CoPlavix tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

clopidogrel, acetylsalicylic acid

Available from:

Sanofi Winthrop Industrie

ATC code:

B01AC30

INN (International Name):

clopidogrel, acetylsalicylic acid

Dosage:

75mg+ 100mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-03-17

Patient Information leaflet

-3-
SANOFI
AMBARES - FRANCE
LIBELLÉ: NOT COPLAVIX 75/100 CP TC RL XD
SENS D’ENROULEMENT
PORTRAIT
4A NORD/NORTH
4A - 4B
-
PAYSAGE
1A EST/EAST
1A - 2B
X
ITEM CODE:
757951
Article : LEAFLET/NOTICE
Code laetus : 266
Country : XE
Color Nbr : 1
REF FICHE TECHNIQUE
Based on: 635177
Format : 170x210 TC
Font :-Ocean san pro san-
AMBRS-M002187 NOT_S
-
Proof n°: 3
C. requirement
:
CRX V4 01/2015
Font size : 7
AMBRS-M002188 NOT_DC
AMBRS-M002189 NOT_DP
-
Creation Date: 20/06/2019
USED COLOR PRINTABLE :
Pantone Reflex Blue
NO PRINTABLE COLOR :
Plan
By : B VIGUIE
AMBRS-M002190 NOT_TC
AMBRS-M002191 NOT_TP
X
Modif Date: 03/07/2019
By : B VIGUIE
AMBRS-M002192 NOT_QP
-
"CoPlavix contient de l’huile de ricin hydrogénée"), acide
stéarique
et silice colloïdale anhydre
-
enrobage du comprimé : lactose monohydraté (voir rubrique 2
"CoPlavix contient du lactose"), hypromellose (E464), dioxyde de
titane (E171), triacétine (E1518), oxyde de fer rouge (E172)
-
agent polissant : cire de carnauba
QU’EST-CE QUE COPLAVIX ET CONTENU DE L’EMBALLAGE EXTÉRIEUR
Les comprimés pelliculés de CoPlavix 75 mg/100 mg sont ovales,
légèrement biconvexes, légèrement roses et portent l’inscription
"C75"
gravée sur une face et l'inscription "A100" sur l'autre face.
CoPlavix est
présenté dans une boîte en carton contenant :
-
14,
28
et
84
comprimés
sous
plaquettes
thermoformées
en
aluminium.
-
30x1,
50x1,
90x1
et
100x1
comprimé
sous
plaquettes
thermoformées en aluminium pour délivrance à l’unité.
Toutes les présentations peuvent ne pas être commercialisées.
TITULAIRE DE L'AUTORISATION DE MISE SUR LE MARCHÉ
Sanofi Clir SNC
54, rue La Boétie
75008 Paris - France
FABRICANT
Sanofi Winthrop Industrie
1 rue de la Vierge, Ambarès et Lagrave
33565 Carbon Blanc Cedex - France
LA DERNIÈRE DATE À LAQUELLE CETTE NOTICE A ÉTÉ MODIFIÉE EST
_OCTOBRE 2018._
PACKAGE LEAFLET: INFORMATION FOR THE USER
FILM COATED TABLETS
clopidogrel/ acetylsalicylic acid
WHAT IS IN THIS LEAFLET:
1.
What CoPlavix is and what it is used for
2.
What

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
CoPlavix
Nonproprietary Name: clopidogrel / acetylsalicylic acid
2.
QUANTITATIVE AND QUALITATIVE COMPOSITION
Active ingredient:
clopidogrel and acetylsalicylic acid. Each tablet contains 75 mg of
clopidogrel (as hydrogen sulphate) and
100 mg of acetylsalicylic acid.
The other ingredients are:
Tablet core: mannitol (E421), macrogol 6000, microcrystalline
cellulose, low substituted
hydroxypropylcellulose, maize starch, hydrogenated castor oil,stearic
acid and colloidal anhydrous silica.
Tablet coating: lactose monohydrate, hypromellose (E464), titanium
dioxide (E171), triacetin (E1518),
red iron oxide (E172)
Polishing agent: carnauba wax
3.
PHARMACEUTICAL FORM
film-coated tablets
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CoPlavix is taken to prevent blood clots forming in hardened arteries
which can lead to atherothrombotic
events (such as stroke, heart attack, or death).
You have been prescribed CoPlavix in place of the two separate
medicines, clopidogrel and ASA, to help
prevent blood clots because you have experienced a severe type of
chest pain known as ‘unstable angina’
or heart attack (myocardial infarction). For the treatment of this
condition your doctor may have placed a
stent in the blocked or narrowed artery to restore efective blood
flow.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION.
The usual dose is one tablet of CoPlavix per day to be taken orally
with a glass of water, with or without
food.
4.3 CONTRAINDICATIONS
Do not take CoPlavix
-
if you are allergic (hypersensitive) to clopidogrel, acetylsalicylic
acid (ASA) or any of the other
ingredients of CoPlavix,
-
if you are allergic to other products called non-steroidal
anti-inflammatory products usually used
to treat painful and/or inflammatory conditions of muscles or joints,
-
if you have a medical condition that include the combination of
asthma, nasal discharge (runny
nose) and polyps (a type of growth in the nose),
-
if you have a medical condition that is cur