Clopidogrel HEXAL 75 mg film-coated tablets

Clopidogrel HEXAL contains the active ingredient Clopidogrel which belongs to a group of medicines called antiplatelet medicinal products. Platelets (so-called thrombocytes) are very small structures, 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 HEXAL 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 HEXAL 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 (disturbed blood flow in arms or legs caused by vascular occlusions) 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.

Do not take Clopidogrel HEXAL:

- If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel HEXAL;
- 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 HEXAL.

Take special care with Clopidogrel HEXAL:

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

Children and adolescents

Clopidogrel HEXAL 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 HEXAL 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 HEXAL 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 HEXAL with food and drink

Clopidogrel HEXAL 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 HEXAL. If you become pregnant while taking Clopidogrel HEXAL, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

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

Important information about some of the ingredients of Clopidogrel HEXAL: Clopidogrel HEXAL contains hydrogenated castor oil which
may cause stomach upset or diarrhoea.

Always take Clopidogrel HEXAL exactly as your doctor has told you. You should check 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 HEXAL (4 tablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75 mg tablet of Clopidogrel HEXAL per day to be taken orally with or without food, and at the same time each day.

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

If you take more Clopidogrel HEXAL 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 HEXAL
If you forget to take a dose of Clopidogrel HEXAL, but remember within 12 hours of your usual time, take your tablet straight away 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 the forgotten individual doses.

If you stop taking Clopidogrel HEXAL

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 HEXAL 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 HEXAL?).
• 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 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 HEXAL.
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 2 ?Take special care with Clopidogrel HEXAL?).

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 data.

Other side effects reported with clopidogrel are:
-Common side effects:
Diarrhoea, abdominal pain, indigestion or heartburn.

-Uncommon side effects:
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.

-Rare side effect:
Vertigo.

-Very rare side effects:
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.

Store in the original blister in order to protect from moisture.

Keep out of the reach and sight of children.

Do not use Clopidogrel HEXAL after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
Do not use Clopidogrel HEXAL if you notice any visible sign of damage of blister or film-coated tablets.

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 HEXAL contains

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as besilate).

The other ingredients are:

Tablet core:

Macrogol 6000
Cellulose, microcrystalline (E460)
Crospovidone type A
Castor oil, hydrogenated

Film-coating:

Macrogol 6000
Ethylcellulose (E462)
Titanium dioxide (E 171)

What Clopidogrel HEXAL looks like and contents of the pack

Clopidogrel HEXAL 75 mg film-coated tablets are white to off-white, marbled, round and biconvex. They are supplied in cardboard cartons containing 14, 28, 30, 50, 84, 90 and 100 tablets in aluminium blisters. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Acino Pharma GmbH
Am Windfeld 35
83714 Miesbach
Germany

Manufacturer

Acino AG
Am Windfeld 35
83714 Miesbach
Germany

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

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

LuxembourgLuxemburg HEXAL AG Industriestraße 25 D-83607 Holzkirchen AllemagneDeutschland TélTel 49 8024 908 0 BelgiëBelgiqueBelgien Sandoz N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde België Tel 32 02 722 97 97

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Lietuva

Sandoz Pharmaceuticals d.d.,
Branch Office Lithuania
Seimyniskiu Str. 3A
LT-09312 Vilnius
Tel: +370 5 2636037

This leaflet was last approved in.

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