Cibacen 10 mg Film Coated Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Benazepril hydrochloride

Διαθέσιμο από:

Mylan IRE Healthcare Limited

Φαρμακολογική κατηγορία (ATC):

C09AA; C09AA07

INN (Διεθνής Όνομα):

Benazepril hydrochloride

Δοσολογία:

10 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

ACE inhibitors, plain; benazepril

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

1999-06-16

Φύλλο οδηγιών χρήσης

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 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 10mg 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).

If you have taken or are currently taking sacubitril/valsartan, a
medicine used to treat
a type of long-term (chronic) heart failure in adults, as the risk of
angioedema (rapid swelling
under the skin in an area such as the throat) is increased.

WARNINGS AND PRECAUTIONS
Talk to your

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
24 November 2020
CRN00C1SN
Page 1 of 12
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 (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 10 mg 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 e.g. 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 5mg in ord