Plavix 75mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clopidogrel

Available from:

DE Pharmaceuticals

ATC code:

B01AC04

INN (International Name):

Clopidogrel

Dosage:

75mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02090000

Patient Information leaflet

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
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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

Summary of Product characteristics

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