Country: Netherlands
Language: Dutch
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TICAGRELOR 60 mg/stuk
Centrafarm B.V. Van de Reijtstraat 31-E 4814 NE BREDA
TICAGRELOR 60 mg/stuk
Filmomhulde tablet
CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CARMELLOSE CALCIUM (E 466) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
PL Ticagrelor DE6093+5 – 2022-09-22/JCB PACKAGE LEAFLET: INFORMATION FOR THE USER TICAGRELOR CF 60 MG, FILMOMHULDE TABLETTEN TICAGRELOR CF 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 [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 antiplatelets. WHAT [PRODUCT NAME] IS USED FOR [60 mg:] [Product 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 [90 mg:] [Product 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 • unstable angina (angina or chest pain that is not well controlled) It reduces the chance of you having another heart attack, stroke, or dying from a condition related to your heart or blood vessels. HOW [PRODUCT NAME] WORKS [Product name] affects cells called ‘platelets’ (also called thrombocytes). These blood cells are very small and help stop bleeding by clumping together to plug tiny holes in blood Read the complete document
SmPC Ticagrelor DE6093+5 – 2022-09-22/JCB SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ticagrelor CF 60 mg, filmomhulde tabletten Ticagrelor CF 90 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 60 mg ticagrelor. Each film-coated tablet contains 90 mg ticagrelor. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). [60 mg:] Round, biconvex, pink film-coated tablets, diameter approximately 8 mm. [60 mg:] Round, biconvex, yellow film-coated tablets, diameter approximately 9 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) • 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 and then continued at 90 mg twice daily. Treatment with 90 mg [Product name] twice daily is recommended for 12 months in ACS patients unless discontinuation is clinically indicated (see section 5.1). _History of myocardial infarction _ 60 mg [Product name] 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 90 mg [Product name] 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 SmPC T Read the complete document