Benazecare Flavour 20 mg Tablets for Dogs

Composition

Each tablet contains:

Active substance:

Benazepril hydrochloride 20 mg

Excipients:

Qualitative composition of excipients and other constituents

Lactose monohydrate

Pregelatinized starch

Croscarmellose sodium

Castor oil, hydrogenated

Beef flavour 201627

White to beige oblong tablet with breakline on both sides.

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Pharmacological properties

4.1 ATCvet code: QC09AA07

4.2 Pharmacodynamics

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).

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

Benazepril hydrochloride reduces the blood pressure and volume load on the heart in dogs with congestive heart failure.

4.3 Pharmacokinetics

After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (Tmax 0.5 hour in dogs) 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) 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.

Benazeprilat concentrations decline biphasically: the initial fast phase (t1/2=1.7 hours in dogs) represents elimination of free drug, while the terminal phase (t1/2=19 hours in dogs) 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 benazepril hydrochloride leads to slight bioaccumulation of benazeprilat (R=1.47 in dogs 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. The clearance of benazeprilat is not affected in dogs with impaired renal function and therefore no adjustment of benazepril hydrochloride dose is required in cases of renal insufficiency.

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Target species

Dogs.

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Indications

Treatment of congestive heart failure.

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Dosage

Oral use.

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

The veterinary medicinal product 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:

BENAZECARE FLAVOUR 20 mg

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.

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Contraindications

Do not use in cases 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 3.7).

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Adverse reactions

Dogs:

Undetermined frequency Vomiting1 (cannot be estimated from the Incoordination available data): Fatigue Elevated creatinine2 1 Transient 2 In dogs with chronic kidney disease, at the start of therapy. A moderate increase in

plasma creatinine concentrations following the 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.

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

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 the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

No evidence of renal toxicity of the veterinary medicinal product has been observed in dogs 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.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Wash hands after use.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label 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.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy, lactation and fertility:

Do not use during pregnancy or lactation. The safety of benazepril hydrochloride has not been established in breeding, pregnant or lactating dogs. Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally non-toxic doses.

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Interactions

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, 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 benazepril hydrochloride in combination with a potassium-sparing diuretic because of the risk of hyperkalaemia.

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Overdose

Benazepril hydrochloride reduced erythrocyte counts 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 dogs.

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

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

Aluminium/aluminium blister packs containing 14 tablets, packed in a cardboard box with a package leaflet. The veterinary medicinal product is supplied in packs of 14, 28, 56 or 140 tablets. Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C.

Store in a dry place.

Divided tablets should be stored in the blister pack. The blister pack should be inserted back into the cardboard box.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: 48 hours.

Any divided tablet portion remaining after 48 hours should be discarded.

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Disposal of unused product

product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with

any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 32742/4037

8 DATE OF FIRST AUTHORISATION

24 August 2006

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

June 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 06 November 2025

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Registration holder

Ecuphar NV

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