País: República de Sud-àfrica
Idioma: anglès
Font: South African Health Products Regulatory Authority (SAHPRA)
LeBasi Pharmaceuticals (Pty) Ltd
90,0 mg
TABLET
EACH TABLET CONTAINS TICAGRELOR 90,0 mg
Registrered
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 Llegiu el document complet
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 Llegiu el document complet