Clopidogrel ratiopharm
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
12-12-2013
Produktets egenskaber
(SPC)
12-12-2013
Offentlige vurderingsrapport
(PAR)
12-12-2013
Aktiv bestanddel:
clopidogrel
Tilgængelig fra:
Archie Samuel s.r.o.
ATC-kode:
B01AC04
INN (International Name):
clopidogrel
Terapeutisk gruppe:
Antithrombotic agents
Terapeutisk område:
Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Terapeutiske indikationer:
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. For further information please refer to section 5.1.
Produkt oversigt:
Revision: 5
Autorisation status:
Withdrawn
Autorisation dato:
2009-09-23
Indlægsseddel
22
B. PACKAGE LEAFLET
Medicinal product no longer authorised
23 PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL RATIOPHARM 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 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 Clopidogrel ratiopharm is and what it is used for
2.
What you need to know before you take Clopidogrel ratiopharm
3.
How to take Clopidogrel ratiopharm
4.
Possible side effects
5.
How to store Clopidogrel ratiopharm
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL RATIOPHARM IS AND WHAT IT IS USED FOR
Clopidogrel ratiopharm contains the active ingredient Clopidogrel
which belongs to a group of
medicines called antiplatelet medicinal products. Platelets (so-called
thrombocytes) are very small
structures, 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 ratiopharm 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 Clopidogrel ratiopharm 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 (disturbed blood flow in arms or
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel ratiopharm 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Excipients with known effect: Each film-coated tablet contains 3.80 mg
of hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, marbled, round and biconvex film-coated tablets.
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.
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.
If a dose is missed:
-
Within less than 12 hours after regular scheduled time: patients
should take the dose
immediately and then take the next dose at the regular scheduled time.
-
For more than 12 hours: patients should take the next dose at the
regular scheduled time
and should not double the dose.
Paediatric population
Clopidogrel should not be used in children because of efficacy
concerns (see section 5.1).
Renal impairment
Therapeutic experience is limited in patients with renal impairment
(see section 4.4).
Hepatic impairment
Therapeutic experience is limited in patients with moderate hepatic
disease who may have
bleeding diatheses (see section 4.4).
Method of administration
For oral use
It may be given with or without food.
Medicinal product no longer authorised
3
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 2 or section
6.1.
Severe hepatic impairment.
Active pathological bleedin
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