Clopidogrel Acino Pharma

País: Unión Europea

Idioma: inglés

Fuente: EMA (European Medicines Agency)

Ingredientes activos:

clopidogrel

Disponible desde:

Acino Pharma GmbH

Código ATC:

B01AC04

Designación común internacional (DCI):

clopidogrel

Grupo terapéutico:

Antithrombotic agents

Área terapéutica:

Peripheral Vascular Diseases; Stroke; Myocardial Infarction

indicaciones terapéuticas:

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.

Resumen del producto:

Revision: 1

Estado de Autorización:

Withdrawn

Fecha de autorización:

2009-09-21

Información para el usuario

B. PACKAGE LEAFLET
21
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL ACINO PHARMA 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 is and what it is used for
2.
Before you take Clopidogrel Acino Pharma
3.
How to take Clopidogrel Acino Pharma
4.
Possible side effects
5.
How to store Clopidogrel Acino Pharma
6.
Further information
1.
WHAT CLOPIDOGREL ACINO PHARMA IS AND WHAT IT IS USED FOR
Clopidogrel Acino Pharma 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 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 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 ACINO PHARMA
DO NOT TAKE CLOPIDOGREL ACINO PHA

Ficha técnica

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Acino Pharma 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Excipients: each film-coatedtablet 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
haemorrhage.