Vetmedin Chew 1.25 mg, 5 mg and 10 mg chewable tablets for dogs Species: Dogs Therapeutic indication: Pharmaceuticals: Cardiovascular and respiratory preparations Active ingredient: Pimobendan Product:Vetmedin Chew 1.25 mg, 5 mg and 10 mg chewable tablets for dogs Product index: Vetmedin Chew Presentation Chewable tablet. Brownish, oval, divisible tablet, scored on both sides. One 1.25 mg chewable tablet contains 1.25 mg pimobendan as active substance. One 5 mg chewable tablet contains 5 mg pimobendan as active substance. One 10 mg chewable tablet contains 10 mg pimobendan as active substance. The tablets can be divided into equal parts. Uses For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid valve regurgitation) (See section 'Dosage and administration'). 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 'Contra-indications, warnings, etc'). For the treatment of dogs with myxomatous mitral valve disease (MMVD) in the preclinical stage (asymptomatic with a systolic mitral murmur and evidence of increased heart size) to delay the onset of clinical symptoms of heart failure (see section 'Contra-indications, warnings, etc'). Dosage and administration Oral use. 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 5 kg, this corresponds to one 1.25 mg chewable tablet in the morning and one 1.25 mg chewable tablet in the evening. For a body weight of 20 kg, this corresponds to one 5 mg chewable tablet in the morning and one 5 mg chewable tablet in the evening. 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. Administration of pimobendan should take place approximately one hour before feeding. Pimobendan may also be used in combination with a diuretic, e.g. furosemide or torasemide. To allow accurate dosing according to body weight, the chewable tablet can be halved along the designated score line. Contra-indications, warnings, etc 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. The product has not been tested in cases of asymptomatic DCM in Dobermans with atrial fibrillation or sustained ventricular tachycardia. The product has not been tested in cases of asymptomatic myxomatous mitral valve disease in dogs with significant supraventricular and/or ventricular tachyarrhythmia. Do not use in cases of hypersensitivity to the active substance or any of the excipients. 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). For use in the preclinical stage of myxomatous mitral valve disease (stage B2, according to ACVIM consensus: asymptomatic with mitral murmur ≥3/6 and cardiomegaly due to myxomatous mitral valve disease), a diagnosis should be made by means of a comprehensive physical and cardiac examination which should include echocardiography or radiography where appropriate. (See also 'Further Information' section). Monitoring of cardiac function and morphology is recommended in animals treated with pimobendan. The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of animals. 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 treated displaying adverse reactions) - 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). 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. In pharmacological studies no interaction between the cardiac glycoside ouabain (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. 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. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use. To avoid accidental ingestion of the product by a child, divided or unused tablets should be returned to the open blister pocket and placed back in the cardboard box. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Advice to doctors: accidental ingestion, especially by a child, may lead to the occurrence of tachycardia, orthostatic hypotension, flushing of the face and headaches. Pharmaceutical precautions Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life of the divided (halved) tablets after opening the immediate packaging: 3 days Do not store above 25°C. Divided tablets should be returned to the open blister pocket and placed back in the cardboard box. Keep out of sight and reach of children. For animal treatment only. To be supplied only on veterinary prescription. Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements. Legal category Legal category: POM-V