Clopidogrel Acino - patient leaflet, side effects, dosage

Patient leaflet - Clopidogrel Acino

- If you have any side effects, including any side effects not listed in this leaflet, talk doctor or pharmacist. See section 4.What is in this leaflet:1.2.3.4.5.6.What Clopidogrel Acino is and what it is used forWhat you need to know before you take Clopidogrel AcinoHow to take Clopidogrel AcinoPossible side effectsHow to store Clopidogrel AcinoContents of the pack and other information1.What Clopidogrel Acino is and what it is use

Clopidogrel Acino contains clopidogrel and 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 Acino is taken by adults 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 Acino 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.

You have an irregular heartbeat, a condition called ‘atrial fibrillation’, and you cannot take medicines known as ‘oral anticoagulants’ (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing. You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid or the combined use of Clopidogrel and acetylsalicylic acid for this condition. Your doctor should have prescribed Clopidogrel Acino plus acetylsalicylic acid if you cannot take ‘oral anticoagulants’ and you do not have a risk of major bleeding.

2. What you need to know before you take Clopidogrel AcinoDo not take Clopidogrel Acino: If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).

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 taking Clopidogrel Acino.

Warnings and precautions

Talk to your doctor or pharmacist before taking Clopidogrel Acino:

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).

used to treat your disease.
– a recent serious injury.
– a recent surgery (including dental)
– a planned surgery (including dental) in the next seve if you have had a clot in an artery of your brain (ischaemic last seven days.

oke) which occurred within the

if you have kidney or liver disease.

if you have had an allergy or reaction to any m

While you are taking Clopidogrel Acino:

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).

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). Your doctor may order blood tests.

Children and adolescents

Do not give this medicine to children because it does not work.

Other medicines and Clopidogrel Acino

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

Some other medicines may influence the use of Clopidogrel Acino or vice versa.

You should specifically tell your doctor if you take

– medicines that may increase your risk of bleeding such as:

o oral anticoagulants, medicines used to reduce blood clotting,

o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints,

o heparin or any other injectable medicine used to reduce blood clotting,

o ticlopidine, other antiplatelet agent,

o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,

– omeprazole or esomeprazole, medicines to treat upset stomach,
– fluconazole or voriconazole, medicines to treat fungal infections,
– efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,
– carbamazepine, a medicine to treat some forms of epilepsy
– moclobemide, medicine to treat depression,
– repaglinide, medicine to treat diabetes,
– paclitaxel, medicine to treat cancer.

If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Acino 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.

Clopidogrel Acino with food and drink

Clopidogrel Acino may be taken with or without food.

Pregnancy and breast-feeding

It is preferable not to take this product during pregnancy.

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

ll your doctor or your pharmacist

You should not breast-feed while taking this medicine.

If you are breastfeeding or planning to breast-feed, talk to your doctor before taking this medicine.

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

Driving and using machines

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

Clopidogrel Acino contains hydrogenated castor oil May cause stomach upset or diarrhoea.

3. How to take Clopidogrel Acino

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose, including for patients with a condition called ‘atrial fibrillation’ (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Acino per day to be taken orally with or without food, and at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Acino (4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel Acino per day as described above.

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

If you take more Clopidogrel Acino 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 Acino

If you forget to take a dose of Clopidogrel Acino, 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 ta double dose to make up for a forgotten tablet.

If you stop taking Clopidogrel Acino

st before

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

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

acist.

them.

4. Possible side effects

Like all medicines, this medicine can cause side effects, althoug

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

5. How to store Clopidogrel Acino

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

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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 th

Do not use Clopidogrel Acino if you notic

isible sign of damage of blister or film-coated tablets.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other informationWhat Clopidogrel Acino ontainsThe active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as besilate).The other ints are:

Macrogol 6000

Cellulose, microcrystalline (E460)

Crospovidone type A

Castor oil, hydrogenated

Film-coating:

Macrogol 6000

Ethylcellulose (E462)

Titanium dioxide (E 171)

What Clopidogrel Acino looks like and contents of the pack

Clopidogrel Acino 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 and Manufacturer

Acino AG

Am Windfeld 35 83714 Miesbach Germany

Manufacturer