Clopidogrel Acino Pharma GmbH
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-07-2012
Charakterystyka produktu
(SPC)
26-07-2012
Sprawozdanie z oceny publicznego
(PAR)
26-07-2012
Składnik aktywny:
clopidogrel
Dostępny od:
Acino Pharma GmbH
Kod ATC:
B01AC04
INN (International Nazwa):
clopidogrel
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Wskazania:
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.
Podsumowanie produktu:
Revision: 1
Status autoryzacji:
Withdrawn
Data autoryzacji:
2009-09-21
Ulotka dla pacjenta
B. PACKAGE LEAFLET
21
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL ACINO PHARMA GMBH 75 MG FILM-COATED TABLETS
Clopidogrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist,
IN THIS LEAFLET
:
1.
What Clopidogrel Acino Pharma GmbH is and what it is used for
2.
Before you take Clopidogrel Acino Pharma GmbH
3.
How to take Clopidogrel Acino Pharma GmbH
4.
Possible side effects
5.
How to store Clopidogrel Acino Pharma GmbH
6.
Further information
1.
WHAT CLOPIDOGREL ACINO PHARMA GMBH IS AND WHAT IT IS USED FOR
Clopidogrel Acino Pharma GmbH 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 Acino Pharma GmbH 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 Acino Pharma GmbH 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 legs
caused by vascular
occlusions)
2.
BEFORE YOU TAKE CLOPIDOGREL A
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Charakterystyka produktu
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Acino Pharma GmbH 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Excipients: each film-coated tablet contains 3.80 mg of hydrogenated
castor oil.
For a 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).
2
Medicinal product no longer authorised
Method of administration
For oral use
It may be given with or without food.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Severe hepatic impairment.
Active pathological bleeding such as peptic ulcer or intracranial
haemorr
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