Ticagrelor PharOS 60 mg film-coated tablets

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

TICAGRELOR

थमां उपलब्ध:

PharOS – Pharmaceutical Oriented Services Limited Lesvou str. (end), Thesi Loggos, Industrial Zone, 144 52 Metamorfossi Attikis,, Greece

ए.टी.सी कोड:

B01AC24

INN (इंटरनेशनल नाम):

TICAGRELOR 60 mg

फार्मास्यूटिकल फॉर्म:

FILM-COATED TABLET

रचना:

TICAGRELOR 60 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

ANTITHROMBOTIC AGENTS

उत्पाद समीक्षा:

Licence number in the source country: NOT APPLICAPABLE

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2020-11-30

सूचना पत्रक

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TICAGRELOR PHAROS 60 MG FILM-COATED TABLETS
TICAGRELOR PHAROS 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 PharOS is and what it is used for
2.
What you need to know before you take Ticagrelor PharOS
3.
How to take Ticagrelor PharOS
4.
Possible side effects
5.
How to store Ticagrelor PharOS
6.
Contents of the pack and other information
1.
WHAT TICAGRELOR PHAROS IS AND WHAT IT IS USED FOR
WHAT TICAGRELOR PHAROS IS
Ticagrelor PharOS contains an active substance called ticagrelor. This
belongs to a group of
medicines called antiplatelet medicines.
WHAT TICAGRELOR PHAROS IS USED FOR
_[60 mg] _
Ticagrelor PharOS 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.
_[90 mg] _
Ticagrelor PharOS 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 PHAROS WORKS
Ticagrelor PharOS affects cells call

उत्पाद विशेषताएं

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ticagrelor PharOS 60 mg film-coated tablets
Ticagrelor PharOS 90 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_[60 mg] _
Each film-coated tablet contains 60 mg of ticagrelor.
_[90 mg] _
Each film-coated tablet contains 90 mg of ticagrelor.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
_[60 mg] _
Round, biconvex, pink tablets marked with ‘60’ on one side and
plain on the other, with a diameter
of 8.6 mm ± 5 %.
_[90 mg] _
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 PharOS, 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 PharOS should also take a daily low
maintenance dose of ASA 75-150 mg,
unless specifically contraindicated.
_Acute coronary syndromes _
Ticagrelor PharOS treatment should be initiated with a single 180 mg
loading dose (two tablets of 90
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mg) and then continued at 90 mg twice daily. Treatment with Ticagrelor
PharOS 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 PharOS 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 PharOS 90 mg or other
adenosine diphosphate (ADP)
receptor in