Bioson

Pharmacological properties

the components of the passiflora extract inhibit the conduction of nerve impulses in the spinal cord and brain, reduce the excitability of the central nervous system, which determine the pronounced sedative, mild anti-anxiety and hypnotic effects without the symptom of depression upon waking. calming effect in menopause and premenopausal period. used for vegetative symptoms against diseases of the nervous and cardiovascular systems (with ar, in the recovery period after cerebral vascular crises, neurocirculatory dystonia, in asthenic conditions after infections and other serious diseases). Passiflora eliminates such vegetative symptoms as palpitations, sweating.

Doxylamine Hydrogen Succinate is a H Blocker₁-receptors of the class of ethanolamines, which has a sedative, hypnotic and anti-allergic effect. It has been demonstrated that it reduces the time required to fall asleep, and also improves the duration and quality of sleep.

Pharmacokinetics Not studied.

Indications

Periodic and transient insomnia.

Application

For oral use.

The recommended dose is 1 tablet, if necessary, the dose can be increased to 2 tablets. Take the drug 30 minutes before bedtime.

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

The duration of the course of treatment is up to 10 days. If symptoms persist, consult a doctor.

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

Contraindications

Hypersensitivity to the components of the drug. During pregnancy and breastfeeding. angle-closure glaucoma in the patient’s history or in the family history. urethroprostatic disorders with a risk of urinary retention.

Side effects

The drug is generally well tolerated.

In some cases, such side effects may occur:

From the digestive tract: nausea, vomiting.

From the cardiovascular system: bradycardia, ventricular tachycardia.

From the nervous system: dizziness, drowsiness.

From the immune system: allergic reactions, including skin rashes, itching and vasculitis.

Daytime drowsiness: with the development of such an effect, it is necessary to reduce the dose.

The atropine-like effect of the drug may be manifested by constipation, dry mouth, disturbance of accommodation, and severe heartbeat;

special instructions

Use with caution in patients with severe organic diseases of the digestive tract.

Like all sleeping pills or sedatives, doxylamine hydrogen succinate can exacerbate sleep apnea syndrome (an increase in the number and duration of respiratory arrest).

N₁antihistamines should be used with caution in elderly patients because of the risk of dizziness, which may increase the risk of falls (for example, when people get up at night) with consequences that are often serious for this category of patients.

To prevent drowsiness during the day, you must remember that the duration of sleep after taking the drug should be at least 7 hours.

During the use of the drug should refrain from drinking alcohol and taking medications containing ethanol.

The simultaneous use of stimulating drinks (coffee, tea), as well as emotional and visual stress, physical activity are not recommended.

Use during pregnancy and lactation. Do not use.

Children. The effectiveness and safety of the drug in children under the age of 15 years have not been established, therefore, the use in patients of this category is not recommended.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. It is necessary to pay attention to the risk of daytime drowsiness, which may develop when taking this drug, especially in people who drive vehicles or work with other mechanisms.

Interactions

Preparations of a central inhibitory type of action enhance the effect of the drug.

Concomitant use with benzodiazepines is not recommended. Concomitant use with disulfiram should be avoided.

During treatment should not drink alcoholic beverages.

Combinations of doxylamine with:

• atropine and atropine-like drugs (imipramine antidepressants, anticholinergic antiparkinsonian drugs, atropine antispasmodic drugs, disopyramide, phenothiazine antipsychotics) due to side effects such as urinary retention, constipation, dry mouth;
• other antidepressants that affect the central nervous system, morphine derivatives (painkillers; drugs used to treat cough and replacement therapy), antipsychotics; barbiturates; benzodiazepines; anxiolytics; sedative antidepressants (amitriptyline, doxepin, mianserin, Mirtazapine, trimipramine) sedative N₁antihistamines; antihypertensive agents of central action; others (baclofen, pisotifen, thalidomide) due to increased CNS depression.

Overdose

The first signs of acute poisoning are drowsiness and signs of anticholinergic effects: agitation, dilated pupils, accommodation paralysis, dry mouth, redness of the face and neck, hyperthermia, sinus tachycardia. delirium, hallucinations and athetous movements are sometimes precursors of seizures - rare complications of severe poisoning. even if convulsions do not occur, acute doxylamine poisoning sometimes causes rhabdomyolysis, which may be complicated by acute relapse. such muscle disorder is common, which requires a systematic screening by measuring the activity of KFK.

The treatment is symptomatic. At the early start of therapy, it is recommended to use activated charcoal (50 g for adults, 1 g / kg of body weight for children).

Storage conditions

In the original packaging at a temperature not exceeding 25 ° C.