BEXEPRIL 20 MG FILM-COATED TABLET FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-10-2016
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Active ingredient:
BENAZEPRIL (AS HYDROCHLORIDE) EQUIVALENT TO BENAZEPRIL HYDROCHLORIDE PH.EUR.
Available from:
Chanelle Pharmaceuticals Manufacturing Limited
ATC code:
QC09AA07
INN (International Name):
BENAZEPRIL (AS HYDROCHLORIDE) EQUIVALENT TO BENAZEPRIL HYDROCHLORIDE PH.EUR.
Dosage:
20 mg/tablet
Pharmaceutical form:
Film Coated Tablet
Prescription type:
POM
Therapeutic group:
Canine
Therapeutic area:
Benazepril
Therapeutic indications:
Cardiovascular
Authorization status:
Authorised
Authorization date:
2010-06-04
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bexepril 20 mg Film-coated tablet for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Benazepril
18.42 mg
(equivalent to Benazepril Hydrochloride 20mg)
EXCIPIENT:
Titanium Dioxide (E171)
3.4176 mg
Iron Oxide Yellow (E172)
0.3424 mg
Iron Oxide Red (E172)
0.24 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
A round reddish orange biconvex tablet with break line on one side. The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs weighing more than 40 kg:
Treatment of congestive heart failure associated with, in particular, dilated cardiomyopathy and/or mitral insufficiency.
4.3 CONTRAINDICATIONS
Do not use in any dog that has evidence of cardiac output failure due, for example, to aortic stenosis.
Do not use in animals known to be hypersensitive to the active substance or to any of the excipient(s).
See Section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 28/09/2016_
_CRN 7024622_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal toxicity to the product has been observed in dogs during clinical trials. However, as is routine in
cases of renal insufficiency, it is recommended to monitor plasma creatinine and urea during therapy.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Wash hands after use.
In case of accidental oral ingestion, seek medical advice
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