BENEFORTIN PAL TABS 2.5MGX28

Target species Dogs and cats. 4.2 Indications for use, specifying the target species Dogs: Treatment of congestive heart failure. Cats: Reduction of proteinuria associated with chronic kidney disease. 4.3 Contraindications Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal failure. Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis. Do not use during pregnancy or lactation (section 4.7). 4.4 Special warnings for each target species None. 4.5 Special precautions for use Special precautions for use in animals No evidence of renal toxicity of the veterinary medicinal product has been observed (in dogs or cats) during clinical trials, however, as is routine in cases of chronic kidney disease, it is recommended to monitor plasma creatinine, urea and erythrocyte counts during therapy. The efficacy and safety of benazepril has not been established in dogs and cats below 2.5 kg body weight. The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use. In case of accidental oral ingestion, seek medical advice immediately and show the label or the package leaflet to the physician. Pregnant women should take special care to avoid accidental oral exposure because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy in humans. 4.6 Adverse reactions (frequency and seriousness) In double-blind clinical trials in dogs with congestive heart failure, benazepril was well tolerated with an incidence of adverse reactions lower than observed in placebo treated dogs. A small number of dogs may exhibit transient vomiting, incoordination or signs of fatigue. In cats and dogs with chronic kidney disease, benazepril may increase plasma creatinine concentrations at the start of therapy. A moderate increase in plasma creatinine concentrations following administration of ACE inhibitors is compatible with the reduction in glomerular hypertension induced by these agents, and is therefore not necessarily a reason to stop therapy in the absence of other signs. Benazepril may increase food consumption and body weight in cats. Emesis, anorexia, dehydration, lethargy and diarrhoea have been reported in rare occasions in cats. 4.7 Use during pregnancy, lactation or lay Do not use during pregnancy or lactation. The safety of benazepril hydrochloride has not been established in breeding, pregnant or lactating dogs and cats. Benazepril reduced ovary/oviduct weights in cats when administered daily at 10 mg/kg body weight for 52 weeks. Embryotoxic effects (foetal urinary tract malformation) were seen in trials with laboratory animals (rats) at maternally non-toxic doses. 4.8 Interaction with other medicinal products and other forms of interaction In dogs with congestive heart failure, benazepril hydrochloride has been given in combination with digoxin, diuretics, pimobendan and anti-arrhythmic veterinary medicinal products without demonstrable adverse interactions. In humans, the combination of ACE inhibitors and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal function. The combination of benazepril hydrochloride and other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may lead to additive hypotensive effects. Therefore, concurrent use of NSAIDs or other medications with a hypotensive effect should be considered with care. Renal function and signs of hypotension (lethargy, weakness etc.) should be monitored closely and treated as necessary. Interactions with potassium-preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out. It is recommended to monitor plasma potassium levels when using benazepril in combination with a potassium-sparing diuretic because of the risk of hyperkalaemia.