Krajina: Švédsko
Jazyk: švédčina
Zdroj: Läkemedelsverket (Medical Products Agency)
tikagrelor
Newbury Pharmaceuticals AB
B01AC24
tikagrelor
60 mg
Filmdragerad tablett
mannitol Hjälpämne; tikagrelor 60 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 168 tabletter; Blister, 30 tabletter; Blister, 56 tabletter
Godkänd
2022-02-18
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER TICAGRELOR NEWBURY 60 MG FILM-COATED TABLETS 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 antiplatelet medicines. WHAT [PRODUCT NAME] IS USED FOR This medicine 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. HOW [PRODUCT NAME] WORKS This medicine affects cells called ‘platelets’ (also called thrombocytes). These very small blood cells help stop bleeding by clumping together to plug tiny holes in blood vessels that are cut or damaged. However, platelets can also form clots inside diseased blood vessels in the heart and brain. This can be very dangerous because: • the clot can cut off the blood supply completely; this can cause a heart attack (myocardial infarction) or stroke, or • the clot can partly block the blood vessels to the heart; this Prečítajte si celý dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ticagrelor Newbury 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 60 mg ticagrelor. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Round, biconvex, pink tablets debossed with ‘60’ on one side with a diameter of 8 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) 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 [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 (two tablets of 90 mg) and then continued at 90 mg twice daily. Treatment with [Product 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_ [Product name] 60 mg 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 [Product name] 90 mg 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 one year after stopping previous ADP receptor inhibitor treatment. There are limited data on the efficacy and safety of ticagrelor beyond 3 years of extended treatment. If a switch is needed, t Prečítajte si celý dokument