Sonmil tablets p/o 15mg №10×1

Name Sonmil. Forms of release Tablets. MNNDoxylamine. FTHS hypnotic agent. Basic physical and chemical properties Round-shaped tablets with a biconvex surface, scored, film-coated white or almost white. Active ingredient: doxylamine succinate; 1 tablet contains doxylamine succinate 15 mg; excipients: lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, magnesium stearate; shell: Opadry II White film coating mixture: hypromellose (hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, titanium dioxide (E 171), triacetin. Pharmacotherapeutic group Antihistamines for systemic use. Aminoalkyl esters. Code ATX R06A A09. Pharmacological properties Pharmacodynamics. Doxylamine succinate is a blocker H1-receptor class of ethanolamines with sedative and atropine-like effects.It has been demonstrated that it reduces the time it takes to fall asleep, and also improves the duration and quality of sleep.Pharmacokinetics.Absorption The maximum plasma concentration (Cmax) is reached after an average of 2 hours ( Tmax) after taking doxylamine succinate.Metabolism and excretion The half-life from blood plasma (T½) is on average 10 hours.Doxylamine succinate is partially metabolized in the liver by demethylation and N-acetylation.The half-life can be significantly increased in individuals with 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 dose is found in the urine in the form of unchanged doxylamine. Indications for use Intermittent/transient insomnia in adults. Dosage and administration The drug is intended for adults only. Take orally, once a day, in the evening 15-30 minutes before bedtime, with a small amount of water. The recommended dose is 7.5 mg to 15 mg per day (i.e. half a tablet or one tablet per day). If necessary, the dose may be increased to 30 mg per day (i.e. 2 tablets per day). The elderly and in cases of renal or hepatic insufficiency are advised to reduce the dose. The duration of treatment is from 2 to 5 days. If insomnia persists, treatment should be re-evaluated. Side effects Anticholinergic effects: constipation, urinary retention, dry mouth, visual disturbances (disturbances of accommodation, blurred vision, hallucinations, decreased visual acuity), palpitations, confusion. Rhabdomyolysis, an increase in creatine phosphokinase (CPK) in the blood. Daytime drowsiness, the occurrence of which requires a dose reduction. Cases of drug abuse and addiction have been reported. Also, first generation H1 antihistamines are known to cause sedation, cognitive and psychomotor impairment. Reporting Suspected Adverse Reactions Reporting suspected adverse reactions after drug registration is important. This allows for continuous monitoring of the benefit / risk ratio when using the drug. If any suspected adverse reactions occur, you can report it through the national reporting system (UE Center for Expertise and Testing in Healthcare of the Ministry of Health of the Republic of Belarus, rceth.by). Contraindications – Hypersensitivity to antihistamine drugs, the active substance in the composition of the drug or to any of the excipients indicated in the composition; – Angle-closure glaucoma in the patient’s history or family history; – urethroprostatic disorders with the risk of urinary retention; – children’s age up to 15 years. Interaction with other drugs Combinations that are not recommended Alcohol (alcoholic beverages or alcohol-containing substances) Alcohol increases the sedative effect of most H1 antihistamines. Decreased attention can be dangerous when driving vehicles and working with mechanisms. Alcoholic beverages and medicines containing alcohol should be avoided. Sodium oxybutyrate Enhances depression of the central nervous system. Decreased attention can be dangerous when driving vehicles and working with mechanisms. Combinations to be considered Atropine and other atropine-like drugs Imipramine antidepressants, most atropine-like H1 antihistamines, anticholinergic antiparkinsonian drugs, atropine antispasmodic drugs, disopyramide, phenothiazine antipsychotics, clozapine – increased risk when taken with atropine the occurrence of side effects such as urinary retention, constipation, dry mouth. Other sedative drugs Morphine derivatives (analgesics, antitussives and substitution drugs), antipsychotics, barbiturates, benzodiazepines, nonbenzodiazepine anxiolytics (meprobomate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine); sedative H1 antihistamines; centrally acting antihypertensives; others – baclofen, thalidomide – when taken simultaneously, depression of the central nervous system is observed. Decreased attention can be dangerous when driving vehicles and working with mechanisms. Other hypnotics Increase the depression of the central nervous system. If you are taking any other medicines, consult your doctor about the possibility of using the drug. Precautions Before starting treatment, consult your doctor! Special Warnings Insomnia can be caused by a variety of factors that do not necessarily require medication. Since the drug contains lactose, it is contraindicated in cases of congenital galactosemia, with a syndrome of impaired absorption of glucose and galactose, lactase deficiency. Like all sleeping pills or sedatives, doxylamine succinate can exacerbate sleep apnea (an increase in the number and duration of respiratory arrests). The risk of abuse and addiction to the drug is low, however, there have been cases of abuse and dependence on it. The appearance of signs of abuse or dependence on the drug should be carefully monitored. The duration of taking the drug should not exceed 5 days. Patients with a history of drug use disorders should not take Sonmil. Risk of accumulation Like all medicines, doxylamine succinate remains in the body for approximately five half-lives. The half-life may be significantly increased in the elderly or in patients with renal or hepatic insufficiency. With repeated use, the drug or its metabolites reach an equilibrium concentration much later and at a much higher level. The efficacy and safety of this medicinal product can only be assessed when equilibrium concentration is reached. Dose adjustment may be required. Use in the Elderly Hi-antihistamines should be used with caution in elderly patients due to the risk of cognitive impairment, sedation, slow response and/or vertigo/dizziness, which may increase the risk of falls (eg, when people get up at night), often with serious consequences for this category of patients. Precautions in elderly patients, persons with renal or hepatic insufficiency There have been cases of increased plasma concentrations of doxylamine succinate and a decrease in plasma clearance. In these cases, it is recommended to reduce the dose. Use during pregnancy and lactation Pregnancy. Given the available data, the use of doxylamine is possible at any stage of pregnancy. Before using the drug, consult with your doctor. In the case of the use of the drug in late pregnancy, the atropine and sedative properties of the drug should be taken into account when monitoring the newborn. Lactation. It is not known whether doxylamine is excreted in breast milk. Given the possibility of a sedative effect or increased excitation in newborns, it is not recommended to use the drug during breastfeeding. Fertility. Not applicable. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Persons driving vehicles and working with mechanisms should be warned about the risk of daytime sleepiness when taking this drug. Combinations with other sedative drugs are not recommended, sodium hydroxybutyrate, alcoholic beverages or drugs containing ethyl alcohol are not recommended, this combination should be taken into account when driving vehicles or working with mechanisms (see section “Interaction with other drugs”), since these funds enhance the sedative effect of antihistamines. With insufficient sleep duration, the risk of reduced attention increases. Overdose The first signs of intoxication are drowsiness and anticholenergic symptoms: agitation, dilated pupils, accommodation paralysis, dry mouth, redness of the face and neck, hyperthermia, sinus tachycardia. Delirium, hallucinations and athetotic movements are more often observed in children, sometimes they are harbingers of convulsions, which are a complication of severe intoxication or even coma. Even in the absence of seizures, acute doxylamine intoxication sometimes causes rhabdomyolysis, which can be complicated by acute renal failure. Due to the possibility of developing these disorders, systematic screening is required by measuring the activity of creatine phosphokinase (CPK). Treatment is symptomatic. In the early stages of treatment, it is recommended to use activated charcoal (50 g in adults, 1 g/kg in children). In case of signs of overdose, it is recommended to stop taking the drug and consult a doctor. In the event of an acute overdose, medical attention should be sought immediately. Shelf life 5 years. Do not use the drug after the expiration date. Storage conditions Store in the original packaging at a temperature not exceeding 25 °C. Keep out of the reach of children. Leave conditions By prescription. Packing: 10 tablets in a blister made of PVC film and printed lacquered aluminum foil. 1 or 3 blisters, together with the leaflet, are placed in a pack of cardboard for consumer packaging. Buy Sonmil tablets p/o 15mg No. 10×1