Clopidogrel Qualimed
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
08-09-2014
Karatteristiċi tal-prodott
(SPC)
08-09-2014
Rapport ta 'Valutazzjoni Pubblika
(PAR)
08-09-2014
Ingredjent attiv:
clopidogrel (as hydrochloride)
Disponibbli minn:
Qualimed
Kodiċi ATC:
B01AC06
INN (Isem Internazzjonali):
clopidogrel
Grupp terapewtiku:
Antithrombotic agents
Żona terapewtika:
Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Indikazzjonijiet terapewtiċi:
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.
Sommarju tal-prodott:
Revision: 4
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2009-09-23
Fuljett ta 'informazzjoni
B. PACKAGE LEAFLET
23
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL QUALIMED 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 Qualimed is and what it is used for
2.
Before you take Clopidogrel Qualimed
3.
How to take Clopidogrel Qualimed
4.
Possible side effects
5.
How to store Clopidogrel Qualimed
6.
Further information
1.
WHAT CLOPIDOGREL QUALIMED IS AND WHAT IT IS USED FOR
Clopidogrel Qualimed 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 Qualimed 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 Qualimed 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.
BEFORE YOU TAKE CLOPIDOGREL QUALIMED
DO NOT TAKE CLOPIDOGREL QUALIMED
•
if you are allergic (hypersensitive) to clopidogrel or any of the
other ingredients of Clopidogrel
Qualimed;
•
if you have a medical condition that is currently cau
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Karatteristiċi tal-prodott
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Qualimed 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as
hydrochloride).
Excipient:
Each film-coated tablet contains 13 mg hydrogenated castor oil.
For a 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
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.
4.4
SPECIAL WARNINGS AND PRECAUTI
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