The risk of QTc prolongation and torsades de pointes is likely to be increased if clomipramine is co-administered with drugs that can cause increased plasma clomipramine levels. In both instances the treatment should initially be given in small gradually increasing doses and its effects monitored. They are also recommended during prolonged therapy.Skin and mucous membrane bleeding has been reported with clomipramine. Adults. Specifically, men with PE who did not initially benefit from 25 mg clomipramine easily tolerated 20–30 mg daily while simultaneously gaining significant benefit from the drug. Therefore, concurrent use of these drugs with clomipramine is not recommended (see section 4.4). Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.Patients with depressive disorders, both adult and paediatric, may experience worsening of depression and/or suicidality or other psychiatric symptoms, whether or not they are taking antidepressant medication.Clomipramine should not be used in the treatment of depressive states, phobias and cataplexy associated with narcolepsy in children and adolescents under the age of 18 years (see section 4.1).Antidepressants increase the risk of suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominately aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. The quantity of unchanged clomipramine and desmethylclomipramine excreted in the urine amounts to about 2% and 0.5% of the administered dose respectively.In the elderly, plasma clomipramine concentrations may be higher for a given dose than would be expected in younger patients because of reduced metabolic clearance.The effects of hepatic and renal impairment on the pharmacokinetics of clomipramine have not been determined.Phospholipidosis and testicular changes considered to be secondary to the phospholipidosis, commonly associated with tricyclic compounds, have been observed with clomipramine hydrochloride at doses Clomipramine hydrochloride demonstrated evidence of embryotoxicity No teratogenic effects were detected in mice, rats, and rabbits at doses up to 100, 50, and 60 mg/kg, respectively.The administration of clomipramine hydrochloride to mice and rats for 104 weeks did not show any evidence of carcinogenicity at dose levels representing 16 - 20 times the estimated oral MRHD of 5 mg/kg on a mg/kg basis.Packs of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168 and 180 capsules in either:1) Polypropylene containers with tamper evident polythylene caps and optional use of polyethylene ullage fillerBuilding 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL4.5 Interaction with other medicinal products and other forms of interaction6.6 Special precautions for disposal and other handling9. It allows continued monitoring of the benefit/risk balance of the medicinal product. Monitoring therapeutic response of tricyclic antidepressants at high dose oestrogen regimens (50 micrograms daily) is recommended and dose adjustments may be necessary.This drug may also increase plasma concentrations of tricyclic antidepressants, whose dosage should therefore be reduced.Concomitant administration of valproate with clomipramine may cause inhibition of CYP2C and/or UGT enzymes resulting in increased serum levels of clomipramine and desmethylclomipramine.Concomitant administration of Clomipramine with grapefruit, grapefruit juice, or cranberry juice may increase the plasma concentrations of clomipramine.Rifampicin (CYP3A and CYP2C inducer), may decrease clomipramine concentrations as concomitant administration of drugs known to induce cytochrome P450 enzymes, particularly CYP3A4, CYP2C19 may accelerate the metabolism and decrease the efficacy of clomipramine.Concomitant administration of ion exchange resins such as cholestyramine or colestipol may reduce the plasma levels of clomipramine.

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