SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Pimocard 1.25 mg flavoured tablets for dogs.

(Belgium, Estonia, Germany, Ireland, Italy, Latvia, Lithuania, The Netherlands, United Kingdom)

Cardisure 1.25 mg flavoured tablets for dogs.

(Czech, Hungary, Slovenia, Slovakia)

Pimosure 1.25mg flavoured tablets for dogs.

(Portugal and Spain)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 tablet contains:

Active substance:

Pimobendan 1.25 mg

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet

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

The tablets can be divided into 2 equal parts.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

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

4.3 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 4.7.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

The blood glucose should be tested regularly during treatment in dogs with existing diabetes mellitus.

Monitoring of cardiac function and morphology is recommended in animals treated with pimobendan.

See also section 4.6.

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

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.

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

4.6 Adverse reactions (frequency and seriousness)

In rare cases a slight positively chronotropic effect (rise in heart rate) and vomiting can occur. However, these effects are dose-dependent and can be avoided by reducing the dose.

In rare cases transient diarrhoea, anorexia or lethargy have been observed. In rare cases, an increase in mitral valve regurgitation has been observed during chronic pimobendan treatment in dogs with mitral valve disease.

Although a relationship with pimobendan has not been clearly established, in very rare cases, signs of effects on primary haemostasis (petechiae on mucous membranes, subcutaneous haemorrhages) may be observed during treatment. These signs disappear when the treatment is withdrawn.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7 Use during pregnancy or lactation

Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic or foetotoxic effect. 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.

4.8 Interaction with other medicinal products and other forms of interaction

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.

Do not exceed the recommended dosage.

Determine the body weight accurately before treatment to ensure correct dosage.

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. Each dose should be given approximately one hour before feeding.

T
he product may be combined with a diuretic treatment such as furosemide.

To break a single scored 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

An overdose may cause vomiting, a positive chronotropic effect, apathy, ataxia, heart murmurs or hypotension. 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.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Cardiac stimulants excl. cardiac glycosides, phosphodiesterase inhibitors.

ATCvet code: QC01CE90

5.1 Pharmacodynamic properties

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 symptomatic valvular insufficiency in conjunction with furosemide the 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 symptomatic dilated cardiomyopathy in conjunction with furosemide, enalapril and digoxin, the product has been shown to improve the quality of life and to extend life expectancy in treated dogs.

5.2 Pharmacokinetic particulars

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 the faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cellulose, microcrystalline (E460)

Croscarmellose sodium

Magnesium stearate

Natural meat flavour

6.2 Incompatibilities

Not applicable

6.3 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: Remaining tablet portions should be given at the next administration.

6.4. Special precautions for storage

Do not store above 30°C.

Return any divided tablet to the opened blister .

6.5 Nature and composition of 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.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

The Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm 16849/4042

9. DATE OF FIRST AUTHORISATION

15 June 2012

10. DATE OF REVISION OF THE TEXT

January 2016

Approved: 13/01/2016