Benefortin Flavour Tablets

Benefortin Flavour Tablets.

Uses:
Dogs: Treatment of congestive heart failure.

Cats: Reduction of proteinuria associated with chronic kidney disease. (Benefortin Flavour 2.5 mg and 5 mg tablets for cats and dogs only).

Dosage and administration:
The veterinary medicinal product should be given orally once daily, with or without food. The duration of treatment is unlimited. The tablets are flavoured and are taken voluntarily by most dogs and cats.

Cats: Tablets should be administered orally at a minimum dose of 0.5 mg (range 0.5 - 1.0) benazepril hydrochloride/kg body weight once daily according to the following dosing tables:

Benefortin Flavour 2.5 mg tablets for cats

Weight of cat (kg)

Number of tablets

2.5 - 5

1 tablet

>5 - 10

2 tablets

Benefortin Flavour 5 mg tablets for cats

Weight of cat (kg)

Number of tablets

2.5 - 5

0.5 tablet

>5 - 10

1 tablet

Dogs: Tablets should be administered orally at a minimum dose of 0.25 mg (range 0.25-0.5) benazepril hydrochloride/kg body weight once daily, according to the following table. The dose may be doubled, still administered once daily, to a minimum dose of 0.5 mg/kg (range 0.5-1.0), if judged clinically necessary and advised by the veterinary surgeon, according to the dosing tables below:

Benefortin Flavour 2.5 mg tablets for dogs

Weight of dog (kg)

Standard dose

Double dose

2.5-5

0.5 tablet

1 tablet

>5-10

1 tablet

2 tablets

Benefortin Flavour 5 mg tablets for dogs

Weight of dog (kg)

Standard dose

Double dose

5-10

0.5 tablets

1 tablet

>10-20

1 tablet

2 tablets

Benefortin Flavour 20 mg tablets for dogs

Weight of dog (kg)

Standard dose

Double dose

>20-40

0.5 tablet

1 tablet

>40-80

1 tablet

2 tablets

Contra-indications, warnings, etc:
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 during pregnancy or lactation.

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 is recommended to monitor plasma creatinine, urea and erythrocyte counts during therapy. The efficacy and safety of benazepril has not been established in dogs and cats below 2.5 kg body weight.

In double-blind clinical trials in dogs with congestive heart failure, benazepril was well tolerated with an incidence of adverse reactions lower than observed in placebo treated dogs.

A small number of dogs may exhibit transient vomiting, incoordination or signs of fatigue. In cats and dogs with chronic kidney disease, benazepril may increase plasma creatinine concentrations at the start of therapy. A moderate increase in plasma creatinine concentrations following administration of ACE inhibitors is compatible with the reduction in glomerular hypertension induced by these agents, and is therefore not necessarily a reason to stop therapy in the absence of other signs.

Benazepril may increase food consumption and body weight in cats. Emesis, anorexia, dehydration, lethargy and diarrhoea have been reported in rare occasions in cats.

Do not use during pregnancy or lactation. The safety of benazepril hydrochloride has not been established in breeding, pregnant or lactating dogs and cats. Benazepril reduced ovary/oviduct weights in cats when administered daily at 10 mg/kg body weight for 52 weeks. Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally non-toxic doses.

In dogs with congestive heart failure, benazepril hydrochloride has been given in combination with digoxin, diuretics, pimobendan and anti-arrhythmic veterinary medicinal products without demonstrable adverse interactions.

In humans, the combination of ACE inhibitors and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal function. The combination of benazepril hydrochloride and other anti-hypertensive agents (e.g. calcium channel blockers, ß-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects. Therefore, concurrent use of NSAIDs or other medications with a hypotensive effect should be considered with care. Renal function and signs of hypotension (lethargy, weakness etc.) should be monitored closely and treated as necessary. Interactions with potassium-preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out. It is recommended to monitor plasma potassium levels when using benazepril in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.

Benazepril reduced erythrocyte counts in normal cats when dosed at 10 mg/kg body weight once daily for 12 months and in normal dogs when dosed at 150 mg/kg body weight once daily for 12 months, but this effect was not observed at the recommended dose during clinical trials in cats or dogs.

Transient reversible hypotension may occur in cases of accidental overdose. Therapy should consist of intravenous infusion of warm isotonic saline.

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. 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 pregnancy in humans.

Pharmaceutical precautions:
Shelf-life of veterinary medicinal product as packaged for sale: 18 months.

Tablet halves should be used within 2 days.

Do not store above 25°C. Store in a dry place.

Each time an unused half tablet is stored, it should be returned to the open blister space and inserted back into the cardboard box and kept in a safe place out of the reach of children.

For animal treatment only - to be supplied only on a veterinary prescription.

Keep out of the sight and reach of children.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category:
POM-V

Packaging Quantities:
2.5 mg presentation PVC/Aluminium/Polyamide blister-forming laminate with aluminium lidding foil with 14 tablets/blister. Cardboard box with 1 blister strip of 14 tablets (14 tablets) Cardboard box with 2 blister strips of 14 tablets (28 tablets) Cardboard box with 4 blister strips of 14 tablets (56 tablets) Cardboard box with 10 blister strips of 14 tablets (140 tablets) 5 mg presentation: PVC/Aluminium/Polyamide blister-forming laminate with aluminium lidding foil with 14 tablets/blister. Cardboard box with 1 blister strip of 14 tablets (14 tablets) Cardboard box with 2 blister strips of 14 tablets (28 tablets) Cardboard box with 4 blister strips of 14 tablets (56 tablets) Cardboard box with 10 blister strips of 14 tablets (140 tablets) 20 mg presentation PVC/Aluminium/Polyamide blister-forming laminate with aluminium lidding foil with 7 tablets/blister. Cardboard box with 1 blister strip of 7 tablets (7 tablets) Cardboard box with 2 blister strips of 7 tablets (14 tablets) Cardboard box with 4 blister strips of 7 tablets (28 tablets) Cardboard box with 10 blister strips of 7 tablets (70 tablets) Not all pack sizes may be marketed.