CLONAZEPAM MEVON TABLETS 0.5 MG [SIN17075P]

Product Info

CLONAZEPAM MEVON TABLETS 0.5 MG

[SIN17075P]

4.1 Therapeutic indications
All clinical forms of epileptic disease and seizures in infants, children and adults, especially absence seizures (petit mal), including atypical absence; primary or secondarily generalised tonic-clonic (grand mal), tonic or clonic seizures; partial (focal) seizures with elementary or complex symptomatology; various forms of myoclonic seizures, myoclonus and associated abnormal movements.

4.2 Posology and method of administration
The scored tablets facilitate the administration of lower daily doses in the initial stages of treatment.

Posology

Adults

Initial dosage should not exceed 1 mg/day.

The maintenance dosage for adults normally falls within the range 4 to 8 mg.

Elderly

The elderly are particularly sensitive to the effects of centrally depressant drugs and may experience confusion. It is recommended that the initial dose should not exceed 0.5 mg/day.

These are total daily dosages which should be divided into 3 or 4 doses taken at intervals throughout the day. If necessary, larger doses may be given at the discretion of the physician, up to a maximum of 20 mg daily. The maintenance dose should be attained after 2 to 4 weeks of treatment.

Paediatric population

To ensure optimum dosage adjustment, children should be given the 0.5 mg tablets.

Initial dosage should not exceed 0.25 mg/day for infants and small children (1 to 5 years) and 0.5 mg/day for older children.

The maintenance dosage normally falls within the ranges:

In some forms of childhood epilepsy, certain patients may cease to be adequately controlled by clonazepam. Control may be re-established by increasing the dose or interrupting treatment with clonazepam for 2 or 3 weeks. During the interruption in therapy, careful observation and other drugs may be needed.

Hepatic Impairment

Patients with severe hepatic impairment should not be treated with clonazepam (see section 4.3).

Patients with mild to moderate hepatic impairment the dose should be adjusted to individual requirements and will probably be lower.

Method of administration

For oral administration

Treatment should be started with low doses. The dose may be increased progressively until the maintenance dose suited to the individual patient has been found.

The dosage of clonazepam must be adjusted to the needs of each individual and depends on the individual response to therapy. The maintenance dosage must be determined according to clinical response and tolerance.

The daily dose should be divided into 3 or 4 equal doses. If doses are not equally divided, the largest dose should be given before retiring. Once the maintenance dose level has been reached, the daily amount may be given in a single dose in the evening.

Simultaneous administration of more than one antiepileptic drug is a common practice in the treatment of epilepsy and may be undertaken with clonazepam. The dosage of each drug may be required to be adjusted to obtain the optimum effect. If status epilepticus occurs in a patient receiving oral clonazepam, intravenous clonazepam may still control the status. Before adding clonazepam to an existing anticonvulsant regimen, it should be considered that the use of multiple anticonvulsants may result in an increase of undesired effects.

4.3 Contraindications

• Known hypersensitivity to benzodiazepines

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Acute pulmonary insufficiency

• Severe respiratory insufficiency

• Sleep apnoea syndrome

• Myasthenia gravis

• Severe hepatic insufficiency

Clonazepam must not be used in patients in a coma, or in patients known to be abusing pharmaceuticals, drugs or alcohol.