Cadigrel tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

clopidogrel (clopidogrel bisulfate)

Available from:

CADILA PHARMACEUTICALS LTD.

ATC code:

B01AC04

INN (International Name):

clopidogrel (clopidogrel bisulfate)

Dosage:

75mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/3x10/) in blister, (30/3x10/) in strip

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-04-22

Patient Information leaflet

CADIGREL 75MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
CADIGREL 75 MG 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 Cadigrel is and what it is used for
2. What you need to know before you take Cadigrel.
3. How to take Cadigrel
4. Possible side effects
5. How to store Cadigrel
6. Contents of the pack and other information
1. WHAT CADIGREL IS AND WHAT IT IS USED FOR
Cadigrel 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).
Cadigrel is taken by adults to prevent blood clots (thrombi) forming
in hardened blood vessels
(arteries), a process known as atherothrombosis, which can lead to
atherothrombotic events (such
as stroke, heart attack, or death).
You have been prescribed Cadigrel to help prevent blood clots and
reduce the risk of these
severe events because:
•
You have a condition of hardening of arteries (also known as
atherosclerosis), and
•
You have previously experienced a heart attack, stroke or have a
condition known as
peripheral arterial disease, or
•
You have experienced a severe type of chest pain known as ‘unstable
angina’ or
‘myocardial infarction’ (heart attack). For the treatment of this
condition your doctor may
have placed a stent in the blocked or narro

Summary of Product characteristics

MODULE 1
1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS CLOPIDOGREL TABLETS USP 75MG
1389, DHOLKA – 382 225, AHMEDABAD, GUJARAT STATE, INDIA.
1. NAME OF THE MEDICINAL PRODUCT
Cadigrel (Clopidogrel Tablets USP 75mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of Clopidogrel
3. PHARMACEUTICAL FORM
Film-coated tablet.
Brown, round, biconvex, film coated tablets, plain on both sides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Prevention of atherothrombotic events_
Clopidogrel is indicated in
• Adult patients suffering from myocardial infarction (from a few
days until less than 35 days),
ischaemic stroke (from 7 days until less than 6 months) or established
peripheral arterial disease.
• Adult patients suffering from acute coronary syndrome:
-
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, in combination with acetylsalicylic acid (ASA).
- ST segment elevation acute myocardial infarction, in combination
with ASA in medically
treated patients eligible for thrombolytic therapy.
_Prevention of atherothrombotic and thromboembolic events in atrial
fibrillation_
In adult patients with atrial fibrillation who have at least one risk
factor for vascular events, are
not suitable for treatment with Vitamin K antagonists (VKA) and who
have a low bleeding risk,
clopidogrel is indicated in combination with ASA for the prevention of
atherothrombotic and
thromboembolic events, including stroke.
For further information please refer to section 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
• Adults and elderly
Clopidogrel should be given as a single daily dose of 75 mg.
In patients suffering from acute coronary syndrome:
-
Non-ST
segment
elevation
acute
coronary
syndrome
(unstable
angina
or
non-Q-wave
myocardial infarction): clopidogrel treatment should be initiated with
a single 300-mg loading
dose and then continued at 75 mg on