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Imovane
Zopiclone - film-coated scored tablets

Composition
Active ingredient: zopiclone. Each tablet contains 7.5 mg zopiclone.
Excipients: lactose, calcium hydrogen phosphate, wheat starch, sodium starch glycolate, magnesium stearate. Film coating: hypromellose, titanium dioxide (E 171).

Properties
Pharmaco-therapeutic class: HYPNOTICS and SEDATIVES (N: Nervous system)

Zopiclone is a cyclopyrrolone, related to the benzodiazepine drugs. Its pharmacological properties are: hypnotic, sedative, anxiolytic, anti-convulsant, muscle-relaxant. These effects are related to a specific agonist action at central receptors belonging to the GABAA macromolecular complex, modulating the opening of the chloride ion channel. Zopiclone reduces the time to onset of sleep and the frequency of nocturnal awakenings, increases the duration of sleep and improves both the quality of sleep and the quality of awakening.

In insomniac patients, zopiclone decreases stage I, increases stage II, while preserving or prolonging the deep sleep stages (III and IV) and the paradoxical sleep.

Zopiclone is rapidly absorbed. Peak concentrations are reached within 1.5-2 hours and they are approximately 60 ng/ml after administration of 7.5 mg. Absorption is not modified by food. Plasma protein binding is weak (approximately 45 %) and non saturable. After repeated administration, there is no accumulation of zopiclone and its metabolites. Interindividual variations appear to be low. An in vitro study indicates that cytochrome P450 (CYP) 3A4 is the major isoenzyme involved in the metabolism of zopiclone. The principal metabolites are the N-oxide derivative (active) and the Ndemethyl metabolite (inactive). Their apparent half-lives evaluated from urinary data are approximately 4.5 hours and 7.4 hours respectively. At recommended doses, the elimination half-life of the unchanged zopiclone is approximately 5 hours. Zopiclone is eliminated by the urinary route (approximately 80 %) mainly in the form of free metabolites and in the faeces (approximately 16 %). In renal insufficiency, no accumulation of zopiclone or of its metabolites has been detected after prolonged administration. In cirrhotic patients, the plasma clearance of zopiclone is reduced by approximately 40 % in relation with the decrease of the demethylation process. Therefore dosage will have to be modified in these patients. In elderly patients, notwithstanding a slight decrease in hepatic metabolism and lengthening of elimination half-life to approximately 7 hours, various studies have not shown plasma accumulation of drug substance on repeated dosing.

When should this medicinal product be used (Therapeutic indications)
IMOVANE is intended for treatment of transient, short-term and chronic insomnia in adults (including difficulties with falling asleep, nocturnal awakening, and early wakening).

How should this medicinal product be used
Strictly follow the recommended dosage unless directed otherwise by the physician.

Dosage and method of administration
Adults: the recommended dose is one 7.5 mg IMOVANE tablet by oral route. This dose should not be exceeded. The product must be taken just before retiring for the night.

Treatment duration
Transient insomnia: 2 to 5 days.
Short term insomnia: 2 to 3 weeks.
Chronic insomnia: long term treatment should be considered only after a consultation with a specialist.

The dosage should be gradually decreased before discontinuation of treatment. 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.

Special populations
In elderly and in patients with impaired liver function or chronic respiratory insufficiency: a starting dose of 3.75 mg zopiclone (half a tablet) is recommended initially. The dosage subsequently may be increased to 7.5 mg.

In patients with renal insufficiency: although no accumulation of zopiclone or of its metabolites has been detected In cases of renal insufficiency, it is recommended that patients with impaired renal function should start treatment with 3.75 mg. The safe and effective dose of zopiclone has not been established in children and young adults less than 18 years.

When should this medicinal product not he used (contraindications)

IMOVANE should not be used in the following cases:

myasthenia gravis (chronic progressive muscle disease),

hypersensitivity (allergy) to zopiclone or to any of the excipients,

respiratory failure,
severe sleep apnea syndrome (respiratory pauses during sleep),

severe liver insufficiency.


Warnings and precautions
Use of sedative/hypnotics agents like zopiclone may lead to the development of physical and psychological dependence or abuse. Risks of dependence or abuse increase with: dose and duration of treatment, history of alcohol and/or drug abuse, use with alcohol or other psychotropics. In case of physical dependence, stopping the treatment suddenly may lead to withdrawal symptoms: insomnia, headache, muscular pains, anxiety, tension, agitation, confusion and irritability.

 

Rebound insomnia
A transient syndrome whereby the symptoms that led to treatment with sedative/hypnotic agents recur in an enhanced form, may occur on withdrawal of hypnotic treatment. Since the risk of such phenomena is greater after abrupt discontinuation of zopiclone, especially after prolonged treatment, it is, therefore, recommended to decrease the dosage gradually and to advise the patient accordingly. (see Undesirable effects).


Some loss of efficacy of other hypnotics may develop after repeated use. However, there is an absence of marked tolerance with zopiclone for treatment periods up to 4 weeks.


Anterograde amnesia (inability to remember recent events) may occur, especially when sleep is interrupted or when retiring to bed is delayed after the intake of the tablet. To reduce the possibility of memory disturbances, patients should ensure that they take the tablet strictly when retiring for the night and that they are able to have a full night sleep. Other psychiatric and paradoxical reactions have been reported (see Undesirable effects).


Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling) which can occur as early as the first time the product is taken.


Somnambulism and associated behaviours: Sleep walking 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. The use of alcohol and other CNS-depressants with zopiclone appears to increase the risk of such behaviours, as does the use of zopiclone at doses exceeding the maximum recommended dose. Discontinuation of zopiclone should be strongly considered for patients who report such behaviours (See Interactions: Alcohol, and Undesirable effects: Psychiatric reactions). As with other hypnotics, zopiclone does not constitute a treatment of depression and may even mask its symptoms.

 

Patients intolerants to gluten or lactose should be warned of the presence of wheat starch (gluten) and lactose in IMOVANE tablets.

 

Driving
Due to the risks of drowsiness, memory disturbances, difficulty in concentrating, visual disturbances and muscle pain linked to the use of this medicinal product, drivers and machine operators should be extremely careful. These risks are increased by the concomitant intake of alcohol. If you drink alcohol during the treatment, do not drive. The risk of impaired vigilance is even greater when sleep duration is insufficient

 

Pregnancy and lactation
The use of zopiclone during pregnancy is not recommended. If zopiclone is used during the last three months of pregnancy or during labour, due to the pharmacological action of the product, effects on the neonate, such as hypothermia, hypotonia and respiratory depression can be expected.


Zopidone should not be used by nursing mothers.

 

Overdose
In case of overdose, contact immediately your physician.
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, 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. Symptomatic and supportive treatment is recommended; attention should be paid to respiratory and cardiovascular functions. Gastric lavage or activated charcoal is only useful when performed soon after ingestion. Hemodialysis is of no value due to the large volume of distribution of zopiclone. Flumazenil may be a useful antidote.

Interactions
In order to avoid possible interactions with other medicines inform your physician or pharmacist about any other current treatment.

 

Concomitant intake with alcohol or alcohol containing-medicinal products is not recommended. The sedative effect of zopiclone may be enhanced when the product is used in combination with alcohol, This affects the ability to drive or use machines.

 

Enhancement of the central depressive effect may occur in cases of concomitant use with CNS depressants: neuroleptics, hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anesthetics and sedative antihistaminics.


Since zopiclone is metabolized by the cytochrome P450 (CYP) 3A4 isoenzyme, plasma levels of zopiclone may be increased when co-administered with CYP3A4 inhibitors. Conversely, plasma levels of zopiclone may be decreased when co-administered with CYP3A4 inducers. In case of concomitant administration with erythromycin the hypnotic effects of zopiclone may be enhanced.

Undesirable effects
Please tell your physician or pharmacist, if you experience any adverse effect with the use of this product.
Bitter taste in the mouth is the most common side-effect observed with zopiclone.


Other adverse reactions which have been reported are: dizziness, headache, residual somnolence, dyspepsia (gastric discomfort), nausea, dry mouth, allergic or cutaneous reactions such as pruritus (itching) and rash. Quincke's edema (swelling of the face, tongue, throat or larynx) and/or anaphylactic reactions (severe rapid onset allergic reactions) have been reported very rarely, Anterograde amnesia may occur.

 

Psychiatric and paradoxical reactions such as nightmares, irritability, confusion, hallucinations, aggressiveness, inappropriate behaviour possibly associated with amnesia, sleep walking (see Warnings and Precautions: somnambulism and associated behaviour), have been reported rarely. Withdrawal and rebound insomnia have been occasionally observed at the discontinuation of the treatment (see Warnings and precautions).


Mild to moderate increases in serum transaminases and/or alkaline phosphatase have been reported very rarely.

Storage
Store below 25C. Keep out of the reach of children.

Expiry date
Do not use later than the date of expiry indicated on the outer packaging.

Presentation
Box of 20 tablets in PVC/aluminium blisters.

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