The use of CLOMENT should be limited to severely ill schizophrenic patients who are non-responsive to, or intolerant of classical neuroleptic drug treatment, due to significant risk that CLOMENT can cause fatal agranulocytosis.
Physicians who prescribe this medicine should comply fully with the required safety measures. Each patient who receives CLOMENT should be reminded at every consultation to contact the treating physician immediately if any kind of infection begins to develop. Particular attention should be paid to flu-like complaints such as fever or sore throat and to any other evidence of infection, which may be indicative of neutropenia.
Patients who are being treated with CLOMENT must have initially normal leucocyte findings (baseline white blood cell count >3500/mm3 and normal differential blood count) before initiation of treatment. Regular white blood cell (WBC) counts and, if possible, absolute neutrophil counts (ANC) (weekly during the first 18 weeks and at least every two weeks thereafter throughout treatment and for one month after discontinuation of treatment) should be performed.
Orthostatic hypotension, with or without syncope, can occur with CLOMENT treatment. Collapse can be profound and may be accompanied by cardiac and/or respiratory arrest. Such events are more likely to occur during initial titration in association with rapid dose escalation; but they may occur even after the first dose. Therefore, patients commencing CLOMENT treatment require close medical supervision. Caution should be used in administering CLOMENT to patients having a history of seizures or other predisposing factors. The dose appears to be an important predictor of a seizure, with a greater likelihood at the higher CLOMENT doses used. Because of the substantial risk of seizure associated with clozapine use, patients should be advised not to engage in any activity where sudden loss of consciousness could cause serious risk to themselves or others, e.g. the operation of complex machinery, driving a vehicle, swimming, climbing, etc.
|||Hypersensitivity to any of the components in CLOMENT.|
|||Patients with a history of drug-induced, toxic or idiosyncratic granulocytopenia/agranulocytosis or neutropenia.|
|||Should not be given simultaneously with other agents, which have a well-known potential to suppress bone marrow function.|
|||Impaired bone marrow function, myeloproliferative disorders or any abnormalities of white blood cell count or differential blood count.|
|||Alcoholic and other toxic psychoses, drug intoxication, comatose conditions and glaucoma.|
|||Circulatory collapse and/or central nervous system depression of any cause.|
|||Severe renal or cardiac disorders.|
|||Active liver disease associated with nausea, anorexia or jaundice; progressive liver disease and hepatic failure.|
|||Safety in children under the age of 16 years has not been established.|
|||Pregnancy and lactation.|
|||Since CLOMENT may cause sedation and weight gain, thereby increasing the risk of thromboembolism, immobilisation of the patient should be avoided.|
|Patients in whom CLOMENT has been discontinued as a result of white blood cell deficiencies (see above), must not be re-exposed to CLOMENT.|
|1.||Patients who are to receive CLOMENT should be warned about the significant risk of developing agranulocytosis. They should be informed that weekly blood tests are required to monitor for the occurrence of agranulocytosis. Patients should be advised to report immediately the appearance of lethargy, weakness, fever, sore throat, malaise, mucous membrane ulceration or other possible signs of infection. Particular attention should be paid to any flu-like complaints or other symptoms that might suggest infection.|
|2.||Patients should be informed of the significant risk of seizure during CLOMENT treatment and they should be advised to avoid driving and any other potentially hazardous activity while taking CLOMENT.|
|3.||Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose instructions.|
|4.||Patients should notify their physician if they are taking, or plan to take, any prescription or over-the-counter medicines or alcohol.|
|5.||Patients should notify their physician if they become pregnant or intend to become pregnant during therapy.|
|6.||Female patients should not breast feed whilst taking CLOMENT.|
|7.||Patients should be informed that if they stop taking CLOMENT for more than 2 days, they should not start their medication at the same dosage, but should contact their physician for dosing instructions.|
|CLOMENT 25 mg:||A round, yellow flat bevel-edged tablet with 25over a pressure sensitive breakline on one side, and plain on the other side.|
|CLOMENT 100 mg:||A round, yellow flat bevel-edged tablet with 100over a pressure sensitive breakline on one side, and plain on the other side.|
|CLOMENT 25 mg:||Clear transparent PVC/PVDC/PE/Aluminium blister packs of 100 tablets.|
|CLOMENT 100 mg:||Clear transparent PVC/ PVDC/PE/Aluminium blister packs of 100 tablets.|
|CLOMENT 25 mg:||35/2.6.5/0373|
|CLOMENT 100 mg:||35/2.6.5/0374|