Ticagrelor Viatris 60 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ticagrelor

Available from:

Viatris Limited

ATC code:

B01AC24

INN (International Name):

Ticagrelor

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

ticagrelor

Authorization status:

Not marketed

Authorization date:

2021-03-12

Summary of Product characteristics

Health Products Regulatory Authority
16 February 2024
CRN00DW4Y
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ticagrelor Viatris 60 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg ticagrelor.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Round, biconvex, pink tablets marked with '60' on one side and plain
on the other, with a diameter of 8.6 mm ± 5 %.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ticagrelor Viatris, 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 Viatris should also take a daily low
maintenance dose of ASA 75-150 mg, unless specifically
contraindicated.
_Acute coronary syndromes_
Ticagrelor Viatris 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 Viatris 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 Viatris 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 Viatris 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. Th