Sonmil

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SONMIL (SONMIL)

Composition:

Active ingredient: 1 tablet contains 15 mg of doxylamine succinate;

Excipients: lactose monohydrate; magnesium stearate; sodium croscarmellose; microcrystalline cellulose;

Coating: Opadry II White film-coating mixture: hypromellose (hydroxypropyl methylcellulose); lactose monohydrate; polyethylene glycol (macrogol); titanium dioxide (E 171); triacetin.

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: white or almost white, round, biconvex tablets with a score line, film-coated.

Pharmacotherapeutic group. Antihistamines for systemic use.

ATC Code: R06AA09. Sedatives and hypnotics. ATC Code: N05CM.

Pharmacological properties.

Pharmacodynamics.

Doxylamine succinate is an H1-histamine receptor antagonist of the ethanolamine class, which has sedative and atropine-like effects. It has been shown to reduce the time required to fall asleep, as well as to improve sleep duration and quality.

Pharmacokinetics.

Maximum plasma concentration (Cmax) is reached on average within 2 hours (Tmax) after administration of doxylamine succinate.

The average elimination half-life from plasma (T½) is approximately 10 hours.

Doxylamine succinate is partially metabolized in the liver via demethylation and N-acetylation. The elimination half-life may be significantly prolonged in elderly individuals or in patients with renal or hepatic impairment.

Various metabolites formed during degradation are not quantitatively significant, as 60% of the administered dose is excreted in urine as unchanged doxylamine.

Clinical characteristics.

Indications.

Intermittent and transient insomnia in adults.

Contraindications.

Hypersensitivity to doxylamine succinate, to excipients, or to other antihistamine medicinal products.

History of closed-angle glaucoma in the patient or family history of closed-angle glaucoma.

Urethroprostatic disorders with risk of urinary retention.

Interaction with other medicinal products and other forms of interaction.

Alcohol enhances the sedative effect of most H1-antihistamines. Consumption of alcoholic beverages and use of medicinal products containing ethanol should be avoided.

Concomitant use with sodium oxybate should be avoided due to increased central nervous system depression. Reduced reaction speed may be hazardous when driving or operating machinery.

It should be noted that when the medicinal product is used in combination with:

• atropine and atropine-like medicinal products (tricyclic antidepressants, anticholinergic antiparkinsonian agents, atropine-containing spasmolytics, disopyramide, phenothiazine neuroleptics, as well as clozapine), adverse effects such as urinary retention, constipation, and dry mouth may occur;
• other central nervous system-affecting antidepressants (morphine derivatives (analgesics, antitussive agents, substitution therapy agents), neuroleptics; barbiturates, benzodiazepines; anxiolytics other than benzodiazepines; sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine); sedative H1-antihistamines; centrally acting antihypertensives; others: baclofen, pizotifen, thalidomide), increased central nervous system depression may occur.

Special precautions for use

Insomnia may have various causes that do not necessarily require medication; therefore, consultation with a physician is recommended before starting treatment with this medicinal product.

Since the medicine contains lactose, it is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome, or lactase deficiency.

Like all hypnotic or sedative agents, doxylamine succinate may exacerbate sleep apnea syndrome (increasing the number and duration of breathing pauses).

The risk of abuse and development of drug dependence is low. However, cases of abuse leading to drug dependence have been reported. Patients should be closely monitored for early signs of abuse or dependence. Treatment duration should not exceed 5 days. The use of this medicinal product is not recommended in patients with a history of disorders related to psychoactive substance use.

Doxylamine succinate remains in the body for approximately 5 elimination half-lives.

The elimination half-life may be significantly prolonged in elderly individuals and in patients with renal or hepatic impairment. With repeated administration, the drug or its metabolites reach steady-state concentrations much later and at higher levels. The efficacy and safety of the drug can only be assessed after steady-state conditions have been achieved.

Dose adjustment may be required (see section "Method of administration and dosage").

H1-antihistamines should be used with caution in elderly patients due to the risk of dizziness, which increases the risk of falls (e.g., when getting up at night), potentially leading to serious consequences in this patient group.

In elderly patients with renal or hepatic impairment, increased plasma concentrations and reduced plasma clearance of the drug are observed. Dose reduction is recommended.

To prevent daytime drowsiness, it is important to ensure that sleep duration after taking the medicine is at least 7 hours.

Use during pregnancy or breastfeeding

Available data indicate that doxylamine may be used during pregnancy after consultation with a physician. If the medicine was administered late in pregnancy, the anticholinergic and sedative properties of the active substance should be considered when monitoring the newborn.

It is unknown whether doxylamine passes into breast milk; therefore, the use of this medicinal product is not recommended during breastfeeding.

Effect on ability to drive or operate machinery

When taking this medicine, the risk of daytime drowsiness should be considered, particularly for individuals who drive or operate machinery. The risk of reduced reaction speed is increased if sleep duration is insufficient.

Dosage and Administration

For oral use. Take 15–30 minutes before bedtime.

The recommended dose is 7.5–15 mg per day (½–1 tablet per day). If necessary, the dose may be increased to 30 mg per day (2 tablets per day).

In elderly patients and patients with renal or hepatic impairment, a reduced dose is recommended.

The duration of treatment is 2–5 days.

If insomnia persists for more than 5 days, consult a physician regarding the appropriateness of continuing treatment.

Children. The medicinal product must not be used in children (under 18 years of age).

Overdose

Symptoms. The initial symptoms of acute poisoning include drowsiness and signs of anticholinergic effects: agitation, mydriasis, paralysis of accommodation, dry mouth, facial and neck flushing, hyperthermia, and sinus tachycardia. Delirium, hallucinations, and athetoid movements are more commonly observed in children; these may sometimes precede seizures—a rare complication of severe poisoning—or even coma. Even in the absence of seizures, acute poisoning with doxylamine may occasionally cause rhabdomyolysis, which can lead to acute renal failure. This muscular disorder is relatively common and requires systematic screening by measuring creatine phosphokinase activity.

Treatment. Treatment is symptomatic. In early stages of poisoning, activated charcoal is recommended (50 g for adults, 1 g/kg for children).

Side effects.

Anticholinergic effects rarely develop: constipation, urinary retention, dry mouth, visual disturbances (accommodation disorder), tachycardia, confusion.

Daytime drowsiness: if this effect occurs, the dose should be reduced.

Allergic reactions are possible, including skin rash and itching.

There have been reports of drug abuse and development of drug dependence.

In addition, it is known that H1-antihistamine medicinal products cause sedative effect, cognitive disorders, and psychomotor impairment.

Shelf life. 5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets in a blister; 1 blister per carton.

10 tablets in a blister; 3 blisters per carton.

Dispensing category.

№ 10 – over-the-counter;

№ 30 – prescription only.

Manufacturer: JSC "KYIV VITAMIN PLANT".

Manufacturer's address and place of business:

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua