SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Vetmedin Chew10 mg chewable tablets for dogs (AT, BE, DE, IE, IT, LI, LU, NL, UK)

Vetmedin vet. 10 mg chewable tablets for dogs (CY, DK, EL, ES, FI, IS, NO, PL, PT, SE)

Vetmedin S 10 mg chewable tablets for dogs (BG, CZ, EE, FR, HR, HU, LT, LV, RO, SI, SK)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One chewable tablet contains:

Active substance:

Pimobendan 10 mg

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablet.

Brownish, oval, divisible tablet, scored on both sides.

The tablet can be divided into equal halves.

4. CLINICAL PARTICULARS

4.1 Target species

Dog

4.2 Indications for use, specifying the target species

For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid valve regurgitation). (See also section 4.9).

For the treatment of dilated cardiomyopathy in the preclinical stage (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter) in Doberman Pinschers following echocardiographic diagnosis of cardiac disease (see section 4.4 and 4.5).

4.3 Contraindications

Do not usepimobendan 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 pimobendanis 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

The product has not been tested in cases of asymptomatic DCM in Dobermans with atrial fibrillation or sustained ventricular tachycardia.

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.

For use in the “preclinical stage” of dilated cardiomyopathy (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter), a diagnosis should be made by means of a comprehensive cardiac examination (incl. echocardiographic examination and possibly Holter monitoring).

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, lactation or lay

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. The safety of the 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 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.

4.9 Amounts to be administered and administration route

Determine the bodyweight accurately before treatment to ensure correct dosage.

A dosage range of 0.2 mg to 0.6 mg pimobendan/kg body weight, divided into two daily doses, should be respected.

The preferable daily dose is 0.5 mg pimobendan/kg body weight, divided into two daily doses.

For a body weight of 40 kg, this corresponds to one 10 mg chewable tablet in the morning and one 10 mg chewable tablet in the evening.

Do not exceed the recommended dosage.

Pimobendan is orally administered. Administration of pimobendan should take place approximately one hour before feeding.

Pimobendan may also be used in combination with a diuretic, e.g. furosemide.

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

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

An overdose may cause a positive chronotropic effect, vomiting, 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 benzimadazole-pyridazinone derivative has a positively inotropic action and possesses pronounced vasodilator properties.

The positive inotropic effect of pimobendan is mediated by two action mechanisms: increase in calcium sensitivity of cardiac myofilaments and inhibition of phosphodiesterase III. Thus the positive inotropism is triggered neither by an action similar to that of the cardiac glycosides nor sympathomimetically.

The vasodilator effect arises from inhibition of phosphodiesterase III.

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.

In a randomized and placebo controlled study including Doberman Pinschers with preclinical dilated cardiomyopathy (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter following echocardiographic diagnosis), the time to onset of congestive heart failure or sudden death was extended and survival time was prolonged among dogs administered pimobendan.

Additionally, there was a reduction in the heart size of dogs treated with pimobendan in the preclinical stage of dilated cardiomyopathy. Efficacy evaluation is based on data from 19 (of 39) and 25 (of 37) dogs that reached the primary efficacy endpoint in the pimobendan and the placebo group, respectively.

5.2 Pharmacokinetic particulars

Absorption:

After oral administration of this veterinary medicinal productthe absolute bioavailability of its active substance is 60 - 63%. Since simultaneous or previous food intake reduces the bioavailability, pimobendan should be administered about 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 demethylated by oxidation to the major active metabolite (UD-CG212). Further metabolic steps are phase II conjugates of UD-CG212, such as glucuronides and sulphates.

Elimination:

The plasma elimination half-life of pimobendan is 0.4 ± 0.1 hours, which corresponds to the high clearance of 90 ± 19 ml/min/kg and the short mean residence of 0.5 ± 0.1 hours.

The most significant active metabolite is eliminated with a plasma elimination half-life of 2.0 ± 0.3 hours. Almost the entire dose is eliminated in the faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Microcrystalline cellulose

Starch, Pregelatinized

Sodium starch glycolate (Type A)

Macrogol 6000

Stearoyl macrogolglycerides

Dried yeast

Liver powder flavour

Talc

Magnesium stearate

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 the divided (halved) tablets after opening the blister: 3 days.

6.4. Special precautions for storage

Do not store above 25°C.

Divided tablets should be returned to the open blister pocket and placed back in the cardboard box.

6.5 Nature and composition of immediate packaging

Heat sealed Aluminium// PVC/ Aluminium/ Polyamide blister strip containing 10 tablets.

Cardboard box with 2 blister strips of 10 tablets (20 tablets)

Cardboard box with 5 blister strips of 10 tablets (50 tablets)

Cardboard box with 10 blister strips of 10 tablets (100 tablets)

Not all packs 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 products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Ltd.

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

8. MARKETING AUTHORISATION NUMBER

Vm 00015/4094

9. DATE OF FIRST AUTHORISATION

08 April 2015

10. DATE OF REVISION OF THE TEXT

August 2016

Approved: 10 August 2016