DuoPlavin
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
07-07-2023
Produktets egenskaber
(SPC)
07-07-2023
Offentlige vurderingsrapport
(PAR)
16-02-2023
Aktiv bestanddel:
clopidogrel, Acetylsalicylic acid
Tilgængelig fra:
Sanofi Winthrop Industrie
ATC-kode:
B01AC30
INN (International Name):
clopidogrel, acetylsalicylic acid
Terapeutisk gruppe:
Antithrombotic agents
Terapeutisk område:
Acute Coronary Syndrome; Myocardial Infarction
Terapeutiske indikationer:
DuoPlavin is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (ASA). DuoPlavin 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 (PCI);ST segment elevation acute myocardial infarction (STEMI) in patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy.For further information please refer to section 5.1.
Produkt oversigt:
Revision: 30
Autorisation status:
Authorised
Autorisation dato:
2010-03-14
Indlægsseddel
41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUOPLAVIN 75 MG/75 MG FILM-COATED TABLETS
DUOPLAVIN 75 MG/100 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 DuoPlavin is and what it is used for
2.
What you need to know before you take DuoPlavin
3.
How to take DuoPlavin
4.
Possible side effects
5
How to store DuoPlavin
6.
Contents of the pack and other information
1.
WHAT DUOPLAVIN IS AND WHAT IT IS USED FOR
DuoPlavin 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).
DuoPlavin 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 DuoPlavin 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 ‘unstable
angina’ or heart attack (myocardial infarction). For the treatment
of this condition your doctor may
have placed a stent in the blocked or narrowed artery to restore
effective blood flow.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DUOPLAV
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
DuoPlavin 75 mg/75 mg film-coated tablets
DuoPlavin 75 mg/100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DuoPlavin 75 mg/75 mg film-coated tablets
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate) and 75 mg of
acetylsalicylic acid (ASA).
_Excipients with known effect: _
Each film-coated tablet contains 7 mg of lactose and 3.3 mg of
hydrogenated castor oil.
DuoPlavin 75 mg/100 mg film-coated tablets
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate) and 100 mg of
acetylsalicylic acid (ASA).
_Excipients with known effect: _
Each film-coated tablet contains 8 mg of lactose and 3.3 mg of
hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
DuoPlavin 75 mg/75 mg film-coated tablets
Yellow, oval, slightly biconvex, engraved with «C75» on one side and
«A75» on the other side.
DuoPlavin 75 mg/100 mg film-coated tablets
Light pink, oval, slightly biconvex, engraved with «C75» on one side
and «A100» on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DuoPlavin is indicated for the secondary prevention of
atherothrombotic events in adult patients
already taking both clopidogrel and acetylsalicylic acid (ASA).
DuoPlavin 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 (PCI)
•
ST segment elevation acute myocardial infarction (STEMI) in patients
undergoing PCI
(including patients undergoing a stent placement) or medically treated
patients eligible for
thrombolytic/ fibrinolytic therapy
For further information please refer to section 5.1.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly _
DuoPlavin 75 mg/75 mg film-coated ta
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