Ticagrelor CF 60 mg, filmomhulde tabletten

Țară: Țările de Jos

Limbă: olandeză

Sursă: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredient activ:

TICAGRELOR 60 mg/stuk

Disponibil de la:

Centrafarm B.V. Van de Reijtstraat 31-E 4814 NE BREDA

INN (nume internaţional):

TICAGRELOR 60 mg/stuk

Forma farmaceutică:

Filmomhulde tablet

Compoziție:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CARMELLOSE CALCIUM (E 466) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; TITAANDIOXIDE (E 171)

Calea de administrare:

Oraal gebruik

Data de autorizare:

1900-01-01

Prospect

PL Ticagrelor DE6093+5 –
2022-09-22/JCB
PACKAGE LEAFLET: INFORMATION FOR THE USER
TICAGRELOR CF 60 MG, FILMOMHULDE TABLETTEN
TICAGRELOR CF 90 MG, FILMOMHULDE TABLETTEN
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. See section 4.
WHAT IS IN THIS LEAFLET
1. What [Product name] is and what it is used for
2. What you need to know before you take [Product name]
3. How to take [Product name]
4. Possible side effects
5. How to store [Product name]
6. Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
WHAT [PRODUCT NAME] IS
[Product name] contains an active substance called ticagrelor. This
belongs to a group of
medicines called antiplatelets.
WHAT [PRODUCT NAME] IS USED FOR
[60 mg:]
[Product name] in combination with acetylsalicylic acid (another
antiplatelet agent) is to be
used in adults only. You have been given this medicine because you
have had
•
a heart attack, over a year ago
[90 mg:]
[Product name] in combination with acetylsalicylic acid (another
antiplatelet agent) is to be
used in adults only. You have been given this medicine because you
have had
•
a heart attack
•
unstable angina (angina or chest pain that is not well controlled)
It reduces the chance of you having another heart attack, stroke, or
dying from a condition
related to your heart or blood vessels.
HOW [PRODUCT NAME] WORKS
[Product name] affects cells called ‘platelets’ (also called
thrombocytes). These blood cells are
very small and help stop bleeding by clumping together to plug tiny
holes in blood

Caracteristicilor produsului

SmPC Ticagrelor DE6093+5 –
2022-09-22/JCB
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ticagrelor CF 60 mg, filmomhulde tabletten
Ticagrelor CF 90 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg ticagrelor.
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).
[60 mg:]
Round, biconvex, pink film-coated tablets, diameter approximately 8
mm.
[60 mg:]
Round, biconvex, yellow film-coated tablets, diameter approximately 9
mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
[Product name], co-administered with acetylsalicylic acid (ASA), is
indicated for the prevention
of atherothrombotic events in adult patients with
•
acute coronary syndromes (ACS)
•
a history of myocardial infarction (MI) and a high risk of developing
an atherothrombotic
event (see sections 4.2 and 5.1)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients taking [Product name] should also take a daily low
maintenance dose of ASA 75-
150 mg, unless specifically contraindicated.
_Acute coronary syndromes _
[Product name] treatment should be initiated with a single 180 mg
loading dose and then
continued
at
90 mg
twice
daily.
Treatment
with
90 mg
[Product
name]
twice
daily
is
recommended for 12 months in ACS patients unless discontinuation is
clinically indicated (see
section 5.1).
_History of myocardial infarction _
60 mg [Product name] twice daily is the recommended dose when an
extended treatment is
required for patients with a history of MI of at least one year and a
high risk of an
atherothrombotic event (see section 5.1). Treatment may be started
without interruption as
continuation therapy after the initial one-year treatment with 90 mg
[Product name] or other
adenosine diphosphate (ADP) receptor inhibitor therapy in ACS patients
with a high risk of an
atherothrombotic event. Treatment can also be initiated up to 2 years
from the MI, or within
SmPC T