Reslip tabs 15mg #30

Reslip instruction

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Trade name: Reslip
International non-proprietary name: doxylamine
Dosage form: film-coated tablets

Composition

1 tablet contains:
active ingredient: doxylamine succinate 15 mg;
auxiliary substances: lactose monohydrate 50.0 mg, silicon dioxide colloid (aerosil) 0.5 mg, microcrystalline cellulose 27.7 mg, croscarmellose sodium 5.0 mg, povidone 0.8 mg, magnesium stearate 1.0 mg.
excipients for the shell: hypromellose (hydroxypropylmethylcellulose) 1.8 mg, macrogol 6000 (polyethylene glycol 6000) 0.6 mg, titanium dioxide 0.6 mg.

Description

Tablets covered with a film coat of white or almost white color, biconvex, oblong with rounded ends, with a risk. On the cross section, the inner layer is white or almost white.
Pharmacotherapeutic group: antagonist of H1-histamine receptors.
ATX code: R06AA09.

Pharmacological properties

Pharmacodynamics:

Blocker of H1-histamine receptors from the group of ethanolamines. It has hypnotic, antihistamine, sedative and m-holinoblocking action. 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 determined on average 2 hours after ingestion. Metabolized in the liver. It penetrates well through the histohematetic barriers, including the blood-brain barrier. It is excreted by 60% kidneys in unchanged form, in part - through the gastrointestinal tract. The half-life of doxylamine is about 10 hours.

Pharmacokinetics of the drug in specific patient groups:

In patients older than 65 years, as well as with hepatic and renal failure, the half-life may be prolonged. When the course of treatment is repeated, the stable concentration of the drug and its metabolites in the blood plasma is reached 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; closed angle glaucoma or family history of angle-closure glaucoma; diseases of the urethra and prostate gland, accompanied by a violation of the outflow of urine; lactose intolerance, lactase deficiency, glucose-galactose malabsorption; children and adolescence up to 15 years.

Carefully

Patients with history of apnea cases are due to the fact that doxylamine can aggravate the nocturnal sleep apnea (sudden respiratory arrest in sleep).
Patients over 65 years of age - in connection with possible dizziness and slow reaction, the safety of falls (for example, during night awakenings after taking sleeping pills), and also because of the possible increase in the half-life.
Patients with renal and hepatic insufficiency (the half-life may increase).

Application in pregnancy and during breastfeeding

Based on adequate and well-controlled studies, dock-sylvestin can be used in pregnant women throughout pregnancy.
The use of the drug Reslip during the period of breastfeeding is contraindicated. If you need to use the drug during breastfeeding, breastfeeding should be discontinued.

Dosing and Administration

Inside. For ½ - 1 tablet a day, with a small amount of liquid, 15-30 minutes before bedtime.
If the treatment is ineffective, the dose can be increased to two tablets on the recommendation of the doctor.
Duration of treatment from 2 to 5 days; If insomnia persists, it is necessary to consult a doctor.

Use in special patient groups

Patients with renal and hepatic insufficiency:
In connection with the data on the increase in the concentration in the blood plasma and the decrease in the plasma clearance of doxylamine, a dose correction is recommended in the direction of decrease.

Use in patients over 65 years of age:

H1-histamine receptor blockers should be cautiously assigned to this group of patients due to possible dizziness and delayed reactions with the risk of falls (for example, at night awakenings after taking sleeping pills). In view of these differences in plasma concentration, a decrease in plasma clearance and an increase in half-life, a dose correction is recommended.

Side effects of Reslip

From the gastrointestinal tract: constipation, dry mouth.
From the cardiovascular system: a feeling of heartbeat.
From the side of the organ of vision: visual impairment and accommodation, unclear vision.
From the nervous system: drowsiness during the day (in this case, the dose of the drug should be reduced), confusion, hallucinations.
From the side of the kidneys and urinary tract: urinary retention.
On the part of laboratory indicators: an increase in the level of creatine phosphokinase.
From the musculoskeletal system: rhabdomyolysis.
If any of the unwanted reactions listed in the manual is aggravated or you notice any other undesirable phenomena not listed in the instructions, inform your doctor.

Overdose

Symptoms: daytime sleepiness, excitation, dilated pupil (mydriasis), accommodation disorders, dry mouth, redness of the face and neck skin (hyperemia), fever (hyperthermia), sinus tachycardia, frustration, hallucinations, mood reduction, anxiety, impairment coordination of movements, trembling (tremor), involuntary movements (athetosis), convulsions (epileptic syndrome), coma.
Involuntary movements sometimes are harbingers of convulsions, which may indicate an intense degree of poisoning. Even in the absence of convulsions severe poisoning with doxylamine can cause the development of rhabdomyolysis, which is often accompanied by acute renal failure. In such cases, standard therapy with a constant control of the level of creatine phosphokinase is shown.
When symptoms of poisoning appear, you should immediately consult a doctor.
Treatment: symptomatic (m-holinomimetiki, etc.), as a first aid is shown the reception of activated charcoal (in the amount of 50 g for adults and 1 g / kg of body weight for children).

Interaction with other drugs

With the simultaneous use of the preparation Reslip with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, antitussives), neuroleptics, anxiolytics, sedative H1 - antihistamines, central antihypertensive drugs, thalidomide, baclofen, and pisotifenum, the inhibitory effect on the central nervous system (CNS) is enhanced. With simultaneous administration with m-holinoblocking agents (atropine, imipramine antidepressants, antiparkinsonics, atropine antispasmodics, disopyramide, phenothiazine antipsychotics), the risk of such side effects as urinary retention, constipation, and dry mouth increases.
Since alcohol increases the sedative effect of the majority of antagonists of H1-histamine receptors, incl. and the preparation of Reslip, it is necessary to avoid its simultaneous use of alcoholic beverages and drugs containing alcohol.

special instructions

It should be taken into account that insomnia can be caused by a number of reasons, in which there is no need to prescribe this medication.
The preparation of Reslip has a sedative effect, suppresses cognitive abilities and slows down the psychomotor reactions. The first generation of H1-antihistamines can have m-cholinoblocking, 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 the nocturnal sleep apnea (sudden stopping of breathing in sleep), increasing the number and duration of apnea attacks.
One tablet contains 50 mg of lactose monohydrate, which should be taken into consideration in patients with a rare congenital intolerance of galactose deficiency lactase Lappa or glucose-galactose malabsorption.
Impact on the ability to drive vehicles and mechanisms
In connection with the possible drowsiness during the day, you should avoid driving, working with mechanisms and other activities that require increased concentration and speed of psychomotor reactions.

Form of issue

Tablets, film-coated, 15 mg.
By 10, 14, 28 or 30 tablets in a contour mesh box made of a polyvinyl chloride film of aluminum printed lacquered.
For 1, 2, 3, 4 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions

In dry, the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life - 2 years. Do not use after the expiry date printed on the package.

Leave conditions

You can buy Reslip without a prescription.