Ticagrelor Mylan 90 mg film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Ticagrelor

متاح من:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC رمز:

B01AC24

INN (الاسم الدولي):

Ticagrelor

جرعة:

90 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

المجال العلاجي:

ticagrelor

الوضع إذن:

Not marketed

تاريخ الترخيص:

2021-03-12

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
TICAGRELOR MYLAN 60 MG FILM-COATED TABLETS
TICAGRELOR MYLAN 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ticagrelor Mylan is and what it is used for
2.
What you need to know before you take Ticagrelor Mylan
3.
How to take Ticagrelor Mylan
4.
Possible side effects
5.
How to store Ticagrelor Mylan
6.
Contents of the pack and other information
1.
WHAT TICAGRELOR MYLAN IS AND WHAT IT IS USED FOR
WHAT TICAGRELOR MYLAN IS
Ticagrelor Mylan contains an active substance called ticagrelor. This
belongs to a group of medicines
called antiplatelet medicines.
WHAT TICAGRELOR MYLAN IS USED FOR
Ticagrelor Mylan 60 mg film-coated tablets:
Ticagrelor Mylan 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.
It reduces the chances of you having another heart attack, stroke or
dying from a disease related to your
heart or blood vessels.
Ticagrelor Mylan 90 mg film-coated tablets:
Ticagrelor Mylan 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, or
•
unstable angina (angina or chest pain that is not well controlled).
It reduces the chances of you having another heart attack, stroke or
dying from a disease related to your
heart or blood vessels.
HOW TICAGRELOR MYLAN WORK

خصائص المنتج

Health Products Regulatory Authority
11 May 2023
CRN00DFVF
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ticagrelor Mylan 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' on one side and plain
on the other, with a diameter of 9.6 mm ± 5 %.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ticagrelor Mylan, co-administered with acetylsalicylic acid (ASA), is
indicated for the prevention of atherothrombotic events in
adult patients with

acute coronary syndromes (ACS) or

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 Ticagrelor Mylan should also take a daily low
maintenance dose of ASA 75-150 mg, unless specifically
contraindicated.
_Acute coronary syndromes_
Ticagrelor Mylan treatment should be initiated with a single 180 mg
loading dose (two tablets of 90 mg) and then continued at
90 mg twice daily. Treatment with Ticagrelor Mylan 90 mg twice daily
is recommended for 12 months in ACS patients unless
discontinuation is clinically indicated (see section 5.1).
_History of myocardial infarction_
Ticagrelor Mylan 60 mg 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 Ticagrelor Mylan 90 mg 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
one year after stopping previous ADP receptor inhibitor
treatment. There are limited d