Instructions for use Sonmil film-coated tablets 15 mg blister No. 10
Composition
active ingredient: 1 tablet contains doxylamine succinate 15 mg;
excipients: lactose monohydrate; magnesium stearate; croscarmellose sodium, microcrystalline cellulose;
shell: Opadry II White film coating mixture: hypromellose (hydroxypropylmethylcellulose); lactose monohydrate; polyethylene glycol (macrogol); titanium dioxide (E 171); triacetin.
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, with a score, covered with a white or almost white film coat.
Pharmacotherapeutic group
Antihistamines for systemic use.
ATX code R06A A09. Hypnotics and sedatives N05C M.
Pharmacological properties
Pharmacodynamics
Doxylamine succinate is an ethanolamine class H1-histamine receptor blocker with sedative and atropine-like effects. It has been shown to reduce the time it takes to fall asleep and improve the duration and quality of sleep.
Pharmacokinetics
The maximum concentration in blood plasma (Cmax) is reached on average 2 hours (Tmax) after administration of doxylamine succinate.
The mean plasma elimination half-life (T½) is on average 10 hours.
Doxylamine succinate is partially metabolized in the liver by demethylation and N-acetylation. The half-life may be significantly increased in the elderly or in patients with renal or hepatic insufficiency.
The various metabolites formed during the breakdown of the molecule are not quantitatively significant, since 60% of the administered dose is found in the urine in the form of unchanged doxylamine.
Indication
Periodic and transient insomnia.
Contraindication
Hypersensitivity to doxylamine succinate or to other antihistamine drugs.
Angle-closure glaucoma in the patient's history or in the family history.
Uretroprostatic disorders with risk of urinary retention.
Interaction with other medicinal products and other types of interactions
Alcohol enhances the sedative effect of most H1 antihistamines. Alcoholic beverages and medications containing ethanol should be avoided.
The following combinations of the drug should be taken into account:
- atropine and atropine-like drugs (imipramine antidepressants, anticholinergic antiparkinsonian drugs, atropine antispasmodics, disopyramide, phenothiazine neuroleptics) due to the occurrence of such side effects as urinary retention, constipation, dry mouth;
- other antidepressants that affect the central nervous system (morphine derivatives (painkillers; drugs used to treat cough and replacement therapy), neuroleptics; barbiturates, benzodiazepines; anxiolytics other than benzodiazepines; sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine); sedative H1-antihistamines; centrally acting antihypertensives; others: baclofen, pizotifen, thalidomide) due to increased depression of the central nervous system.
Application features
Since the drug contains lactose, it is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome, and lactase deficiency.
Like all hypnotics or sedatives, doxylamine succinate may exacerbate sleep apnea syndrome (increased number and duration of breathing stops).
H1-antihistamines should be used with caution in elderly patients due to the risk of dizziness, which may increase the risk of falls (for example, when getting up at night) with consequences that are often serious in this category of patients.
To prevent drowsiness during the day, it is important to remember that the duration of sleep after using the drug should be at least 7 hours.
Use during pregnancy or breastfeeding
Available data suggest that doxylamine can be used during pregnancy after consultation with a doctor. If the drug is used in the last trimester of pregnancy, the atropine-like and sedative effects of the drug should be taken into account when monitoring the newborn.
It is not known whether doxylamine passes into breast milk, therefore it is not recommended to use the drug during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Attention should be paid to the risk of daytime drowsiness, especially in persons driving vehicles or working with other mechanisms, which may develop when using this medicinal product.
Method of administration and doses
For oral use. Take 15-30 minutes before bedtime.
The recommended dose is 7.5-15 mg per day (1/2-1 tablet per day). If necessary, the dose can be increased to 30 mg per day (2 tablets per day).
The duration of the treatment course is 2-5 days.
If insomnia persists for longer than 5 days, you should consult a doctor regarding the appropriateness of further use of the drug.
Children
The medicine should not be used in children under 15 years of age.
Overdose
Symptoms.
The first signs 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 athetoid movements are more common in children; they are sometimes precursors of seizures - a rare complication of severe poisoning. 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, requiring systematic screening by measuring creatine phosphokinase activity.
Treatment.
Treatment is symptomatic. Early initiation of treatment is recommended with activated charcoal (50 g for adults, 1 g/kg for children).
Adverse reactions
Anticholinergic effects rarely develop: constipation, dry mouth, accommodation disorders, palpitations.
Daytime drowsiness: if this effect develops, the dose should be reduced.
Allergic reactions are possible, including skin rashes and itching.
Expiration date
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 or 3 blisters in a pack.
Vacation category
Without a prescription.
Producer
PJSC "Kyiv Vitamin Plant".
Location of the manufacturer and its business address
04073, Ukraine, Kyiv, Kopylivska St., 38.
