Donormyl effervescent tablets 15mg №10×2

Name:
Donormil tab spike.15mg in tubes No. 10 in pack No. 2
Description:
Tablets are white, cylindrical, flat, with bevelled edges and a risk for dividing on one side, soluble in water with an effervescent reaction, chipping is acceptable. The main active ingredient Doxylamine succinate Release form text Dosage 20 pcs Pharmacodynamics Doxylamine succinate is a blocker of H1-histamine receptors of the ethanolamine class, which has sedative and atropine-like effects. Reduces time to fall asleep, and improves the duration and quality of sleep. Pharmacokinetics The maximum concentration (Cmax) in blood plasma is reached on average 1 hour (Tmax) after taking doxylamine succinate. The plasma half-life (T?) averages 10 hours. Doxylamine succinate is partially metabolized in the liver by demethylation and N-acetylation. Various metabolites that are formed as a result of the breakdown of the molecule are quantitatively insignificant, since 60% of the dose taken is found in the urine as unchanged doxylamine. Indications for use Intermittent/transient insomnia. Dosing and Administration The recommended dose is 7.5–15 mg per day, i.e. ?–1 tablet per day. The tablet is dissolved in a glass of water and taken orally 15-30 minutes before bedtime. If necessary, on the advice of a doctor, the dose can be increased to 30 mg per day, that is, 2 tablets per day. For the elderly and in cases of renal or hepatic insufficiency, it is recommended to reduce the dose. The duration of treatment is 2-5 days. If insomnia does not improve after 5 days, treatment should be re-evaluated. Use during pregnancy and lactation Considering the available data, the use of doxylamine is possible during pregnancy, regardless of the term. Before using the drug, consult with your doctor. In the case of the use of the drug in late pregnancy, the atropine-like and sedative properties of the drug should be taken into account when monitoring the newborn. There are no data on the release of doxylamine into breast milk, therefore, given the possibility of sedation or paradoxical arousal of the newborn, it is not recommended to take the drug during breastfeeding. PrecautionsInsomnia can be caused by many factors that do not necessarily require medication. The Donormil tablet contains 563 mg of sodium, which should be taken into account at daily intake if prescribed to patients who are on a diet low in sodium. Doxylamine succinate, like all sleeping pills or sedatives, can aggravate pre-existing sleep apnea syndrome (an increase in the number and duration of respiratory arrests). Accumulation risk 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 H1 antihistamines should be used with caution in elderly patients due to the risk of cognitive impairment, sedation and/or feeling dizzy, which may increase the risk of falls (eg, when people get up at night), often with serious consequences for this categories of patients. Precautions in elderly patients, persons with renal or hepatic insufficiency In the elderly, persons with renal or hepatic insufficiency, an increase in the concentration of doxylamine succinate in plasma and a decrease in plasma clearance may be observed. In these cases, it is recommended to reduce the dose. If symptoms persist or worsen while taking the medicine, stop taking the medicine and consult a doctor. Interaction with other drugs Combinations that are not recommended Ethyl alcohol enhances the sedative effect of most H1 antihistamines. Decreased attention can be dangerous when driving vehicles and working with mechanisms. Alcoholic beverages and medicines containing ethyl alcohol should be avoided. Sodium oxybutyrate enhances the depression of the central nervous system. Combinations to be considered Atropine and other atropine-like drugs (imipramine antidepressants, most H1 antihistamines, anticholinergic antiparkinsonian drugs, atropine antispasmodics, disopyramide, phenothiazine antipsychotics, clozapine) increase the severity of side effects such as urinary retention, constipation, dry mouth. Other sedatives (morphine derivatives (analgesics; drugs used to treat coughs and substitution therapy), antipsychotics, barbiturates, benzodiazepines, nonbenzodiazepine anxiolytics (meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedatives H1-antihistamines, centrally acting antihypertensives, other drugs (baclofen, thalidomide)) increase the depression of the central nervous system. Decreased attention can be dangerous when driving vehicles and working with mechanisms. Other sleeping pills increase the depression of the central nervous system. If you are taking other medicines at the same time, you should consult your doctor. Contraindications hypersensitivity to the active substance or excipient, which is part of the drug; closed-angle glaucoma in the family history or history of the patient; urethroprostatic disorders with the risk of urinary retention; breastfeeding period; children’s age up to 15 years. Composition One tablet contains: active substance – doxylamine succinate 15 mg; excipients: sodium bicarbonate, anhydrous citric acid, anhydrous sodium hydrogen phosphate, anhydrous sodium sulfate, sodium benzoate, macrogol 6000. Overdose The first signs of an overdose are drowsiness and symptoms of anticholinergic effects: agitation, dilated pupils, accommodation paralysis, dry mouth, redness of the face and neck , hyperthermia, sinus tachycardia. Delirium, hallucinations and athetotic movements are more common in children, sometimes they are harbingers of convulsions or even coma – rare complications of severe intoxication. 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 by measuring the activity of creatine phosphokinase (CPK) is required. In case of overdose, you should immediately consult a doctor. Treatment is symptomatic. Early initiation of treatment is recommended to use activated charcoal (50 g in adults, 1 g/kg in children). Side effects Anticholinergic effects: constipation, urinary retention, dry mouth, visual disturbances (blurred vision, blurred vision, hallucinations, visual disturbances), palpitations, confusion. Rhabdomyolysis, an increase in creatine phosphokinase (CPK) in the blood. Daytime drowsiness, the occurrence of which requires a dose reduction. Also, the first generation of H1 antihistamines are known to cause sedation, cognitive and psychomotor impairment. In the event of adverse reactions, including those not listed in this leaflet, you should stop taking the drug and consult a doctor. Storage conditions Store in a place protected from moisture at a temperature not exceeding 25 ° C. Keep out of the reach of children! Shelf life 3 years Do not use after the expiration date. 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