Clopidogrel BMS
clopidogrel
clopidogrel
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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.
What Clopidogrel BMS is and what it is used for
Before you take Clopidogrel BMS
How to take Clopidogrel BMS
Possible side effects
5 How to store Clopidogrel BMS
6. Further information
Medicinal product no longer authorised
Clopidogrel BMS belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, smaller than red or white blood cells, 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 BMS 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 BMS 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, 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.
If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel BMS;
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 BMS.
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel BMS:
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 are taking another type of medicine (see ‘Taking other medicines’).
if you have kidney or liver disease
While you are taking Clopidogrel BMS:
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 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’).
Medicinal product no longer authorised
Your doctor may order blood tests.
You should tell your doctor or pharmacist if you notice any side effect not listed in section 4 ‘POSSIBLE SIDE EFFECTS’ or if you notice that a side effect gets serious.
Clopidogrel BMS is not intended for use in children or adolescents.
Some other medicines may influence the use of Clopidogrel BMS or vice versa.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The use of oral anticoagulants (medicines used to reduce blood clotting) with Clopidogrel BMS is not recommended.
You should specifically tell your doctor if you take a non-steroidal anti-inflammatory drug, usually used to treat painful and/or inflammatory conditions of muscle or joints, or if you take heparin or any other medicine used to reduce blood clotting, or if you take a proton pump inhibitor (e.g, omeprazole) for upset stomach.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel BMS 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 BMS may be taken with or without food.
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 BMS. If you become pregnant while taking Clopidogrel BMS, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
While taking Clopidogrel BMS, consult your doctor about the breast-feeding of a baby. Ask your doctor or pharmacist for advice before taking any medicine.
Clopidogrel BMS is unlikely to affect your ability to drive or to use machines.
Clopidogrel BMS contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
Clopidogrel BMS also contains hydrogenated castor oil which may cause stomach upset or diarrhoea.
Always take Clopidogrel BMS exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Medicinal product no longer authorised
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel BMS (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the usual dose is one 75-mg tablet of Clopidogrel BMS per day to be taken orally with or without food, and at the same time each day.
You should take Clopidogrel BMS 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 BMS, 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 individual doses.
For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Clopidogrel BMS by referring to the calendar printed on the blister.
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 BMS can cause side effects, although not everybody gets them.
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 BMS’).
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 ‘Take special care with Clopidogrel BMS’).
Medicinal product no longer authorised
Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon side effects (affects 1 to 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Rare side effect (affects 1 to 10 patients in 10,000): Vertigo.
Very rare side effects (affects less than 1 patient in 10,000): 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.
Keep out of the reach and sight of children.
Do not use Clopidogrel BMS after the expiry date which is stated on the carton and on the blister.
Refer to the storage conditions on the carton.
If Clopidogrel BMS is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
If Clopidogrel BMS is supplied in all aluminium blisters, it does not require any special storage conditions.
Do not use Clopidogrel BMS if you notice any visible sign of deterioration.
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.
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
The other ingredients are mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose in the tablet core, and lactose (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172), titanium dioxide (E171), and carnauba wax in the tablet coating.
Medicinal product no longer authorised
Clopidogrel BMS 75-mg film-coated tablets are round, biconvex, pink, engraved on one side with the number ‘75’ and on the other side with the number ‘1171’. Clopidogrel BMS is supplied in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 tablets in PVC/PVDC/Aluminium blisters or in all aluminium blisters, or 50x1 tablets in PVC/PVDC/Aluminium blisters or in all aluminium perforated unit-dose blisters. Not all pack sizes may be marketed.
Marketing Authorisation Holder: Bristol Myers Squibb Pharma EEIG Uxbridge Business Park
Sanderson Road Uxbridge UB8 1DH United Kingdom
Manufacturer:
Sanofi Winthrop Industrie
1, rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France and/or
Sanofi-Synthelabo Limited, Edgefield Avenue, Fawdon
Newcastle Upon Tyne, Tyne & Wear NE3 3TT - UK, United Kingdom
and/or
Sanofi Winthrop Industrie
6, boulevard de l'Europe, F-21800 Quétigny, France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V. Tél/Tel: + 32 2 352 76 11
BRISTOL-MYERS SQUIBB BELGIUM S.A./N.V. Tél/Tel: + 32 2 352 76 11
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Tel: + 44 (0800) 731 1736
BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT. Tel: +370 5 2790 762
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