Expiration date: 02/2026

Packaging and release form

Film-coated tablets, 0.02 - 30 pcs per pack.

Dosage form

Round biconvex tablets coated with a white or almost white film coating. In the cross section, the core of the tablet is white or almost white in color.

Composition

Each film-coated tablet contains:

Active substance: 2,8-dimethyl-5-(2-phenylethyl)-2,3,4,5-tetrahydro-1H-pyrido[4,3-b]indole (as hydrochloride) 20 mg

Other ingredients (auxiliary substances) are:

the core of the tablet:

• anhydrous lactose
• hydrogenated castor oil
• potato starch

film shell (Opadray 03F180011 white):

• hypromellose
• titanium dioxide (E171)
• macrogol-6000

Pharmacotherapeutic group

of psycholeptics; anxiolytic agents; other anxiolytic agents

Pharmacodynamics

Characteristic of the drug:

The drug AVIANDR® belongs to the pharmacotherapeutic group: psycholeptics; anxiolytic agents; other anxiolytic agents.

Mechanism of action:

The drug AVIANDR® has anti-anxiety and antidepressant activity due to its ability to inhibit (suppress) the transmission of nerve impulses in adrenergic, serotonin, histamine and dopamine receptors of the brain.

Indications

AVIANDR® is indicated for use in adults over 18 years of age for the treatment of generalized anxiety disorder.

In case of anxiety after a coronavirus infection (COVID-19): in patients with a stress reaction and impaired adaptation, mild to moderate severity.

Contraindications

Carefully follow all the instructions of the attending physician. They may differ from the general information provided in this leaflet.

Do not take the drug AVIANDR®:

• If you are allergic to the active substance (2,8-dimethyl-5-(2-phenylethyl)-2,3,4,5-tetrahydro-1H-pyrido[4,3-b]indole hydrochloride) or any other components of the drug (listed in section 6 of the leaflet),
• With epilepsy or organic brain lesions,
• Do not take AVIANDR® if you are taking antidepressants from the monoamine oxidase inhibitor (MAO) group and within 2 weeks after their withdrawal,
• If you have moderate to severe renal insufficiency (GFR < 60 ml/min),
• If you have mild, moderate and severe liver failure (class A, B and C according to the Child-Pugh classification (or scale)).

With caution:

Take AVIANDR® as prescribed by your doctor.

Be sure to inform your doctor and take AVIANDR® with caution:

• If you have a cardiovascular disease,
• If you have diabetes mellitus or other endocrine diseases,
• If you suffer from alcohol or drug addiction.

Children and teenagers

Do not give the drug to children aged 0-18 years due to the lack of data on the effectiveness and safety of the drug in this category.

If you are pregnant or breastfeeding, think you are pregnant, or are planning a pregnancy, consult your doctor before using the drug.

Pregnancy

Do not take the drug AVIANDR®, it is contraindicated during pregnancy.

Breastfeeding

Do not take AVIANDR®. If it is necessary to use the drug during breastfeeding (lactation), breastfeeding should be discontinued.

Method of administration and dosage

Always take the drug in full accordance with the recommendations of your doctor. If in doubt, consult your doctor.

Recommended dose

Treatment of generalized anxiety disorder

The drug AVIANDR® is administered orally 1 tablet (20 mg) 2 times a day (morning and evening). Since generalized anxiety disorder is a chronic disease, the duration of treatment is determined by the doctor.

Treatment of anxiety conditions, including after coronavirus infection (COVID-19): in patients with a leading complaint of anxiety, mood background changes, short temper and irritability; in patients with a stress reaction and impaired adaptation, mild and moderate severity.

The drug AVIANDR® is administered orally 1 tablet (20 mg) 2 times a day (morning and evening). The duration of the course of use of the drug is 4 weeks.

If necessary, on the recommendation of a doctor, the duration of treatment can be increased to 6 weeks.

The way and method of administration

The drug AVIANDR® is taken orally, 30 minutes before meals.

Duration of therapy

The duration of the course of treatment is determined by the doctor, depending on your condition and diagnosis.

If you forgot to take the drug AVIANDR®

If you missed taking the drug, do not take a double dose to compensate for the missed pill. Just take the next dose at the usual time.

If you have questions about the use of the drug, contact your doctor.

Side effects

Possible adverse reactions

Like all medications, AVIANDR® can cause undesirable reactions, but they do not occur in everyone.

Most adverse reactions are mild or moderate. They usually occur within the first two weeks of treatment and are transient.

List of adverse reactions:

The following are possible adverse reactions by frequency of occurrence. If these adverse reactions are severe, contact your doctor, pharmacist, or healthcare professional.

Often (may occur in no more than 1 person out of 10)

• Drowsiness
• Headache
• Dizziness
• General weakness (asthenia)

 Tingling or numbness in the extremities (paresthesia)

Infrequently (may occur in no more than 1 person out of 100)

• Insomnia (insomnia)
• Poor sleep quality
• Increased anxiety
• Attention disorder
• Reduced response to stimuli
• Taste disorder (dysgeusia)
• Nausea
• Pain in the upper abdomen
• Constipation
• Excessive sweating (hyperhidrosis)
• Muscle stiffness
• Tension of the masticatory muscles (trism)
• Back pain
• Increased creatine phosphokinase levels in the blood
• Decrease in hemoglobin levels in the blood

Reporting of adverse reactions

If you experience any adverse reactions, consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the leaflet. You can also report adverse reactions directly through the message system of the member States of the Eurasian Economic Union.

By reporting adverse reactions, you help to get more information about the safety of the drug.

Overdose

If you have taken AVIANDR® more than you should have

There are no data on overdose cases. In case of overdose, dizziness, general weakness, drowsiness, depression of the level of consciousness are possible.

If you have taken an overdose of AVIANDR®, contact your doctor immediately. Within 1.5 hours after taking an increased dose of the drug, take activated charcoal or rinse your stomach.

There is no special antidote for intoxication or overdose. In case of overdose, your doctor will prescribe symptomatic therapy to maintain vital body functions.

Drug interaction

Tell your doctor that you are taking, have recently taken, or may start taking any other medications, including over-the-counter medications.

The drug AVIANDR® may interact with other drugs. As a result, the amount of AVIANDR® or other drugs in your blood may vary.

Be sure to tell your doctor if you are taking any of the following medications:

• Drugs with sedative effects (for example, tranquilizers, antipsychotics, hypnotics and antiallergic drugs);
• Antidepressants (for example, sertraline, paroxetine, amitriptyline, etc.);
• Triptans (sumatriptan, zolmitriptan, etc.);
• Opioid analgesics (tramadol, promedol, etc.);
• Drugs that are inhibitors of the CYP2D6 enzyme (for example, diphenhydramine, ketoconazole, quinidine, hydroxychloroquine).

Interaction with food and drinks

AVIANDR® is taken 30 minutes before meals.

During the treatment period, you should refrain from drinking alcohol.

Special instructions

AVIANDR® contains lactose and hydrogenated castor oil

If you are intolerant of certain sugars, consult your doctor before taking this medicine.

Given the low content of castor oil in one tablet of the drug, no adverse reactions associated with the action of this auxiliary substance are expected.

Driving vehicles and working with mechanisms

When using the drug, it is contraindicated to drive vehicles and work with mechanisms.

Storage temperature

from 2℃ to 25℃