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The product code(s) for this leaflet is: PL 08553/0766.
Clopidogrel 75 mg film-coated tablets
Clopidogrel 75 mg film-coated tablets
Clopidogrel 300 mg film-coated tablets
clopidogrel
1. What Clopidogrel is and what it is used for
2. What you need to know before you take Clopidogrel
3. How to take Clopidogrel
4. Possible side effects
5. How to store Clopidogrel
6. Contents of the pack and other information
Clopidogrel contains clopidogrel and belongs to a group of medicines 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 of blood clots forming (a process called thrombosis).
Clopidogrel 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 to help prevent blood clots and reduce the risk of these severe events because:
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel.
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel:
While you are taking Clopidogrel:
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 or vice versa.
You should specifically tell your doctor if you take
If you have experienced severe chest pain (unstable angina or heart attack), transient ischemic attack or ischemic stroke in mild severity, 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 may be taken with or without food.
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. If you become pregnant while taking clopidogrel, 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.
Clopidogrel is unlikely to affect your ability to drive or to use machines.
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.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium free’.
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 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 or 600 mg of clopidogrel (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of clopidogrel per day as described above.
If you have experienced symptoms of a stroke which go away within a short period of time (also known as transient ischemic attack) or an ischemic stroke mild in severity, your doctor may give you 300 mg of clopidogrel (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of clopidogrel per day as described above with acetylsalicylic acid for 3 weeks. Then the physician would prescribe either clopidogrel alone or acetylsalicylic acid alone.
You should take clopidogrel 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.
Clopidogrel 75 mg film-coated 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 a forgotten tablet.
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, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effect reported with clopidogrel 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 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 ‘Warnings and precautions’).
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 in taste or loss of taste of food.
Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 that month.
This medicinal product does not require any special storage conditions.
Do not use this medicine if you notice any visible sign of deterioration.
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 or 300 mg of clopidogrel (as hydrogen sulphate).
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, silica, colloidal anhydrous, crospovidone, sodium stearyl fumarate
Tablet coating: hypromellose (E464), talc (E553b), macrogol (E1521), titanium dioxide (E171), red iron oxide (E172)
Clopidogrel 75 mg film-coated tablets are pink round, coated tablets, 7 debossed on one side, plain on the other side. Dimensions of tablets (diameter) are 7.65 ±0.5 mm.
Clopidogrel 75 mg is supplied in cardboard cartons with OPA/Alu/PVC-Alu blisters or PVC/Aclar-Alu blisters containing 20, 28, 28 x 1, 30, 30 x1, 50, 56, 84, 90, 98, 100 and 500 film-coated tablets.
Clopidogrel 300 mg film-coated tablets are pink oval, coated tablets, 3H debossed on one side, plain on the other side. Dimensions of tablets (length x width) are 16.75 ±0.5 mm X 8.85 ±0.5 mm.
Clopidogrel 300 mg is supplied in cardboard cartons with OPA/Alu/PVC-Alu blisters or PVC/Aclar-Alu blisters containing 30 film-coated tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in February 2024