Reslip tablets p / o 15mg, No. 30

Transient sleep disturbances.

Inside. By ? - 1 tablet a day with a small amount of liquid, 15-30 minutes before bedtime.

If treatment is ineffective, the dose may be increased to two tablets on the recommendation of a doctor.

Duration of treatment is from 2 to 5 days; if insomnia persists, a doctor should be consulted.

active substance: doxylamine succinate 15 mg;

excipients: lactose monohydrate 50.0 mg, colloidal silicon dioxide (aerosil) 0.5 mg, microcrystalline cellulose 27.7 mg, croscarmlose sodium 5.0 mg, povidone 0.8 mg, magnesium stearate 1.0 mg.

excipients for the shell : hypromellose (hydroxypropyl methylcellulose) 1.8 mg, macrogol 6000 (polyethylene glycol 6000) 0.6 mg, titanium dioxide 0.6 mg.

Hypersensitivity to doxylamine and other components of the drug, or to other antihistamines; angle-closure glaucoma or family history of angle-closure glaucoma; diseases of the urethra and prostate, accompanied by a violation of the outflow of urine; lactose intolerance, lactase deficiency, glucose-galactose malabsorption; children and adolescents up to 15 years old.

Carefully

Patients with a history of sleep apnea - due to the fact that doxylamine can aggravate sleep apnea syndrome (sudden cessation of breathing during sleep).

Patients over 65 years of age - due to possible dizziness and delayed reactions with a risk of falls (for example, with night awakenings after taking sleeping pills), as well as due to a possible increase in the half-life.

Patients with renal and hepatic insufficiency (half-life may increase).

Trade name: ReslipЃ

International non-proprietary name: doxylamine

Dosage form: film-coated tablets

Composition

1 tablet contains:

active substance: doxylamine succinate 15 mg;

excipients: lactose monohydrate 50.0 mg, colloidal silicon dioxide (aerosil) 0.5 mg, microcrystalline cellulose 27.7 mg, croscarmlose sodium 5.0 mg, povidone 0.8 mg, magnesium stearate 1.0 mg.

excipients for the shell : hypromellose (hydroxypropyl methylcellulose) 1.8 mg, macrogol 6000 (polyethylene glycol 6000) 0.6 mg, titanium dioxide 0.6 mg.

Description

Film-coated tablets of white or almost white color, biconvex, oblong in shape with rounded ends, with a risk. In cross section, the inner layer is white or almost white.

Pharmacotherapeutic group: antagonist of H1-histamine receptors.

ATX code: R06AA09.

Pharmacological properties

Pharmacodynamics:

H1-histamine receptor blocker from the ethanolamine group. It has a hypnotic, antihistamine, sedative and m-anticholinergic effect. Reduces the time of falling asleep, increases the duration and quality of sleep, does not change the phase of sleep. The duration of the action is 6-8 hours.

Pharmacokinetics:

After oral administration, doxylamine is rapidly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in blood plasma is, on average, determined 2 hours after ingestion. Meta-bolized in the liver. It penetrates well through histohematogenous barriers, including the blood-brain barrier. It is excreted by 60% by the kidneys unchanged, partly through the gastrointestinal tract. The half-life of doxylamine is about 10 hours.

Pharmacokinetics of the drug in special groups of patients:

In patients over 65 years of age, as well as in hepatic and renal insufficiency, the half-life may be lengthened. With repeated courses of treatment, a stable concentration of the drug and its metabolites in the blood plasma is achieved later and at a higher level.

Indications for use

Transient sleep disturbances.

Contraindications

Hypersensitivity to doxylamine and other components of the drug, or to other antihistamines; angle-closure glaucoma or family history of angle-closure glaucoma; diseases of the urethra and prostate, accompanied by a violation of the outflow of urine; lactose intolerance, lactase deficiency, glucose-galactose malabsorption; children and adolescents up to 15 years old.

Carefully

Patients with a history of sleep apnea - due to the fact that doxylamine can aggravate sleep apnea syndrome (sudden cessation of breathing during sleep).

Patients over 65 years of age - due to possible dizziness and delayed reactions with a risk of falls (for example, with night awakenings after taking sleeping pills), as well as due to a possible increase in the half-life.

Patients with renal and hepatic insufficiency (half-life may increase).

Application during pregnancy and during breastfeeding

Based on adequate and well-controlled studies, doxilamine can be used in pregnant women throughout the entire period of pregnancy.

The use of the drug ReslipЃ during breastfeeding is contraindicated. If necessary, the use of the drug during breastfeeding, breastfeeding should be discontinued.

Method of administration and dosage

Inside. By ? - 1 tablet a day with a small amount of liquid, 15-30 minutes before bedtime.

If treatment is ineffective, the dose may be increased to two tablets on the recommendation of a doctor.

Duration of treatment is from 2 to 5 days; if insomnia persists, a doctor should be consulted.

Application in special patient groups

Patients with renal and hepatic impairment:

In connection with data on an increase in plasma concentration and a decrease in plasma clearance of doxylamine, a dose adjustment downward is recommended.

Application in patients over 65 years of age:

H1-histamine receptor blockers should be used with caution in this group of patients due to possible dizziness and delayed reactions with a risk of falls (for example, with nighttime awakenings after taking sleeping pills). In view of the data of an increase in plasma concentration, a decrease in plasma clearance and an increase in the half-life, a dose adjustment downward is recommended.

Side effect

From the gastrointestinal tract: constipation, dry mouth.

On the part of the cardiovascular system: palpitations.

From the side of the organ of vision: visual impairment and accommodation, blurred vision.

From the nervous system: daytime sleepiness (in this case, the dose of the drug should be reduced), confusion, hallucinations.

From the kidneys and urinary tract: urinary retention.

On the part of laboratory parameters: an increase in the level of creatine phosphokinase.

From the musculoskeletal system: rhabdomyolysis.

If any of the adverse reactions indicated in the instructions are aggravated or you notice any other undesirable effects that are not indicated in the instructions, inform your doctor.

Overdose

Symptoms: daytime sleepiness, agitation, pupil dilation (mydriasis), accommodation disturbances, dry mouth, redness of the face and neck (hyperemia), fever (hyperthermia), sinus tachycardia, consciousness disorder, hallucinations, decreased mood, anxiety, disturbance coordination of movements, tremors (tremors), involuntary movements (athetosis), convulsions (epileptic syndrome), coma.

Involuntary movements are sometimes harbingers of seizures, which may indicate a severe degree of poisoning. Even in the absence of seizures, severe doxylamine poisoning can cause rhabdomyolysis, which is often accompanied by acute renal failure. In such cases, standard therapy with constant monitoring of creatine phosphokinase levels is indicated.

If symptoms of poisoning appear, you should immediately consult a doctor.

Treatment: symptomatic (m-cholinomimetics, etc.), as a means of first aid, the intake of activated carbon is indicated (in an amount of 50 g - for adults and 1 g / kg of body weight for children).

Interaction with other medicinal products

While taking ReslipЃ with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, antitussives), antipsychotics, sedatives thalidomide, baclofen, pizotifen enhances the inhibitory effect on the central nervous system (CNS). When taken simultaneously with m-anticholinergic drugs (atropine, imipramine antidepressants, antiparkinsonian drugs, atropine antispasmodics, disopyramide, phenothiazine antipsychotics), the risk of side effects such as urinary retention, constipation, dry mouth increases.

Since alcohol enhances the sedative effect of most antagonists of H1-histamine receptors, incl. and the drug ReslipЃ, it is necessary to avoid its simultaneous use of alcoholic beverages and drugs containing alcohol.

special instructions

It should be borne in mind that insomnia can be caused by a number of reasons that do not require the appointment of this drug.

The drug ReslipЃ has a sedative effect, suppresses cognitive abilities and slows down psychomotor reactions. The first generation of H1-antihistamines can have m-anticholinergic, anti-alpha-adrenergic and antiserotonin effects, which can cause dry mouth, constipation, urinary retention, accommodation and vision disorders.

Like all sleeping pills or sedatives, doxylamine can aggravate sleep apnea (sudden stopping of breathing during sleep) by increasing the number and duration of apnea attacks.

One tablet of the drug contains 50 mg of lactose monohydrate, which should be taken into account in patients with rare congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Influence on the ability to drive vehicles and mechanisms

Due to possible drowsiness during the daytime, you should avoid driving vehicles, working with mechanisms and other activities that require an increased concentration of attention and speed of psychomotor reactions.

Release form

Film-coated tablets, 15 mg.

On 10, 14, 28 or 30 tablets in a blister strip packaging from a film of polyvinyl chloride and printed aluminum foil varnished.

1, 2, 3, 4 blister packs, together with instructions for use, are placed in a cardboard box.

Storage conditions

In a dry, dark place at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life

2 years. Do not use after the expiration date printed on the package.

Vacation conditions

On prescription.