Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Benazepril hydrochloride
Mylan IRE Healthcare Limited
C09AA; C09AA07
Benazepril hydrochloride
5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain; benazepril
Not marketed
1999-06-16
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER CIBACEN 5MG FILM COATED TABLETS Benazepril hydrochloride 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 symptoms 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. IN THIS LEAFLET: 1. What Cibacen is and what it is used for 2. What you need to know before you take Cibacen 3. How to take Cibacen 4. Possible side effects 5. How to store Cibacen 6. Contents of the pack and other information 1. WHAT CIBACEN IS AND WHAT IT IS USED FOR Cibacen film-coated tablets contain 5mg benazepril hydrochloride. This is one of a group of medicines called ACE inhibitors. Cibacen is used to treat high blood pressure. It can also be used to treat some types of heart or kidney disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKEN CIBACEN DO NOT TAKE CIBACEN If you are allergic to benazepril or any other ACE inhibitor or to any of the ingredients in the tablets (listed in section 6) If you previously had a reaction to an ACE inhibitor involving hoarseness, swelling of the face, mouth, hands or feet, or sudden breathing problems If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. If you are more than 3 months pregnant. (it is also better to avoid Cibacen in early pregnancy – see pregnancy section). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Cibacen If you are taking any of the following medicines used to treat high blood pressure: – An angiotensin II receptor blocker (ARBs) (also known as sartans – for example, valsartan, telmisartan, irb Прочетете целия документ
Health Products Regulatory Authority 24 November 2020 CRN00C1SN Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cibacen 5 mg Film Coated Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg benazepril hydrochloride. Excipients: Each tablet contains 142mg lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablets. Light-yellow, ovaloid, slightly biconvex film-coated tablets scored on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of hypertension as monotherapy or combined with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1). As adjunctive therapy in patients with congestive heart failure. Treatment of patients with mild-to-moderate progressive chronic renal insufficiency (creatinine clearance 30-60 mL/min), with the exception of those with polycystic kidney disease. See sections 4.3, 4.4, 4.5 and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS:Hypertension:_ The usual initial dosage is 10mg given as a single dose which may be titrated to 20mg once daily if necessary. The dosage should be adjusted according to blood pressure response, generally at intervals of 1-2 weeks. In some patients, the antihypertensive effect may diminish towards the end of the dosing interval, and the total daily dosage should then be divided into two equal doses. The maximum recommended daily dose in hypertensive patients is 40mg, given as a single dose or two doses. If Cibacen alone does not produce a sufficient fall in blood pressure, another antihypertensive drug eg. a thiazide-type diuretic or calcium antagonist (initially at a low dose) may be added concomitantly (see sections 4.3, 4.4, 4.5 and 5.1). In the case of previous diuretic treatment the diuretic should be discontinued for 2-3 days before commencing Cibacen and reinstituted subsequently if necessary. If it is not possible to discontinue the diuretic, the initial dose of Cibacen should be reduced to 5mgin order to a Прочетете целия документ