Clopidogrel Acino
clopidogrel
Clopidogrel
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
What Clopidogrel Acino is and what it is used for
What you need to know before you take Clopidogrel Acino
How to take Clopidogrel Acino
Possible side effects
How to store Clopidogrel Acino
Contents of the pack and other information
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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.
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 before taking Clopidogrel Acino.
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).
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.
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if you have had an allergy or reaction to any medicine used to treat your disease.
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.
Do not give this medicine to children because it does not work.
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:
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 injectable medicine used to reduce blood clotting,
ticlopidine, other antiplatelet agent,
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 may be taken with or without food.
It is preferable not to take this product during pregnancy.
Medicinal product no longer authorised
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist 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.
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.
Clopidogrel Acino is unlikely to affect your ability to drive or to use machines.
May cause stomach upset or diarrhoea.
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.
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You should take Clopidogrel Acino for as long as your doctor continues to prescribe it.
Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
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 take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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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).
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.
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).
Common side effects (may affect up to 1 in 10 people): Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon side effects (may affect up to 1 in 100 people):
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Rare side effect (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Very rare side effects (may affect up to 1 in 10,000 people):
Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes intaste of food.
In addition, your doctor may identify changes in your blood or urine test results.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of
this medicine.
Store in the original blister in order to protect from moisture. Keep this medicine out of the sight and reach of children.
Medicinal product no longer authorised
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 that month.
Do not use Clopidogrel Acino if you notice any visible 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.
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)
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.
Acino AG
Am Windfeld 35
83714 Miesbach Germany
Acino AG
Am Windfeld 35
83714 Miesbach Germany
For any information about this medicine, please contact the Marketing Authorisation Holder.
Medicinal product no longer authorised