Clopidogrel DURA

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

clopidogrel (as hydrochloride)

Dostupné z:

Mylan dura GmbH

ATC kód:

B01AC04

INN (Medzinárodný Name):

clopidogrel

Terapeutické skupiny:

Antithrombotic agents

Terapeutické oblasti:

Peripheral Vascular Diseases; Stroke; Myocardial Infarction

Terapeutické indikácie:

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.

Prehľad produktov:

Revision: 6

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2009-07-21

Príbalový leták

B. PACKAGE LEAFLET
22
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL DURA 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 have any side effects, including any side effects not listed in
this leaflet, please talk to
your doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Clopidogrel dura is and what it is used for
2.
What you need to know before you take Clopidogrel dura
3.
How to take Clopidogrel dura
4.
Possible side effects
5.
How to store Clopidogrel dura
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL DURA IS AND WHAT IT IS USED FOR
Clopidogrel dura contains clopidogrel and 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 dura 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 dura 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOPIDOGREL DURA
DO NOT TAKE CLOPIDOGREL DURA
•
if you are allergic to clopidogrel or

Súhrn charakteristických

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel dura 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as
hydrochloride).
Excipient with known effect:
Each film-coated tablet contains 13 mg hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round and slightly convex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Prevention of atherothrombotic events _
Clopidogrel is indicated in:
•
Adults 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
2
Medicinal product no longer authorised
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.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Severe hepatic impairment.
•
Active pathological bleeding such as peptic ulcer or intracranial
haemorr