Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
ZOFENOPRIL CALCIUM; Hydrochlorothiazide
Menarini International Operations Luxembourg S.A.
C09BA; C09BA15
ZOFENOPRIL CALCIUM; Hydrochlorothiazide
30 mg/12.5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors and diuretics; zofenopril and diuretics
Not marketed
2005-05-13
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BIFRIL PLUS 30 mg /12.5 mg film-coated tablets (zofenopril calcium / 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. 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. See section 4. WHAT IS IN THIS LEAFLET: 1. What Bifril Plus is and what it is used for 2. What you need to know before you take Bifril Plus 3. How to take Bifril Plus 4. Possible side effects 5. How to store Bifril Plus 6. Content of the pack and other information 1. WHAT BIFRIL PLUS IS AND WHAT IT IS USED FOR Bifril Plus contains zofenopril calcium 30 mg and hydrochlorothiazide 12.5 mg as the active ingredients. Zofenopril calcium is a cardiovascular drug which belongs to a group of blood pressure lowering medicines called angiotensin converting enzyme (ACE) inhibitors. Hydrochlorothiazide is a diuretic, that acts by increasing the amount of urine you produce. Bifril Plus is used to treat mild to moderate high blood pressure (hypertension), when this is not adequately controlled by taking zofenopril alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIFRIL PLUS DO NOT TAKE BIFRIL PLUS IF YOU: are more than 3 months pregnant (It is also better to avoid Bifril Plus in early pregnancy - see “pregnancy section”). are allergic to zofenopril calcium or to hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6) are allergic to other sulphonamide-derived substances (like hydrochlorothiazide, which is a sulphonamide-derived drug) have had any previous allergic reaction to any other ACE inhibitor such as captopril o Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 10 November 2019 CRN008Y6G Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bifril Plus 30 mg/12.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 28.7 mg of zofenopril as 30 mg of zofenopril calcium and 12.5 mg of hydrochlorothiazide. Excipients with known effect: Each film-coated tablet contains 56.20 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pastel-red, round, slightly bi-convex tablets of 9 mm with a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of mild to moderate essential hypertension. This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on zofenopril alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults_ Dose titration with the individual components (i.e. zofenopril and hydrochlorothiazide) is recommended before changing to the fixed dose combination. When clinically appropriate direct change from monotherapy to the fixed combination may be considered. _Patients without volume or salt depletion_ The usual effective dose is one tablet once daily. _Patients suspected of volume or salt depletion_ The use of Bifril Plusis not recommended. _Elderly (over 65 years)_ In the elderly with normal creatinine clearance no dose adjustment is necessary. In the elderly with reduced creatinine clearance (less than 45 mL/min) the use of Bifril Plusis not recommended. Creatinine clearance may be estimated from serum creatinine by the following Cockroft-Gault formula: [(140-age) * weight (Kg)] CrCl (mL/min) = _______________________________________ 72 *serum Cr (mg/dL) The above method provides creatinine clearance in males. For females the value obtained should be multiplied by 0.85. Health Products Regulatory Authority 10 N Διαβάστε το πλήρες έγγραφο