1. Name of the medicinal product
Zopiclone 7.5mg Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 7.5mg of the active ingredient zopiclone.
Excipient with known effect:
Each film-coated tablet contains 30.8 mg lactose anhydrous
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White, film coated, oval tablet having a breakline, with ZZ on one side and 7.5 on the other.
The tablet can be divided into equal halves.
4. Clinical particulars
4.1 Therapeutic indications
Zopiclone Tablets 7.5mg are indicated for the short-term treatment of insomnia in adults.
Benzodiazepines and benzodiazepine-like agents are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. Long term continuous use is not recommended. A course of treatment should employ the lowest effective dose.
4.2 Posology and method of administration
The lowest effective dose should be used.
Zopiclone should be taken in a single dose and not re-administered during the same night.
Treatment duration
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-evaluation of the patient's status. (see section 4.4)
Posology
Adults:
The recommended dose for adults is 1 tablet (7.5mg zopiclone). This dose should not be exceeded. The tablet should be taken just before retiring.
Impaired renal function:
Although accumulation of zopiclone and/or its metabolites has not been shown in patients with impaired renal function, a starting dose of 3.75mg is recommended in these patients.
Impaired hepatic function
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 dosage of 7.5mg zopiclone may be used with caution in some cases depending on effectiveness and acceptability.
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.
Elderly:
A starting dose of 3.75mg is recommended, this dose may consequently be increased to 7.5mg if considered clinically necessary depending on patient effectiveness and acceptability. (See section 4.4).
Children and adolescents:
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
Method of administration
Zopiclone is for oral use only
4.3 Contraindications
Zopiclone is contraindicated in patients with any of the following:
history of hypersensitivity to zopiclone or to any of the excipients
myasthenia gravis
severe hepatic impairment
sleep apnoea syndrome
respiratory failure
Zopiclone should not be given to children or adolescents younger than 18 years of age.
4.4 Special warnings and precautions for use
Risk of dependence:
Clinical experience to date suggests that the risk of dependence is minimal when the duration of treatment is limited to not more than 4 weeks, however, as with the benzodiazepines and other benzodiazepine-like drugs, (even at therapeutic doses) there is a risk of physical and psychological dependence or abuse.This risk increases with dose and length of treatment and use with alcohol or other psychotropics. Patients with a history of alcohol and/or drug abuse or those with personality disorders are more at risk of dependence and this should be considered when prescribing zopiclone. If a patient does become dependent, abrupt cessation of treatment may result in withdrawal symptoms including: extreme anxiety, headaches, muscle pain, tension, confusion and restlessness and irritability. In severe cases symptoms may also include depersonalisation, derealisation, numbness and tingling of the extremities, hypersensitivity to noise, light and physical contact, hallucinations or epileptic seizures.
Rare cases of abuse have been reported.
Withdrawal:
The termination of treatment with zopiclone is unlikely to be associated with withdrawal effects when the duration of treatment is limited to 4 weeks. Patients may benefit from tapering off the dose before discontinuation (see also section 4.8)
Patients with a history of depression, anxiety or psychotic disorders
Benzodiazepines and benzodiazepine-like substances, such as zopiclone, are not recommended as the primary treatment of psychoses.
Zopiclone does not constitute a treatment for depression (or anxiety linked with depression) and may even mask its symptoms (suicide may be precipitated in such patients).
Any underlying cause of the insomnia should also be addressed before symptomatic treatment to avoid under treating potentially serious effects of depression.
Tolerance:
Some loss of efficacy to the hypnotic effects of benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks. However with zopiclone no marked tolerance occurred during treatment periods of up to four weeks.
Rebound insomnia:
A transient syndrome where the symptoms which led to treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form on discontinuation of therapy. It may be accompanied by other reactions including mood changes, anxiety and restlessness. Since the risk of withdrawal/rebound phenomena may be increased after prolonged treatment, or abrupt discontinuation of therapy, it is therefore, recommended to decrease the dosage gradually and to advise the patient accordingly.
A course of treatment should employ the lowest effective dose for the minimum length of time necessary for the effective treatment. See section 4.2 for guidance on possible treatment regimen. A course of treatment should not continue for longer than 4 weeks including any tapering off (see section 4.8).
Amnesia:
Amnesia is rare, but anterograde amnesia may occur, especially if sleep is interrupted or when retiring to bed is delayed after taking the tablet. Situations when this might occur should therefore be avoided and the patient should ensure that they are able to have a full night's sleep (uninterrupted sleep of about 7 to 8 hours)
Psychomotor impairment
Like other sedative/hypnotic drugs, zopiclone has CNS-depressant effects. The risk of psychomotor impairment, including impaired driving ability, is increased if: zopiclone is taken within 12 hours of performing activities that require mental alertness, a dose higher than the recommended dose is taken, or zopiclone is co-administered with other CNS depressants, alcohol or with other drugs that increase the blood levels of zopiclone (see section 4.5). Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle following administration of zopiclone and in particular during the 12 hours following that administration.
Psychiatric and 'Paradoxical' reactions:
It is known that reactions such as restlessness, agitation, irritability, aggression, delusion, outbursts of rage, nightmares, hallucinations, psychoses, unsuitable behaviour and other behavioural disturbances may occur during the use of benzodiazepines and benzodiazepine-like substances. If this is the case administration of the medicinal product should be discontinued. These reactions are more likely to occur in the elderly.
Somnambulism and associated behaviours:
Sleepwalking and other associated behaviours such as 'sleep driving', preparing and eating food or making phone calls with amnesia for the event, have been reported in patients who have taken zopiclone and were not fully awake. It appears that there is an increased risk of such behaviour with the concomitant use of alcohol, other CNS depressants or the use of zopiclone at doses exceeding the maximum recommended dose. If such behaviours are reported, administration of zopiclone should be discontinued (see Section 4.5).
Specific patient groups:
Use in elderly:
Hypnotics should be avoided in the elderly who are at risk of becoming ataxic and confused and so liable to fall and injure themselves. If, based on clinical need, a decision to treat is nevertheless taken, treatment should be initiated at a lower dose (see section 4.2) and co-administration of zopiclone with CYP3A4 inhibitors should be avoided (see section 4.5).
Use in respiratory insufficiency
As hypnotics have the capacity to depress respiratory drive, precautions should be observed if zopiclone is prescribed to patients with compromised respiratory function (see section 4.8). A lower dose is advised for patients with chronic respiratory insufficiency due to the risk of respiratory depression.
Use in hepatic insufficiency
A reduced dosage is recommended, (see section 4.2).Benzodiazepines and benzodiazepine-like substances are not suitable for the treatment of patients with severe hepatic insufficiency, since they may promote the occurrence of encephalopathy (see section 4.3).
Use in renal insufficiency
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