Country: Malta
Language: English
Source: Medicines Authority
hydrochlorothiazide 6.25 mg, bisoprolol fumarate 5 mg
Jenson Pharmaceutical Services Limited
C07BB07
hydrochlorothiazide, bisoprolol fumarate
film-coated tablet
Authorised
2012-01-06
PAGE 1 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE USER BISOPROHYDROCHLOR 2.5 MG/6.25 MG FILM-COATED TABLETS BISOPROHYDROCHLOR 5 MG/6.25 MG FILM-COATED TABLETS BISOPROHYDROCHLOR 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. Whatis and what it is used for 2. What you need to know before you take Read the complete document3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT 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 DO NOT TAKE IF YOU - are allergic to bisoprolol,
PAGE 1 OF 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BISOPROHYDROCHLOR 2.5 MG/6.25 MG FILM-COATED TABLET BISOPROHYDROCHLOR 5 MG/6.25 MG FILM-COATED TABLET BISOPROHYDROCHLOR 10 MG/6.25 MG FILM-COATED TABLET 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.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. Read the complete document5 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. 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 is indicated in adults only. PAGE 2 OF 15 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