Each tablet contains:

Fortekor Flavour 5mg tablets for cats and dogs:

Active substance: Benazepril hydrochloride 5 mg.

Fortekor Flavour 20mg tablets for dogs:

Active substance: Benazepril hydrochloride 20 mg.

For the full list of excipients, see Pharmaceutical particulars section.

Tablets.

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

The tablets can be divided into halves.

Dogs and cats.

Dogs:

Treatment of congestive heart failure.

Cats:

Reduction of proteinuria associated with chronic kidney disease.

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 (section below).

None.

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 the veterinary medicinal product has not been established in dogs and cats below 2.5 kg body weight.

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.

Not applicable.

Adverse reactions (frequency and seriousness)

Dogs:

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

In cats and dogs with chronic kidney disease, the product 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.

The veterinary medicinal product may increase food consumption and body weight in cats.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.

Do not use during pregnancy or lactation. The safety of the veterinary medicinal product 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, the veterinary medicinal product 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 the product and other anti-hypertensive agents (e.g. calcium channel blockers, β-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 the veterinary medicinal product in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.

The veterinary medicinal product should be given orally once daily, with or without food. The duration of treatment is unlimited.

This product is flavoured and are taken voluntarily by most dogs and cats.

Dogs:

This veterinary medicinal product 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.

The veterinary medicinal product 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 table:

The veterinary medicinal product 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.

Not applicable.

Pharmacotherapeutic group: ACE Inhibitors, plain.

ATC vet code: QC09AA07.

Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat. Benazeprilat is a highly potent and selective inhibitor of ACE, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone. Therefore, it blocks effects mediated by angiotensin II and aldosterone, 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).

The veterinary medicinal product causes long-lasting inhibition of plasma ACE activity in dogs and cats, with more than 95% inhibition at peak effect and significant activity (>80% in dogs and >90% in cats) persisting 24 hours after dosing.

The product reduces the blood pressure and volume load on the heart in dogs with congestive heart failure.

In cats with experimental renal insufficiency, the veterinary medicinal product normalized the elevated glomerular capillary pressure and reduced the systemic blood pressure.

Reduction in glomerular hypertension may retard the progression of kidney disease by inhibition of further damage to the kidneys. Placebo controlled clinical field studies in cats with chronic kidney disease (CKD) have demonstrated that FORTEKOR Flavour significantly reduced levels of urine protein and urine protein to creatinine ratio (UPC); this effect is probably mediated via reduced glomerular hypertension and beneficial effects on the glomerular basement membrane.

No effect of the veterinary medicinal product on survival in cats with CKD has been shown, but the product increased the appetite of the cats, particularly in more advanced cases.

After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (Tmax 0.5 hour in dogs and within 2 hours in cats) and decline quickly as the active substance is partially metabolised by liver enzymes to benazeprilat. The systemic bioavailability is incomplete (~13% in dogs) due to incomplete absorption (38% in dogs, <30% in cats) and first pass metabolism.

In dogs, peak benazeprilat concentrations (Cmax of 37.6 ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 1.25 hours.

In cats, peak benazeprilat concentrations (Cmax of 77.0 ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 2 hours.

Benazeprilat concentrations decline biphasically: the initial fast phase (t1/2=1.7 hours in dogs and t1/2=2.4 hours in cats) represents elimination of free drug, while the terminal phase (t1/2=19 hours in dogs and t1/2=29 hours in cats) reflects the release of benazeprilat that was bound to ACE, mainly in the tissues. Benazepril and benazeprilat are extensively bound to plasma proteins (85-90%), and in tissues are found mainly in the liver and kidney.

There is no significant difference in the pharmacokinetics of benazeprilat when benazepril hydrochloride is administered to fed or fasted dogs. Repeated administration of the veterinary medicinal product leads to slight bioaccumulation of benazeprilat (R=1.47 in dogs and R=1.36 in cats with 0.5 mg/kg), steady state being achieved within a few days (4 days in dogs).

Benazeprilat is excreted 54% via the biliary and 46% via the urinary route in dogs and 85% via the biliary and 15% via the urinary route in cats. The clearance of benazeprilat is not affected in dogs or cats with impaired renal function and therefore no adjustment of the dose of the product is required in either species in cases of renal insufficiency

Cellulose microcrystalline
Crospovidone
Povidone K30
Basic butylated methacrylate copolymer
Silicon dioxide anhydrous
Sodium laurilsulphate
Dibutyl sebacate
Silica colloidal anhydrous
Stearic acid
Yeast powder
Artificial powdered beef flavour

Not applicable.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life of tablet halves: 2 days

Fortekor Flavour 5mg tablets: Do not store above 25 °C.

Fortekor Flavour 20mg tablets: This veterinary medicinal product does not require any special storage conditions.

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 the sight and reach of children.

14 tablets per aluminium/aluminium blister. Cardboard box with:

1 blister (14 tablets)

2 blisters (28 tablets)

4 blisters (56 tablets)

10 blisters (140 tablets)

Not all pack sizes may be marketed.

Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

NA

Fortekor Flavour 5mg tablets for cats and dogs: Vm 00879/5019

Fortekor Flavour 20mg tablets for dogs: Vm 00879/5020

28 April 2010

August 2023