Land: Malta
Språk: engelsk
Kilde: Medicines Authority
hydrochlorothiazide 12.5 mg, bisoprolol fumarate 5 mg
Jenson Pharmaceutical Services Limited
C07BB07
hydrochlorothiazide, bisoprolol fumarate
film-coated tablet
Authorised
2012-03-28
PAGE 1 OF 8 PACKAGE LEAFLET: INFORMATION FOR THE USER COBISOMYL 5 MG/12.5 MG FILM-COATED TABLETS COBISOMYL 10 MG/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 or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Cobisomyl is and what it is used for 2. What you need to know before you take Cobisomyl 3. How to take Cobisomyl 4. Possible side effects 5. How to store Cobisomyl 6. Contents of the pack and other information 1. WHAT COBISOMYL 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 in the treatment of high blood pressure in patients whose blood pressure is not sufficiently controlled by bisoprolol or hydrochlorothiazide alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COBISOMYL DO NOT TAKE COBISOMYL IF YOU - are allergic to bisoprolol, hydrochlorothiazide, other thia Les hele dokumentet
PAGE 1 OF 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT COBISOMYL 5 MG/12.5 MG FILM-COATED TABLET COBISOMYL 10 MG/25 MG FILM-COATED TABLET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mg/12.5 mg film-coated tablet contains: 5 mg bisoprolol fumarate 12.5 mg hydrochlorothiazide Each 10 mg/25 mg film-coated tablet contains: 10 mg bisoprolol fumarate 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. Cobisomyl 5 mg/12.5 mg film-coated tablet A pinkish grey, film coated, round, biconvex tablet debossed with ‘BH4’ over ‘M’ on one side and breakline on the other side of the tablet. 5/12.5 mg only: The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Cobisomyl 10 mg/25 mg film-coated tablet A reddish grey, film coated, round, biconvex tablet debossed with ‘BH5’ over ‘M’ on one side and breakline on the other side of the tablet. 10/25 mg only: The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. The fixed-dose combination of bisoprolol fumarate/hydrochlorothiazide 5 mg/12.5 mg or bisoprolol fumarate/hydrochlorothiazide 10 mg/25 mg is indicated in patients whose blood pressure cannot be adequately controlled using bisoprolol or hydrochlorothiazide alone. Cobisomyl is indicated in adults only. PAGE 2 OF 12 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Individual dose titration with each single component is recommended. If clinically appropriate, a direct switch from monotherapy to the fixed combination may be taken into consideration. The usual dose is 5 mg bisoprolol and 1 Les hele dokumentet