CIBACEN 10 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENAZEPRIL HYDROCHLORIDE

Available from:

Meda Health Sales Ireland Limited

ATC code:

C09AA07

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Dosage:

10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain

Authorization status:

Authorised

Authorization date:

2006-06-13

Patient Information leaflet

T5008307
MED
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SPECIFIC
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Da
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.  |  SEM
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M
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TURING G
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N/A
CIBAC
EN 10 MG 
TAB
T5008307
T5008249
# 124955
N/A
IE
, ENGLISH
148  X  420  MM
PAGE 
1 OF 2
GI-
C-0003 / GI-
C-0001
243
Package Leaflet: Information for the user
CIBACEN 10MG
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cibacen 10 mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg benazepril hydrochloride
Excipients: Each tablet contains 132mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Dark yellow, round slightly biconvex, film-coated tablets with beveled edges.
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 po