Clopidogrel 75mg Film-Coated Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even iftheir signs of illness are the same as yours.
• Ifyou get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• The full name of this medicine is Clopidogrel 75mg Film-coated Tablets but within the leaflet it will be referred to as Clopidogrel tablets.
What is in this leaflet:
J What Clopidogrel tablets are and what they are used for a What you need to know before you take a How to take J Possible side effects ^ How to store
a Contents of the pack and other information j What Clopidogrel tablets are and what they are used for
Clopidogrel tablets belong to a group ofmedicines called antiplatelet medicinal products. Platelets are very small structures in the blood, which clump together during blood clotting. By preventing this clumping, antiplatelet medicinalproducts reduce the chances of blood clots forming (a process called thrombosis).
Clopidogrel tablets are 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 tablets 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
• previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or
• experienced a severe type of chest pain known as'unstable angina'or 'myocardial infarction'(heart attack). For the treatment ofthis 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.
• 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 growingYou should have been told that'oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel tablets and acetylsalicylic acid for this condition. Your doctor should have prescribed Clopidogrel tablets plus acetylsalicylic acid if you cannot take'oral anticoagulants'and you do not have
a risk of major bleeding.
a What you need to know before you take
Do not take Clopidogrel tablets if you
• are allergic (hypersensitive) to clopidogrel, soya oil, peanut oil or any of the other ingredients of this medicine (listed in section 6)
• have a medical condition that is currently causing bleeding such as a stomach
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ulcer or bleeding within the brain
• 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 tablets.
Warnings and precautions
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel tablets 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)
• blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs orjoints of your body).
• recent serious injury
• recent surgery (including dental)
• planned surgery (including dental) in the next seven days
• have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
• have kidney or liver disease
• have had allergy or reaction to any medicine used to treat your disease
While you are taking Clopidogrel tablets:
• You should tell your doctor if a surgery (including dental) is planned.
• You should also tell your doctor immediately ifyou develop a medical condition (also known asThrombotic Thrombocytopenic Purpura orTTP) 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 tablets are not intended for use in children or adolescents.
Other medicines and Clopidogrel tablets:
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 Clopidorel tablets 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 injectable medicine used to reduce blood clotting,
• omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach
• fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections,
• 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 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 tablets with food and drink Clopidogrel tablets may be taken with or without food.
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Actavis, Barnstaple, EX32 8NS, UK
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 should tell your doctor or your pharmacist before taking Clopidogrel tablets. If you become pregnant while taking Clopidogrel tablets, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
You should not breastfeed while taking this medicine.
If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine.
Askyour doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Clopidogrel tablets is unlikely to affect your ability to drive or to use machines.
Important information about some of the ingredients of Clopidogrel tablets
Clopidogrel tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars (e.g lactose), contact your doctor before taking this medicine.
Clopidogrel tablets contain soya oil. If you are allergic to peanut or soya, do not take this medicine
a How to take
Always take this medicine 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 (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start oftreatment Then, the usual dose is one 75 mg tablet of Clopidogrel per day to be taken orally with or without food, and at the same time each day.
You should take Clopidogrel tablets for as long as your doctor continues to prescribe it.
If you take more Clopidogrel tablets 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 tablets
If you forget to take a dose of Clopidogrel, 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 the forgotten tablet.
If you stop taking Clopidogrel tablets
Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping.
If you have any further questions on the use of this medicine, askyour doctor or pharmacist.
J Possible side effects
Like all medicines, Clopidogrel tablets 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'Warnings and precautions').
• 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 reported with Clopidogrel tablets 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 tablets
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 Continued top of next column AAAF9376 50753334
your doctor straightaway (see section 2'Warnings and precautions').
Other side effects reported with Clopidogrel tablets are:
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.
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 in taste of food.
In addition, your doctor may identify changes in your blood or urine test results.
Ifyou have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist.
Reporting of side effects
Ifyou get any side effects, talk to your doctor or pharmacistThis includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.
^ How to store
Keep out of the sight and reach of children.
Do not use Clopidogrel tablets after the expiry date which is stated on the pack, after EXP
This medicinal product does not require any special storage conditions.
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 protect the environment.
j Contents of the pack and other information
What Clopidogrel tablets contain
• The active substance is clopidogrel as besilate. Each tablet contains 75mg of clopidogrel.
•The other ingredients are:
Tablet core: lactose anhydrous, microcrystalline cellulose, crospovidone Type A, glycerol dibehenate, talc.
Tablet coating: polyvinyl alcohol, talc, macrogol 3350, lecithin (soya oil) (E322), titanium dioxide (E171), iron oxide red (E172).
What Clopidogrel tablets look like and contents of the pack
Film-coated tablet.
Pink 9 mm round, biconvex, film-coated tablet, engraved with"II"on one face.
Pack sizes: 28 and 30
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegur 76-78, 220 Hafnarfjor5ur, Iceland Manufacturer
Actavis UK Limited, Barnstaple, EX32 8NS, UK This leaflet was last revised in September 2013.
Ifyou would like a leaflet with larger text, please contact 01271 311257.
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