Plavix 300mg tablets

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Clopidogrel hydrogen sulfate

Доступно од:

Sanofi

АТЦ код:

B01AC04

INN (Међународно име):

Clopidogrel hydrogen sulfate

Дозирање:

300mg

Фармацеутски облик:

Tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: ; GTIN: 5000283653219

Информативни летак

1
SANOFI
AMBARES - FRANCE
LIBELLÉ: NOT PLAVIX 300MG CP DC RL GB
SENS D’ENROULEMENT
PORTRAIT
4A NORD/NORTH
4A - 4B
X
PAYSAGE
1A EST/EAST
1A - 2B
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ITEM CODE:
734441
Article : LEAFLET/NOTICE
Code laetus : 819
Country : GB
Color Nbr : 1
REF FICHE TECHNIQUE
Based on: 701303
Format : 170X210-DC
Font :
OCEAN SANS PRO SAN
AMBRS-M002187 NOT_S
-
Proof n°: 3
C. requirement
:
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, which can lead
to

Карактеристике производа

OBJECT 1
PLAVIX 300MG 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, en