Clopidogrel 75mg film coated tablets

• 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 if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• If you are allergic (hypersensitive) 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.

Talk to your doctor or pharmacist before taking Clopidogrel:

• 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 (ischemic stroke) which occurred within the last seven days.
• if you have kidney or liver disease.
• if you have had an allergy or reaction to any medicine used to treat your disease.
• if you had a past medical history of non-traumatic brain hemorrhage.

• 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 ‘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.

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:

• 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 or other antiplatelet agents.
  • a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression.
  • rifampicin (used to treat severe infections).
• omeprazole or esomeprazole, medicines to treat upset stomach.
• fluconazole or voriconazole, medicines to treat fungal infections.
• efavirenz, or other anti-retroviral medicines (used to treat HIV 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.
• opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioid (used to treat severe pain).
• rosuvastatin (used to lower your cholesterol level).

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.

Clopidogrel contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This may cause stomach upset or diarrhoea.

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, 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.

• 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 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 1,000 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.

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).

The other ingredients are mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose in the tablet core, and lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), iron oxide red (E172), titanium dioxide (E171), and carnauba wax in the tablet coating.

Clopidogrel are round, biconvex, pink, film-coated tablets, approx. 8.5 mm in length, engraved on one side with the number “75” and on the other side with the number “1171”.

They are supplied in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 tablets in PVC/PVDC/Aluminium blisters, or 28, 30 and 90 tablets in brown glass bottle with white HDPE closure and desiccant.

Not all pack sizes may be marketed.

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