Aviandr 20 mg 30 pcs

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

For anxiety states after coronavirus infection (COVID-19): in patients with a stress reaction and adaptation disorder, mild to moderate severity.

The active substance is: 2,8-dimethyl-5-(2-phenylethyl)-2,3,4,5-tetrahydro-1H-pyrido[4,3-b]indole hydrochloride.

Each film-coated tablet contains 20 mg 2,8-dimethyl-5-(2-phenylethyl)-2,3,4,5-tetrahydro-1H-pyrido[4,3-b]indole (as hydrochloride).

Other ingredients (excipients) are:

tablet core:

• lactose anhydrous
• castor oil hydrogenated
• potato starch

film coating (Opadry 03F180011 white):

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using the drug.

Pregnancy
Do not take 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.

Do not take 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 package leaflet),
• In case of epilepsy or organic brain damage,
• Do not take AVIANDR ^®  if you are taking antidepressants from the monoamine oxidase inhibitor (MAO) group and for 2 weeks after their withdrawal,
• If you have moderate to severe renal impairment (SCF < 60 ml/min),
• If you have mild, moderate or severe liver failure (Child-Pugh class A, B or C).

Special instructions and precautions

Take AVIANDR® as prescribed ^by  your doctor.

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

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

Children and teenagers

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

Like all medicines, AVIANDR® ^can  cause side effects, although not everybody gets them.

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

List of adverse reactions:

Possible side effects are listed below by frequency of occurrence. If these side effects occur severely, contact your doctor, pharmacist or healthcare professional.

Common (may occur in no more than 1 in 10 people)

• Drowsiness
• Headache
• Dizziness
• General weakness (asthenia)
• Tingling or numbness in the extremities (paresthesia)

Uncommon (may affect up to 1 in 100 people)

• Insomnia
• Poor quality of sleep
• Increased anxiety
• Attention deficit disorder
• Reduced response to stimuli
• Taste disturbance (dysgeusia)
• Nausea
• Pain in the upper abdomen
• Constipation
• Excessive sweating (hyperhidrosis)
• Muscle stiffness
• Tension of the masticatory muscles (trismus)
• Pain from the back
• Increased levels of creatine phosphokinase in the blood
• Decreased hemoglobin levels in the blood

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines. AVIANDR ^®  may interact with other medicines. This may change the amount of AVIANDR ^®  or other medicines in your blood. Be sure to tell your doctor if you are taking any of the following medicines:

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

Interaction with food and drinks

The drug AVIANDR® ^is  taken 30 minutes before meals.

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

Always take the medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.

Recommended Dose

Treatment of Generalized Anxiety Disorder

The drug AVIANDR ^®  is used 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 the leading complaint of anxiety, mood swings, irascibility and irritability; in patients with stress reaction and adaptation disorder, mild to moderate severity.

The drug AVIANDR ^®  is used 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.

Route 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 take more AVIANDR® ^than  you should

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

If you have taken more than the recommended dose of AVIANDR ^® , consult a doctor immediately. Within 1.5 hours after taking an increased dose of the drug, take activated charcoal or wash out your stomach.

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

If you forget to take AVIANDR ^®

If you miss a dose, do not take a double dose to make up for the missed pill. Just take your next dose at your usual time.

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

Considering the insignificant content of castor oil in one tablet of the drug, no adverse reactions associated with the action of this excipient are expected.

Film-coated

tablets Round, biconvex, film-coated tablets of white or almost white colour. The tablet core is white or almost white in cross-section.

10 tablets in a blister pack made of a combined material based on aluminium foil (PA/Alu/PVC) and printed lacquered aluminium foil.

30 tablets in a polyethylene bottle sealed with a polypropylene cap with a moisture absorber and first-opening control.

1 bottle or 3 blister packs together with a leaflet are placed in a cardboard pack.

Keep the medicine out of reach of children so that children cannot see it.

Do not use the medicine after the expiration date (storage date) indicated on the package. The expiration date is the last day of the given month.

Store the medicine at a temperature not exceeding 25 °C in the original packaging (bottle, blister) to protect from light.

Do not dispose of the medicine down the drain. Ask your pharmacist how to dispose of the medicine when it is no longer needed. Following these measures will help protect the environment.