Cardisure Flavoured 1.25 mg Tablets for Dogs

Composition

Each tablet contains:

Active substances:

Pimobendan 1.25 mg

Excipients:

Qualitative composition of excipients and other constituents

Cellulose, microcrystalline

Croscarmellose sodium

Magnesium stearate

Natural meat flavour

Light brown, round tablets, scored on one side and plain on the other side.

The tablets can be divided into 2 equal parts.

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Pharmacological properties

4.1 ATCvet code :

QC01CE90

4.2 Pharmacodynamics

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

Pimobendan exerts its stimulatory myocardial effect by a dual mode of action: it increases calcium sensitivity of cardiac myofilaments and inhibits phosphodiesterase (type III). It also exhibits a vasodilatory action through inhibition of phosphodiesterase III activity.

When used in cases of valvular insufficiency in conjunction with furosemide, the veterinary medicinal product has been shown to improve the quality of life and extend life expectancy in treated dogs.

When used in a limited number of cases of dilated cardiomyopathy in conjunction with furosemide, enalapril and digoxin the veterinary medicinal product has been shown to improve the quality of life and to extend life expectancy in treated dogs.

4.3 Pharmacokinetics

Absorption:

Following oral administration of this veterinary medicinal product the absolute bio-availability of the active principle is 60-63%. Since this bio-availability is considerably reduced when pimobendan is administered with food or shortly thereafter, it is recommended to treat animals approximately 1 hour before feeding.

Distribution:

The volume of distribution is 2.6 l/kg, indicating that pimobendan is distributed readily into the tissues. The mean plasma protein binding is 93%.

Metabolism:

The compound is oxidatively demethylated to its major active metabolite (UD-CG 212). Further metabolic pathways are phase II conjugates of UD-CG-212, in essence glucuronides and sulphates.

Elimination:

The plasma elimination half-life of pimobendan is 1.1 ± 0.7 hours. The main active metabolite is eliminated with a plasma elimination half-life of 1.5 ± 0.2 hours. Almost the entire dose is eliminated via faeces.

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Target species

Dogs.

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Indications

For the treatment of canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy.

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Dosage

Oral use.

Do not exceed the recommended dosage.

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

The tablets should be administered orally at a dose range of 0.2 mg to 0.6 mg pimobendan/kg body weight per day. The preferable daily dose is 0.5 mg pimobendan/kg body weight. The dose should be divided into two administrations (0.25 mg/kg body weight each), one half of the dose in the morning and the other half approximately 12 hours later. The maintenance dose should be individually adjusted by the responsible veterinarian according to the severity of the disease.

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

To break a tablet into two halves, place the tablet on an even surface with the scored side up, hold one half of the tablet and press down on the other half.

Each dose should be given approximately one hour before feeding.

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Contraindications

Do not use in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic stenosis).

See also section 3.7.

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Adverse reactions

Dogs:

Rare (1 to 10 animals / 10 000 animals treated): Increased heart ratea,b, Increase in mitral valve regurgitationc, Vomitingb, Diarrhoead, Anorexiad, Lethargyd

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

aModerate positive chronotropic effect.

bThese effects are dose-dependent and may be avoided by reducing the dose in these cases.

cHas been observed during chronic pimobendan treatment in dogs with mitral valve disease.

dTransient.

eAlthough a relationship with pimobendan has not been clearly established, signs of effects on primary haemostasis may be observed during treatment. These signs 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:

The veterinary medicinal product is flavoured. To avoid accidental ingestion the tablets should be stored out of reach of dogs.

An in vitro study in rat tissue demonstrated that pimobendan increased glucose-induced insulin release from pancreatic β-cells in a dose-dependent manner. If the veterinary medicinal product is administered to diabetic dogs, blood glucose levels should be carefully monitored.

As pimobendan is metabolised in the liver, particular care should be taken when administering the veterinary medicinal product to dogs with severe hepatic insufficiency.

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

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

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

Wash hands after use.

To the physician: 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

The safety of the veterinary medicinal product has not been established during pregnancy or lactation.

Pregnancy and lactation:

Use only according to the benefit-risk assessment by the responsible veterinarian.

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic or foetotoxic effects. However, these studies have shown evidence of maternotoxic and embryotoxic effects at high doses and have also shown that pimobendan is excreted into milk.

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Interactions

In pharmacological studies no interaction between the cardiac glycoside ouabain and pimobendan was detected. The pimobendan-induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and the β-antagonist propranolol.

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Overdose

In the case of overdose, a positive chronotropic effect and vomiting 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.

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Special warnings

The veterinary medicinal product should be administered on an empty stomach at least one hour before meals, as absorption is reduced when given with feed.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

Aluminium – PVC/PE/PVDC blister:

10 tablets per blister: 2, 5, 10 or 25 blisters per carton.

Aluminium – Aluminium blister:

10 tablets per blister: 2, 5, 10 or 25 blisters per carton.

Not all pack sizes may be marketed.

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Storage

Do not store above 30 °C.

Return any divided tablet to the opened blister and use within 3 days.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months. Shelf life of divided tablets after first opening the blister: 3 days.

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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 16849/5015 (GB)

Vm 16849/3015 (NI)

8 DATE OF FIRST AUTHORISATION

9 August 2011

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

July 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.

Gavin Hall Approved: 06 January 2026

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Registration holder

Eurovet Animal Health B.V.

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