Ticagrelor Newbury 60 mg Filmdragerad tablett

מדינה: שוודיה

שפה: שוודית

מקור: Läkemedelsverket (Medical Products Agency)

מרכיב פעיל:

tikagrelor

זמין מ:

Newbury Pharmaceuticals AB

קוד ATC:

B01AC24

INN (שם בינלאומי):

tikagrelor

כמות:

60 mg

טופס פרצבטיות:

Filmdragerad tablett

הרכב:

mannitol Hjälpämne; tikagrelor 60 mg Aktiv substans

סוג מרשם:

Receptbelagt

leaflet_short:

Förpacknings: Blister, 168 tabletter; Blister, 30 tabletter; Blister, 56 tabletter

מצב אישור:

Godkänd

תאריך אישור:

2022-02-18

עלון מידע

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TICAGRELOR NEWBURY 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 [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 antiplatelet medicines.
WHAT [PRODUCT NAME] IS USED FOR
This medicine 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 [PRODUCT NAME] WORKS
This medicine 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

מאפייני מוצר

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ticagrelor Newbury 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 debossed with ‘60’ on one side with
a diameter of 8 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) 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 [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 (two tablets of 90 mg)
and then continued at 90 mg twice daily. Treatment with [Product name]
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_
[Product name] 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 [Product name] 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 on the efficacy and safety of
ticagrelor beyond 3 years of extended
treatment.
If a switch is needed, t