DONORMYL 15 mg Scored Effervescent Tablet Tube 10

Doxylamine succinate................................................................................................................. 15 mg

For one scored effervescent tablet.

Excipients with known effect: one tablet contains 563 mg of sodium and 75 mg of sodium benzoate (E211).

Occasional insomnia in adults.

Dosage

The recommended dose is 7,5 to 15 mg per day (i.e. ½ to 1 tablet per day). It may be increased to 30 mg per day (i.e. 2 tablets per day) if necessary.

In elderly subjects, patients with renal or hepatic insufficiency : it is recommended to reduce the dose.

Method of administration

Oral use.

A single intake per day in the evening, 15 to 30 minutes before bedtime.

Dissolve the tablet in a glass of water.

Duration of treatment

The duration of treatment is 2 to 5 days.

If insomnia persists for more than 5 days, the clinical situation should be reassessed.

Known hypersensitivity to antihistamines, to the active substance or to any of the excipients listed in section Composition.

Personal or family history of acute angle-closure glaucoma.

Urethroprostatic disorders at risk of urinary retention.

Children under 15 years of age.

Special warnings

Insomnia may have various causes that do not necessarily require taking a medicine.

Doxylamine succinate, like any hypnotic or sedative, may worsen pre-existing sleep apnoea syndrome (increase in the number and duration of apnoeas).

The risk of abuse and drug dependence is low; however, cases of abuse and drug dependence have been reported. The occurrence of signs suggesting misuse or dependence should be closely monitored. The duration of treatment must not exceed 5 days. The use of DONORMYL in patients with a history of substance use disorder is not recommended.

Risk of accumulation

Like all medicines, doxylamine succinate persists in the body for a period of approximately 5 half-lives (see section Pharmacokinetics).

In elderly patients or those suffering from renal or hepatic impairment, the half-life may be considerably prolonged. On repeated administration, the medicine or its metabolites reach the steady-state plateau much later and at a much higher level. Only after a steady-state plateau has been reached is it possible to assess both the efficacy and the safety of the medicine.

A dose adjustment may be necessary (see section Dosage and administration).

Elderly subject

H antihistamines should be used with caution in elderly subjects, due to the risk of cognitive disorders, sedation, slow reactivity and/or dizziness/light-headedness that may promote falls (for example when getting up at night), with consequences often serious in this population.₁ H antihistamines should be used with caution in elderly subjects, due to the risk of cognitive disorders, sedation, slow reactivity and/or dizziness/light-headedness that may promote falls (for example when getting up at night), with consequences often serious in this population.

Precautions for use

Elderly subject, renal or hepatic impairment

An increase in plasma concentrations and a decrease in plasma clearance are observed. It is recommended to reduce the dose.

Excipients with known effects:

This medicine contains 563 mg of sodium per effervescent tablet, equivalent to 28,15 % of the maximum daily sodium intake recommended by the WHO. The maximum daily dose of this product (2 effervescent tablets) is equivalent to 56,3 % of the maximum daily sodium intake recommended by the WHO. DONORMYL 15 mg, scored effervescent tablet has a high sodium content. To be taken into account in people on a low-sodium diet.

This medicine contains 75 mg of sodium benzoate (E211) per effervescent tablet.

Combinations not recommended

+ Alcohol (beverage or excipient)

Potentiation of the sedative effect of the H antihistamine by alcohol₁. Impaired alertness may make driving vehicles and using machines dangerous.

Avoid taking alcoholic beverages and medicines containing alcohol.

+ Sodium oxybate

Increased central depression. Impaired alertness may make driving vehicles and using machines dangerous.

Associations to be taken into account

+ Anticholinesterases

Risk of reduced efficacy of the anticholinesterase through antagonism of acetylcholine receptors by the atropinic agent.

+ Other atropinic medicines

Imipramine-type antidepressants, most H antihistamines₁ anticholinergic, anticholinergic antiparkinsonian drugs, anticholinergic antispasmodics, disopyramide, phenothiazine neuroleptics and clozapine.

Additive atropine-like undesirable effects such as urinary retention, constipation, dry mouth...

+ Other sedative medicines

Morphine derivatives (analgesics, antitussives and substitution treatments), neuroleptics; barbiturates; benzodiazepines; anxiolytics other than benzodiazepines (for example, meprobamate); hypnotics; sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine); H antihistamines₁ sedatives; centrally acting antihypertensives; baclofen, thalidomide.

Increased central depression. Impaired alertness may make driving vehicles and using machines dangerous.

+ Other hypnotics

Increased central depression.

+ Morphinics

Significant risk of colonic akinesia, with severe constipation.

Pregnancy

Given the available data, the use of doxylamine is possible during pregnancy, regardless of the stage of pregnancy.

In case of treatment at the end of pregnancy, take into account the anticholinergic and sedative properties of this molecule when monitoring the newborn.

Breast-feeding

The passage of doxylamine into breast milk is not known. Given the possibilities of sedation or paradoxical excitation in the newborn, this medicine is not recommended in case of breastfeeding.

Fertility

Not applicable.

Warn drivers of vehicles and users of machines of the possible risk of daytime drowsiness.

The combination with other sedative medicines, sodium oxybate, alcoholic beverages or medicines containing alcohol should be avoided or taken into account when driving or using machines (see section Interactions) as they potentiate the sedative effect of antihistamines.

If the duration of sleep is insufficient, the risk of impaired alertness is further increased.

Anticholinergic effects: constipation, urinary retention, dry mouth, visual disturbances (accommodation disorders, blurred vision, hallucinations, visual impairment), heart palpitations, confusion.

Rhabdomyolysis, increase in blood creatine phosphokinase (CPK).

Daytime drowsiness, which requires a reduction of the dose.

Cases of abuse and dependence have been reported.

Furthermore, first-generation H₁ antihistamines are known to cause sedation, cognitive disorders and impairment of psychomotor performance.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/.

The first manifestations of acute intoxication are drowsiness and signs of the anticholinergic series: agitation, mydriasis, paralysis of accommodation, dry mouth, redness of the face and neck, hyperthermia and sinus tachycardia. Delirium, hallucinations and athetoid movements are more often observed in children; they sometimes herald the occurrence of convulsions, which are rare complications of massive intoxications or even of coma. Even in the absence of convulsions, acute doxylamine intoxication is sometimes responsible for rhabdomyolysis, which may be complicated by acute renal failure. This muscle involvement is not exceptional, which justifies its systematic screening by measuring creatine phosphokinase (CPK) activity.

Treatment is symptomatic. When management is early, administration of activated charcoal (50 g in adults, 1 g/kg in children) is desirable.

Pharmacotherapeutic class: ANTIHISTAMINE FOR SYSTEMIC USE

ATC code: R06AA09

Doxylamine succinate is an H₁ antihistamine of the ethanolamine class possessing a sedative effect and an atropine-like effect. It has been shown to reduce the time to fall asleep and to improve the duration and quality of sleep.

Absorption

The maximum concentration (C_max) in the blood is reached on average after 1 hour (T_max) after taking doxylamine succinate.

Metabolism and Elimination

The plasma elimination half-life (T 1/2) is on average 10 hours.

Doxylamine succinate is partially metabolised in the liver by demethylation and N-acetylation.

The various metabolites resulting from the degradation of the molecule are quantitatively minor, since 60 % of the administered dose is recovered in the urine in the form of unchanged doxylamine.

3 years.

Store at a temperature not exceeding 25 °C.

Store protected from moisture.

Replace the cap on the tube immediately after use.

No special requirements.