국가: 네덜란드
언어: 네덜란드어
출처: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TICAGRELOR 60 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
TICAGRELOR 60 mg/stuk
Filmomhulde tablet
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 ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL (E 1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), 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)
Oraal gebruik
2020-12-16
1 Sandoz B.V. Page 1/9 Tilobrastil 60 mg, 90, filmomhulde tabletten RVG 125283-4 1313-v3 1.3.1.3 Bijsluiter Oktober 2022 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TILOBRASTIL 60 MG, FILMOMHULDE TABLETTEN TILOBRASTIL 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 that is not well cont 전체 문서 읽기
1 Page 1/26 Tilobrastil 60 mg, 90 mg, filmomhulde tabletten RVG 125283-4 1311-V3 1.3.1.1 Summary of Product Characteristics Oktober 2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tilobrastil 60 mg, filmomhulde tabletten Tilobrastil 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 Page 2/26 Tilobrastil 60 mg, 90 mg, filmomhulde tabletten RVG 125283-4 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 an extended treatment is required for patient 전체 문서 읽기