In Adult patients with moderate to high-risk Transient Ischemic Attack (TIA) (ABCD2 score ≥4) or minor Ischemic Stroke (IS) (NIHSS2 ≤3):²

Clopidogrel 300 mg should be given as a loading dose within 24 hours of either the TIA or IS event Followed by Clopidogrel 75 mg once daily and Aspirin (75 mg - 100 mg once daily).² Treatment with Clopidogrel and Aspirin should be started within 24 hours of the event and be continued for 21 days followed by single antiplatelet therapy.²

Plavix^® Clopidogrel 75mg film-coated tablets

Indications

You have been prescribed Plavix to help prevent blood clots and reduce the risk of these severe events because:

• You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease.
• You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial infarction’ (heart attack).
• You have a condition of hardening of arteries (also known as atherosclerosis). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You may also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
• You have experienced symptoms of a stroke which go away within a short period of time (also known as transient ischemic attack) or a stroke mild in severity. You may also be given acetylsalicylic acid by your doctor starting 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) which prevent new clots from forming and prevent existing clots from growing ‘You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid or combined use of Plavix and acetylsalicylic acid for this condition your doctor should have prescribed Plavix plus acetylsalicylic acid if you cannot take oral anticoagulants and you do not have a risk of major bleeding.

Dosage

The recommended dose, including for patients with a condition called ‘atrial fibrillation’ (an irregular heartbeat), is one 75 mg tablet of Plavix.’ per day to be taken orally with or without food, and at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Plavix (1 tablet of300 mg or 4 tablets of75mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Plavix per day as described above.

If you have experienced symptoms of a stroke which go away within a short period of time (also known as transient ischemic attack) or a stroke mild in severity, your doctor may give you 300 mg of Plavix (1 tablet of300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Plavix per day as described above with acetylsalicylic acid for 3 weeks. Then the physician would prescribe either Plavix alone or acetylsalicylic acid alone.

You should take Plavix for as long as your doctor continues to prescribe it.

Contraindications

• Do not take Plavix
• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine.
• 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.

Warnings and precautions

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 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.

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 developed medical condition (also known as Thrombotic Thrombocytopenic Purpura or TIP) that include 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).
• 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 straightway. Plavix contain lactose
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine . Plavix contains hydrogenated castor oil
• This may cause stomach upset or diarrhoea.
• Your doctor may order blood tests.

Children and adolescents

Do not give this medicine to children because it does not work.

Pregnancy and lactation

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.

Driving and using machines

Plavix is unlikely to affect your ability to drive or to use machines.

Side effects (Most common and common)

Contact your doctor immediately if you experience: fever, signs of infection or extreme tiredness.
This 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 · 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 Plavix 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 experience prolonged bleeding when taking Plavix 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.

Other side effects include:

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

Diarrhea, abdominal pain, indigestion or heartburn.

• Always read the full prescribing information.
• Healthcare professionals are asked to report any suspected adverse reactions to Egyptian pharmacovigilance center (EPVC).
• Egyptian drug authority plavix leaflet approval date 25-1-2022.

Approved by Egyptian Drug Authority: HF0065OA628/022023. Invalidation date: 07/09/2023. Kindly report any violated online promotional, educational and awareness material not having this message to The General administration for Regulation of Marketing & Advertising Materials at: www.edaegypt.gov.eg

For further information, please contact: SANOFI Egypt 3,
EL Massaneh St., Zeitoun, Cairo, Egypt, P.O. BOX:1486
TEL.: +202 22860000-22860060 Fax: +202 22860107 - 22860112 

MAT-EG-2202029/V1.0/June2023