Snovitel - instructions for use, dose, side effects, contraindications

active substance: zolpidem tartrate in terms of 100% of the substance -10 mg; Excipients: Ludypress LCEE [lactose monohydrate 94.7 - 98.3 %, povidone 3-4%], silicon dioxide colloid, magnesium stearate.

Shell composition: hypromellose, propylene glycol, talc, titanium dioxide, indigocarmine.

Description:

The tablets covered with a film cover, blue color, round, biconcave.

Pharmacotherapeutic group:Sleeping pills.

ATX: & nbsp

N.05.C.F.02 Zolpidem

Pharmacodynamics:

The hypnotic drug from the group of imidazopyridines. Has a sedative, slightly expressed anxiolytic, anticonvulsant and central muscle relaxant effect. Excites benzodiazepine receptors (omega) in the alpha subunit of GABA receptor complexes,localized in the region of the IV plate of sensory-motor cortical zones, reticular parts of the black substance, visual tubercles of the ventral thalamic complex, bridge, pallid sphere and others. Interaction with omega receptors leads to the discovery of neuronal ionoform channels for chloride ions. Shortens the time of falling asleep, reduces the number of nocturnal awakenings, increases the duration of sleep and improves its quality. Lengthens the II stage of sleep and the stage of deep sleep (III-IV).

Pharmacokinetics:

Quickly absorbed from the gastrointestinal tract. The time to reach the maximum concentration in the blood plasma after ingestion is 0.5-3 hours. Bioavailability is 70%. The connection with plasma proteins is 92%. Between the dose of the drug and its concentrations in the plasma there is a linear relationship. Metabolised in the liver. It is excreted by the kidneys - 56% in the form of inactive metabolites and through the intestines - 37%. Does not induce liver enzymes. Half-life is 0.7-3.5 hours. It does not accumulate.

In elderly patients, clearance may decrease in plasma without a significant increase in half-life (an average of 3 hours), while the maximum concentration of the drug in the blood plasma increases by 50%. In patients with severe renal dysfunction, the clearance decreases slightly.In patients with impaired liver function, bioavailability increases, the half-life increases to 10 hours.

Indications:

Sleep disorders: difficulty falling asleep, early and nocturnal awakenings.

Contraindications:

Hypersensitivity, severe hepatic insufficiency, nocturnal apnea (including presumed), acute alcohol intoxication with impaired vital functions, children's age (up to 15 years); pregnancy; lactation period, galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Carefully:

Chronic obstructive pulmonary disease (at the stage of exacerbation), respiratory failure, myasthenia gravis, hepatic / renal failure, alcoholism, drug abuse or drug dependence in history, depression.

Dosing and Administration:

Inside (just before bedtime), adults and children over 15 years of age - in a single dose of 10 mg. The course of treatment - no more than 4 weeks.

Side effects:

From the digestive system: abdominal pain, nausea, vomiting, diarrhea.

From the nervous system: confusion, memory impairment, hallucinations, dizziness, anxiety,"nightmarish" dreams, severe headache, daytime sleepiness; disorders of coordination of movements, muscle weakness, diplopia, anterograde amnesia.

Allergic reactions: skin rash, itching.

Other: drug dependence (with prolonged use).

Overdose:

Symptoms: impaired consciousness (from a semi-conscious state to a mild coma), cardiovascular and respiratory disorders.

Treatment: gastric lavage, as an antidote is recommended flumazenil. Even with severe excitation, the administration of any sedative drugs is unacceptable. Dialysis is ineffective. If necessary, symptomatic therapy in a hospital.

Interaction:

Opioid analgesics, antitussive drugs, barbiturates, antidepressants, sedatives, antihistamines, benzodiazepines, clonidine, antipsychotic drugs (neuroleptics) and ethanol increase the risk of developing symptoms of central nervous system depression.

Flumazenil eliminates sleeping pills.

Benzodiazepine anxiolytic drugs (tranquilizers) increase the risk of drug dependence.

Strengthens the action of imipramine and chlorpromazine, prolongs the half-life of chlorpromazine (chlorpromazine enhances drowsiness and incidence of anterograde amnesia), reduces the maximum concentration in the blood plasma of imipramine.

Special instructions:

At the expressed infringements of function of a liver the dose reduction is shown.

When applied at recommended doses of more than 4 weeks, cancellation of treatment should be gradual.

With prolonged use, the risk of addiction increases.

When prescribing the drug to patients with concomitant depressive conditions, it is necessary to take into account the possibility of strengthening suicidal tendencies,

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions, as well as when using ethanol.

Form release / dosage:

Tablets, film-coated, 10 mg.

Packaging:

For 10 tablets in a planar cell package.

1 or 2 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

List of 1 potent BACO substances. List B. In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N003290 / 01

Date of registration:24.04.2009

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Information update date: & nbsp18.10.2015

Illustrated instructions

Instructions

Snovitel® (Snovitel®)