国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
BENAZEPRIL HYDROCHLORIDE
Meda Health Sales Ireland Limited
C09AA07
BENAZEPRIL HYDROCHLORIDE
5 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
ACE inhibitors, plain
Authorised
2006-06-13
T5008306 MED A SPECIFIC ATION BO X M anufac tur er U sed t empla te Code (P ZN, EAN, Da tama tr ix) Pr oduc t (+P ack Siz e) Commen ts Fon ts used TR ADE G OTHIC Colours used M in. f on t- siz e t ex t M eda C ode / no . BLACK 8 PT Replac ed no . Dieses Kor rektur -PDF wur de v on uns mit g rößt er S or gfalt erst ellt und einer in ter nen Q ualitä tssicherungsprüfung un ter zogen. D en - noch bedeut et jeder Eing riff in die Da tei auch ein R isiko . W ir bitt en deshalb , den v or liegenden Kor rektur ab zug eingehend und umfas - send zu prüf en. F ür F ehler , die erst nach er teilt er F reigabe f est ge - st ellt w er den, über nimm t die Typophar ma GmbH keine Haf tung . TYPOPHARMA G MBH M ühlestr . 57 D -79539 L ör rach pr oduktion@t ypophar ma.c om w w w .typophar ma.c om typophar ma no: Or der no . Coun tr y/ language Technical c olours CUTTING Componen t Siz e CORR EC TIONS / NO . OF PR OOF S 4 Release Da te & sig n.: Cor rec tion R emar k: requir ed Page no . 1 07.12.2016 VM 5 Dr awing no . 2 6 Laetus no . | SEM | 172 3 7 ! PLEASE TURN O VERPRINTING ON ! M EDA M ANUFAC TURING G MBH N/A CIBAC EN 5 MG TAB T5008306 T5008248 # 124954 N/A IE , ENGLISH 148 X 420 MM PAGE 1 OF 2 GI- C-0003 / GI- C-0001 242 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 a 完全なドキュメントを読む
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, with the exception of those with polycystic kidney disease. 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 at least 3 days before commencing Cibacen and reinstituted subsequently if necessary. If it is not 完全なドキュメントを読む