Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BISOPROLOLFUMARAAT SAMENSTELLING overeenkomend met ; BISOPROLOL ; HYDROCHLOORTHIAZIDE
Mylan B.V.
C07BB07
BISOPROLOLFUMARAAT COMPOSITION corresponding to ; BISOPROLOL ; HYDROCHLOROTHIAZIDE
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; MACROGOL 400 ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT (E 487) ; POLYDEXTROSE (E 1200) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Bisoprolol And Thiazides
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 0-WATER; MACROGOL 400; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMLAURILSULFAAT (E 487); POLYDEXTROSE (E 1200); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2011-12-21
Versie: december 2018 PAGE 1 OF 9 PACKAGE LEAFLET: INFORMATION FOR THE USER BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 2,5/6,25 MG, FILMOMHULDE TABLETTEN BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 5/6,25 MG, FILM FILMOMHULDE TABLETTEN BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 10/6,25 MG, FILMOMHULDE TABLETTEN bisoprolol fumarate hydrochlorothiazide 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 of pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Bisoprololfumaraat/Hydrochloorthiazide Mylan is and what it is used for 2. What you need to know before you take Bisoprololfumaraat/Hydrochloorthiazide Mylan 3. How to take Bisoprololfumaraat/Hydrochloorthiazide Mylan 4. Possible side effects 5. How to store Bisoprololfumaraat/Hydrochloorthiazide Mylan 6. Contents of the pack and other information 1. WHAT BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN IS AND WHAT IT IS USED FOR The active substances are bisoprolol and hydrochlorothiazide: Bisoprolol belongs to the family of medicines called beta-blockers and it is used to decrease blood pressure. Hydrochlorothiazide belongs to the family of medicines called thiazide diuretics (also known as “water tablets”). This product helps to lower blood pressure by increasing the elimination of urine. This medicine is recommended for the treatment of mild to moderate high blood pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN DO NOT TAKE BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN IF YOU - are allergic to bisoprolol, hydrochlorothiazide, other thiazides, sulphonamides (subst Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bisoprololfumaraat/Hydrochloorthiazide Mylan 2,5/6,25 mg, filmomhulde tabletten Bisoprololfumaraat/Hydrochloorthiazide Mylan 5/6,25 mg, film filmomhulde tabletten Bisoprololfumaraat/Hydrochloorthiazide Mylan 10/6,25 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 mg/6.25 mg film-coated tablet contains: 2.5 mg bisoprolol fumarate 6.25 mg hydrochlorothiazide Each 5 mg/6.25 mg film-coated tablet contains: 5 mg bisoprolol fumarate 6.25 mg hydrochlorothiazide Each 10 mg/6.25 mg film-coated tablet contains: 10 mg bisoprolol fumarate 6.25 mg hydrochlorothiazide Excipient with known effect: Each tablet contains: 29.3 mg lactose (anhydrous) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Diameter: 7.6 mm. BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 2.5 MG/6.25 MG FILM-COATED TABLET A yellow, film coated, round, biconvex tablet debossed with ‘BH1’ on one side and ‘M’ on the other side of the tablet. BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 5 MG/6.25 MG FILM-COATED TABLET A light pink, film coated, round, biconvex tablet debossed with ‘BH2’ on one side and ‘M’ on the other side of the tablet. BISOPROLOLFUMARAAT/HYDROCHLOORTHIAZIDE MYLAN 10 MG/6.25 MG FILM-COATED TABLET A white, film coated, round, biconvex tablet debossed with ‘BH3’ on one side and ‘M’ on the other side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mild to moderate arterial hypertension. Bisoprololfumaraat/Hydrochloorthiazide Mylan is indicated in adults only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dose titration of each active ingredient to the individual patient is recommended. If clinically appropriate patients can be transferred from monotherapy to the fixed combination therapy. In order to individually adjust the posology, Bisoprololfumaraat/Hydrochloorthiazide Mylan is available in the following dosages: Bisoprololfumaraat/Hydrochloorthiazide Mylan Lees het volledige document