TICAVEL 90 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

LeBasi Pharmaceuticals (Pty) Ltd

Dosage:

90,0 mg

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS TICAGRELOR 90,0 mg

Authorization status:

Registrered

Patient Information leaflet

LeBasi Pharmaceuticals (Pty) Ltd
90 mg Ticagrelor
Film-coated tablet
Date of Registration: 15 August 2023
Page 1 of 11
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S3
TICAVEL 90 MG FILM-COATED TABLETS
TICAGRELOR
CONTAINS SUGAR ALCOHOL: 126 MG MANNITOL PER TABLET.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING TICAVEL 90
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
TICAVEL 90 has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What TICAVEL 90 is and what it is used for
2.
What you need to know before you take TICAVEL 90
3.
How to take TICAVEL 90
4.
Possible side effects
5.
How to store TICAVEL 90
6.
Contents of the pack and other information
1.
WHAT TICAVEL 90 IS AND WHAT IT IS USED FOR
TICAVEL 90 contains an active substance called ticagrelor. This
belongs to a group of medicines
called antiplatelet medicines. Platelets are very small fragments in
the blood that clump together
during blood clotting. TICAVEL 90 helps prevent this clumping and
reduces the risk of blood clots
LeBasi Pharmaceuticals (Pty) Ltd
90 mg Ticagrelor
Film-coated tablet
Date of Registration: 15 August 2023
Page 2 of 11
forming.
TICAVEL 90 is used in combination with low dose acetylsalicylic acid
(aspirin) in adults to help
prevent blood clots and reduce the risk of having or dying from
conditions caused by blood clots. This
includes:
•
a stroke
•
heart attack, or
•
heart or blood vessel problems.
It reduces the chances of you having a heart attack, stroke or dying
from a disease related to your
heart or blood vessels.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TICAVEL 90
DO NOT TAKE TICAVEL 90:
•
if you are hypersensitive (allergic) to ticagrelor or to any of the
other ingredients of TICAVEL 90
listed in section 6 of this leaflet;
•
if you are actively bleeding due

Summary of Product characteristics

LeBasi Pharmaceuticals (Pty) Ltd
90 mg Ticagrelor
Film-coated tablet
Date of Registration: 15 August 2023
Page 1 of 22
PROFESSIONAL INFORMATION FOR TICAVEL 90
SCHEDULING STATUS
S3
1.
NAME OF THE MEDICINE
TICAVEL 90 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90 mg ticagrelor.
_Excipients with known effect: _
Contains sugar alcohol: 126 mg mannitol per tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Yellow coloured, round, biconvex, film-coated tablets, debossed with
"90 & M" on one side and plain
on other side, free from physical defects.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TICAVEL 90 is indicated for the prevention of thrombotic events
(cardiovascular death, myocardial
infarction and stroke) in patients with acute coronary syndromes (ACS)
(unstable angina, non-ST
elevation myocardial infarction [NSTEMI] or ST elevation myocardial
infarction [STEMI]) including
patients managed medically, and those who are managed with
percutaneous coronary intervention
(PCI) or coronary artery by-pass grafting (CABG).
LeBasi Pharmaceuticals (Pty) Ltd
90 mg Ticagrelor
Film-coated tablet
Date of Registration: 15 August 2023
Page 2 of 22
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
TICAVEL 90 treatment should be initiated with a single 180 mg loading
dose (2 tablets of 90 mg) and
then continued at 90 mg twice daily.
Patients taking TICAVEL 90 should also use aspirin daily unless
specifically contraindicated.
Following an initial dose of aspirin, TICAVEL 90 should be used with a
maintenance dose of aspirin of
75 – 150 mg daily (see sections 4.4 and 5.1).
_ _
Medical practitioners who desire to switch patients from clopidogrel
to TICAVEL 90 should administer
the first 90 mg dose of TICAVEL 90 24 hours following the last dose of
clopidogrel. There is no data
on switching patients from other ADP receptor inhibitors to TICAVEL
90.
Treatment is recommended for at least 12 months unless discontinuation
of TI