Plavix 75 mg 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 have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

1. What Plavix is and what it is used for
2. What you need to know before you take Plavix
3. How to take Plavix
4. Possible side effects
5. How to store Plavix
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 Plavix.

If any of the situations mentioned below apply to you, you should tell your doctor before taking Plavix:

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

While you are taking Plavix:

• 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 Plavix 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 Plavix 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.

Plavix 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 Plavix. If you become pregnant while taking Plavix, 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.

Plavix 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 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 Plavix, 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.

For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Plavix by referring to the calendar printed on the blister.

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.

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via 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 tablet contains 75 mg of clopidogrel (as hydrogen sulphate).

The other ingredients are (see section 2 ‘Plavix contains lactose’ and ‘Plavix contains hydrogenated castor oil’):

• Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose,
• Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171),
• Polishing agent: carnauba wax.

Plavix 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’. Plavix 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
• 50x1 tablets in PVC/PVDC/Aluminium blisters or in all aluminium unit-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturers:

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.