Heartmedin

Pack:
15 tablets per blister: 2, or 4 blisters per carton for 2,5 mg, 10 tablets per blister: 3 or 6 blisters per carton for 10 mg
Pharmaceutical form:
The tablets can be divided into 2 equal parts.
Active substance:
Pimobendan
Detail:
Anhydorous citric acid, Silicon dioxide, F-Melt Type M, Magnesium stearate
Description:
Group:
Veterinary product
Animal:
Dog

 

 

SUMMARY OF PRODUCT CHARACTERISTICS

 

 

  1. NAME OF THE VETERINARY MEDICINAL PRODUCT

 

Heartmedin 2,5 mg tablets for dogs

Heartmedin10 mg tablets for dogs

 

 

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Qualitative composition                             Quantitative composition

Active substance:

Pimobendan                                                            2,5 mg/tablet

Pimobendan                                                           10 mg/tablet

 

Excipients: 

For a full list of excipients, see section 6.1

 

  1. PHARMACEUTICAL FORM

 

Tablet

The tablets can be divided into 2 equal parts.

 

  1. 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.

 

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

 

4.3      Contraindications

 

The product should not be used 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 4.7.

 

 

4.4      Special warnings for each target species

 

This product should only be used in dogs with cardiac insufficiency

 

4.5      Special precautions for use

(i) Special precautions for use in animals

 

To avoid accidental ingestion, unused halves of tablets should be placed back inside the blister and stored out of reach of dogs.

 

(ii) Special precautions for  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)

 

A moderate positive chronotropic effect and vomiting may occur in rare cases.  However, these effects are dose-dependent and may be avoided by reducing the dose in these cases. In rare cases transient diarrhoea, anorexia or lethargy have been observed.

 

4.7    Use during pregnancy, lactation or lay

 

Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic, 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 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.

 

 

  • Amounts to be administered and administration route

 

Do not exceed the recommended dosage.

 

Determine the bodyweight 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.

 

Table to show dosing guide

Daily Pimobendan Dosage: 0.2 – 0.6 mg/kg. The preferable daily dose is 0.5 mg/kg

No. of tablets per administration

MorningEvening
Body

Weight

(kg)

Daily

Dosage (mg)

1.25 mg2.5 mg5 mg10 mg1.25 mg2.5 mg5 mg10 mg
< 51.25½½
5 – 102.511
11 – 20511
21 – 401011
41 – 602011
> 60301 ½1 ½

 

 

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

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

 

 

 

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

 

In case of overdose symptomatic treatment should be initiated.

 

4.11  Withdrawal period(s)

 

Not applicable.

 

  1. PHARMACOLOGICAL PROPERTIES

 

Pharmacotherapeutic group: Cardiac stimulant (phosphodiesterase inhibitor)

 

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.

 

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 faeces.

 

  1. PHARMACEUTICAL PARTICULARS

 

 

6.1    List of excipients

 

Anhydorous citric acid

Silicon dioxide

F-Melt Type M

Magnesium stearate

 

6.2    Incompatibilities

 

None known.

 

6.3    Shelf life

 

Shelf life of the veterinary medicinal product as packaged for sale: 24 months.

 

6.4.   Special precautions for storage

 

Keep in dry

Return any divided tablet to the opened blister.

Do not store above 25°C

 

6.5    Nature and composition of immediate packaging

 

2,5 mg tablet

Aluminium – PVC/PE/PVDC blister:

15 tablets per blister: 2, or 4 blisters per carton.

 

10 mg tablet

 

Aluminium – PVC/PE/PVDC blister:

10 tablets per blister: 3 or 6 blisters per carton.

 

Not all presentations 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, if appropriate

 

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

 

 

  1. MARKETING AUTHORISATION HOLDER

 

Cymedica spol. s r.o.
Pod Nádražím 308,

CZ – 268 01

Hořovice

 

 

  1. MARKETING AUTHORISATION NUMBER

 

 

РК-ВП-4-3024-15

 

Heartmedin