Pimocard 10 mg flavoured tablets for dogs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Pimobendan
Available from:
Eurovet Animal Health B.V.
ATC code:
QC01CE90
INN (International Name):
Pimobendan
Dosage:
10 mg/tablet
Pharmaceutical form:
Tablet
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Dogs
Therapeutic area:
pimobendan
Therapeutic indications:
Cardiovascular
Authorization status:
Authorised
Authorization number:
VPA10989/067/004
Authorization date:
2016-01-22

Read the complete document

Health Products Regulatory Authority

05 October 2017

CRN000V2M

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1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Pimocard 10 mg flavoured tablets for dogs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 tablet contains:

Active substance:

Pimobendan 10 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 4 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.

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4.5 Special precautions for use

Special precautions for use in animals

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.

This product may cause cardiovascular effects in the event of accidental ingestion.

4.6 Adverse reactions (frequency and seriousness)

A slight positively chronotropic effect (rise in heart rate) and vomiting can occur in

rare cases. However, these effects are dose-dependent and can be avoided by

reducing the dose.

Transient diarrhoea, anorexia or lethargy have been observed in rare cases.

An increase in mitral valve regurgitation has been rarely observed during chronic

pimobendan treatment in dogs with mitral valve disease.

Signs of effects on primary haemostasis (petechiae on mucous membranes,

subcutaneous haemorrhages) may be observed during treatment in very rare cases,

although a relationship with pimobendan has not been clearly established. 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 treated displaying adverse)

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

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

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

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

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4.7 Use during pregnancy, lactation or lay

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 pharmacologicalstudies 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 diltiazem

and the β-antagonist propranolol.

4.9 Amounts to be administered and administration route

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.

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

To break a double scored tablet into quarters, place the tablet on an even surface

with the scored side up and apply pressure on the middle with your thumb.

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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 or IMMUNOLOGICAL 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 veterinary medicinal product

has been shown to improve the quality of life and to extend life expectancy in

treated dogs.

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5.2 Pharmacokinetic properties

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: 3 days.

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6.4 Special precautions for storage

Do not store above 30°C.

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

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:

5 tablets per blister: 4, 10, 20 or 50 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 products should be disposed of in accordance with local

requirements.

7 MARKETING AUTHORISATION HOLDER

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

Netherlands

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10989/067/004

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 22

January 2016

Date of latest renewal: 29

September 2017

10 DATE OF REVISION OF THE TEXT

September 2017

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