Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
ZOFENOPRIL CALCIUM
Menarini International Operations Luxembourg S.A.
C09AA; C09AA15
ZOFENOPRIL CALCIUM
60 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain; zofenopril
Not marketed
1999-03-04
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BIFRIL 30MG 7.5MG 15MG 60MG film-coated tablets (zofenopril calcium) 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 is and what it is used for 2. What you need to know before you take Bifril 3. How to take Bifril 4. Possible side effects 5. How to store Bifril 6. Contents of the pack and other information 1. WHAT BIFRIL IS AND WHAT IT IS USED FOR Bifril contains zofenopril calcium 30 mg 7.5 mg 15 mg 60 mg which belongs to a group of blood pressure lowering medicines called angiotensin converting enzyme (ACE) inhibitors. Bifril is used to treat the following conditions: high blood pressure (hypertension). heart attack (acute myocardial infarction) in people who may or may not show signs and symptoms of heart failure, and who have not received treatment that helps dissolve blood clots (thrombolytic therapy). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIFRIL DO NOT TAKE BIFRIL IF YOU: are allergic to zofenopril calcium or any of the other ingredients of this medicine (listed in section 6) have had any previous allergic reaction to any other ACE inhibitor such as captopril or enalapril have a history of severe swelling and itching around the face, nose and throat (angioneurotic edema) associated with previous ACE inhibitor therapy, or if you suffer from hereditary/idiopathic angioneurotic oedema (rapid swelling of the skin, tissues, digestive tract and other organs) have taken or are currently taking sacubitril/valsartan, a medici Izlasiet visu dokumentu
Health Products Regulatory Authority 25 July 2019 CRN008Y3R Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BIFRIL 60 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each BIFRIL 60 mg tablet contains 60 mg of zofenopril calcium as 57.3 mg of zofenopril. Excipients with known effect: Each BIFRIL 60 mg film-coated tablet contains 138.8 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White oblong film coated tablets with a breakline. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Hypertension_ BIFRIL is indicated for the treatment of mild to moderate essential hypertension. _Acute Myocardial Infarction_ BIFRIL is indicated for the treatment initiated within the first 24 hours of patients with acute myocardial infarction with or without signs and symptoms of heart failure, who are haemodynamically stable and have not received thrombolytic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ _ _ HYPERTENSION _ _ _Adults_ The need for dosage titration should be determined by measurement of blood pressure just before the next dose. The dose should be increased at an interval of four weeks. _Patients without volume or salt depletion:_ Treatment should be started with 15 mg once daily and titrated upwards to achieve optimal blood pressure control. The usual effective dose is 30 mg once daily. The maximum dose is 60 mg per day administered in a single or two divided doses. In case of inadequate response, other antihypertensive agents such as diuretics may be added (see Sections 4.3, 4.4, 4.5 and 5.1). _ _ _Patients suspected of volumeor salt depletion_ Health Products Regulatory Authority 25 July 2019 CRN008Y3R Page 2 of 14 First-dose hypotension may occur in high risk patients (see Special warnings and precautions for use). Initiation of therapy with ACE inhibitors requires correction of salt and/or volume deficiencies, discontinuation of an existi Izlasiet visu dokumentu