Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
SANOFI-AVENTIS SOUTH AFRICA (PTY) LTD
Tablet
Each tablet contains ASPIRIN 100,0 mg CLOPIDOGREL HYDROGEN SULPHATE equivalent to CLOPIDOGREL 75,0 mg
2017-02-11
1 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S3 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: PLAVIX ® 75 MG Film-coated tablets Clopidogrel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PLAVIX. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. PLAVIX has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT PLAVIX CONTAINS: The active substance is clopidogrel. Each film-coated tablet contains clopidogrel hydrogen sulphate (form II) equivalent to 75 mg of the clopidogrel base. The other inactive ingredients are mannitol (sugar), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose in the tablet core, and lactose (milk sugar), hypromellose, triacetin, red iron oxide (E172), titanium dioxide (E171) and carnauba wax in the tablet coating. WHAT PLAVIX IS USED FOR: 2 You have been prescribed PLAVIX to help prevent blood clots and reduce the risk of these events because: You have a condition of hardening of arteries (also known as atherosclerosis), and You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or You have experienced a severe type of chest pain known as “unstable angina” or “myocardial infarction” (heart attack). In this case you should 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. BEFORE YOU TAKE PLAVIX: DO NOT TAKE PLAVIX: if you are hypersensitive (allergic) to the active ingredient clopidogrel or to any of the other ingredients of PLAVIX. if you are hypersensitive (allergic) to other anti-platelet medicines called thienopyridine (such as ticlopidine, prasugrel), used to prevent blood clots. if you have a medical condition that Read the complete document
1 SCHEDULING STATUS: S3 PROPRIETARY NAME AND DOSAGE FORM: PLAVIX® 75 MG FILM-COATED TABLETS COMPOSITION: Each film-coated tablet contains: Clopidogrel hydrogen sulphate (form II) equivalent to 75 mg of clopidogrel base. Inactive excipients: Mannitol (sugar), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose in the tablet core, and lactose (milk sugar), hypromellose, triacetin, red iron oxide (E172), titanium dioxide (E171), and carnauba wax in the tablet coating. Contains sugar and lactose monohydrate. CATEGORY AND CLASS: A 8.2 Anticoagulants PHARMACOLOGICAL ACTION: PHARMACODYNAMIC PROPERTIES: Clopidogrel is a specific and potent inhibitor of platelet aggregation. Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor, and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Biotransformation of clopidogrel is necessary to produce 2 inhibition of platelet aggregation. However, an active metabolite responsible for the activity of the drug has not been isolated. Clopidogrel also inhibits platelet aggregation induced by other agonists by blocking the amplification of platelet activation by released ADP. Clopidogrel acts by irreversibly modifying the platelet ADP receptor. Consequently, platelets exposed to clopidogrel are affected for the remainder of their lifespan and recovery of normal platelet function occurs at a rate consistent with platelet turnover (approximately 7 days). Dose-dependent inhibition of platelet aggregation was noted 2 hours after single oral doses of clopidogrel. Repeated doses of 75 mg per day produced inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7. At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40 % and 60 %. Platelet aggregation and bleeding time gradually returned to baselin Read the complete document