Plavix 75 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Plavix 75 mg film-coated tablets

clopidogrel

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Plavix is and what it is used for

Plavix contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells found in the blood that clump together when blood clots. Antiplatelet medicines prevent this clumping and thereby reduce the chance of blood clots forming (a process known as thrombosis).

Plavix is given to adults to help prevent blood clots (thrombi) from 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 Plavix to help prevent blood clots and reduce the risk of these serious events because:

• you have a condition that causes hardening of the arteries (also known as atherosclerosis), and
• you have previously had a heart attack, stroke, or you have a condition called peripheral arterial disease, or
• you have experienced a severe type of chest pain known as “unstable angina” or “heart attack”. For the treatment of this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clots).
• you have experienced symptoms of a stroke that disappeared within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also give you acetylsalicylic acid within the first 24 hours.
• you have an irregular heartbeat, a condition called “atrial fibrillation”, and you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists) that prevent the formation of new clots and prevent existing clots from growing. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Plavix and acetylsalicylic acid for this condition. Your doctor has prescribed Plavix plus acetylsalicylic acid if you cannot take “oral anticoagulants” and you have no risk of serious bleeding.

2. What you need to know before taking Plavix

Do not take Plavix

• If you are allergic (hypersensitive) to clopidogrel or to any of the other components of this medicine (listed in section 6).
• If you have active bleeding, such as a stomach ulcer or bleeding in the brain.
• If you have severe liver disease.

If you think any of these may apply to you, or if you have any doubts, consult your doctor before taking Plavix.

Warnings and precautions

Before starting treatment with Plavix, inform your doctor if you are in any of the following situations:

• If you are at risk of bleeding (haemorrhage) because:

  • you have a disease that involves a risk of internal bleeding (such as a stomach ulcer).
  • you have a blood disorder that predisposes you to internal bleeding (bleeding into tissues, organs, or joints).
  • you have recently suffered a serious injury.
  • you have recently undergone surgery (including dental surgery).
  • you are scheduled to undergo surgery (including dental surgery) within the next seven days.

• If you have had a blood clot in a brain artery (ischaemic stroke) within the last 7 days.

• If you have liver or kidney disease.

• If you have had an allergic reaction or adverse reaction to any medication used to treat your condition.

• If you have a history of non-traumatic intracranial haemorrhage (bleeding in the brain not caused by injury).

During treatment with Plavix:

• Inform your doctor if you are scheduled for surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bruises) under the skin which may appear as localized red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• If you cut yourself or sustain an injury, bleeding may take longer than usual to stop. This is related to how the medicine works, as it prevents blood from forming clots. For minor cuts or injuries, such as those occurring while shaving, this is not usually a concern. However, if you are concerned about blood loss, consult your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may request blood tests.

Children and adolescents

This medicine should not be given to children, as it is not effective.

Taking Plavix with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may affect how Plavix works, or Plavix may affect how other medicines work.

You must specifically inform your doctor if you are taking:

• Medicines that may increase the risk of bleeding, such as:

  • Oral anticoagulants, medicines used to reduce blood clotting,
  • Non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints,
  • Heparin, or any other injectable medicine used to reduce blood clotting,
  • Ticlopidine, another antiplatelet agent,
  • A serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other drugs of the same type), medicines commonly used to treat depression,
  • Rifampicin (used for serious infections)

• Omeprazole or esomeprazole, medicines used to treat stomach discomfort,

• Fluconazole or voriconazole, medicines used to treat fungal infections,

• Efavirenz, or other antiretroviral medicines (used to treat HIV infections),

• Carbamazepine, a medicine used to treat certain forms of epilepsy,

• Moclobemide, a medicine for depression,

• Repaglinide, a medicine for the treatment of diabetes,

• Paclitaxel, a medicine for cancer treatment,

• Opioids: if you are being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),

• Rosuvastatin (used to lower cholesterol levels).

If you have experienced severe chest pain (unstable angina or myocardial infarction), transient ischaemic attack, or mild ischaemic stroke, you may have been prescribed Plavix in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. A single dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) is generally not expected to cause problems, but prolonged use under other circumstances should be discussed with your doctor.

Taking Plavix with food and drinks

Plavix can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or think you may be pregnant, inform your doctor or pharmacist before taking Plavix. If you become pregnant while taking Plavix, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

You must not breastfeed while taking this medicine.

If you are breastfeeding or planning to breastfeed, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is unlikely that Plavix will affect your ability to drive or operate machinery.

Plavix contains lactose

If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), consult him before taking this medicine.

Plavix contains hydrogenated castor oil

This may cause stomach discomfort and diarrhoea.

3. How to take Plavix

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg Plavix tablet daily, taken orally with or without food, at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe 300 mg or 600 mg of Plavix (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) to be taken once at the beginning of treatment. After that, the recommended dose is one 75 mg Plavix tablet daily, as described above.

If you have experienced stroke symptoms that disappear within a short time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe 300 mg of Plavix (1 tablet of 300 mg or 4 tablets of 75 mg) once at the beginning of treatment. After that, the recommended dose is one 75 mg Plavix tablet daily, as described above, together with acetylsalicylic acid for 3 weeks. After this period, your doctor will prescribe either Plavix alone or acetylsalicylic acid alone.

You should continue taking Plavix for as long as your doctor prescribes it.

If you take more Plavix than you should

Contact your doctor or go to the nearest hospital emergency department, as there is an increased risk of bleeding.

If you forget to take Plavix

If you forget to take a dose of Plavix but remember within 12 hours of the time you were supposed to take it, take the tablet immediately and take the next one at your usual time.

If you forget for more than 12 hours, simply take the next dose at your usual time. Do not take a double dose to make up for a forgotten tablet.

With the pack sizes of 7, 14, 28 and 84 tablets, you can check the last day you took a Plavix tablet by looking at the calendar printed on the blister pack.

If you stop taking Plavix

Do not stop your treatment unless your doctor tells you to do so. Contact your doctor or pharmacist before stopping this medicine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Plavix can have adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

• Fever, signs of infection, or extreme fatigue. These symptoms may be due to a rare decrease in certain blood cells.
• Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red spots and/or confusion (see section 2 “Warnings and precautions”).
• Swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin. These may be signs of an allergic reaction.

The most frequently reported adverse effect with Plavix is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases have also been reported of: bleeding from blood vessels in the eyes, intracranial bleeding, pulmonary bleeding, or joint bleeding.

If you experience prolonged bleeding while taking Plavix

If you cut yourself or sustain a wound, the bleeding may take longer than usual to stop. This is related to the medicine's mechanism of action, as it prevents blood from forming clots. For minor cuts or wounds, such as those occurring during shaving, this is usually not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Warnings and precautions”).

Other adverse effects include:

Common adverse effects (may affect up to 1 in 10 people):

Diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon adverse effects (may affect up to 1 in 100 people):

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rashes, itching, dizziness, tingling and numbness.

Rare adverse effects (may affect up to 1 in 1,000 people):

Dizziness, breast enlargement in males.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with coughing; generalized allergic reactions (for example, feeling of warmth with sudden general discomfort up to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mouth lining (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste.

Adverse effects with unknown frequency (cannot be estimated from available data): Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

In addition, your doctor may observe changes in the results of your blood or urine tests.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Plavix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister, after EXP. The expiry date is the last day of the month indicated.

See storage conditions on the packaging.

Store below 30°C when Plavix is presented in PVC/PVDC/aluminum blisters.

When Plavix is presented in any aluminum blister, no special storage conditions are required.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Plavix

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

The other components 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), iron oxide red (E172), and titanium dioxide (E171).
• Polishing: carnauba wax.

Appearance of the product and contents of the pack

Plavix 75 mg coated tablets are round, biconvex, pink in colour, with the number “75” engraved on one side and “1171” on the other. Plavix is available in cardboard packs containing:

• 7, 14, 28, 30, 84, 90 and 100 tablets in PVC/PVDC/Aluminium blisters or Aluminium/Aluminium blisters,
• 50x1 tablets in PVC/PVDC/Aluminium blisters or single-dose aluminium blisters.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturers:

Sanofi Winthrop Industrie
1, Rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France.

or

Delpharm Dijon
6, Boulevard de l’Europe, F - 21800 Quétigny, France

or

Sanofi S.r.l.
Strada Statale 17, Km 22
67019 Scoppito (AQ) – Italy

or

Sanofi Winthrop Industrie
30-36 avenue Gustave Eiffel
37100 Tours
France

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this summary:

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/