Clopidogrel Qualimed 75 mg film-coated tablets

Clopidogrel Qualimed belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, smaller than red or white blood cells, 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 Qualimed 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 Qualimed 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.

Do not take Clopidogrel Qualimed

• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Qualimed;
• 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 Qualimed.

Take special care with Clopidogrel Qualimed

If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Qualimed:

• 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 Qualimed:

• 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 Qualimed 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 Qualimed 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,
• or if you take 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.

An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period), a substance present in many medicines used to relieve pain and lower fever, should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Qualimed with food and drink
Clopidogrel Qualimed 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 Qualimed. If you become pregnant while taking Clopidogrel Qualimed, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

While taking Clopidogrel Qualimed, 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 Qualimed is unlikely to affect your ability to drive or to use machines.

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

Always take Clopidogrel Qualimed 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 of Clopidogrel Qualimed per day to be taken orally with or without food, and at the same time each day.

You should take Clopidogrel Qualimed for as long as your doctor continues to prescribe it.

If you take more Clopidogrel Qualimed 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 Qualimed:
If you forget to take a dose of Clopidogrel Qualimed, 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.

If you stop taking Clopidogrel Qualimed:

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.

Like all medicines, Clopidogrel Qualimed 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 Qualimed?).
• 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 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 Qualimed

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 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 Qualimed?).

Other side effects reported 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.

Keep out of the reach and sight of children.
Do not use Clopidogrel Qualimed 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.

What Clopidogrel Qualimed contains

• The active substance is clopidogrel. Each film-coated tabletcontains 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 film-coating.

What Clopidogrel Qualimed looks like and contents of the pack

The film-coated tablets are pink, round and slightly convex.
Boxes of 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in blisters are available. Boxes of 30x1 film-coated tablets in perforated unit dose blisters are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Qualimed, 117 allée des Parcs, 69 800 Saint Priest, France

Manufacturer

KRKA, d.d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

BelgiëBelgiqueBelgien Mylan bvbasprl TélTel 0032 2 658 61 00 LuxembourgLuxemburg Mylan bvbasprl TélTel 0032 2 658 61 00 Belgium

Bulgaria Mylan SAS Tel 33 4 37 25 75 00 France Hungary Mylan Kft Tel 36 1 8026993

Ceská republika MylanPharmaceuticals s.r.o. Tel 420 274 770 201 Malta George Borg Barthet Ltd Tel 356 21244205

Danmark Mylan ApS Tlf 45 3694 4568 Nederland Mylan B.V Tel 31 033 2997080

Deutschland Mylan dura GmbH Tel 49-0 6151 9512 0 Norge Mylan AB Tlf 46 8-555 227 50 Sverige

Eesti Mylan SAS Tel 33 4 37 25 75 00 France Österreich Arcana Arzneimittel GmbH Tel 43 1 416 24 18

Greece Generics Pharma Hellas 30 210 9936410 Polska Mylan Sp.z.o.o Tel 48 22 5466400

España Mylan Pharmaceuticals, S.L tel 34 93 3786400 Portugal Mylan, Lda. Phone 00351 21 412 7200

France Qualimed Tel 33 4 37 25 75 00 România Mylan SAS Tel 33 4 37 25 75 00 France

Ireland Mc Dermott Laboratories Ltd Slovenija Mylan SAS

Tel 33 4 37 25 75 00 France Tel 1800 272 272 Allphar 353 1 4041600 Ísland Actavis Group PTC ehf Sími 354 5503300 Slovenská republika Mylan sr.o Tel 421 2 32 604 901

SuomiFinland Mylan OY Italia Mylan S.p.A Tel 3902-61246921 PuhTel 358 9-46 60 03

Cyprus Pharmaceutical Trading Co Ltd 35 7 24656165 Sverige Mylan AB Tel 46 8-555 227 50

Latvija Mylan SAS Tel 33 4 37 25 75 00 France United Kingdom Generics UK Ltd Tel 44 1707 853000

Lietuva

Mylan SAS
Tel: +33 4 37 25 75 00 (France)

This leaflet was last approved in MM/YYYY.

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