CLOPIDOGREL PENSA 75 Milligram Film Coated Tablet
国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
资料单张 有效成分:
CLOPIDOGREL BESILATE
可用日期:
Pensa Pharma AB
INN（国际名称）:
CLOPIDOGREL BESILATE
剂量:
75 Milligram
药物剂型:
Film Coated Tablet
处方类型:
Product subject to prescription which may be renewed (B)
授权状态:
Authorised
授权日期:
0000-00-00
资料单张
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL PENSA 75 MG FILM-COATED TABLETS
Clopidogrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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 of the side effects, talk to your doctor, pharmacist or
nurse.
This includes
any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.What Clopidogrel Pensa is and what it is used for
2. What you need to know before you take Clopidogrel Pensa
3.How to take Clopidogrel Pensa
4.Possible side effects
5.How to store Clopidogrel Pensa
6. Contents of the pack and other information
1. WHAT CLOPIDOGREL PENSA IS AND WHAT IT IS USED FOR
Clopidogrel Pensa 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).
Clopidogrel Pensa is taken 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 Clopidogrel Pensa 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
artherosclerosis), 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
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产品特点
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clopidogrel Pensa 75 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel besilate).
Excipient with known effect: each tablet contains 2.80 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round, biconvex, film-coated tablets with '75' embossed on one side and a diameter of approximately 8.3 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
• 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.
• 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.
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 once a
day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily). Since higher
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