Epilease Caps 250Mg 60S

Target species Dogs 4.2 Indications for use, specifying the target species This product is indicated for use as an anti-epileptic therapy adjunct to phenobarbital in refractory cases of epilepsy in dogs. 4.3 Contraindications Do not use in cases of known hypersensitivity to bromide, or to any of the excipients. 4.4 Special warnings for each target species The concentration of bromide in serum, the clinical response and the therapeutic effect of administration of the product vary between individuals (see section 4.9) A high chloride intake can increase the elimination of bromide (see section 4.8). Therefore, whilst it is not necessary for dogs receiving this product to be on a low salt diet, an increase in the dog’s salt intake may require an adjustment in bromide dose. The salt content of a dog’s diet during the treatment period should not be altered drastically, and should be maintained at a stable level. It is advisable not to change the dog’s diet during therapy. 4.5 Special precautions for use i) Special precautions for use in animals Do not abruptly discontinue therapy as this may precipitate seizures. This product should be used with caution in dogs with renal insufficiency (see section 4.6 and 4.10). A reduction in chloride intake could cause bromide intoxication (see section 4.8 and 4.10). Dogs weighing less than 16.67 kg cannot be accurately dosed with the recommended initial dose rate of 15 mg/kg twice daily as the minimum dose achievable is 500 mg per day as two 250 mg capsules, see section 4.9. Close monitoring for adverse reactions is advisable at higher serum bromide concentrations. ii) Special precautions for the person administering the veterinary medicinal product to animals • Do not break capsules. • Do not use this product if you have known sensitivity to bromide. • Discontinue handling this product if you develop any signs of skin irritation, including itchiness, rash, peeling or flaking of skin or redness. Seek medical attention if irritation persists, showing the physician the carton or package leaflet. • If this product is ingested, seek medical attention immediately and show the physician the carton or package leaflet. • Wash hands thoroughly immediately after handling and/or administering the product. • Advice to doctor: Bromide intoxication can be treated by administration of sodium chloride or a suitable chloruretic agent. iii) Other precautions None. 4.6 Adverse reactions (frequency and seriousness) The most common adverse reactions are somnolence, ataxia (hind end weakness and loss of coordination), polyuria, polydipsia, nausea which may be accompanied by vomiting, pancreatitis and erythematous dermatitis (bromide rash). Less common adverse reactions are behavioural changes such as irritability or restlessness. Side effects may appear in dogs on higher doses of therapy, and symptoms usually disappear after the dose is decreased. If the dog appears too sedated, assess the serum concentrations of both bromide and phenobarbital to determine whether the dose of either should be reduced. If potassium bromide dose is reduced, serum bromide concentrations should be monitored in order to ensure that they fall within the therapeutic range. 4.7 Use during pregnancy, lactation or lay Bromide transfer to the offspring occurs when administered in high amounts to dam rats in early pregnancy, with detrimental effects on the offspring. In the absence of studies to demonstrate the safety of bromide in pregnant and lactating bitches when used at the recommended doses, the product should not be used in these animals.
Vat Rate: 20%