Clozapin-BP

Clozapinum

Each Clozapin-BP 25 mg tablet contains clozapine 25 mg (excipient with known effect: lactose monohydrate 48 mg). Each Clozapin-BP 100 mg tablet contains clozapine 100 mg (excipient with known effect: lactose monohydrate 192 mg).

Indication: Treatment-resistant schizophrenia in patients unresponsive to, or with severe neurological adverse reactions to, other antipsychotics, including atypical ones. Also psychotic disorders in Parkinson's disease when standard treatment has failed.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; − Patients unable to undergo regular blood tests; − History of drug-induced toxic or idiosyncratic granulocytopenia/agranulocytosis (except granulocytopenia/agranulocytosis caused by previous chemotherapy); − History of clozapine-induced agranulocytosis; − Impaired bone marrow function; − Uncontrolled epilepsy; − Alcoholic and other toxic psychoses, drug intoxication, coma; − Circulatory collapse and/or central nervous system depression of any cause; − Severe renal impairment or severe cardiac disorders, myocarditis; − Active liver disease associated with nausea, anorexia or jaundice; progressive liver disease, hepatic failure; − Paralytic ileus; − Treatment with Clozapine-BP must not be started concomitantly with medicinal products having a substantial potential to cause agranulocytosis; concomitant administration of depot antipsychotics is not recommended.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Agranulocytosis The potentially severe adverse reactions of clozapine therapy are granulocytopenia and agranulocytosis, which occur with an estimated frequency of 3% and 0.7%, respectively. Agranulocytosis can be life-threatening. The incidence of agranulocytosis and the death rate among those who develop it have decreased markedly since the introduction of white blood cell and absolute neutrophil count monitoring. Accordingly, the following precautionary measures are mandatory and must be carried out in accordance with official recommendations. Because of the risks associated with treatment with Clozapine-BP, its administration is restricted to patients in whom treatment is indicated as described in section 4.1 and who: − initially have a normal white blood cell count (WBC) ≥ 3500/mm³ (3.5 x 10⁹/L) and neutrophils ≥ 2000/mm³ (2.0 x […]