ZIMOVANE Film-coated tablet Ref.[7841] Active ingredients: Zopiclone

Posology

Use the lowest effective dose. Zimovane should be taken in a single intake and not be re-administered during the same night.

As with all hypnotics, long term use of zopiclone is not recommended. Treatment should be as short as possible and should not exceed four weeks including the period of tapering off. Extension beyond the maximum treatment period should not take place without re-evaluation of the patient’s status, since the risk of abuse and dependence increases with the duration of treatment (see section 4.4).

The product should be taken just before retiring for the night.

Adults

The recommended dose is 7.5 mg zopiclone by the oral route shortly before retiring.

Elderly patients

A lower dose of 3.75 mg zopiclone should be employed to start treatment in the elderly. Depending on effectiveness and acceptability, the dosage subsequently may be increased if clinically necessary.

Paediatric population

Zopiclone should not be used in children and adolescents less than 18 years. The safety and efficacy of zopiclone in children and adolescents aged less than 18 years have not been established.

Patients with hepatic insufficiency

As elimination of zopiclone may be reduced in patients with hepatic dysfunction, a lower dose of 3.75 mg zopiclone nightly is recommended. The standard dose of 7.5 mg zopiclone may be used with caution in some cases, depending on effectiveness and acceptability.

Renal insufficiency

Accumulation of zopiclone or its metabolites has not been seen during treatment of insomnia in patients with renal insufficiency. However, it is recommended that patients with impaired renal function should start treatment with 3.75 mg.

Chronic respiratory insufficiency

In patients with chronic respiratory insufficiency, a starting dose of 3.75 mg zopiclone is recommended initially. The dosage subsequently may be increased to 7.5 mg.

The product should be taken just before retiring for the night.

Method of administration

For oral use only.

Each tablet should be swallowed whole without sucking, chewing or breaking.

Fatal dose not known.

Symptoms

Overdose is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma according to the quantity ingested. In mild cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, symptoms may include ataxia, hypotonia, hypotension, methaemoglobinaemia, respiratory depression, and coma. Overdose should not be life threatening unless combined with other CNS depressants, including alcohol. Other risk factors, such as the presence of concomitant illness and the debilitated state of the patient, may contribute to the severity of symptoms and very rarely can result in fatal outcome.

Management

Symptomatic and supportive treatment in adequate clinical environment is recommended, attention should be paid to respiratory and cardiovascular functions.

Consider activated charcoal if an adult has ingested more than 150 mg or a child more than 1.5 mg/kg within one hour. Alternatively, consider gastric lavage in adults within one hour of a potentially life-threatening overdose. If CNS depression is severe consider the use of flumazenil. It has a short half-life (about an hour). NOT TO BE USED IN MIXED OVERDOSE OR AS A “DIAGNOSTIC” TEST. Management should include general symptomatic and supportive measures including a clear airway and monitoring cardiac and vital signs until stable.

24 months.

Store below 30°C.

Keep the blister in the outer carton in order to protect from light and moisture.

PVC/aluminium foil blisters containing 56, 28, 14, 7 or 3 film-coated tablets, and in a starter pack containing 3 film-coated tablets.

Not all pack sizes may be marketed.

No special requirements.