Ticagrelor Krka 60 mg film-coated tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Ticagrelor

थमां उपलब्ध:

KRKA, d.d., Novo mesto

ए.टी.सी कोड:

B01AC24

INN (इंटरनेशनल नाम):

Ticagrelor

डोज़:

60 milligram(s)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

चिकित्सीय क्षेत्र:

ticagrelor

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2021-02-12

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TICAGRELOR KRKA 60 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 Krka is and what it is used for
2.
What you need to know before you take Ticagrelor Krka
3.
How to take Ticagrelor Krka
4.
Possible side effects
5.
How to store Ticagrelor Krka
6.
Contents of the pack and other information
1.
WHAT TICAGRELOR KRKA IS AND WHAT IT IS USED FOR
WHAT TICAGRELOR KRKA IS
Ticagrelor Krka contains an active substance called ticagrelor. This
belongs to a group of medicines
called antiplatelet medicines.
WHAT TICAGRELOR KRKA IS USED FOR
Ticagrelor Krka 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.
HOW TICAGRELOR KRKA WORKS
Ticagrelor Krka 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

उत्पाद विशेषताएं

Health Products Regulatory Authority
09 May 2023
CRN00DKDL
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ticagrelor Krka 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).
Light pink, round, biconvex, film-coated tablets marked with 60 on one
side.
Tablet dimensions: approximately 8 mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ticagrelor Krka , 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 Krka should also take a daily low
maintenance dose of ASA 75-150 mg, unless specifically
contraindicated.
_Acute coronary syndromes_
Ticagrelor Krka 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 Krka 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 Krka 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 Krka 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 data