Instructions Adaptol capsules 300 mg blister No. 20
Composition
active ingredient: mebicar
1 capsule contains Mebicar 300 mg;
excipients: methylcellulose, calcium stearate, titanium dioxide (E171), gelatin.
Dosage form
Capsules.
Main physicochemical properties: hard gelatin capsules of white/white color, containing white or almost white powder, allowed in the form of a compressed column that crumbles when touched with a glass rod. Heterogeneity in particle size is allowed.
Pharmacotherapeutic group
Psycholeptics. Other anxiolytics. ATX code NO5B X.
Pharmacological properties
Pharmacodynamics.
The active ingredient of the drug Adaptol® - mebicar, is close in chemical structure to the body's natural metabolites: its molecule consists of two methylated urea fragments, which are part of a bicyclic structure.
Adaptol® has moderate tranquilizing (anxiolytic) activity, relieves or reduces feelings of restlessness, anxiety, fear, internal emotional tension and irritation. The sedative effect of the drug is not accompanied by muscle relaxation and impaired coordination of movements. The drug does not reduce mental and motor activity, so Adaptol® can be used during the working day or during study. The drug does not create an elevated mood, a feeling of euphoria. On this basis, Adaptol® is classified as a daytime tranquilizer. It does not exhibit a hypnotic effect, but enhances the effect of hypnotics and improves sleep when it is disturbed.
In addition to its sedative effect, Adaptol® has a nootropic effect. The drug improves cognitive functions, increases attention and mental performance, without stimulating the symptoms of productive psychopathological disorders, such as delusions and pathological emotional activity.
Adaptol® has antioxidant activity, therefore it acts as a membrane stabilizer, adaptogen and cerebroprotector in oxidative stress of various origins.
Adaptol® acts on the activity of the structures of the limbic-reticular complex, in particular on the emotional zones of the hypothalamus, and also affects all 4 main neurotransmitter systems - GABAergic, cholinergic, serotoninergic and adrenergic, which contributes to their balance and integration, but does not have a peripheral adrenonegative effect. The neurotransmitter profile of Adaptol® contains a dopamine-positive component. The drug exhibits antagonistic activity against the excitation of the adrenergic and glutamatergic systems and enhances the functioning of the inhibitory serotonin and GABAergic mechanisms of the brain. The drug has normastenic properties.
Adaptol® facilitates nicotine withdrawal.
Pharmacokinetics.
When administered orally, bioavailability is 77–80%; up to 40% of the drug binds to erythrocytes; the remaining 60% does not bind to blood proteins and is contained in the blood plasma in a free state, due to which the drug spreads in the body without hindrance and freely passes through membranes. The maximum concentration in the blood serum is reached in 30 minutes, the high level remains for 3-4 hours, then gradually decreases. The drug is completely excreted from the body with urine during the day, does not accumulate and is not subject to biochemical transformations in the body.
Indication
Neuroses and neurosis-like conditions accompanied by irritation, emotional lability, feelings of anxiety and fear; to improve the tolerance of neuroleptics or tranquilizers in order to eliminate the somatovegetative and neurological side effects caused by them; cardialgia of various genesis (not associated with ischemic heart disease).
As part of complex therapy for nicotine addiction as a means of reducing the urge to smoke.
Contraindication
Hypersensitivity to Mebicar or to any of the excipients of the drug.
Interaction with other medicinal products and other types of interactions
Adaptol® can be combined with neuroleptics, tranquilizers (benzodiazepines), hypnotics, antidepressants and psychostimulants.
Application features
Habituation, dependence, and withdrawal syndrome have not been established when using Adaptol®.
It should be used with caution in patients with impaired liver and kidney function and patients with arterial hypotension.
Use during pregnancy or breastfeeding
Adaptol® penetrates well into all tissues and body fluids.
There is insufficient data regarding the safety of the drug during pregnancy and breastfeeding, therefore it is not recommended to prescribe the drug to pregnant and breastfeeding women.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised when driving vehicles, as sometimes the use of the drug can cause a decrease in blood pressure.
Method of administration and doses
Adaptol® should be taken orally, regardless of meals.
Adults 300-600 mg 2-3 times a day. If necessary, the dose can be increased. The maximum single dose is 3 g, the maximum daily dose is 10 g.
For the treatment of nicotine addiction, the drug is used at 600-900 mg 3 times a day daily for 5-6 weeks.
Children
The drug is not intended for use in children.
Overdose
Adaptol® is low-toxic. In case of a significant overdose, side effects may be increased (including allergic reactions, dyspeptic disorders, weakness, temporary decrease in blood pressure and body temperature).
Treatment: gastric lavage and standard detoxification methods should be used.
Adverse reactions
Adaptol® is usually well tolerated.
From the cardiovascular system: rarely - a decrease in blood pressure.
Gastrointestinal: rarely - dyspeptic disorders (including nausea, vomiting, diarrhea).
In this case, the dose of the drug should be reduced.
On the part of the respiratory system: rarely - bronchospasm.
Skin and subcutaneous tissue disorders: rarely – allergic reactions (including skin rashes, itching, urticaria, angioedema). In case of an allergic reaction, discontinue use of the drug.
General disorders: rarely - decreased body temperature, weakness, dizziness. In case of a decrease in blood pressure and/or body temperature (body temperature may decrease by 1-1.5 ° C), the drug does not need to be discontinued. Blood pressure and body temperature normalize independently.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 capsules in a blister. 2 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
JSC "Olainfarm"/JSC "Olainfarm".
Location of the manufacturer and its business address
5 Rupnicu street, Olaine, LV-2114, Latvia.
