Land: Malta
Språk: engelska
Källa: Malta Medicines Authority
HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
C07BB07
HYDROCHLOROTHIAZIDE 6.25 mg BISOPROLOL FUMARATE 2.5 mg
FILM-COATED TABLET
HYDROCHLOROTHIAZIDE 6.25 mg BISOPROLOL FUMARATE 2.5 mg
POM
BETA BLOCKING AGENTS
Authorised
2012-01-06
PAGE 1 OF 9 PACKAGE LEAFLET PAGE 2 OF 9 PACKAGE LEAFLET: INFORMATION FOR THE USER BISOCOMBIMYL 2.5 MG/6.25 MG FILM-COATED TABLETS BISOCOMBIMYL 5 MG/6.25 MG FILM-COATED TABLETS BISOCOMBIMYL 10 MG/6.25 MG FILM-COATED TABLETS 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 Bisocombimyl is and what it is used for 2. What you need to know before you take Bisocombimyl 3. How to take Bisocombimyl 4. Possible side effects 5. How to store Bisocombimyl 6. Contents of the pack and other information 1. WHAT BISOCOMBIMYL 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 BISOCOMBIMYL DO NOT TAKE BISOCOMBIMYL IF YOU - are allergic to bisoprolol, hydrochlorothiazide, other thiazides, sulphonamides (substances chemically related to hydrochlorothiazide) or any of the other ingredients of this medicine (listed in section 6). - suffer from severe asthma - have heart failure which is not controlled by treatment, or cardiogenic shock (a serious cardiac disorder causing a drop in blood pressure and circulatory failure) - ha Läs hela dokumentet
PAGE 1 OF 17 SUMMARY OF PRODUCT CHARACTERISTICS PAGE 2 OF 17 1. NAME OF THE MEDICINAL PRODUCT Bisocombimyl 2.5 mg/6.25 mg film-coated tablets Bisocombimyl 5 mg/6.25 mg film-coated tablets Bisocombimyl 10 mg/6.25 mg film-coated tablets 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 and 0.7 mg macrogol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Diameter: 7.6 mm. BISOCOMBIMYL 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. BISOCOMBIMYL 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. BISOCOMBIMYL 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. Bisocombimyl is indicated in adults only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology PAGE 3 OF 17 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, Bisocombimyl is available in the following dosages: Bisocombimyl 2.5 mg/6.25 mg, film-coated tablets Bisocombimyl 5 mg/6.25 mg, film-coated tablets Bisocombimyl 10 mg/6.25 mg, film-coated tablets The low dose 2.5 mg/6.25 mg may be used for dose titration if in the judgement of the clinician this is required fo Läs hela dokumentet