Registration certificate holder: Johnson & Johnson Consumer Inc., USA. Manufacturer: Johnson & Johnson Medical, Inc., USA/Johnson & Johnson Medical, Inc., USA. Registration number: LP–006756 dated 08/19/2021.

Release form, composition and packaging.

Film-coated tablets 0.5 mg. 10, 20 or 30 tablets in a blister of aluminum foil and PVC/PE/PVDH film. 3, 5 or 10 blisters in a cardboard pack.

14 tablets each in an aluminum foil blister. 2, 4 or 6 blisters in a cardboard pack.

Film-coated tablets 1 mg. 7, 14 or 28 tablets in a blister of aluminum foil and PVC/PE/PVDH film. 4, 7 or 14 blisters in a cardboard pack. 14 tablets per blister. 1, 2 or 4 blisters in a cardboard pack. Film-coated tablets 2 mg.

There are 14 pieces in a contour cell package. There are 2 contour cell packages in the package. In a package of 1 or 2 blisters of 14 pcs. In a package: 1 blister, 1 or 2 packages of cell contour.

Description of the dosage form.

White or almost white, round, biconvex tablets, film-coated, engraved with “APX 0.5” on one side.

Pharmacological action.

Antipsychotic agent (neuroleptic), has a pronounced anxiolytic effect.

Indications.

Treatment of generalized anxiety disorder. Treatment of panic disorder with or without agoraphobia. Treatment of social anxiety disorder.

Dosage regimen.

Take orally, regardless of the meal.

For the prevention of acute anxiety and psychotic symptoms, as well as for the treatment of panic attacks and social anxiety disorder, an initial dose of 0.25 mg once a day is recommended. If necessary, the dose can be increased to 0.5–1 mg / day.

The initial dose for the prevention and treatment of generalized anxiety disorder is 0.75–1.5 mg / day, if necessary, the dose can be increased to 3 mg / day in 3 doses.

The maximum daily dose is 6 mg.

The duration of treatment and the dosage regimen for chronic conditions is determined by the doctor individually for each patient.

Overdose.

Symptoms: depression of the central nervous system, respiratory depression, coma.

Therapy: symptomatic, with respiratory depression, artificial ventilation of the lungs is performed.

Drug interaction.

Alcohol, anticonvulsants (for example, phenytoin) enhance the depressing effect on the central nervous system.

Paracetamol, other drugs with hepatotoxic effects, increase the risk of toxic effects on the liver.

Levodopa increases the risk of developing neuroleptic malignant syndrome (NMS).

Carbamazepine and rifampicin reduce plasma concentrations.

Fluoxetine, fluvoxamine, citalopram, paroxetine increase plasma concentrations, which may increase the risk of side effects.

Antihypertensive drugs can increase the decrease in blood pressure.

Storage conditions.

Store at a temperature not exceeding 30 ° C.

Expiration date.

3 years. Do not use after the expiration date.