Slipzone tablets 15 mg No. 30

"Slipzon ®" tablets are used for periodic and transient insomnia in adults.

Composition

The active substance is doxylamine hydrosuccinate (one film-coated tablet contains 15 mg of doxylamine hydrosuccinate).

Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate; film coating: hypromellose, titanium dioxide, macrogol 400, black iron oxide, red iron oxide.

Contraindication

Method of application

The recommended dose is 7.5-15 mg per day (½-1 tablet per day). If necessary, the dose can be increased to 30 mg per day (two tablets per day).

Directions for use: For oral use. Take once a day 15-30 minutes before bedtime. Swallow the tablet with the required amount of water.

The duration of treatment is 2-5 days. If insomnia persists for more than 5 days, the appropriateness of further use of the drug should be reconsidered.

Application features

Pregnant women

Based on the available data, doxylamine can be used during pregnancy after consultation with a doctor. If the drug is used at the end of pregnancy, the atropine-like and sedative properties of this molecule should be taken into account when monitoring the newborn.

It is not known whether doxylamine passes into breast milk. Given the possibility of causing lethargy or paradoxical excitement in the infant, the use of the drug is not recommended during breastfeeding.

Children

The drug should not be used in children under 18 years of age.

Drivers

Patients who drive or operate machinery should be advised of the risk of daytime drowsiness. They should be advised not to use sedatives, sodium oxybate, alcoholic beverages or alcohol-containing medications as concomitant therapy, or to consider the sedative effect of antihistamines when using such combinations. The risk of impaired concentration increases with insufficient sleep duration.

Overdose

Symptoms

The first symptoms of acute poisoning are drowsiness and signs of anticholinergic effects: agitation, dilated pupils, paralysis of accommodation, dry mouth, flushing of the face and neck, hyperthermia, sinus tachycardia. Delirium, hallucinations and athetotic movements are more common in children, sometimes they are precursors of seizures - rare complications of severe poisoning or even coma. Even if seizures do not occur, acute doxylamine poisoning sometimes causes rhabdomyolysis, which can be complicated by acute renal failure. This muscle disorder is common and requires systematic screening by measuring the activity of creatine phosphokinase (CPK).

Treatment

Treatment is symptomatic. At early initiation of treatment, it is recommended to use activated charcoal (50 g - for adults, 1 g/kg - for children).

Side effects

Anticholinergic effects: constipation, urinary retention, dry mouth, visual disturbances (impaired accommodation, blurred vision, hallucinations, impaired visual acuity), rapid heartbeat, confusion.

Rhabdomyolysis, increased CPK levels in the blood.

Daytime drowsiness requiring dose reduction.

Allergic reactions are possible, including skin rashes and itching.

In addition, first-generation H 1 antihistamines are known to cause lethargy, cognitive impairment, and psychomotor impairment.

Storage conditions

Keep out of the reach of children. This medicinal product does not require any special storage conditions.

Shelf life - 2 years.