prescribed, or occasionally up to 1000 mg in 24 h. However, discuss with your doctor its prolonged use in other circumstances.

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

Pregnancy and breast-feeding

It is not recommended to use this medicine during pregnancy.
If you are pregnant or think you might be pregnant, tell your doctor before treatment start. If you become pregnant while taking Clopidogrel Apotex, tell your doctor immediately.

You should stop breast-feeding while taking Clopidogrel Apotex, as it is not known if clopidogrel passes into breast milk.

Driving and using machines

Clopidogrel Apotex is unlikely to affect your ability to drive or use machines.

Important information about some of the ingredients of Clopidogrel Apotex

Clopidogrel Apotex contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact you doctor before taking this medicine.

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Always take Clopidogrel Apotex 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 daily, every day at the same time.

Take the tablet(s) with some liquid, with or without food.

If you take more Clopidogrel Apotex than you should

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

If you forget to take Clopidogrel Apotex

If you forget to take Clopidogrel Apotex, but remember within 12 hours of your usual time, take your tablet straightaway. Then take your next tablet at the usual time.
If you forget for more than 12 hours, skip the missed dose. Then 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 Apotex

You should take Clopidogrel Apotex as long as your doctor prescribes it.
Do not stop the treatment without discussing it with your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Clopidogrel Apotex can cause side effects, although not everybody gets them. Side effects may occur with certain frequencies, which are defined 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 date

Contact your doctor immediately if you experience:

• decrease of some blood cells: fever, signs of infection or extreme tiredness.
• liver problems: 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 Apotex?).
• allergic reactions: swelling in the mouth, skin rash, itching and blistering.

The most common side effect is bleeding, which may appear as:

• bruising and haematoma
• nose bleed, blood in the urine
• bleeding in the stomach or bowels or less frequently in the eye, head, lung or joints

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 ?Take special care with Clopidogrel Apotex?).

Other side effects:

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Common side effects

• abdominal pain, indigestion or heartburn
• diarrhoea

Uncommon side effects

• headache, dizziness
• stomach ulcer
• vomiting, nausea
• constipation, excessive gas in stomach or intestines
• rashes, itching
• sensation of tingling and numbness

Rare side effects

• vertigo

Very rare side effects

• fever
• jaundice
• severe abdominal pain with or without back pain, pain in joints or muscles
• generalised allergic reactions
• blisters of the skin and skin allergy
• swelling in the mouth
• inflammation of the mouth (stomatitis)
• breathing difficulties, sometimes with cough
• decrease in blood pressure
• confusion, hallucinations
• 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.

Keep out of the reach and sight of children.

Do not use Clopidogrel Apotex after the expiry date which is stated on the carton and on the blister after EXP.

This medicinal product does not require any special storage conditions.

Do not use Clopidogrel Apotex if you notice any visible sign of deterioration.

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 Apotex contains

• The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
• The other ingredients are:

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Core: Microcrystalline cellulose,hydroxypropylcellulose (E463) , mannitol (E421) , crospovidone (type A) , citric acid monohydrate , macrogol 6000 , stearic acid , talc Coating: Hypromellose (E464) , iron oxide red (E172) , lactose monohydrate , triacetin (E1518) , titanium dioxide (E171)

What Clopidogrel Apotex looks like and contents of the pack

Clopidogrel Apotex film-coated tablets are pink, round and biconvex.
They are supplied in PVC/PE/PVDC/Alu blisters or in PA/ALL/PVC-Alu blisters packed in cartons containing 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Apotex Europe BV
Darwinweg 20
2333 CR, Leiden
The Netherlands

Manufacturer
Pharmathen S.A.,
6 Dervenakion
15351 Pallini Attiki
Greece

Or

Pharmathen International S.A
Industrial Park Sapes
Rodopi Prefecture, Block No 5
Rodopi 69300
Greece

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

BelgiëBelgiqueBelgien NV Apotex SA TélTel32 475.35.40. LuxembourgLuxemburg NV Apotex SA Tel 32 475.35.40

Apotex Europe B.V. Tel 31 71. 565.77. 77 Magyarország Apotex Europe B.V. Tel 31 71. 565.77. 77

eská republika Apotex R s.r.o. Tel 420 234.705.700 Malta Apotex UK Limited Tel44 15.25. 24.35.50 Danmark Apotex Europe B.V. Tlf31 71. 565.77. 77 Nederland Apotex Nederland B.V. Tel31 71. 52.43.100

Deutschland Apotex Europe B.V. Tel31 71. 565.77. 77 Norge Apotex Europe B.V. Tlf31 71. 565.77. 77

Eesti Österreich

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Apotex Europe B.V. Tel 31 71. 565.77. 77 Apotex Europe B.V. Tel 31 71. 565.77. 77

NEXUS MEDICALS S.A. 30 210 28 52 266 Polska Apotex Inc. Korporacja Przedstawicielstwo w Polsce Tel48 22.311.20.00

España APOTEX ESPAÑA S.L. Tel34 91.486.15.65 Portugal Apotex Europe B.V. Tel31 71. 565.77. 77

France NV APOTEX SA Tel32 475.35.40 România Apotex Europe B.V. Tel31 71. 565.77. 77

Ireland Apotex UK Limited Tel44 15.25. 24.35.50 Slovenija Apotex Europe B.V. Tel31 71. 565.77. 77

Ísland Apotex Europe B.V. Sími31 71. 565.77. 77 Slovenská republika Apotex Europe B.V. Tel31 71. 565.77. 77

Italia Apotex Europe B.V. Tel31 71. 565.77. 77 SuomiFinland Apotex Europe B.V. PuhTel31 71. 565.77. 77

Apotex Europe B.V. 31 71. 565.77. 77 Sverige Apotex Europe B.V. Tel31 71. 565.77. 77

Latvija Apotex Europe B.V. Tel31 71. 565.77. 77 United Kingdom Apotex UK Limited Tel44 15.25. 24.35.50

Lietuva
Apotex Europe B.V.
Tel:+31 71. 565.77. 77

This leaflet was last approved in:

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