FORTEKOR 5 MG FILM-COATED TABLETS FOR CATS AND DOGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENAZEPRIL HYDROCHLORIDE

Available from:

Elanco Europe Ltd

ATC code:

QC09AA07

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Dosage:

5 mg/tablet

Pharmaceutical form:

Film Coated Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Canine, Feline

Therapeutic area:

benazepril

Therapeutic indications:

Cardiovascular

Authorization status:

Authorised

Authorization date:

2016-04-22

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
FORTEKOR 5 mg film-coated tablets for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Benazepril hydrochloride 5 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Light yellow, ovaloid, slightly biconvex tablets with score on both
sides, marked “CG” on one side and “LV” on the
reverse.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs:
Treatment of congestive heart failure.
Cats:
Treatment 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.
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 in pregnancy or lactation (section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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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 or cats) during clinical
trials, however, as is routine in cases of chronic kidney disease, it