Ticagrelor Sandoz 60 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

TICAGRELOR 60 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

INN (Algemene Internationale Benaming):

TICAGRELOR 60 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; GLYCEROL MONOCAPRYLOCAPRAAT, TYPE I ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2020-12-16

Bijsluiter

1
Page 1/10
Ticagrelor Sandoz
®
60 mg, 90 mg, filmomhulde tabletten
RVG 125285-6
1313-v3
1.3.1.3 Bijsluiter
Oktober 2022
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TICAGRELOR SANDOZ
® 60 MG, FILMOMHULDE TABLETTEN
TICAGRELOR SANDOZ
® 90 MG, FILMOMHULDE TABLETTEN
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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
WHAT [NATIONALLY COMPLETED NAME] IS
[Nationally completed name] contains an active substance called
ticagrelor. This belongs to a
group of medicines called antiplatelet medicines.
WHAT [NATIONALLY COMPLETED NAME] IS USED FOR
_[60 mg] _
[Nationally completed name] 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] _
[Nationally completed name] 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 th

Productkenmerken

1
1A Pharma
Page 1/26
Ticagrelor Sandoz 60 mg, 90 mg, filmomhulde
tabletten
RVG 125285-6
1311-V3
1.3.1.1 Summary of Product Characteristics
Oktober 2022
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ticagrelor Sandoz 60 mg, filmomhulde tabletten
Ticagrelor Sandoz 90 mg, filmomhulde tabletten
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
[Nationally completed 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 [Nationally completed name] should also take a daily
low maintenance dose
of ASA 75-150 mg, unless specifically contraindicated.
_Acute coronary syndromes _
[Nationally completed name] treatment should be initiated with a
single 180 mg loading dose
2
1A Pharma
Page 2/26
Ticagrelor Sandoz 60 mg, 90 mg, filmomhulde
tabletten
RVG 125285-6
1311-V3
1.3.1.1 Summary of Product Characteristics
Oktober 2022
(two tablets of 90 mg) and then continued at 90 mg twice daily.
Treatment with [Nationally
completed 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 _
[Nationally completed name] 60 mg twice daily is the recommended dose
when a