SUMMARY OF PRODUCT CHARACTERISTICS
- NAME OF THE VETERINARY MEDICINAL PRODUCT
Heartmedin 2,5 mg tablets for dogs
Heartmedin10 mg tablets for dogs
- 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
- PHARMACEUTICAL FORM
Tablet
The tablets can be divided into 2 equal parts.
- 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 |
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Daily Pimobendan Dosage: 0.2 – 0.6 mg/kg. The preferable daily dose is 0.5 mg/kg |
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No. of tablets per administration |
|||||||||
| Morning | Evening | ||||||||
| Body
Weight (kg) |
Daily
Dosage (mg) |
1.25 mg | 2.5 mg | 5 mg | 10 mg | 1.25 mg | 2.5 mg | 5 mg | 10 mg |
| < 5 | 1.25 | ½ | – | – | – | ½ | – | – | – |
| 5 – 10 | 2.5 | 1 | – | – | – | 1 | – | – | – |
| 11 – 20 | 5 | – | 1 | – | – | – | 1 | – | – |
| 21 – 40 | 10 | – | – | 1 | – | – | – | 1 | – |
| 41 – 60 | 20 | – | – | – | 1 | – | – | – | 1 |
| > 60 | 30 | – | – | – | 1 ½ | – | – | – | 1 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.
- 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.
- 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.
- MARKETING AUTHORISATION HOLDER
Cymedica spol. s r.o.
Pod Nádražím 308,
CZ – 268 01
Hořovice
- MARKETING AUTHORISATION NUMBER
РК-ВП-4-3024-15
