Order of Ministry of Health Protection of Ukraine
22.11.2011 № 810
Certificate of State Registration
№ UA /5497/01/01
for Medical Use of Preparation
Acting substance: 1 capsule contains 10 mg of afobazol in terms of dry substance.
Supplementary substances: potato flour, microcrystal cellulose, lactose monohydrate, povidone, magnesium stearate.
Pharmaceutical form. Tablets.
Tablets of white or cream-white color of plane cylindrical form with bevel.
Name and location of manufacturer.
Open Joint Stock Company “PHARMSTANDART-LEKSREDSTVA”
1 A/18, 2nd Agregatna street, Kursk, Russian Federation, 305022.
Pharmacotherapeutic group. Anxiolitics. Code ATC N05B X.
Afobazol® is a derivative of 2-mercaptobenzimidiazole, selective anxiolitic that does not belong to class of agonists of benzodiazepine receptors. It prevents from development of membrane-dependent changes in GABA receptor.
The preparation has anxiolitic action with activating component that is not accompanied by hypnosedative effects (sedative action is exhibited in doses that by 40-50 times surpass ED50 for anxiolitic action). The preparation has no myorelaxing properties, negative influence on indices of memory and attention. At its use medicated dependence is not formed and withdrawal symptoms are not developed.
The preparation action is realized mainly in the form of combination of anxiolitic (removing anxiety) and stimulating (activating) effects. Reduction or removal of anxiety feeling (concern, bad forebodings, fear, soreness), tonicity (fearfulness, tearfulness, feeling of solicitude, unfitness to relax, insomnia, fear), as well as somatic (muscular, sensorial, cardiovascular, breathing, gastroenteric symptoms), vegetative (dryness in mouth, sweating, dizziness), cognitive (difficulties at attention concentration, weak memory) abnormalities occur on the 5-7th day of therapy with the preparation. The maximum effect is achieved up to the end of the 4th week of the therapy and is preserved after the preparation cessation, in average during 1-2 weeks. The preparation use is especially justified for asthenical persons in case of anxiety, lack of confidence, elevated soreness and emotional instability, tendency to emotionally stress reactions.
Indications for use.
Qualms: generalized anxious disorders, neurasthenia, adaptation disorders at patients with dermatological, oncologic, somatic (bronchial asthma, syndrome of innervated intestinal tract, system lupus erythematosus, ischemic heart disease, arterial hypertension, arrhythmia) diseases.
In combination of complex therapy of sleep disorders related to anxiety, neurocirculatory asthenia, premenstrual syndrome, for alleviation of state at smoking withdrawal symptoms.
Elevated sensitivity to components of the preparation.
Adequate safety measures at use.
The preparation contains lactose, therefore, patients with rare genetic forms of intolerance to galactose, insufficiency of lactase or glucose-galactose malabsorption syndrome should not use the preparation.
Use during pregnancy or breast feeding. Use of the preparation during pregnancy or breast feeding the preparation use is contraindicative.
Ability to influence on quick reaction capability at driving motor transport or work with other mechanisms. No investigations as to study of influence on ability to drive transport facilities or work with other mechanisms were carried out.
Children. Use of the preparation for children is contraindicative.
Posology and method of administration.
For adult persons and children it is recommended to use internally, after meal.
Usually it is recommended to use 1 tablet trice per day. The maximum daily dose is 60 mg. The period of therapy is 2-4 weeks. According to doctor prescription it is possible to prolong the period up to 3 months.
In case of considerable overdose the sedative effect and elevated sleepiness development is possible without muscle relaxation display. As urgent aid it is used 20 % solution of caffeine sodium benzoate by 1 ml twice-trice per day subdermally.
Allergic reactions are possible (including pruritus, urticaria fever, sneezing, rhinitis, dermatitis, vasculitis), headache.
Interaction with other remedies and other kinds of interactions.
Afobazol® does not influence on narcotic effect of ethanol and hypnotic action of thiopental. It potentiates anticonvulsive effect of carbamazepine.
It results in elevation of anxiolytic action of diazepam.
Do not use after shelf life expiry indicated on the package.
Recommendations on storage.
It should be stored in original package in childproof places at temperature maximum 25 °C.
Tablets № 20 in blister. By 3 blisters in cardboard package.
Category of supply.
Date of the last revision.
Stamp: It is coordinated with registration dossier materials and authentically true data as to this preparation use.