Fatrobendan 10 mg, Chewable Tablets for Dogs

Composition

Each tablet contains:

Active substance:

Pimobendan …………………..10 mg

Excipients:

Square brownish tablet with two break marks divisible into two or four equal parts.

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Pharmacological properties

4.1 ATCvet code: QC01CE90

4.2 Pharmacodynamics

Pimobendan, a benzimadazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilatative properties.

The positive inotropic effect of pimobendan is mediated by two mechanisms of action: increase in calcium sensitivity of cardiac myofilaments and inhibition of phosphodiesterase (type III).

The vasodilator effect arises from inhibition of phosphodiesterase III. When used in cases of mitral valve disease and dilated cardiomyopathy in conjunction with other standard therapy, the veterinary medicinal product may reduce the progression of myocardial damage.

4.3 Pharmacokinetics

Absorption:

Following oral administration of pimobendan, the absolute bioavailability of the active substance is 60-63%. As this bioavailability is considerably reduced by concomitant consumption of food or by administration of the veterinary medicinal product immediately after meals, it is recommended to administer the veterinary medicinal product one hour before feeding.

Distribution:

The volume of distribution is 2.6 l/kg, and indicates that pimobendan is distributed immediately into the tissues. The binding to plasma proteins is, on average, 93%.

Metabolism:

Pimobendan is subjected to a process of oxidative demethylation which leads to the formation of its principal active metabolite (UD-CG 212). Further metabolic pathways are formed by the phase II conjugation of UD-CG 212, mainly to glucuronides and sulphates.

Elimination:

The plasma elimination half-life of pimobendan is 0.4 ± 0.1 h, consistent with a high clearance rate (90 ± 19 ml/min/kg) and a short mean residence time (0.5 ± 0.1 h).

The principal active metabolite has a plasma elimination half-life of 2.0 ± 0.3 h. Almost the entire dose administered is eliminated via the faeces.

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Target species

Dogs.

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Indications

The veterinary medicinal product is indicated for the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid valve regurgitation).

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Dosage

For oral use.

Do not exceed the recommended dosage.

To ensure a correct dosage, body weight should be determined as accurately as possible.

The veterinary medicinal product must be administered orally within the dosage range of 0.2 mg to 0.6 mg pimobendan/kg bodyweight per day. The daily dose should be divided into two equal doses (i.e. 0.1 mg to 0.3 mg pimobendan/kg bodyweight) administered approximately 12 hours apart.

Each dose must be administered approximately 1 hour before feeding.

In cases of mild congestive heart failure, a daily dose at the lower end of the dose range (i.e., 0.1 mg/kg administered twice daily) may be adequate. If, however, a clear response is not observable within one week, the dosage should be increased. The maximum recommended dose is up to 0.3 mg/kg/dose administered twice daily.

To allow accurate dosing according to body weight, the chewable tablet can be divided along the designated score line.

The following table can be used as a guide to determine the number of tablets to administer to achieve a dose of 0.25 mg/kg – to be amended depending on clinical signs and response:

Approximate dose to be repeated morning and evening 12h apart, corresponding to approximately 0.25 mg of pimobendan/kg b.w.

For dogs weighing less than 10 kg, the 1.25 mg or 5 mg strengths of the veterinary medicinal product may be more suitable.

The veterinary medicinal product may be combined with a diuretic treatment (e.g. furosemide).

Return any divided tablets to the blister pack. Divided tablets should be used at the next administration.

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Contraindications

Do not use pimobendan in hypertrophic cardiomyopathies or in diseases in which an improvement in cardiac output cannot be achieved for functional or anatomical reasons (e.g. aortic stenosis).

Since pimobendan is metabolised mainly via the liver, it should not be used in dogs with severe impairment of liver function (see also section 3.7).

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Dogs:

Rare (1 to 10 animals / 10,000 animals treated): Increased heart ratea,b; Vomitingb, Diarrhoeac; Anorexiac, Lethargyc; Heart valve disorderd.

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Mucosa petechiaee, Skin (subcutaneous) haemorrhagee.

a moderately positive chronotropic effect.

b these effects are dose-dependent and can be avoided by reducing the dose.

c transient.

d an increase in mitral valve regurgitation has been observed during chronic pimobendan treatment in dogs with mitral valve disease.

e these signs of effects on primary haemostasis disappear when the treatment is withdrawn.

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:

This veterinary medical product should only be used in dogs with cardiac insufficiency.

Monitoring of cardiac function and morphology is recommended in animals treated with pimobendan (see also section 3.6).

Use with caution in epileptic dogs.

The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

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

People with known hypersensitivity to pimobendan should avoid contact with the veterinary medicinal product.

To avoid accidental ingestion, especially by a child, unused tablets parts should be placed back into the blister and carton and carefully kept away from children. Part-used tablets should be used at the time of the next dose.

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

Wash hands after use.

Advice to doctors: accidental ingestion, especially by a child, may lead to the occurrence of tachycardia, orthostatic hypotension, flushing of the face and headaches.

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 and lactation:

Laboratory studies in rats and rabbits have not produced any evidence of an effect on fertility. However, these studies have shown evidence of maternotoxic and embryotoxic effects at high doses, and have also shown that pimobendan is excreted into milk. The safety of the veterinary medicinal product has not been assessed in pregnant or nursing bitches. Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

In pharmacological studies no interaction between the cardiac glycoside oubain (strophanthin) and pimobendan was observed.

The pimobendan-induced increase in cardiac contractility is attenuated by the calcium antagonists verapamil and diltiazem and by the β-antagonist propranolol.

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Overdose

In the case of overdose, a positive chronotropic effect, vomiting, apathy, ataxia, heart murmurs or hypotension may occur.

In this situation, the dosage should be reduced and appropriate symptomatic treatment should be initiated. In prolonged exposure (6 months) of healthy beagle dogs at 3 and 5 times the recommended dose, mitral valve thickening and left ventricular hypertrophy were observed in some dogs. These changes are of pharmacodynamic origin.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

PVC/PE/PVdC/PE/PVC blister sealed with thermoheated aluminium foil containing 10 tablets.

Package-sizes:

- Cardboard box with 1 blister of 10 tablets (10 tablets)

- Cardboard box with 5 blisters of 10 tablets (50 tablets)

- Cardboard box with 10 blisters of 10 tablets (100 tablets)

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

Return any divided tablets to the blister pack

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Shelf life

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

Divided tablets should be used at the next administration. Any divided tablets remaining after the last administration should be discarded.

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Disposal of unused product

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 11557/5007

8 DATE OF FIRST AUTHORISATION

24 July 2026

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

July 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

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

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Registration holder

Fatro S.p.A.

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