Reslip^® (Tablets) Instructions for Use

Marketing Authorization Holder

Aliym, JSC (Russia)

Contact Information

ALIUM JSC (Russia)

ATC Code

R06AA09 (Doxylamine)

Active Substance

Doxylamine (Rec.INN registered by WHO)

Dosage Form

Reslip®

Film-coated tablets, 15 mg: 10, 14, 20, 28, 30, 40, 42, 56, 60, 84, 90, 112, or 120 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, biconvex, oblong in shape with rounded ends, with a score; the inner layer is white or almost white on the cross-section.

Excipients: lactose monohydrate – 50 mg, colloidal silicon dioxide (aerosil) – 0.5 mg, microcrystalline cellulose – 27.7 mg, croscarmellose sodium – 5 mg, povidone – 0.8 mg, magnesium stearate – 1 mg.

Film coating composition: hypromellose (hydroxypropyl methylcellulose) – 1.8 mg, macrogol 6000 (polyethylene glycol 6000) – 0.6 mg, titanium dioxide – 0.6 mg.

10 pcs. – blister packs (1, 2, 3, 4) – cardboard boxes.
14 pcs. – blister packs (1, 2, 3, 4) – cardboard boxes.
28 pcs. – blister packs (1, 2, 3, 4) – cardboard boxes.
30 pcs. – blister packs (1, 2, 3, 4) – cardboard boxes.

Clinical-Pharmacological Group

Hypnotic drug

Pharmacotherapeutic Group

Histamine H1-receptor antagonist

Pharmacological Action

A histamine H₁-receptor blocker from the ethanolamines group. It has a hypnotic, sedative, and m-anticholinergic blocking effect. It reduces the time to fall asleep, increases the duration and quality of sleep, and does not alter sleep phases.

The duration of action is 6-8 hours.

Pharmacokinetics

Absorption and Distribution

Absorption is high. C_max in plasma is reached on average 2 hours after oral administration. It penetrates well through histohematic barriers, the BBB.

Metabolism and Excretion

It is metabolized in the liver. 60% is excreted by the kidneys unchanged, partially through the intestines. The T_1/2 of doxylamine is about 10 hours.

Pharmacokinetics in Special Patient Groups

In patients over 65 years of age, as well as in hepatic and renal insufficiency, the T_1/2 may be prolonged. With repeated courses of treatment, the C_ss of the drug and its metabolites in plasma is reached later and at a higher level.

Indications

• Transient sleep disorders.

ICD codes

Dosage Regimen

The drug is taken orally, 15-30 minutes before bedtime. The tablets should be taken with a small amount of liquid.

The recommended dose is 1/2-1 tablet/day. If the treatment is ineffective, the dose may be increased to 2 tablets on the doctor’s recommendation.

The duration of treatment is from 2 to 5 days; if insomnia persists, the patient should consult a doctor.

Due to data on increased plasma concentration and decreased plasma clearance of doxylamine, a dose reduction is recommended for patients with renal and hepatic impairment.

Histamine H₁-receptor blockers should be prescribed with caution to patients over 65 years of age due to possible dizziness and slowed reactions with a risk of falls (e.g., during nighttime awakenings after taking sleeping pills). Due to data on increased plasma concentration, decreased plasma clearance, and increased T_1/2 of doxylamine, a dose reduction is recommended.

Adverse Reactions

From the digestive system constipation, dry mouth.

From the cardiovascular system palpitations.

From the organ of vision visual and accommodation disturbances, blurred vision.

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

From the urinary system urinary retention.

From laboratory parameters increased CPK activity.

From the musculoskeletal system rhabdomyolysis.

If any of the adverse reactions listed in the instructions worsen or any other adverse events not listed in the instructions are noted, the patient must inform the doctor.

Contraindications

• Angle-closure glaucoma or family history of angle-closure glaucoma;
• Diseases of the urethra and prostate gland accompanied by impaired urine outflow;
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• Childhood and adolescence under 15 years;
• Hypersensitivity to doxylamine, other components of the drug, or other antihistamines.

With caution in patients with a history of apnea (due to the fact that Doxylamine may worsen nocturnal apnea syndrome); patients over 65 years of age (due to possible dizziness and slowed reactions with a risk of falls (e.g., during nighttime awakenings after taking sleeping pills), as well as due to a possible increase in T_1/2); patients with renal and hepatic impairment (T_1/2 may increase).

Use in Pregnancy and Lactation

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

If the drug is prescribed in the later stages of pregnancy, the atropine-like and sedative properties of doxylamine should be taken into account when monitoring the condition of the newborn.

It is not known whether Doxylamine passes into breast milk. Due to the possibility of developing sedative and excitatory effects in the child, breastfeeding should not be done while using the drug.

Use in Hepatic Impairment

The drug should be prescribed with caution to patients with hepatic impairment.

Use in Renal Impairment

The drug should be prescribed with caution to patients with renal impairment.

Pediatric Use

The use of the drug is contraindicated in children and adolescents under 15 years of age.

Geriatric Use

The drug should be prescribed with caution to patients over 65 years of age.

Special Precautions

It should be taken into account that insomnia can be caused by a number of reasons for which there is no need to prescribe this drug.

The drug Reslip^® has a sedative effect, suppresses cognitive abilities, and slows psychomotor reactions. The first generation of histamine H₁-receptor blockers may have m-anticholinergic, anti-alpha-adrenergic, and antiserotonin effects, which can cause dry mouth, constipation, urinary retention, accommodation and vision disturbances.

Like all hypnotic or sedative drugs, Doxylamine may worsen nocturnal apnea syndrome 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.

Effect on the ability to drive vehicles and mechanisms

Due to possible daytime sleepiness, driving vehicles, working with mechanisms, and other activities requiring increased concentration and speed of psychomotor reactions should be avoided.

Overdose

Symptoms daytime sleepiness, agitation, mydriasis, accommodation disturbances, dry mouth, flushing of the skin of the face and neck, hyperthermia, sinus tachycardia, impaired consciousness, hallucinations, depressed mood, anxiety, impaired coordination of movements, tremor, athetosis, convulsions (epileptic syndrome), coma.

Involuntary movements are sometimes precursors to convulsions, which may indicate a severe degree of poisoning. Even in the absence of convulsions, severe doxylamine poisoning can cause the development of rhabdomyolysis, which is often accompanied by acute renal failure. In such cases, standard therapy with constant monitoring of CPK activity is indicated.

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

Treatment symptomatic (m-cholinomimetics and other agents), as first aid, taking activated charcoal (50 g – for adults and 1 g/kg of body weight – for children) is indicated.

Drug Interactions

When Reslip^® is used concomitantly with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, antitussives), neuroleptics, anxiolytics, histamine H₁-receptor blockers with sedative effect, centrally acting antihypertensive drugs, thalidomide, baclofen, pizotifen, the depressant effect on the CNS is enhanced.

When used concomitantly with m-anticholinergic agents (atropine, imipramine antidepressants, antiparkinsonian drugs, atropinic antispasmodics, disopyramide, phenothiazine neuroleptics), the risk of such side effects as urinary retention, constipation, dry mouth increases.

Since ethanol enhances the sedative effect of most histamine H₁-receptor antagonists, including the drug Reslip^®, the simultaneous use of this drug with alcoholic beverages and medicinal products containing ethanol should be avoided.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.