Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
Clozarem 25 mg tablets.
Clozarem 100 mg tablets.
Clozarem can cause agranulocytosis. Its use should be limited to patients:
Prescribing physicians must comply fully with the required safety measures. At each consultation, a patient receiving Clozarem should be reminded to contact the treating physician immediately if any kind of infection begins to develop. Particular attention must be paid to flu-like complaints such as fever or sore throat and to other evidence of infection, which may be indicative of neutropenia (see section 4.4).
Clozarem must be dispensed under strict medical supervision in accordance with official recommendations (see section 4.4).
Clozapine is associated with an increased risk of myocarditis which has, in rare cases, been fatal. The increased risk of myocarditis is greatest in the first 2 months of treatment. Fatal cases of cardiomyopathy have also been reported rarely (see section 4.4).
Myocarditis or cardiomyopathy should be suspected in patients who experience persistent tachycardia at rest, especially in the first 2 months of treatment, and/or palpitations, arrythmias, chest pain and other signs and symptoms of heart failure (e.g. unexplained fatigue, dyspnoea, tachypnoea) or symptoms that mimic myocardial infarction (see section 4.4).
If myocarditis or cardiomyopathy are suspected, Clozarem treatment should be promptly stopped and the patient immediately referred to a cardiologist (see section 4.4).
Patients who develop clozapine-induced myocarditis or cardiomyopathy should not be re-exposed to clozapine (see section 4.3 and 4.4).
| Pharmaceutical Form |
|---|
|
Tablet. Clozarem 25 mg tablets: Yellow, round, NC tablets, scored on one side. The tablet can be divided into equal doses. Clozarem 100 mg tablets: Yellow, round, NC, crossed tablets. The tablet can be divided into equal doses. |
Each tablet contains clozapine 25 mg and 100 mg respectively.
Excipient(s) with known effect:
These products contain 23,87 mg and 95,5 mg lactose respectively.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Clozapine |
Clozapine has been shown to be an antipsychotic agent that is different from classic antipsychotics. Clozapine has potent anti-alpha-adrenergic, anticholinergic, antihistaminic, and arousal-reaction-inhibiting effects. It has also been shown to possess antiserotoninergic properties. |
| List of Excipients |
|---|
|
Cellulose microcrystalline |
Clozarem 25 mg tablets: PVC/Aluminium blisters. Pack sizes of 20, 30, 40, 50, 60, 100, 1000 tablets.
PP containers with PE closure. Pack size of 1000 tablets.
Clozarem 100 mg tablets: PVC/Aluminium blisters. Pack size of 50 tablets.
PP containers with PE closure. Pack size of 1000 tablets.
Not all pack sizes may be marketed.
Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
Clozarem 25 mg tablets: 20348
Clozarem 100 mg tablets: 19378
Clozarem 25 mg tablets:
Date of first authorization: 02 June 2008
Date of latest renewal: 02 January 2013
Clozarem 100 mg tablets:
Date of first authorization: 19 February 2002
Date of latest renewal: 22 December 2010
| Drug | Countries | |
|---|---|---|
| CLOZAREM | Albania, Cyprus, Hong Kong, Malta |
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