PRILBEN
Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
23-11-2012
Summary of Product characteristics
(SPC)
23-11-2012
Active ingredient:
benazepril hydrochloride 4.6 mg
Available from:
CHEMO IBERICA SA
ATC code:
QC09AA07
Pharmaceutical form:
Tablet
Therapeutic group:
benazepril
Therapeutic area:
Cats, Dogs
Authorization date:
2012-12-02
Patient Information leaflet
PACKAGE LEAFLET
PRILBEN
®
vet 5 film-coated tablet for dogs and cats
[FR]
PRILBEN vet 5
mg film-coated tablet for dogs and cats
Benazepril hydrochloride
[DE/PL]
Prilben vet 5 mg film-coated tablet for dogs
and cats
Benazepril hydrochloride
[SE]
PRILBEN
®
vet 5 mg film-coated tablet for dogs and cats
Benazepril hydrochloride
[BE/DK/EL/ES/FI/IT/NL/PT/UK]
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION
HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder
Chemo Ibérica, S.A.
Gran Vía Carlos III, 98 – 7ª
08028 Barcelona
SPAIN
Manufacturer for the batch release
Laboratorios LICONSA, S.A
Avda. Miralcampo, 7, Pol. Ind. Miralcampo
Azuqueca de Henares, 19200 Guadalajara
SPAIN
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
PRILBEN
®
vet 5 film-coated tablet for dogs and cats
[FR]
PRILBEN vet 5
mg film-coated tablet for dogs and cats
[PL]
PRILBEN vet 5
mg film-coated tablet for dogs and cats
Benazepril hydrochloride
[DE]
Prilben vet 5
mg film-coated tablet for dogs and cats
Benazepril hydrochloride
[SE]
PRILBEN
®
vet 5 mg film-coated tablet for dogs and cats
Benazepril hydrochloride
[BE/DK/EL/ES/FI/IT/NL/PT/UK]
3.
STATEMENT
OF
THE
ACTIVE
SUBSTANCE(S)
AND
OTHER
INGREDIENT(S)
Each divisible tablet contains:
Benazepril .......................................... 4.6 mg
(equivalent to Benazepril Hydrochloride 5 mg)
Excipients :
Titanium dioxide (E171) ..................... 1.929 mg
Iron oxide yellow (E172) .................... 0.117 mg
Iron oxide red
Read the complete document
Summary of Product characteristics
12463 PRILBEN 5 renewal SPC D90D81
S)
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT:
PRILBEN vet 5 film-coated tablet for dogs and cats
[FR]
PRILBEN vet 5 mg film-coated tablet for dogs and cats
[PL]
PRILBEN vet 5 mg film-coated tablet for dogs
and cats
Benazepril hydrochloride
[DE]
Prilben vet 5 mg film-coated tablet for dogs
and cats
Benazepril hydrochloride
[SE]
PRILBEN vet 5 mg film-coated tablet for dogs
and cats
Benazepril hydrochloride
[BE/DK/EL/ES/FI/IT/NL/PT/UK]
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each divisible tablet contains:
Benazepril ......................................... 4.6 mg
(equivalent to Benazepril Hydrochloride 5 mg)
Excipients :
Titanium dioxide (E171)................... 1.929 mg
Iron oxide yellow (E172) .................. 0.117 mg
Iron oxide red (E172) ....................... 0.014 mg
Iron oxide black (E172).................... 0.004 mg
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM:
Film-Coated TabletBeige oblong biconvex
film-coated divisible tablets
4. CLINICAL PARTICULARS:
4.1 TARGET SPECIES:
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING TARGET SPECIES:
Dogs:
Treatment of congestive heart failure.
Cats:
Reduction of proteinuria associated with chronic kidney disease.
4.3 . CONTRAINDICATIONS:
Do not use in case of hypersensitivity to the active substance or to any of the
excipients.
12463 PRILBEN 5 renewal SPC D90D81
S)
Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal
failure.
Do not use in cases of cardiac o
Read the complete document
