Instructions for use Aminalon-KV hard capsules 250 mg No. 50
Composition
active ingredient: γ-aminobutyric acid;
1 capsule contains γ-aminobutyric acid in terms of 100% substance 250 mg;
excipients: methylcellulose, calcium stearate.
Dosage form
The capsules are hard.
Main physicochemical properties: hard gelatin capsules with a white body and a blue cap. The contents of the capsules are white powder or pressed mass.
Pharmacotherapeutic group
Other psychostimulants and nootropics. ATX code N06B X.
Pharmacological properties
Pharmacodynamics.
g-aminobutyric acid (GABA) is the main mediator of inhibitory processes in the central nervous system (CNS). The neurometabolic effect of the drug is mainly due to the stimulating effect on the GABA-ergic system, which ensures the normalization of the dynamics of nervous processes.
Under the influence of GABA, energy processes in brain tissues are also activated, their respiratory activity increases, and blood supply improves.
The drug promotes the restoration of motor activity, speech, and other cortical functions after cerebral circulation disorders. It has a psychostimulating effect: improves mental activity, memory, and concentration, and also alleviates vestibular disorders and sleep disorders.
Pharmacokinetics.
The drug is rapidly absorbed from the digestive tract, undergoes biotransformation in the liver. The breakdown products are excreted from the body mainly with urine; partially with carbon dioxide in exhaled air.
Indication
As part of the complex treatment of diseases of the central nervous system:
vascular diseases of the brain (atherosclerosis, damage to cerebral vessels in arterial hypertension);
chronic cerebral circulatory insufficiency with impaired memory, concentration, speech, dizziness, headache;
encephalopathy (alcoholic, post-stroke, post-traumatic);
cerebral palsy;
mental retardation in children (age 5 and older);
senile dementia (early stages of dementia);
sea and air sickness (for prevention and treatment of the symptom complex of motion sickness).
Contraindication
Hypersensitivity to any of the components of the drug; acute renal failure.
Interaction with other medicinal products and other types of interactions
When used together with benzodiazepine drugs (tranquilizers, anticonvulsants), as well as with sedatives (barbiturates), a mutual enhancement of the effect is observed.
Pyridoxine hydrochloride (vitamin B6) may also enhance the effect of the drug.
When used in combination with benzodiazepine drugs, each of the drugs should be administered in the minimum or average effective doses.
If it is necessary to use any medications simultaneously, you should consult a doctor.
Application features
At the beginning of treatment, blood pressure monitoring is necessary due to the possibility of its fluctuations.
It is not recommended to use the drug in the evening and before bedtime due to possible sleep disturbance.
It is not recommended to drink alcohol during treatment with the drug.
Use during pregnancy or breastfeeding
It is not recommended to prescribe the drug to women during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
With prolonged use of the drug, caution should be exercised by persons engaged in potentially hazardous activities that require increased attention and high speed of psychomotor reactions when driving vehicles or working with other mechanisms. In the first days of using the drug, you should refrain from driving or working with potentially dangerous mechanisms.
Method of administration and doses
The medicine should be taken orally before meals.
Adults are prescribed 2–5 capsules (500–1250 mg) per dose, depending on the course and severity of the disease. The daily dose is usually 6–12 capsules (1500–3000 mg) in 3 doses.
Children should be prescribed the drug starting from the age of 5, depending on the course and severity of the disease, 2–12 capsules (500–3000 mg) per day. The daily dose should be divided into 3 doses, the course of treatment should be from 2 weeks to 6 months. If necessary, repeat courses should be carried out (after consulting a doctor).
For the treatment of the symptom complex of motion sickness, adults are prescribed 2 capsules (500 mg) and children over 5 years of age are prescribed 1 capsule (250 mg) 3 times a day for 3–4 days. For preventive purposes, adults are prescribed 2 capsules (500 mg) 3 times a day for 3 days preceding a trip or possible motion sickness.
The duration of the course of treatment is determined by the doctor individually.
Children
It is not recommended to prescribe the medicine to children under 5 years of age.
Overdose
If the therapeutic doses of the drug are significantly exceeded and the recommended treatment regimens are not followed, nausea, vomiting, intestinal disorders, headache, fever, fluctuations in blood pressure, and sleep disturbances may develop. In such cases, the drug should be discontinued. Treatment is symptomatic.
Side effects
In some cases, the following are possible:
from the digestive tract: dyspeptic phenomena, nausea, vomiting;
from the nervous system: sleep disturbances, insomnia;
Cardiovascular system: blood pressure fluctuations (more often in the first days of use);
from the immune system: allergic reactions, including skin rashes, itching;
general: feeling hot, fever.
These phenomena usually disappear when the dosage is reduced.
If any adverse reactions occur, discontinue use of the drug and consult a doctor.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 capsules in blisters.
10 capsules in a blister; 5 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Address
04073, Ukraine, Kyiv, Kopylivska St., 38.
