Clopidogrel 75mg Film-Coated Tablets
Read all of this leaflet carefully before you start taking this
medicine because it contains important informationfor you.
• Keep this leaflet. You may need to read it again.
• Ifyou 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 if their signs of illness are the same as yours.
• Ifyou have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. 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.
In this leaflet:
1 What Clopidogrel tablets are and what they are used for
■ 2 What you need to know before you take Clopidogrel tablets
3| How to take Clopidogrel tablets
4| Possible side effects
5| How to store Clopidogrel tablets Contents of the pack and other information
1) What Clopidogrel tablets are and what they are used for
Clopidogrel tablets belong to a group ofmedianes called antiplatelet medicinal products. Platelets are very small structures in the blood, which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances ofblood 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 ofthese severe events because you have:
• a condition ofhardening 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 (aspirin) (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 growing.You should have been told that 'oral anticoagulants'are more effective than acetylsalicylic acid (aspirin) or the combined use of Clopidogrel tablets and acetylsalicylic acid (aspirin) for this condition.Your doctor should have prescribed Clopidogrel tablets plus acetylsalicylic acid (aspirin) if you cannot take 'oral anticoagulants'and you do not have a risk ofmajor bleeding.
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2| 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 ofthe other ingredients ofthis medicine (Listed in section 6)
• have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain
• suffer fiom severe liver disease
Ifyou think any ofthese apply to you, or ifyou are in any doubt at all, consult your doctor before taking Clopidogrel tablets.
Warnings and precautions
If any ofthe situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel tablets ifyou:
• have a risk of bleeding such as a
- medical condition that puts you at risk ofinternal bleeding (such as a stomach ulcer)
- blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints ofyour body).
- recent serious injury
- recent surgery (including dental)
- planned surgery (including dental) in the next seven days
• have had a clot in an artery ofyour brain (isrfiaemic stroke) whirfi occurred within the last seven days
• have kidney or liver disease
• have had allergy or reaction to any mediane 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 as Thrombotic Thrombocytopenic Purpura or TTP) that indudes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing ofthe skin or eyes (jaundice) (see section 4'possible side effects').
• Ifyou cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your mediane works as it prevents the ability ofblood clots to form. For minor cuts and injuries, e.g. cutting yourself, shaving, this is usually ofno concern. However, ifyou 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
Do not give this medicine to children because it does not work
Other medicines and Clopidogrel Tablets:
Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some other medicines may influence the use of Clopidogrel tablets or vice versa.
You should specifically tell your doctor ifyou take
- medicines that may increase your risk ofbleeding 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,
- paclitaxe, medicine to treat cancer.
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If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel in combination with acetylsalicylic acid (aspirin), a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (aspirin) (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 tablets with food and drink
Clopidogrel tablets 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 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 breast-feed while taking this medicine.
If you are breast-feeding 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 tablets are 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. Ifyou 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.
3 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 300mg of Clopidogrel (1 tablet of300mg or 4 tablets of 75mg) once at the start of treatment. Then, the recommended dose is one 75mg 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 ofthe 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 ofthis medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor immediately ifyou experience:
• fever, signs ofinfection or extreme tiredness.These may be due to rare decrease of some blood cells or bacterial infection ofthe lungs.
• signs ofliver problems such as yellowing ofthe 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 ofthe skin. These may be the signs of an allergic reaction. Severe rash involving reddening, peeling and swelling ofthe skin that resembles severe burns (toxic epidermal necrolysis), Severe form of skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome), Widespread skin rash - circular, irregular red patches on the skin ofthe hands and arms (erythema muliforme), swollen face, lips, throat or tongue (angioedema) or enlargement of lymph nodes (drug rash with eosinophilia and systemic symptoms (DRESS)).
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.
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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 ofblood clots to form. For minor cuts and injuries, e.g. cutting yourself shaving, this is usually ofno concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 'warnings and precautions').
Other side effects include:
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 oftingling and numbness.
Rare side effects (may affect up to 1 in 1000 people): Vertigo, enlargement ofbreasts in men.
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); bacterial infection ofthe lungs, skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the taste of food.
In addition, your doctor may identify changes in your blood or urine test results.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at www.mhra.qov.uk/yellowcard
By reporting side effects you can help provide more information on the safety ofthis medicine.
How to store
Keep this medicine out ofthe sight and reach of children.
Do not use Clopidogrel tablets after the expiry date which is stated on the pack after EXP The expiry date refers to the last day ofthat month.
This medianal product does not require any special storage conditions.
Do not use this medicine ifyou notice any sign of deterioriation.
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 information
What Clopidogrel tablets contain
•The active substance is clopidogrel as besilate. Each tablet contains 75mg of clopidogrel.
•The other ingredients are (see section 2"Important information about some of the ingredients of Clopidogrel tablets"):
Tablet core: lactose anhydrous, microcrystalline cellulose, crospovidoneType 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 withTon one face.
Pack sizes: 28 and 30
Marketing Authorisation Holder
Actavis Group FTC ehf. Reykjavikurvegur 76-78 220 HafnaifjorSur Iceland
Manufacturer
Actavis UK Limited, Barnstaple, EX32 8NS, UK This leaflet was last revised in December 2015.
If you would like a leaflet with larger text, please contact 01271 385257.
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Actavis, Barnstaple, EX32 8NS, UK
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