CLOZAREM Tablet (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Clozarem 25 mg tablets. Clozarem 100 mg tablets. Clozarem can cause agranulocytosis. Its use should be limited to patients: with schizophrenia who are non-responsive to or intolerant of antipsychotic medication, ...

2. Qualitative and quantitative composition

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 ...

3. 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 ...

4.1. Therapeutic indications

Treatment-resistant schizophrenia Clozarem is indicated in treatment-resistant schizophrenic patients and in schizophrenia patients who have severe, untreatable neurological adverse reactions to other ...

4.2. Posology and method of administration

Posology The dosage must be adjusted individually. For each patient the lowest effective dose should be used. For doses not realisable/practicable with one strength, other strengths of this medicinal product ...

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 toxic or idiosyncratic granulocytopenia/agranulocytosis ...

4.4. Special warnings and precautions for use

Agranulocytosis Clozarem can cause agranulocytosis. The incidence of agranulocytosis and the fatality rate in those developing agranulocytosis have decreased markedly since the institution of white blood ...

4.5. Interaction with other medicinal products and other forms of interaction

Contraindication of concomitant use Substances known to have a substantial potential to depress bone marrow function must not be used concurrently with Clozarem (see section 4.3.). Long-acting depot antipsychotics ...

4.6. Fertility, pregnancy and lactation

Pregnancy For clozapine, there are only limited clinical data on exposed pregnancies. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...

4.7. Effects on ability to drive and use machines

Owing to the ability of Clozarem to cause sedation and lower the seizure threshold, activities such as driving or operating machinery should be avoided, especially during the initial weeks of treatment. ...

4.8. Undesirable effects

Summary of the safety profile For the most part, the adverse event profile of clozapine is predictable from its pharmacological properties. An important exception is its propensity to cause agranulocytosis ...

4.9. Overdose

In cases of acute intentional or accidental Clozarem overdose for which information on the outcome is available, mortality to date is about 12%. Most of the fatalities were associated with cardiac failure ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Psycholeptics; antipsychotics ATC Code: N05AH02 Mechanism of action Clozapine has been shown to be an antipsychotic agent that is different from classic antipsychotics. ...

5.2. Pharmacokinetic properties

Absorption The absorption of orally administered clozapine is 90 to 95%; neither the rate nor the extent of absorption is influenced by food. Clozapine is subject to moderate first-pass metabolism, resulting ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential (for reproductive toxicity, see ...

6.1. List of excipients

Cellulose microcrystalline Sodium starch glycolate (Type A) Magnesium stearate Talc Lactose monohydrate Povidone Maize starch

6.2. Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Clozarem tablets should be stored below 25 °C, protected from light and moisture.

6.5. Nature and contents of container

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 ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

Clozarem 25 mg tablets: 20348 Clozarem 100 mg tablets: 19378

9. Date of first authorization / renewal of the authorization

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 ...

10. Date of revision of the text

08/01/202008/01/2020

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