CoPlavix tablets film-coated

Ország: Örményország

Nyelv: angol

Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktív összetevők:

clopidogrel, acetylsalicylic acid

Beszerezhető a:

Sanofi Winthrop Industrie

ATC-kód:

B01AC30

INN (nemzetközi neve):

clopidogrel, acetylsalicylic acid

Adagolás:

75mg+ 100mg

Gyógyszerészeti forma:

tablets film-coated

db csomag:

(30/3x10/) in blister

Recept típusa:

Prescription

Engedélyezési státusz:

Registered

Engedély dátuma:

2022-05-16

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
COPLAVIX
®
75 MG/100 MG FILM-COATED TABLETS
clopidogrel/ acetylsalicylic acid
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 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 get any side effects, talk to your doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What CoPlavix is and what it is used for
2. What you need to know before you take CoPlavix
3. How to take CoPlavix
4. Possible side effects
5 How to store CoPlavix
6. Contents of the pack and other information
1. WHAT COPLAVIX IS AND WHAT IT IS USED FOR
CoPlavix contains clopidogrel and acetylsalicylic acid (ASA) 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
in some types of blood vessels (called arteries), antiplatelet
medicinal products reduce
the chances of blood clots forming (a process called
atherothrombosis).
CoPlavix is taken by adults 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 effective blood flow.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COPLAVIX
CONTRAINDICATIONS:
DO NOT TAKE COPLAVIX
• if you are allergic to cl

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
CoPlavix 75 mg/100 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
CoPlavix 75 mg/100 mg film-coated tablets
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate) and 100 mg of
acetylsalicylic acid (ASA).
_Excipients with known effect: _
Each film-coated tablet contains 8 mg of lactose and 3.3 mg of
hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet).
CoPlavix 75 mg/100 mg film-coated tablets
Light pink, oval, slightly biconvex, engraved with «C75» on one side
and «A100» on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CoPlavix is indicated for the secondary prevention of atherothrombotic
events in adult patients
already
taking
both
clopidogrel
and
acetylsalicylic
acid
(ASA).
CoPlavix
is
a
fixed-dose
combination
medicinal product for continuation of therapy in:
• Non-ST segment elevation acute coronary syndrome (unstable angina
or non-Q-wave
myocardial infarction) including patients undergoing a stent placement
following percutaneous
coronary intervention
• ST segment elevation acute myocardial infarction in medically
treated patients eligible for
thrombolytic therapy
For further information please refer to section 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly _
CoPlavix 75 mg/100 mg film-coated tablets
CoPlavix should be given as a single daily 75 mg/100 mg dose.
CoPlavix fixed-dose combination is used following initiation of
therapy with clopidogrel and ASA
given separately, and replaces the individual clopidogrel and ASA
products.
− _In patients with non-ST segment elevation acute coronary syndrome
_(unstable angina or
non-Q-wave myocardial infarction): The optimal duration of treatment
has not been formally
established. Clinical trial data support use up to 12 months, and the
maximum benefit was seen at
3 months (see section 5.1). If the use of CoPlavix is discontinue