Introduction

Novartis

Company name: Novartis Animal Health UK Ltd

Address: Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

Telephone: 01276 694402

Fax: 01276 694403

Presentation

Fortekor Flavour 5mg & 20mg

Tablet.

Beige to light brown, ovaloid, divisible, palatable tablet scored on both sides.

5 mg benazepril hydrochloride (Fortekor Flavour 5)

20mg benazepril hydrochloride (Fortekor Flavour 20)

Uses

FORTEKOR FLAVOUR* is indicated for the treatment of heart failure in dogs. The active ingredient is benazepril. After oral administration, benazepril is rapidly absorbed from the gastrointestinal tract and hydrolysed into benazeprilat, a highly specific and potent inhibitor of angiotensin converting enzyme (ACE). FORTEKOR FLAVOUR* produces significant inhibition of plasma ACE activity for more than 24 hours after a single dose in dogs. Inhibition of ACE leads to reduced conversion of inactive angiotensin I into angiotensin II and therefore reduction in the effects mediated by angiotensin II, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney and remodelling effects (including pathological cardiac hypertrophy and degenerative renal changes).

In dogs with heart failure, FORTEKOR FLAVOUR* lowers the blood pressure and volume loading on the heart. FORTEKOR FLAVOUR* leads to a significant extension of the life span of dogs with heart failure and also improves clinical signs, notably reduction in coughing and improvement of the quality of life.

Benazeprilat is excreted equally by both biliary and urinary routes in dogs.

Dosage and administration

Heart failure in dogs

The recommended dose is 0.25-0.5 mg benazepril hydrochloride/kg bodyweight, to be given orally once daily according to the tabulated heart failure dosage regime:

Heart failure dosage regime
	Fortekor Flavour 5		Fortekor Flavour 20
Weight of dog (kg)	Standard dose	Double dose	Standard dose	Double dose
5 - 10	0.5 tablet	1 tablet
11 - 20	1 tablet	2 tablets
21 - 40			0.5 tablet	1 tablet
41 - 80			1 tablet	2 tablets

FORTEKOR FLAVOUR* can be given with or without food. The duration of treatment is unlimited. The dose may be doubled, still administered once daily if judged clinically necessary and advised by the veterinary surgeon. When the 10 mg dose is required, veterinary surgeons should consider administering two 5 mg tablets to limit the use of half tablets. FORTEKOR FLAVOUR* may be given in combination with digoxin, diuretics and anti-arrhythmic drugs as necessary.

Contra-indications, warnings, etc

For animal treatment only. For oral use only. Wash hands after use. In man, the combination of ACE Inhibitors and NSAIDS can lead to reduced antihypertensive efficacy or impaired renal function. Therefore concurrent use of NSAIDS should be considered with care.

Dogs

Transient signs of hypotension such as tiredness or dizziness may appear in rare cases. Interactions with potassium preserving drugs like spironolactone, triamteren or amilorid cannot be ruled out. It is recommended to monitor plasma potassium levels when using benazepril in combination with a potassium sparing diuretic. As with other ACE inhibitors, the use of hypotensive medicinal products or anaesthetics with a hypotensive effect may add to the anti-hypertensive effect of benazepril. The safety of FORTEKOR FLAVOUR* has not been tested in breeding, pregnant or lactating dogs so should be used only if justified clinically, considering the risk/benefit ratio. As is routine in cases of renal insufficiency, it is recommended to monitor plasma urea and creatinine concentrations. Do not use in any dog that has evidence of cardiac output failure due to aortic stenosis.

Pharmaceutical precautions

Store in a dry place. Do not store above 25°C. Each time an unused half tablet is stored, it should be returned to the open blister space, inserted back into the cardboard box and kept in a safe place out of reach of children. Tablet halves should be used within 2 days.

Legal category

POM-V

Packaging Quantities

Cardboard box with

Fortekor Flavour 5:

Aluminium blister packs each containing 14 tablets

Packs containing 2 blisters (28 tablets).

Packs containing 4 blisters (56 tablets)

Fortekor Flavour 20:

Aluminium blister packs each containing 14 tablets

Pack containing 2 blisters (28 tablets)

Disposal

Any unused product or waste material should be disposed of in accordance with national requirements. Unused product should be returned to the veterinary surgeon.