Donormil, 15 mg 10 pcs

Sleep disorders, insomnia.

Indications

Sleep disorders, insomnia.

Pharmacological effect

H1-histamine receptor blocker from the ethanolamine group.

Special instructions

It should be taken into account 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 H1-antihistamines can have m-anticholinergic, anti-a-adrenergic and antiserotonin effects, which can cause dry mouth, constipation, urinary retention, accommodation and vision disturbances.

Like all hypnotics or sedatives, doxylamine succinate may worsen sleep apnea (sudden cessation of breathing during sleep), 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.

Active ingredient

Doxylamine

Composition

Each film-coated tablet contains 15 mg of doxylamine succinate.

Excipients:

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 impaired outflow of urine;
– congenital galactosemia, glucose-galactose malabsorption, lactase deficiency;
– childhood and adolescence (up to 15 years).

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, when waking up at night after taking sleeping pills), as well as due to a possible increase in the half-life.

Patients with renal and hepatic impairment (half-life may increase).

Side Effects

From the gastrointestinal tract:
– constipation, dry mouth;

Interaction

When taking the drug Donormil® simultaneously with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, antitussives), neuroleptics, anxiolytics, sedative H1 – antihistamines, central antihypertensive drugs, thalidomide, baclofep, pizotifen enhance 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 H1-histamine receptor antagonists, incl. and the drug Donormil, it is necessary to avoid its simultaneous use with alcoholic beverages and medications containing alcohol.

Overdose

Symptoms:
daytime drowsiness, dilated pupils (mydriasis), redness of the facial skin (hyperemia), increased body temperature (hyperthermia), decreased mood, anxiety, impaired coordination of movements, trembling (tremor), involuntary movements of the fingers and toes (athetosis), convulsions (epileptic syndrome), coma.

If symptoms of poisoning appear, consult a doctor immediately.

Treatment:

symptomatic (m-cholinomimetics, etc.).

Storage conditions

Store out of the reach of children, at a temperature of 15-25 °C.

Shelf life

5 years

Manufacturer

UPSA SAS, France