Possia
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
01-02-2013
Charakterystyka produktu
(SPC)
01-02-2013
Sprawozdanie z oceny publicznego
(PAR)
07-01-2011
Składnik aktywny:
Ticagrelor
Dostępny od:
AstraZeneca AB
Kod ATC:
B01AC24
INN (International Nazwa):
ticagrelor
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Peripheral Vascular Diseases; Acute Coronary Syndrome
Wskazania:
Possia, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).
Podsumowanie produktu:
Revision: 2
Status autoryzacji:
Withdrawn
Data autoryzacji:
2010-12-03
Ulotka dla pacjenta
28
B. PACKAGE LEAFLET
Medicinal product no longer authorised
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
POSSIA 90 MG FILM-COATED TABLETS
ticagrelor
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.
WHAT IS IN THIS LEAFLET
1.
What Possia is and what it is used for
2.
What you need to know before you take Possia
3.
How to take Possia
4.
Possible side effects
5.
How to store Possia
6.
Contents of the pack and other information
1. WHAT POSSIA IS AND WHAT IT IS USED FOR
WHAT POSSIA IS
Possia contains the active substance called ticagrelor. This belongs
to a group of medicines called
anti-platelet medicines.
HOW POSSIA WORKS
Possia affects cells called ‘platelets’ (also called
thrombocytes). These very small blood cells help stop
bleeding by clumping together to plug tiny holes in blood vessels that
are cut or damaged.
However, platelets can also form clots inside diseased blood vessels
in the heart and brain. This can be
very dangerous because:
the clot can cut off the blood supply completely - this can cause a
heart attack (myocardial
infarction) or stroke, or
the clot can partly block the blood vessels to the heart - this
reduces the blood flow to the heart
and can cause chest pain which comes and goes (called ‘unstable
angina’).
Possia helps stop the clumping of platelets. This reduces the chance
of a blood clot forming that can
reduce blood flow.
WHAT POSSIA IS USED FOR
Possia is to be used in adults only. You have been given Possia
because you have had:
a heart attack, or
unstable angina (angina or chest pain that is
Przeczytaj cały dokument
Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Possia 90 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 90 mg ticagrelor.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Round, biconvex, yellow tablets marked with ‘90’ above ‘T’ on
one side and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Possia, co-administered with acetylsalicylic acid (ASA), is indicated
for the prevention of
atherothrombotic events in adult patients with Acute Coronary
Syndromes (unstable angina, non ST
elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial
Infarction [STEMI]);
including patients managed medically, and those who are managed with
percutaneous coronary
intervention (PCI) or coronary artery by-pass grafting (CABG).
For further information, please refer to section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Possia treatment should be initiated with a single 180 mg loading dose
(two tablets of 90 mg) and then
continued at 90 mg twice daily.
Patients taking Possia should also take ASA daily, unless specifically
contraindicated. Following an
initial dose of ASA, Possia should be used with a maintenance dose of
ASA of 75-150 mg (see
section 5.1).
Treatment is recommended for up to 12 months unless discontinuation of
Possia is clinically indicated
(see section 5.1). Experience beyond 12 months is limited.
In patients with Acute Coronary Syndromes (ACS), premature
discontinuation with any antiplatelet
therapy, including Possia, could result in an increased risk of
cardiovascular death, or myocardial
infarction due to the patient’s underlying disease. Therefore,
premature discontinuation of treatment
should be avoided.
Lapses in therapy should also be avoided. A patient who misses a dose
of Possia should take only one
90 mg tablet (their next dose) at its scheduled time.
Patients treated with clo
Przeczytaj cały dokument
