CoPlavix 75mg+100mg 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:

2017-12-08

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