Known hypersensitivity to clomipramine and related tricyclic antidepressants. Male breeding dogs.

Clomicalm may cause sporadic vomiting, changes in appetite or lethargy. Vomiting may be reduced by co-administration with a small quantity of food.

Dog: It is recommended to administer Clomicalm to dogs with cardiovascular dysfunction or epilepsy with caution and only after an assessment of the benefit/risk ratio. Because of its potential anticholinergic properties, Clomicalm should also be used with care in dogs with narrow angle glaucoma, reduced gastrointestinal motility or urinary retention. Clomicalm should be used under veterinary supervision. The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25kg or under 6 months of age.

Persons administering the product: In children, accidental ingestion should be regarded as serious. There is no specific antidote. In case of accidental ingestion, seek medical advice immediately and show the product label. Overdose in human beings causes anticholinergic effect although central nervous and cardiovascular systems may also be affected. People with known hypersensitivity to clomipramine should administer the product with caution.

Use during pregnancy and lactation: The safety of Clomicalm has not been established in female dogs during pregnancy and lactation. There was evidence of embryotoxic effects of clomipramine in laboratory animal studies.

Interaction with other medicaments: Recommendations on the interaction between Clomicalm and other medicaments are derived from studies in species other than dogs. Clomicalm may potentiate the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e.g. atropine), other CNS active drugs (e.g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e.g. adrenaline) and coumarine derivatives. It is recommended not to administer Clomicalm in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors. Simultaneous administration with cimetidine may lead to increased plasma levels of clomipramine. Plasma levels of certain anti-epileptic drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.

Overdose: At overdose with 20mg/kg Clomicalm (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing. Overdose with 40mg/kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs. Higher doses (500mg/kg i.e. 250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness. Still higher doses (725mg/kg) produced, in addition, convulsions and death.

Environmental precautions: Any unused product or waste material should be disposed of in accordance with local requirements.