Name:
Normoson tablets 15 mg in a cell. pack No. 10×3
Description:
Round biconvex tablets, coated with white color, with a risk on one side. The main active ingredient Doxylamine Release form tablets Dosage 15 mg Indications for use Periodically occurring insomnia. Dosage and administration NORMOSON is taken orally 1/2-1 tablet per day 15-30 minutes before bedtime. If necessary, on the advice of a doctor, the dose can be increased to two tablets. Individuals with impaired liver or kidney function, elderly or debilitated patients who are particularly sensitive to doxylamine require a dose reduction. Duration of application of the drug NORMOSON is from 2 to 5 days; if insomnia persists for more than five days, treatment should be reassessed. After taking the drug NORMOSON, it is important to take care of enough time for sleep in order to avoid a decrease in the speed of reactions the next morning. Use during pregnancy and lactation During pregnancy, NORMOSON should be used with caution and after consulting a doctor. In the case of using the drug in late pregnancy, the atropine-like and sedative properties of the drug should be taken into account when monitoring the newborn. Since it is not known whether doxylamine passes into breast milk, this medicinal product should not be taken during breastfeeding due to possible sedation or increased arousal in the newborn. Precautions Often, sleep disorders can be associated with a deterioration in general well-being or mental disorders and do not require drug therapy with hypnotic drugs, as they are eliminated by other means or treatment of the underlying disease. Without prior consultation with a doctor, you should not take NORMOSON for the treatment of chronic sleep disorders for a long time. NORMOSON contains lactose, so the drug is contraindicated in cases of congenital galactosemia, glucose and galactose malabsorption syndrome and lactase deficiency. Doxylamine succinate, like all sleeping pills or sedatives, can exacerbate a pre-existing sleep apnea syndrome (an increase in the number and duration of respiratory arrests). Doxylamine succinate remains in the body for approximately five half-lives, as do all drugs. In the elderly or in the presence of renal or hepatic insufficiency, the half-life may be significantly increased. With repeated use, the drug and its metabolites reach an equilibrium concentration much later and at a much higher level. Only when an equilibrium concentration is reached can the efficacy and safety of the drug be assessed. Dose adjustment may be required. Features of use in the elderly In this category of persons, H1-histamine preparations should be used with caution due to the risk of sedation and / or dizziness, resulting in an increased risk of falls (for example, when getting up at night) with consequences that are often serious for this category of patients. In addition, in the elderly and / or in the presence of renal or hepatic insufficiency, an increase in the concentration of doxylamine succinate in plasma and a decrease in plasma clearance are possible. In these situations, a downward dose adjustment is recommended. Influence on the ability to drive a car and work with dangerous mechanisms It is necessary to pay attention to the risk of daytime sleepiness in people who drive vehicles and work with potentially dangerous mechanisms. Especially when taken with alcohol. Therefore, during the period of NORMOSON therapy, it is necessary to avoid driving a car, working with electrical or mechanical equipment and other potentially hazardous activities. With insufficient sleep duration, the risk of reduced attention increases. Interaction with other drugs The sedative effect of H1-antihistamines is enhanced by alcohol. A decrease in concentration and speed of psychomotor reactions can be dangerous when driving vehicles and performing other potentially hazardous activities, therefore, during treatment with doxylamine, it is necessary to avoid drinking alcoholic beverages and taking medicines containing alcohol. Doxylamine in combination with atropine and atropine-like drugs (imipramine antidepressants, anticholinergic antiparkinsonian drugs, atropine antispasmodic drugs, disopyramide, phenothiazine antipsychotics) increases the risk of side effects such as urinary retention, constipation, dry mouth, etc. With the combined use of doxylamine with other drugs that depress the central nervous system: morphine derivatives (painkillers used to treat cough and substitution therapy), neuroleptics, barbiturates, benzodiazepines, anxiolytics (except benzodiazepines), sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative H1 antihistamines, centrally acting antihypertensives, baclofen, pizotifen, thalidomide. Contraindications hypersensitivity (allergy) to doxylamine succinate or other components of the drug; hypersensitivity (allergy) to antihistamines; closed-angle glaucoma (increased intraocular pressure) in history, incl. family; diseases of the urethra and prostate with difficulty urinating; children under 15 years of age; lactation. Composition One tablet contains: Active substance: doxylamine succinate 15.0 mg Excipients: microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silicon dioxide, magnesium stearate, povidone , lactose monohydrate Shell composition: hypromellose, titanium dioxide, macrogol 6000 Overdose In acute drug poisoning, drowsiness and signs of anticholinergic effects occur: agitation, sinus tachycardia, redness of the face and neck, hyperthermia, dilated pupils, accommodation paralysis, dry mouth. Delirium, hallucinations, athetotic movements are observed more often in children and may be harbingers of convulsions that occur during severe poisoning. Even in the absence of convulsions in acute doxylamine poisoning, there is a possibility of rhabdomyolysis, which can be complicated by acute renal failure. In this case, it is necessary to carry out systematic monitoring by measuring the level of creatine phosphokinase. Treatment: In case of overdose, symptomatic treatment is carried out. As a first aid, it is recommended to take activated charcoal (50 g for adults, 1 g / 1 kg of body weight for children). Side effect The frequency of occurrence of side effects is estimated according to the following scheme: very often (? 1/10); often (? 1/100 to < 1/10); infrequently (? 1/1000 to < 1/100); rare (? 1/10,000 to < 1/1,000); very rarely (< 1/10000). From the side of the nervous system: rarely - daytime drowsiness (in this case, the dose of the drug should be reduced); On the part of the organs of vision: rarely - visual impairment; From the side of the cardiovascular system: rarely - palpitations. From the gastrointestinal tract: rarely - dry mouth, constipation. If any of the listed side effects occur, or if any side effects are not mentioned in the package leaflet, you should consult a doctor. Storage conditionsStore at a temperature not exceeding 25°C. Keep out of the reach of children. Buy Normoson tablets p/o 15mg No. 10x3 Price for Normoson tablets p/o 15mg No. 10x3
INN | DOXYLAMINE |
---|---|
The code | 93 536 |
Barcode | 4 810 183 009 525 |
Dosage | 15mg |
Active substance | doxylamine |
Manufacturer | Pharmtekhnologiya LLC, Belarus |
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