Clopidogrel/Acetylsalicylic acid Teva
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
28-04-2017
Karatteristiċi tal-prodott
(SPC)
28-04-2017
Rapport ta 'Valutazzjoni Pubblika
(PAR)
28-04-2017
Ingredjent attiv:
clopidogrel, Acetylsalicylic acid
Disponibbli minn:
Teva Pharma B.V.
Kodiċi ATC:
B01AC30
INN (Isem Internazzjonali):
clopidogrel, acetylsalicylic acid
Grupp terapewtiku:
combinations
Żona terapewtika:
Acute Coronary Syndrome; Myocardial Infarction
Indikazzjonijiet terapewtiċi:
Clopidogrel/Acetylsalicylic acid Teva is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). Clopidogrel/Acetylsalicylic acid Teva is a fixed‑dose combination medicinal product for continuation of therapy in:Non‑ST segment elevation acute coronary syndrome (unstable angina or non‑Q‑wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary interventionST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy
Sommarju tal-prodott:
Revision: 1
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2014-09-01
Fuljett ta 'informazzjoni
59
B. PACKAGE LEAFLET
Medicinal product no longer authorised
60
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIDOGREL/ACETYLSALICYLIC ACID TEVA 75 MG/75 MG FILM-COATED TABLETS
clopidogrel/acetylsalicylic acid
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 get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4. .
WHAT IS IN THIS LEAFLET
1.
What Clopidogrel/Acetylsalicylic acid Teva is and what it is used for
2.
What you need to know before you take Clopidogrel/Acetylsalicylic acid
Teva
3.
How to take Clopidogrel/Acetylsalicylic acid Teva
4.
Possible side effects
5.
How to store Clopidogrel/Acetylsalicylic acid Teva
6.
Contents of the pack and other information
1.
WHAT CLOPIDOGREL/ACETYLSALICYLIC ACID TEVA IS AND WHAT IT IS USED FOR
Clopidogrel/Acetylsalicylic acid Teva contains clopidogrel and
acetylsalicylic acid (ASA) 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 in some types of blood
vessels (called arteries), antiplatelet medicinal products reduce the
chances of blood clots forming (a
process called atherothrombosis).
Clopidogrel/Acetylsalicylic acid Teva is taken by adults to prevent
blood clots forming in hardened
arteries which can lead to atherothrombotic events (such as stroke,
heart attack, or death).
You have been prescribed Clopidogrel/Acetylsalicylic acid Teva in
place of the two separate
medicines, clopidogrel and ASA, to help prevent blood clots because
you have experienced a severe
type of chest pain known as ‘unst
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate) and 75 mg of
acetylsalicylic acid (ASA).
Excipient with known effect:
Each film-coated tablet contains 102.6 mg of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Yellow, film-coated capsule shaped tablets. The tablets have a length
of 14.0 mm and a width of
6.8 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clopidogrel/Acetylsalicylic acid Teva is indicated for the prevention
of atherothrombotic events in
adult patients already taking both clopidogrel and acetylsalicylic
acid (ASA).
Clopidogrel/Acetylsalicylic acid Teva is a fixed-dose combination
medicinal product for continuation
of therapy in:
Non-ST segment elevation acute coronary syndrome (unstable angina or
non-Q-wave
myocardial infarction) including patients undergoing a stent placement
following percutaneous
coronary intervention
ST segment elevation acute myocardial infarction in medically treated
patients eligible for
thrombolytic therapy
For further information please refer to section 5.1.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Adults and elderly population
Clopidogrel/Acetylsalicylic acid Teva should be given as a single
daily 75 mg/75 mg dose.
Clopidogrel/Acetylsalicylic acid Teva is used following initiation of
therapy with clopidogrel and
ASA given separately.
-
_In patients with non-ST segment elevation acute coronary syndrome_
(unstable angina or
non-Q-wave myocardial infarction): The optimal duration of treatment
has not been formally
established. Clinical trial data support use up to 12 months, and the
maximum benefit was seen
at 3 months (see section 5.1). If the use of the combination of
clopidogrel/acetylsalic
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