Plavix 300 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Plavix 300 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. 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. Do 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 effects, talk to your doctor or pharmacist, even if they are effects 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 platelet aggregation inhibitors. Platelets are very small blood cells that clump together when blood clots. Platelet aggregation inhibitors reduce the chance of blood clots (a process known as thrombosis) by preventing this clumping.

Plavix is given to adults to help prevent blood clots (thrombi) in hardened blood vessels (arteries), a condition known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

Your doctor has 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 called atherosclerosis), and
• you have previously had a heart attack, stroke, or you have a disease called peripheral arterial disease, or
• you have experienced a severe type of chest pain known as “unstable angina” or “myocardial infarction.” 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 ischemic attack) or a mild ischemic stroke. Your doctor may also administer 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 stop existing clots from growing. You 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 are unable to take “oral anticoagulants” and 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 because:

• you have a condition 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 allergy or reaction to any medicine used to treat your condition.
  • If you have a history of non-traumatic brain haemorrhage.

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 tiredness, confusion, 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 during shaving, this is not significant. However, if you are concerned about blood loss, consult your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may ask you to have blood tests.

Children and adolescents

This medicine should not be given to children because 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 the use of Plavix or vice versa.

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, 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, or other antiplatelet agents,

• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other drugs of this type), medicines generally used to treat depression,

• rifampicin (used for serious infections),

• omeprazole or esomeprazole, medicines for treating stomach discomfort,

• fluconazole or voriconazole, medicines for treating bacterial and fungal infections,

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

• carbamazepine, a medicine for treating certain forms of epilepsy,

• moclobemide, a medicine for depression,

• repaglinide, a medicine for treating diabetes,

• paclitaxel, a medicine for treating cancer,

• 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 reduce 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) generally should not cause any problems, but prolonged use in 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 plan to breastfeed, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before taking 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 also contains hydrogenated castor oil

This may cause stomach discomfort and diarrhoea.

3. How to take Plavix

Follow exactly the instructions for using 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 this, the recommended dose is one 75 mg Plavix tablet daily, as described above.

If you have experienced symptoms of a stroke that disappear within a short period of 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 this, the recommended dose is one 75 mg Plavix tablet daily as described above, taken together with acetylsalicylic acid for 3 weeks. After this period, your doctor will prescribe either Plavix alone or acetylsalicylic acid alone.

You should take Plavix for as long as your doctor continues to prescribe 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 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 may be due to a rare reduction 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 rash 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 of bleeding from blood vessels in the eyes, intracranial bleeding, pulmonary bleeding, or bleeding into joints have also been reported.

If you experience prolonged bleeding while taking Plavix

If you cut yourself or sustain an injury, bleeding may take longer than usual to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or injuries, such as cutting yourself while 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:

Frequent 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 men.

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 cough; generalized allergic reactions (for example, sensation of warmth with sudden general discomfort up to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mucous membrane of the mouth (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 the available data): Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

In addition, your doctor may observe changes in your blood or urine test results.

Reporting of adverse effects

If you experience any kind 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, following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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 unused medicines and their packaging. 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 300 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, polyethylene glycol 6000, and low-substituted hydroxypropylcellulose.
• Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172), and titanium dioxide (E171).
• Polish: carnauba wax.

Appearance of the product and contents of the pack

Plavix 300 mg coated tablets are oblong, pink in colour, with the number “300” engraved on one side and “1332” on the other. Plavix is available in cardboard packs containing 4x1, 10x1, 30x1 and 100x1 tablets in unit-dose blisters made of Aluminium/Aluminium.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer:

Sanofi Winthrop Industrie

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

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

Date of the most recent review of this leaflet:

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