Zopiclone 7.5mg Tablets(Kent Pharmaceuticals Ltd)

1. Name of the medicinal product
Zopiclone 7.5mg tablets

2. Qualitative and quantitative composition
Each tablet contains 7.5mg of zopiclone

Each tablet also contains 32.0mg Lactose Monohydrate

For full list of excipients, see section 6.1.

3. Pharmaceutical form
Film coated tablet

4. Clinical particulars
4.1 Therapeutic indications
Short term treatment of insomnia, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient.

Long term continuous use is not recommended.

A course of treatment should employ the lowest effective dose.

4.2 Posology and method of administration
Posology

Adults:

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

Elderly:

A lower dose of 3.75mg 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

Children and young adults less than 18 years:

Zopiclone should not be used in children and adolescents less than 18 years. The safe and effective dose has not yet been established.

Patients with hepatic insufficiency:

As elimination of zopiclone may be reduced in patients with hepatic dysfunction, a lower dose of 3.75mg zopiclone nightly is recommended. The standard dose of 7.5mg 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 3.75mg.

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.

Treatment duration:

Transient Insomnia 2-5 days.

Short term insomnia 2-3 weeks.

Treatment with zopiclone should be as short as possible. Generally the duration of treatment varies from a few days to two weeks with a maximum, including the tapering off, of four weeks.

In certain cases an extension beyond the maximum treatment period may be necessary; if so it should take place after re-eva luation of the patient's status. (see warnings on dependence and tolerance in section 4.4)

Method of administration:

Oral. Each film-coated tablet should be swallowed whole without sucking, chewing or breaking just before retiring for the night.

4.3 Contraindications
Zopiclone 7.5mg tablets is contraindicated in patients with myasthenia gravis, respiratory failure, severe sleep apnoea syndrome, severe hepatic insufficiency and those people with a hypersensitivity to zopiclone or to any of the excipients. As with all hypnotics, Zopiclone 7.5mg tablets should not be used in children.

4.4 Special warnings and precautions for use
Use in hepatic insufficiency:

A reduced dosage is recommended; see Posology and method of administration. Benzodiazepines are not indicated to treat pa