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 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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

• If you are allergic 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 this medicine.

If any of the situations mentioned below apply to you, talk to your doctor before taking this medicine:

• 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 have kidney or liver disease
• if you have had an allergy or reaction to any medicines used to treat your disease
• if you have a past medical history of non-traumatic brain haemorrhage.

• You should tell your doctor if you are to have surgery (including dental procedures).
• 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 straight away (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 muscles 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 reduce excess stomach acid,
• fluconazole or voriconazole, medicines to treat fungal infections,
• efavirenz, or other anti-retroviral medicines (used to treat HIV infections),
• moclobemide, medicine to treat depression,
• carbamazepine a medicine used to treat some forms of epilepsy,
• 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 ischaemic attack or ischaemic stroke in mild severity, you may be prescribed this medicine in combination with aspirin, a substance present in many medicines used to relieve pain and lower fever. An occasional use of aspirin (no more than 1,000mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

This medicine may be taken with or without food.

It is preferable not to take this medicine during pregnancy.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking this medicine, 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, contact your doctor before taking this medicine.

Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.

If you forget to take a dose of this medicine, but remember within 12 hours of your usual time, take your tablet straight away 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 this medicine 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 straight away (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 effects (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 or loss of the 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 (website: 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 film-coated tablet contains 75mg of clopidogrel (as besilate).

The other ingredients are:

Tablet core: Microcrystalline cellulose (E460), Mannitol (E421), Hydroxypropylcellulose (E463), Crospovidone (E1202), Citric acid monohydrate (E330), Macrogol 6000 (E1521), Stearic acid (E570), Talc (E553b).

Tablet coating: Hypromellose (E464), Lactose monohydrate, Iron oxide red (E172), Triacetin (E1518), Titanium dioxide (E171).

Clopidogrel film-coated tablets are pink, round and biconvex. They are supplied in PVC/PE/PVDC/Aluminium blisters packed in cartons containing 14, 28, 30, 50, 56, 84, 90, 98, 100 film-coated tablets.

Not all pack sizes may be marketed.

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