ZIMOVANE

Posology Use the lowest effective dose. Zimovane should be taken in a single intake and not be re-administered during the same night. 4). 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.

4). The product should be taken just before retiring for the night. 5 mg zopiclone) by the oral route shortly before retiring. 75mg 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. 75 mg zopiclone nightly is recommended.

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.

75 mg. 75 mg zopiclone is recommended initially. 5 mg. Method of administration For oral use only. Each tablet should be swallowed without sucking or chewing.

The following CIOMS frequency rating is used, when applicable:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). 4). Withdrawal symptoms vary and may include rebound insomnia, muscle pain, anxiety, tremor, sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, hallucinations, panic attacks, muscle aches/cramps, gastrointestinal disturbances and irritability.

In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations. In very rare cases, seizures may occur.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The cause of insomnia should be identified wherever possible, and the underlying factors treated before a hypnotic is prescribed. 2). 3). 2). 8). A lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression.

Use in 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. 2). Drug dependence, tolerance and potential for abuse Use of zopiclone may lead to the development of abuse and/or physical and psychological dependence.

Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.

, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.

Zimovane is contraindicated in patients: • With myasthenia gravis • With respiratory failure • With severe sleep apnoea syndrome • With severe hepatic insufficiency • With hypersensitivity to zopiclone or to any of the excipients. • Who have previously experienced complex sleep behaviours after taking Zimovane As with all hypnotics Zimovane should not be used in children.