Реслип®

General characteristics. Structure:

Active ingredient: 15 mg of a doksilamin of succinate in 1 tablet.

Excipients: lactoses monohydrate, silicon dioxide colloid (aerosil), cellulose microcrystallic, sodium of a kroskarmelloz, povidone, magnesium stearate.

Excipients for a cover: gipromelloz (gidroksipropilmetiltsellyuloz), macrogoal 6000 (polyethyleneglycol 6000), titanium dioxide.

Pharmacological properties:

Pharmacodynamics. H1 blocker - histamine receptors from group of ethanolamines. Renders somnolent, antihistaminic, sedative and m-holinoblokiruyushchee action. Reduces backfilling time, increases duration and quality of a dream, does not change a dream phase. Action duration — 6-8 h.

Pharmacokinetics. After intake доксиламин it is quickly and almost completely absorbed from digestive tract. After intake of a doksilamin in a dose of 25 mg the maximum concentration in a blood plasma (Cmax), equal 99 ng/ml, is defined by 2,4 h (Tmax). It is metabolized in a liver by demethylation and N-acetylation. Well gets through gistogematichesky barriers, including a blood-brain barrier. It is brought to 60% by kidneys in not changed look, partially — through digestive tract. The elimination half-life of a doksilamin (Т½) makes about 10 hours.

Special groups of patients. At patients of advanced age and at patients with a renal or liver failure the elimination half-life of a doksilamin can be extended. At repeated administrations of drug equilibrium concentration of a doksilamin and its metabolites in a blood plasma is reached later and at higher level.

Indications to use:

Symptomatic therapy of passing sleep disorders.

Route of administration and doses:

Inside, washing down with a small amount of liquid. To accept in 15-30 minutes prior to a dream.

For adults and children 15 years the recommended dose are more senior you make 7,5-15 mg (½ or 1 tablet) a day.

If treatment is inefficient, according to the recommendation of the doctor the dose can be increased to 30 mg (2 tablets) a day.

Duration of treatment from 2 to 5 days. If sleeplessness remains more than 5 days, treatment has to be reconsidered by the doctor. The maximum duration of treatment doksilaminy — 14 days.

Patients of advanced age or patients with a renal or liver failure are recommended to reduce a drug dose to 7,5 mg (½ tablets).

Features of use:

Use at pregnancy and during feeding by a breast. Use of the drug Reslip® during pregnancy is not recommended. Use of the drug Reslip® during pregnancy is possible only if the potential advantage for mother exceeds possible risk for a fruit.

Use of the drug Reslip® during breastfeeding is contraindicated. In need of use of drug during breastfeeding, feeding by a breast should be stopped.

It is necessary to take into account that sleep disorders can have various reasons including which are not demanding drug treatment.

To elderly patients drug has to be appointed under observation in connection with risk of development of the expressed sedation and/or dizziness that can lead to the falling having serious effects in this group of the population.

At use of a doksilamin false-negative results of skin tests are possible.

During treatment by the drug Reslip® it is necessary to avoid the use of the alcoholic beverages and medicines containing ethanol.

Influence on ability to control of vehicles and to service of moving mechanisms. During treatment by the drug Reslip® it is necessary to refrain from control of vehicles, service of moving mechanisms and occupations other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

From a nervous system: oppression of TsNS (sedation, drowsiness), stimulation of TsNS (sleeplessness, nervousness, euphoria, irritability, shiver, nightmares, hallucinations, spasms, tremor), headache, dizziness, psychomotor disturbances, lacks of coordination.

From digestive tract: dryness in a mouth, a lock, nausea, vomiting, the raised gastric reflux, pains in epigastric area.

From cardiovascular system: heart consciousness, arrhythmias.

From an organ of sight: accommodation paresis, the obscured sight.

From an urinary system: ischuria.

Others: a ring in ears, a condensation of a secret of glands of respiratory tract, hypotension, disturbances from blood, parasthesias, hypersensitivity reactions.

If any of the undesirable reactions specified in the instruction are aggravated, or you noticed any other undesirable phenomena which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

Simultaneous use of a doksilamin with opioid analgetics, somnolent and sedative medicines, neuroleptics, barbiturates, benzodiazepines, anxiolytics, blockers of H1-histamine receptors, hypotensive medicines of the central action, and also with Baclofenum, pizotifeny and a thalidomide leads to strengthening of the oppressing action on the central nervous system.

In a type of the fact that ethanol strengthens sedation of the majority of blockers of H1-histamine receptors it is necessary to avoid the simultaneous use of a doksilamin and medicines containing ethanol and also the use of alcoholic beverages.

At simultaneous use with m-holinoblokatorami (atropine, tricyclic antidepressants, protivoparkinsonichesky drugs, spasmolysants with m-holinoblokiruyushchimi properties, Disopyramidum, neuroleptics — derivatives of a fenotiazin) the risk of emergence of such undesirable reactions as an ischuria, a lock, dryness in a mouth increases.

Doksilamin it is not necessary to apply along with inhibitors of a monoaminooxidase (MAO). At simultaneous use of MAO inhibitors strengthening of m-holinoblokiruyushchego of action of a doksilamin is also possible.

Results of researches on mice showed dozozavisimy increase in activity of isoenzymes of P450 cytochrome of a liver. Use of a doksilamin led to substantial increase of activity of isoenzymes of CYP2B and moderate induction of isoenzymes of CYP3A and CYP2A. In this regard it is impossible to exclude interactions with medicines, the metabolized specified isoenzymes (for example, antiarrhytmic drugs, HIV protease inhibitors, neuroleptics, b-adrenoblockers, immunodepressants, antiepileptic means).

Contraindications:

Hypersensitivity to a doksilamin or other components of drug, closed-angle glaucoma, a prostate hyperplasia, an ischuria, a lactose intolerance, deficit of lactase, glyukozo-galaktozny malabsorption, children's age up to 15 years, the breastfeeding period.

With care. To patients with apnoea cases in the anamnesis — because доксиламин can aggravate a syndrome of a night apnoea (a sudden apnoea in a dream).

To patients 65 years — in connection with possible dizzinesses and the slowed-down reactions with danger of falling (for example are more senior, at night awakenings after reception of hypnotic drugs), and also in connection with possible increase in an elimination half-life.

To patients with a renal and liver failure (the elimination half-life can increase).

Overdose:

Symptoms: drowsiness, dryness in a mouth, a mydriasis (mydriasis), erubescence of the face and necks (hyperemia), fervescence (hyperthermia), gastrointestinal frustration, tachycardia, arrhythmia, decrease in mood, irritability, alarm, sleeplessness, nightmares, hallucinations, oppression or excitement of the central nervous system, consciousness disturbance, a shiver (tremor), the involuntary movements of fingers of hands and legs (athetosis), spasms (an epileptic syndrome), a coma with a cardiorespiratory collapse. It was reported about cases of a rabdomioliz.

At emergence of the specified symptoms it is necessary to see a doctor urgently.

Treatment: symptomatic and maintenance therapy (including m cholinomimetics, anticonvulsant medicines, artificial ventilation of the lungs). At overdose reasonablly immediate purpose of absorbent carbon (to adult — 50 g, to children — 1 g/kg).

The involuntary movements sometimes are harbingers of spasms that testifies to heavy extent of overdose. Even in the absence of spasms the heavy overdose doksilaminy can cause development of a rabdomioliz who can be followed by a renal failure. In such cases standard therapy with constant control of a kreatinfosfokinaza is shown.

Efficiency of a hemodialysis, haemo filtering and peritoneal dialysis at overdose doksilaminy was not studied, however these methods will be hardly effective in connection with the large volume of distribution of a doksilamin. Efficiency of an artificial diuresis was not established.

Storage conditions:

Period of validity - 2 years. Not to apply after the period of validity specified on packaging. Storage conditions - In the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, 15 mg. On 10, 14, 28 or 30 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2, 3, 4 blister strip packagings together with the application instruction place in a pack from a cardboard.