Benefortin Flavour 20 mg tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benazepril hydrochloride

Available from:

LAVET Pharmaceuticals Ltd

ATC code:

QC09AA07

INN (International Name):

Benazepril hydrochloride

Dosage:

20 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

benazepril

Therapeutic indications:

Cardiovascular

Authorization status:

Authorised

Authorization date:

2012-01-27

Summary of Product characteristics

Health Products Regulatory Authority
24 June 2020
CRN009RKY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Benefortin Flavour 20 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
Benazepril hydrochloride 20.0 mg (equivalent to Benazepril 18.4 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Brownish, oval, divisible, tablet scored on both sides. 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
Dogs:
Treatment of congestive heart failure.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in cases of hypotension, hypovolaemia, hyponatraemia or
acute renal failure.
Do not use in cases of cardiac output failure due to aortic or
pulmonary stenosis.
Do not use during pregnancy or lactation (section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal toxicity of the veterinary medicinal product has
been observed in dogs during clinical trials, however, as is
routine in cases of chronic kidney disease, it is recommended to
monitor plasma creatinine, urea and erythrocyte counts during
therapy.
The chewable tablets are flavoured. In order to avoid any accidental
ingestion, store tablets out of reach of the animals.
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 immediately
and show the label or the package leaflet to the physician.
Health Products Regulatory Authority
24 June 2020
CRN009RKY
Page 2 of 4
Pregnant women should take special care to avoid accidental oral
exposure because angiotensin converting enzyme (ACE)
inhibitors have been found to affect the unborn child during pr