Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clopidogrel
Sanofi
B01AC04
Clopidogrel
75mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02090000; GTIN: 5000283653011
1 SANOFI AMBARES - FRANCE LIBELLÉ: NOT PLAVIX 75 CP DC RL GB/IE SENS D’ENROULEMENT PORTRAIT 4A NORD/NORTH 4A - 4B - PAYSAGE 1A EST/EAST 1A - 2B X ITEM CODE: 734456 Article : LEAFLET/NOTICE Code laetus : 1114 Country : GB/IE Color Nbr : 1 REF FICHE TECHNIQUE Based on: 701307 Format : 170X210-DC Font : OCEAN SANS PRO SAN AMBRS-M002187 NOT_S - Proof n°: 3 C. requirement : CRIE-V1-09/2012/CRGB-V1-05/2012 Font size : 9PT AMBRS-M002188 NOT_DC AMBRS-M002189 NOT_DP X Creation Date: 08/10/2018 USED COLOR PRINTABLE : Pantone Black + Dégradé NO PRINTABLE COLOR : Plan By : I. SOURBE AMBRS-M002190 NOT_TC AMBRS-M002191 NOT_TP - Modif Date: 30/10/2018 By : I. SOURBE AMBRS-M002192 NOT_QP - PACKAGE LEAFLET: INFORMATION FOR THE USER FILM-COATED TABLETS clopidogrel READ ALL OF THIS 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 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. WHAT IS IN THIS LEAFLET 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 1. WHAT PLAVIX IS AND WHAT IT IS USED FOR Plavix contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis). Plavix is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis Read the complete document
OBJECT 1 PLAVIX 75MG TABLETS Summary of Product Characteristics Updated 07-Nov-2018 | SANOFI • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Plavix 75 mg film-coated tablets Plavix 300 mg film-coated tablets 2. Qualitative and quantitative composition Plavix 75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate). _Excipients with known effect: _ Each film-coated tablet contains 3 mg of lactose and 3.3 mg of hydrogenated castor oil. Plavix 300 mg film-coated tablets Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen sulphate). _Excipients with known effect: _ Each film-coated tablet contains 12 mg of lactose and 13.2 mg of hydrogenated castor oil. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Plavix 75 mg film-coated tablets Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side. Plavix 300 mg film-coated tablets Pink, oblong, eng Read the complete document