Imovan

Imovan – the drug used at sleeplessness.

Form of release and structure

Imovan release in the form of tablets, film coated: white, oval, with risky on one of the parties (on 10 pieces in blisters, on 2 blisters in a cardboard pack; on 20 pieces in blisters, on 1 blister in a cardboard pack).

Is a part of 1 tablet:

• Active agent: зопиклон – 7,5 mg;
• Auxiliary components: a calcium hydrophosphate dihydrate – 60 mg; wheat starch – 60 mg; sodium carboxymethylstarch (type A) – 4,95 mg; monohydrate of lactose – 31,575 mg; magnesium stearate – 0,975 mg.

Structure of a cover: titanium dioxide (E171) – 1,65 mg; a gipromelloza – 4,95 mg; a macrogoal of 6000 - 1,65 mg (for drawing a cover on a tablet the ready mix "Opadry OY-S-38906" – 8,25 mg can be used).

Indications to use

Imovan appoint for treatment at adults of sleeplessness (passing, chronic and situational), including difficulties with backfilling, early and night awakenings.

Contraindications

• The expressed respiratory insufficiency;
• Apnoea syndrome in a dream;
• Heavy liver failure;
• Heavy myasthenia;
• Age up to 18 years;
• Hypersensitivity to drug components.

Imovan's reception is not recommended to the feeding and pregnant women.

Route of administration and dosage

Imovan accept inside, before going to bed.

Therapy whenever possible should be carried out quickly (not longer than 1 month). After repeated assessment of a condition of the patient increase in term of treatment is possible.

The recommended adult daily dose – 7,5 mg (exceeding of the specified dose is not recommended). The average duration of use of Imovan makes:

• Passing sleeplessness – 2-5 days;
• Situational sleeplessness – 14-21 days.

At treatment of chronic sleeplessness the doctor determines duration of administration of drug individually.

Patients of advanced age, and also patients with functional disturbances of a liver, a renal failure or chronic pulmonary insufficiency have to begin therapy with 3,75 mg of Imovan. Increase in a daily dose is in case of need possible twice.

Side effects

Most often at Imovan's reception emergence of bitter taste in a mouth is observed.

Besides, during therapy development of disturbances from some systems of an organism which are shown with various frequency is possible:

• Alimentary system: dyspepsia, dryness in a mouth, nausea; in isolated cases – insignificant increase in activity of hepatic transaminases and/or an alkaline phosphatase in blood serum;
• Central nervous system: residual drowsiness after awakening, a headache, dizziness, an ecmnesia; seldom – a depression, hallucinations, dreadful dreams, confusion of consciousness, irritability, aggression, confusion, a lack of coordination of movements, the suppressed mood, inadequate behavior with possible development of amnesia;
• Allergic reactions: rash, skin itch; extremely seldom – anaphylactic reactions, a Quincke's disease.

After the termination of therapy there can be a withdrawal, the shown such symptoms as a tremor, irritability, hallucinations, ricochet sleeplessness, concern, a shiver, the increased perspiration, excitement, a headache, confusion of consciousness, nonsense, tachycardia, dreadful dreams; very seldom – attacks.

Special instructions

Accepting Imovan it is necessary to remember that despite insignificant risk, there is a probability of development of accustoming to a zopiklon and abuses of Risk of emergence of abuse or dependence arises at disturbances of a dose and duration of therapy, abuse of medicines and/or alcohol, a concomitant use with other psychotropic drugs or alcohol.

It is impossible to exclude risk of development of a withdrawal and ricochet sleeplessness after the sharp termination of therapy, especially after long reception of Imovan. Thereof the dose of drug should be reduced gradually.

Drug for treatment of a depression should not be used (can mask its symptoms).

During therapy there can be an ecmnesia, especially after a considerable period between Imovan's reception and withdrawal to a dream or at interruption of a dream. The risk of development of this disturbance decreases at administration of drug just before a dream and ensuring duration of a dream not less than 6 hours.

Imovan can worsen ability to control of motor transport and performance of work with mechanisms therefore during therapy the patient is recommended to abstain from similar types of activity.

Medicinal interaction

The concomitant use of Imovan with alcohol is not recommended as it can strengthen drug sedation.

At combined use of Imovan with some medicines there can be undesirable effects:

• Erythromycin, neuroleptics, somnolent, antiepileptic and sedatives, tranquilizers, antidepressants, opioid analgetics, anesthetics, antihistaminic drugs with sedation: strengthening of the oppressing influence on the central nervous system;
• Trimipramin: decrease in its concentration in plasma and effect of its use;
• CYP3A4 isoenzyme inhibitors (ритонавир, кларитромицин, erythromycin, кетоконазол): increase in concentration of a zopiklon in plasma;
• CYP3A4 isoenzyme inductors (carbamazepine, rifampicin, phenobarbital, Phenytoinum): reduction of concentration of a zopiklon in plasma.

Terms and storage conditions

To store in the place, dry, unavailable to children, at a temperature up to 30 °C.

Period of validity – 3 years.