AMINOLON

INSTRUCTIONS for medical use of the medicinal product AMINALON (AMINALON)

Composition:

Active substance: aminalon (gamma-aminobutyric acid);

1 tablet contains aminalon (gamma-aminobutyric acid) (calculated as 100% substance) 250 mg;

Excipients: microcrystalline cellulose, povidone 25, colloidal anhydrous silicon dioxide, magnesium stearate, Opadry II White 85F18422 (a mixture of substances: polyethylene glycol, talc, titanium dioxide (E 171), polyvinyl alcohol).

Medicinal form. Film-coated tablets.

Main physicochemical characteristics: white or white with a creamy shade, round-shaped, biconvex film-coated tablets.

Pharmacotherapeutic group.

Psychoanaleptics. Other psychostimulants and nootropics.

ATC code N06B X.

Pharmacological properties.

Pharmacodynamics.

Gamma-aminobutyric acid (GABA) is the main mediator of the central nervous system involved in central inhibition processes. Under its influence, brain energy processes are activated, glucose utilization by the brain is improved, tissue respiratory activity is increased, and blood supply is enhanced. The drug improves the dynamics of neural processes in the brain, thinking, memory, and attention, promotes recovery of motor functions and speech after stroke, and exerts a mild psychostimulant effect. It contributes to reduction and stabilization of elevated arterial pressure (AP) and alleviation of subjective symptoms of arterial hypertension (dizziness, sleep disturbances). It has moderate anti-hypoxic and anticonvulsant effects. In patients with diabetes mellitus, it reduces glucose levels; when blood glucose levels are normal, it produces the opposite effect (due to glycogenolysis). In terms of its action, the drug is similar to nootropic agents.

Pharmacokinetics.

Rapidly absorbed from the gastrointestinal tract. Reaches maximum concentration in blood plasma. The final metabolic product of GABA in tissues is succinic acid, which enters the Krebs cycle. A portion of the drug undergoes transamination to form γ-guanidinobutyric acid, which partially breaks down in the liver and kidneys into GABA and urea. Additionally, γ-aminobutyrylcholine, GABA-pantothenyl, homocarnosine, and to a lesser extent, oxobutyric acid are synthesized. Metabolites of GABA and unchanged drug are excreted in urine, partially in expired air as carbon dioxide.

Clinical characteristics.

Indications.

As part of complex treatment of central nervous system disorders:

• cerebral vascular diseases (atherosclerosis, cerebrovascular lesions in arterial hypertension);
• chronic cerebral circulatory insufficiency with memory impairment, attention concentration, speech disorders, dizziness, headache;
• encephalopathy (alcoholic, post-stroke, post-traumatic);
• cerebral palsy in children;
• intellectual developmental delay in children (aged 5 years and older);
• senile dementia (early stages of dementia);
• motion sickness (for prevention and treatment of symptoms related to motion sickness).

Contraindications.

Hypersensitivity to any component of the drug. Acute renal failure.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with benzodiazepine agents (tranquilizers, anticonvulsants) as well as with sedatives (barbiturates), mutual potentiation of effects may occur. Pyridoxine hydrochloride (vitamin B6) may also enhance the effect of gamma-aminobutyric acid.

When used in combination with benzodiazepine agents, each drug should be administered at the lowest or medium effective doses.

Special precautions for use.

During the initial phase of treatment, monitoring of blood pressure is required due to possible fluctuations.

The drug is not recommended to be taken in the evening or before bedtime due to the potential for sleep disturbances.

Alcohol consumption during treatment with this drug is not recommended.

Use during pregnancy or breastfeeding.

The drug is not recommended for administration to women during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Caution is advised for individuals engaged in potentially hazardous activities requiring increased attention and high speed of psychomotor reactions (such as driving vehicles or operating machinery) during prolonged use of the drug. During the first days of treatment, patients should refrain from driving vehicles and operating potentially hazardous machinery.

Method of Administration and Dosage

The drug should be taken orally before meals. For adults, the recommended dose is 2–5 tablets (500–1250 mg) per administration, depending on the course and severity of the disease. The daily dose usually ranges from 6 to 12 tablets (1500–3000 mg), divided into 3 doses.

For children aged 5 years and older, the daily dose is 2–12 tablets (500–3000 mg), depending on the course and severity of the illness. The daily dose should be divided into 3 administrations. Treatment duration ranges from 2 weeks to 6 months. Repeat courses may be administered if necessary.

For treatment of motion sickness symptoms, administer 2 tablets (500 mg) three times daily to adults and 1 tablet (250 mg) three times daily to children aged 5 years and older, for 3–4 days. For prophylactic use, administer to adults 2 tablets (500 mg) three times daily for 3 days prior to travel or anticipated motion exposure.

The duration of treatment is determined individually by the physician.

Children

The medicinal product is not recommended for children under 5 years of age.

Overdose

Symptoms: significantly exceeding therapeutic doses or failure to follow recommended treatment regimens may lead to nausea, vomiting, gastrointestinal disturbances, headache, fever, fluctuations in blood pressure, and sleep disturbances. In such cases, administration of the drug should be discontinued.

Treatment: symptomatic.

Adverse Reactions.

Gamma-aminobutyric acid is very low in toxicity. In some cases, the following reactions may occur:

• Gastrointestinal tract: dyspeptic symptoms, nausea, vomiting;
• Central nervous system: insomnia, sensation of warmth, increased body temperature, sleep disturbances;
• Cardiovascular system: fluctuations in blood pressure;
• Skin: allergic reactions, including skin rashes, itching.

These effects usually resolve quickly upon dose reduction.

If any adverse reactions occur, the use of the drug should be discontinued and medical advice must be sought immediately.

Shelf life. 3 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets per blister, 1, 5, or 10 blisters per cardboard pack.

Supply category. Over-the-counter.

Manufacturer.

JSC «VITAMINS».

Manufacturer's address and place of business.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.

Marketing Authorization Holder.

JSC «VITAMINS».

Address of the Marketing Authorization Holder.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.