Dormymil tablets number 10

Donormil (Donormil) Instructions for use

Composition of the drug

active ingredient: doxylamine succinate;

1 tablet contains doxylamine succinate 15 mg

Auxiliary substances: sodium hydrocarbonate, citric acid, sodium anhydrous phosphate, sodium anhydrous sulfate, sodium benzoate (E 211), macrogol 6000.

Dosage form

Pills are effervescent.

Cylindrical, flat, white tablets with split fork and beveled edges, soluble in water to form an effervescent reaction; chips are allowed.

Name and location of the manufacturer

UPSA SAS, France / UPSA SAS, France.

304, Avenue Jean Pierre, 47000 Aján, France / 304, avenue du Docteur Jean Bru, 47000 Agen, France.

979, avenue de pyrén, 47520 m. Le Passage, France / 979, avenue des Pyrenees, 47520 Le Passage, France.

Pharmacological group

Antihistamines for systemic use. ATC code R06A A09. Sleep and sedative N05C M.

Doxylamine succinate is a blocker of H 1 -histamines receptors of the class of ethanolamines, which has sedative and atropine-like effects. It has been demonstrated that it reduces the time needed for sleep, and also improves the duration and quality of sleep.

The maximum concentration in blood plasma (C max) is reached on average through

1:00 (max) after the administration of docxylamine succinate.

The half-life of the plasma (T ½) is on average 10 hours.

Doxylamine succinate is partially metabolised in the liver via demethylation and N-acetylation. The various metabolites produced by the decay of the molecule are not quantitatively significant, since 60% of the dose is detected in the urine in the form of unchanged doxylamine.

Indications

Periodic and transient insomnia.

Contraindications

Hypersensitivity to doxylamine succinate or other antihistamines.

Glaucoma in the history of a patient or in a family history.

Urethroprostatic disorders with a risk of urinary retention.

Properly applied safety measures

The drug contains 484 mg of sodium per tablet, which should be taken into account when prescribed to patients who are adhering to low-salt diet.

Like all hypnotics or sedatives, doxylamine succinate may aggravate sleep apnea syndrome (an increase in the number and duration of respiratory arrest). H1-antihistamines should be used with caution in elderly patients due to the risk of dizziness, may increase the risk of falls (eg, when people get up at night) with consequences that are often serious for this category of patients.

To prevent drowsiness during the day, it is important to remember that the duration of sleep after taking the drug should be at least 7:00.

Use during pregnancy or breastfeeding

Based on available data, doxylamine can be used during pregnancy, after consultation with a physician. If this drug is used at the end of pregnancy, atropine-like and sedative properties of this molecule should be taken into account when observing the newborn.

It is not known that doxylamine is excreted in breast milk, so it is not recommended to use the drug during breastfeeding.

Ability to influence the speed of reaction when driving motor vehicles or other mechanisms

It is necessary to pay attention to the risk of daytime sleepiness, especially those who manage transport work with mechanisms that can develop when taking this drug.

Where are you

The drug is used for children under the age of 15 years.

Method of administration and dose

For oral use. Apply for 15-30 minutes before bedtime.

The recommended dose is 7.5-15 mg per day (1 / 2-1 tablets per day). If necessary, the dose can be increased to 30 mg per day (2 tablets per day). Before taking the tablet, dissolve in 1/2 cup of water.

Elderly patients and patients with renal or hepatic insufficiency are advised to reduce the dose.

Duration of treatment is 2-5 days.

If insomnia persists for more than 5 days, it is necessary to consult a physician regarding the expediency of further use of the drug.

Overdose

The first signs of acute poisoning are drowsiness and signs of anticholinergic effects: excitement, pupil enlargement, accommodation paralysis, dry mouth, redness of the face and neck, hyperthermia, sinus tachycardia. Delirium, hallucinations and athetic movements are more often observed in children, and sometimes they are precursors to the court - rare complications of massive poisoning. Even if seizures do not occur, acute poisoning Doxillamine occasionally causes rhabdomyolysis, which can be complicated by acute renal failure. Such a muscular disorder is widespread, which requires systematic screening by measuring the activity of KFK. Symptomatic treatment. At an early start of treatment it is recommended to use activated charcoal (50 g for adults, 1 g / kg for children).

Side effects

Rarely develop anticholinergic effects: constipation, dry mouth, disturbance of accommodation, palpitations.

Daytime sleepiness: when developing such an effect, it is necessary to reduce the dose.

Possible allergic reactions, including skin rash, itching.

Interaction with other drugs and other types of interactions

Alcohol strengthens the sedative effect of most of the H 1 antihistamines. Drinking and taking ethanol-containing drugs should be avoided.

The following DonorMil's combinations should be taken into account with:

• atropine and atropine-like drugs (imipramine antidepressants, anticholinergic antiparkinsonian drugs, atropine antispasmodics, disopyramide, phenothiazine neuroleptics) due to the occurrence of side effects such as urinary retention, constipation, dry mouth
• other antidepressants that affect the central nervous system (morphine derivatives (painkillers, cough and substitution therapy), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative N 1 antihistamines, central antihypertensive agents, others: baclofen, pisotyphene, thalidomide) due to increased central nervous system depression.

Shelf life

3 years.

Storage conditions

Store at a temperature not exceeding 25 o C in a place not accessible to children.

Packaging

10 tablets in tub. 1 or 2 tubes in a cardboard box.

Vacation category

No prescription.