Source: Health Products Regulatory Authority (ZA) Revision Year: 2020 Publisher: sanofi-aventis south africa (pty) ltd, 2 Bond Street, Midrand, 1685, South Africa
Short-term treatment of insomnia in adults.
IMOVANE is only indicated when the disorder is severe, disabling or subjecting the individual to extreme stress.
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.
IMOVANE should be taken in a single intake and not be re-administered during the same night.
Long-term use of IMOVANE is not recommended. Treatment should be as short as possible. Generally, the duration of treatment varies from a few days to two weeks, with a maximum, including tapering-off process, of four weeks. In certain cases, extension beyond the maximum treatment period may be necessary. If so, it 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 WARNINGS AND SPECIAL PRECAUTIONS).
One tablet (7,5 mg IMOVANE) orally, shortly before retiring. This dose should not be exceeded.
A lower dose of 3,75 mg IMOVANE (half a tablet) should be employed to start treatment in these patients, and if necessary, the dose may be increased to 7,5 mg.
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.
Overdose is usually manifested by varying degrees of central nervous system depression according to the quantity ingested. In mild cases, symptoms include drowsiness, confusion, and lethargy; in more serious cases, symptoms may include ataxia, hypotonia, hypotension, methaemoglobinaemia, respiratory depression and coma. Overdose may be life-threatening especially when 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 can result in fatal outcome. Symptomatic and supportive treatment in an adequate clinical environment is recommended; attention should be paid to respiratory and cardiovascular functions. Gastric lavage or activated charcoal is only useful when performed soon after ingestion. Haemodialysis is of no value due to the large volume of distribution of zopiclone. Flumazenil may be a useful antidote.
Store at or below 25ºC and protect from light.
Keep out of reach of children.
Blister packs of 30 tablets.
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