Donormil tablets p / o 15mg, No. 30

Sleep disturbances, insomnia.

Inside. 1/2 - 1 tablet a day with a small amount of liquid, 15-30 minutes before bedtime.
If treatment is ineffective, the dose may be increased to two tablets on the recommendation of a doctor.
Duration of treatment is from 2 to 5 days; if insomnia persists, see a doctor.

Application in special groups of patients
Patients with renal and renal insufficiency
In connection with the data on an increase in plasma concentration and a decrease in plasma clearance of doxylamine, dose adjustment is recommended downward.

Use in patients over 65 years of age
Blockers of H 1-histamine receptors should be used with caution in this group of patients due to possible dizziness and delayed reactions with the danger of falling (for example, with nighttime awakenings after taking sleeping pills). In view of the data on an increase in plasma concentration, a decrease in plasma clearance and an increase in the half-life, a dose adjustment downward is recommended.

Each film-coated tablet contains 15 mg of doxylamine succinate.
Excipients: lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, hypromellose, pigment dispersion Sepispers AR 7001 (composition: hypromellose, titanium dioxide, propylene glycol, purified water), macrogol 6000, purified water.

- hypersensitivity to doxylamine and other components of the drug, or to other antihistamines;
- angle-closure glaucoma or family history of angle-closure glaucoma;
- diseases of the urethra and prostate gland, accompanied by a violation of the outflow of urine;
- congenital galactosemia, glucose-galactose malabsorption, lactase deficiency;
- children and adolescents (up to 15 years old).

With caution
Patients with a history of apnea due to the fact that doxylamine succinate can aggravate sleep apnea syndrome (sudden cessation of breathing during sleep). Patients over 65 years of age - due to possible dizziness and delayed reactions with the risk of falls (for example, with night awakenings after taking sleeping pills), as well as due to a possible increase in the half-life.
Patients with renal and hepatic insufficiency (half-life may increase).

Trade name : DONORMIL

International name : doxylamine

Chemical rational name : 2 - [? - (dimethylamino) ethoxy] -? - methylbenzyl] -pyridine succinate

Dosage form : film-coated tablets.

Composition
Each film-coated tablet contains 15 mg of doxylamine succinate.
Excipients: lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, hypromellose, pigment dispersion Sepispers AR 7001 (composition: hypromellose, titanium dioxide, propylene glycol, purified water), macrogol 6000, purified water.

Description
White rectangular tablets with a notch on both sides of the tablet. The color of the tablet at the break is white.

Pharmacotherapeutic group
H1-histamine receptor antagonist.

ATX code : R06AA09

Pharmacological action
Blocker of H1-histamine receptors from the group of ethanolamines. The drug has a hypnotic, sedative and M-anticholinergic effect. Reduces the time of falling asleep, increases the duration and quality of sleep, while not changing the phase of sleep. The duration of action is 6-8 hours.

Pharmacokinetics
Absorption - high, metabolized in the liver. It penetrates well through histohematogenous barriers (including the blood-brain barrier). It is excreted by 60% by the kidneys unchanged, partly through the gastrointestinal tract.

Indications for use
Sleep disorders, insomnia.

Contraindications
- hypersensitivity to doxylamine and other components of the drug, or to other antihistamines;
- angle-closure glaucoma or family history of angle-closure glaucoma;
- diseases of the urethra and prostate gland, accompanied by a violation of the outflow of urine;
- congenital galactosemia, glucose-galactose malabsorption, lactase deficiency;
- children and adolescents (up to 15 years old).

With caution
Patients with a history of apnea due to the fact that doxylamine succinate can aggravate sleep apnea syndrome (sudden cessation of breathing during sleep). Patients over 65 years of age - due to possible dizziness and delayed reactions with the risk of falls (for example, with night awakenings after taking sleeping pills), as well as due to a possible increase in the half-life.
Patients with renal and hepatic insufficiency (half-life may increase).

Application during pregnancy and lactation
The drug should be used with caution during pregnancy. Consult your doctor before using this medicine.

Dosing and Administration
Inside. 1/2 - 1 tablet a day with a small amount of liquid, 15-30 minutes before bedtime.
If treatment is ineffective, the dose may be increased to two tablets on the recommendation of a doctor.
Duration of treatment is from 2 to 5 days; if insomnia persists, see a doctor.

Application in special groups of patients
Patients with renal and renal insufficiency
In connection with the data on an increase in plasma concentration and a decrease in plasma clearance of doxylamine, dose adjustment is recommended downward.

Use in patients over 65 years of age
Blockers of H 1-histamine receptors should be used with caution in this group of patients due to possible dizziness and delayed reactions with the danger of falling (for example, with nighttime awakenings after taking sleeping pills). In view of the data on an increase in plasma concentration, a decrease in plasma clearance and an increase in the half-life, a dose adjustment downward is recommended.

Side effect
From the gastrointestinal tract:
- constipation, dry mouth;

From the side of the cardiovascular system:
- a feeling of palpitations;

From the side of the organ of vision:
- visual impairment and accommodation, blurred vision;

From the side of the kidneys and urinary tract:
- urinary retention;

From the side of the nervous system:
- drowsiness in the daytime (in this case, the dose of the drug should be reduced)
- confusion, hallucinations.

On the part of laboratory parameters:
- an increase in the level of creatine phosphokinase;

From the side of the musculoskeletal system:
- rhabdomyolysis.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects that are not indicated in the instructions, inform your doctor.

Overdose
Symptoms: daytime sleepiness, dilated pupil (mydriasis), redness of the facial skin (hyperemia), fever (hyperthermia), decreased mood, anxiety, impaired coordination of movements, tremors (tremors), involuntary movements of the fingers and toes (athetosis), convulsions (epileptic syndrome), coma.

If symptoms of poisoning appear, you should immediately consult a doctor.
Treatment: symptomatic (m-cholinomimetics, etc.).

Interaction with other medicinal products
While taking the drug DonormilЃ with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, antitussive drugs, anti-cough drugs, antipsychotics), anti-inflammatory drugs , central antihypertensive drugs, thalidomide, baclofep, pizotifen increase the inhibitory effect on the central nervous system (CNS).

When taken simultaneously with m-anticholinergic drugs (atropine, imipramine antidepressants, antiparkinsonian drugs, atropine antispasmodics, disopyramide, phenothiazine antipsychotics), the risk of side effects such as urinary retention, constipation, dry mouth increases.

Since alcohol enhances the sedative effect of most antagonists of H1-histamine receptors, incl. and the drug Donormil, it is necessary to avoid its simultaneous use with alcoholic beverages and drugs containing alcohol.

Special instructions
It should be borne in mind that insomnia can be caused by a number of reasons for which there is no need to prescribe this drug.

The drug has a sedative effect, suppresses cognitive abilities and slows down psychomotor reactions. The first generation of H 1 antihistamines can have m-anticholinergic, anti-a-adrenergic and antiserotonin effects, which can cause dry mouth, constipation, urinary retention, and disturbances in accommodation and vision.

Like all sleeping pills or sedatives, doxylamine succinate can aggravate sleep apnea syndrome (sudden stopping of breathing during sleep) by increasing the number and duration of apnea attacks.

One tablet of the drug contains 100 mg of lactose monohydrate, which should be taken into account in patients with rare congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Release form
15 or 30 coated tablets, 15 mg each in a polypropylene tube, sealed with a polyethylene lid. 1 tube with instructions for use in a cardboard box.

Shelf life is
5 years.
Do not use the drug after the expiration date printed on the package.

Storage
conditions Keep out of the reach of children, at a temperature of 15-25 ? C.

Terms of dispensing from pharmacies
Prescription.