Bexepril 5mg Film-coated Tablet for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Benazepril Hydrochloride

Available from:

Chanelle Pharmaceuticals Manufacturing Ltd

ATC code:

QC09AA07

INN (International Name):

Benazepril Hydrochloride

Pharmaceutical form:

Film-coated tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Cardio Vascular ACE inhibitor

Authorization status:

Expired

Authorization date:

2010-04-23

Summary of Product characteristics

Revised: June 2015
AN: 01657/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bexepril 5mg Film-coated tablet for dogs (BE & IE)
Bexepril 5mg Film-coated tablet for dogs (BG, CY, CZ, DK, EL, ES, HU,
LU, NL, NO,
PT, RO, SI, SK & UK)
Sirdis 5mg Film-coated tablet for dogs (IT)
Bexepril 5mg Film-coated tablets for dogs (PL)
Bexepril 5 Film-coated tablet for dogs (FR)
Bexepril l 5mg Film-coated tablet for dogs, Benazeprilhydochlorid (AT)
Benadog Flavour 5mg Film-coated tablets for dogs, Benzeprilhydochlorid
(DE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Benazepril 4.6mg
(equivalent to Benazepril Hydrochloride 5mg)
EXCIPIENT:
Titanium Dioxide (E171) 0.9348mg
Iron Oxide Yellow (E172) 0.0476mg
Quinoline Yellow Aluminum Lake (E104) 0.0176mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
A round yellow 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 10 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.
Revised: June 2015
AN: 01657/2014
Page 2 of 5
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 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 aft