Land: Nederländerna
Språk: nederländska
Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
RIVAROXABAN 2,5 mg/stuk
RIVAROXABAN 2,5 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLOXAMEER 188 ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLOXAMEER 188 ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
Sandoz B.V. Page 1/10 XABOPLAX 2,5 mg, filmomhulde tabletten RVG 127725 1313-V3 1.3.1.3 Bijsluiter November 2023 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ BIJSLUITER: INFORMATIE VOOR DE PATIËNT_ _ XABOPLAX 2,5 MG, FILMOMHULDE TABLETTEN rivaroxaban 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 You have been given [Nationally completed name] because • you have been diagnosed with an acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) and have been shown to have had an increase in certain cardiac blood tests. [Nationally completed name] reduces the risk in adults of having another heart attack or reduces the risk of dying from a disease related to your heart or your blood vessels. [Nationally completed name] will not be given to you on its own. Your doctor will also tell you to take either: - acetylsalicylic acid or - acetylsalicylic acid plus clopidogrel or ticlopidine. or • you have been diagnosed with a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms. Sandoz B.V. Page 2/10 XABOPLAX 2,5 mg, filmomhulde table Läs hela dokumentet
Sandoz Page 1/34 XABOPLAX 2,5 mg, filmomhulde tabletten RVG 127725 1311-V3 1.3.1.1 Samenvatting van de Productkenmerken November 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Xaboplax 2,5 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg rivaroxaban. Excipient(s) with known effect Each film-coated tablet contains 29 mg lactose, see section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Light yellow, round biconvex tablets of 8.6 mm diameter, debossed with ‘2.5’ on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name], co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1). [Nationally completed name], co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 2.5 mg twice daily. • _ACS _ Sandoz Page 2/34 XABOPLAX 2,5 mg, filmomhulde tabletten RVG 127725 1311-V3 1.3.1.1 Samenvatting van de Productkenmerken November 2023 Patients taking rivaroxaban 2.5 mg twice daily should also take a daily dose of 75 - 100 mg ASA or a daily dose of 75 - 100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine. Treatment should be regularly evaluated in the individual patient weighing the risk for ischaemic events against the bleeding risks. Extension of treatment beyond 12 months should be done on an individual patient basis as experience up to 24 months is limited (see section 5.1). Treatment Läs hela dokumentet