Riik: Malta
keel: inglise
Allikas: Medicines Authority
HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
Jenson Pharmaceutical Services Limited
C07BB07
HYDROCHLOROTHIAZIDE 12.5 mg BISOPROLOL FUMARATE 5 mg
FILM-COATED TABLET
HYDROCHLOROTHIAZIDE 12.5 mg BISOPROLOL FUMARATE 5 mg
POM
BETA BLOCKING AGENTS
Withdrawn
2012-03-28
PAGE 1 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE USER CARDIMYL 5 MG/12.5 MG FILM-COATED TABLETS CARDIMYL 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 Cardimyl is and what it is used for 2. What you need to know before you take Cardimyl 3. How to take Cardimyl 4. Possible side effects 5. How to store Cardimyl 6. Contents of the pack and other information 1. WHAT CARDIMYL 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 CARDIMYL DO NOT TAKE CARDIMYL 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 acute weakness of the heart muscle Lugege kogu dokumenti
PAGE 1 OF 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CARDIMYL 5 MG/12.5 MG FILM-COATED TABLET CARDIMYL 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. Cardimyl 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. Cardimyl 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. Cardimyl 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 Lugege kogu dokumenti