Clopidogrel Sandoz
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-10-2011
Charakterystyka produktu
(SPC)
26-10-2011
Sprawozdanie z oceny publicznego
(PAR)
26-10-2011
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: 2
Status autoryzacji:
Withdrawn
Data autoryzacji:
2009-09-21
Ulotka dla pacjenta
B. PACKAGE LEAFLET
20
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL SANDOZ 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 Sandoz is and what it is used for
2.
Before you take Clopidogrel Sandoz
3.
How to take Clopidogrel Sandoz
4.
Possible side effects
5.
How to store Clopidogrel Sandoz
6.
Further information
1.
WHAT CLOPIDOGREL SANDOZ IS AND WHAT IT IS USED FOR
Clopidogrel Sandoz 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 Sandoz 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 Sandoz 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 SANDOZ
DO NOT TAKE CLOPIDOGREL SANDOZ:
If you are allergic (hypersensitive) to clopidogrel or an
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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 Sandoz 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Excipients: each tablet contains 3.80 mg 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
Adults and elderly
Clopidogrel should be given as a single daily dose of 75 mg with or
without food.
Pharmacogenetics
CYP2C19 poor metaboliser status is associated with diminished response
to clopidogrel. The
optimal dose regimen for poor metabolisers has yet to be determined
(see section 5.2).
Paediatric patients
The safety and efficacy of clopidogrel in children and adolescents
have not yet been
established.
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).
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Severe liver impairment.
Active pathological bleeding such as peptic ulcer or intracranial
haemorrhage.
2
Medicinal product no longer authorised
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Bleeding and haematological disorders _
Due to the risk of bleeding and haematological adverse reactions,
blood cell count determination
and/or
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