IMOVANE

Active material: Zopiclone
When ATH: N05CF01
CCF: Sleeping pills
When CSF: 02.07.01.04
Manufacturer: AVENTIS Laboratories (France)

Pharmaceutical form, composition and packaging

Pills, covered shell1 tab.
zopiclone7.5 mg

10 PC. – packings Valium planimetric (2) – packs cardboard.
20 PC. – packings Valium planimetric (1) – packs cardboard.

 

DESCRIPTION OF ACTIVE SUBSTANCES.

Pharmacological action

Hypnotic from the group of tsiklopirrolona. “Nonbenzodiazepine” benzodiazepine receptor agonist. It has also a sedative, anxiolytic, central muscle-relaxing, anticonvulsant and amnesic properties. Like benzodiazepines zopiclone increases GABA-ergic processes in the brain, vzaymodeystvuya with benzodyazepynovыmy receptors, The resulting increased sensitivity to GABA neurotransmitter-receptor. But, zopiclone, apparently, It interacts with other portions of the benzodiazepine receptor, than benzodiazepines.

Zopiclone reduces sleep time, reduces the number of night awakenings, increases total sleep time. Virtually no effect on sleep structure, It does not reduce significantly the amount of REM sleep. The phenomena of the effects on waking expressed little or no. Readmission of zopiclone are not accompanied by cumulation.

 

Pharmacokinetics

Quickly and completely absorbed from the gastrointestinal tract. Cmax achieved through 1-3 no. Easily passes through the blood-tissue barriers, including GEB, and spread to organs and tissues, incl. brain. T1/2 – 5.5-6 no; not koumouliruet.

 

Testimony

Sleep disorders (difficulty zasыpaniya, frequent nocturnal awakenings, early awakening), transitory, situational and chronic insomnia; sleep disorders in psychiatric disorders, bronchial asthma with night attacks (in combination with a single administration of the daily dose of theophylline).

 

Dosage regimen

Average therapeutic dose is 7.5 mg orally at night, in cases of severe insomnia dose can be increased to 15 mg. In elderly patients, as well as abnormal liver function apply 3.75 mg.

 

Side effect

From the digestive system: feeling the bitter or metallic taste in the mouth, dry mouth, nausea, vomiting.

CNS: dizziness, headache, drowsiness, confusion, anterogradnaya amnesia, hallucinations, nightmares.

Dermatological reactions: skin rash.

 

Contraindications

Severe respiratory failure, pregnancy, lactation (breast-feeding), childhood and adolescence up 15 years, Hypersensitivity to zopiclone.

 

Pregnancy and lactation

Zopiclone is contraindicated during pregnancy and lactation (breast-feeding).

 

Cautions

Be wary appointed to severe hepatic insufficiency.

The risk of drug dependence minimum, if the duration of the use of zopiclone does not exceed 4 weeks. But, potential risk of dependence to Zopiclone there.

The treatment should be deleted alcohol.

Effects on ability to drive vehicles and management mechanisms

The next day, after taking the drug with caution to drive and use machines.

 

Drug Interactions

When applied simultaneously reduces trimipramine concentration in plasma and its effect.

Zopiclone increases the influence of drugs, CNS depressants (incl. ethanol).

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