BrainMax 250 mg + 250 mg 20 pcs blister capsules

As part of the complex therapy for cerebral circulation insufficiency
Mild cognitive impairments, accompanied by manifestations such as memory deterioration, distractibility, decreased ability to concentrate and learn, difficulties in assimilating new information
Reduced work capacity.
Mental and physical overloads (including in athletes, see "Special Instructions")
Asthenic conditions, including those following a new coronavirus infection, accompanied by manifestations such as increased fatigue, sleep disturbances, headaches, dizziness, emotional lability, cognitive function impairments

The BRAINMAX® preparation is taken orally.

• In the complex therapy of cerebral circulation insufficiency, BRAINMAX® is taken at a dose of 2 capsules (500 mg + 500 mg) once daily. The treatment course is 4 weeks. The daily dose may be increased to 2 capsules (500 mg + 500 mg) twice daily at the discretion of the attending physician. The duration of intake may be extended at the discretion of the attending physician.

• For mild cognitive impairments, reduced performance, asthenic conditions, and mental and physical overloads - the daily dose of BRAINMAX® for adults is 2 capsules (500 mg + 500 mg). The daily dose can be taken in one dose (2 capsules in the morning) or divided into 2 doses (1 capsule twice daily). The treatment course is 10 to 14 days.

• For asthenic conditions following a recent coronavirus infection - the daily dose of BRAINMAX® for adults is 4 capsules (1000 mg + 1000 mg). BRAINMAX® is taken at a dose of 2 capsules (500 mg + 500 mg) twice daily. The treatment course is 30 days. Due to the possible development of an excitatory effect, BRAINMAX® is recommended to be taken in the first half of the day.

Composition per 1 capsule:
Active ingredients: ethylmethylhydroxypyridine succinate - 250.0 mg, meldonium dihydrate - 250.0 mg.
Excipients: corn starch - 35.7 mg, microcrystalline cellulose type 101 - 22.0 mg, polyethylene glycol 6000 - 20.0 mg, microcrystalline cellulose type 102 - 10.0 mg, colloidal silicon dioxide - 6.8 mg, magnesium stearate - 5.5 mg.
Capsule: hard gelatin capsule No. 00
Capsule body: titanium dioxide (E 171) - 2.0%, gelatin - up to 100.0%.
Capsule cap: titanium dioxide (E 171) - 1.0%, indigo carmine (E 132) - 0.1333%, gelatin - up to 100.0%.

Hard gelatin capsules No. 00. The capsule body is white, and the capsule cap is blue, opaque.
The contents of the capsules are a white or almost white powder. A slight characteristic odor is permissible. The contents of the capsules may be compacted into clumps that are easily broken apart with pressure from a glass rod.

• hypersensitivity to the components of the drug;

• acute liver failure;

• acute kidney failure;

• increased intracranial pressure (in cases of impaired venous outflow and intracranial tumors);

• pregnancy;

• lactation period;

• age under 18 years.

Caution
Chronic liver and kidney diseases, bronchial asthma
Use during pregnancy and lactation
The drug BRAINMAX® is contraindicated during pregnancy and lactation due to insufficient data on the efficacy and safety of the drug during these periods. Breastfeeding should be discontinued prior to starting the medication.

Meldonium may yield a positive result in doping control tests. As of January 1, 2016, meldonium has been included in the list of prohibited substances by the World Anti-Doping Agency.
Patients with chronic liver and kidney diseases should exercise caution when using the drug for an extended period.
There is insufficient data on the use of the drug in children under 18 years of age.
If the condition does not improve or worsens after the course of therapy, you should consult a doctor. If prolonged use (more than one month) of the drug is necessary, it is recommended to consult a specialist.
Effect on the ability to drive vehicles and operate machinery
During the course of treatment, caution should be exercised when performing work that requires increased attention and quick psychomotor reactions (driving vehicles, operating machinery, etc.).

The frequency of side effects was determined according to the classification of the World Health Organization (WHO): very common (> 10%); common (> 1%, but 0.1%, but 0.01%, but < 0.1%); very rare (< 0.01%); frequency unknown (frequency cannot be determined based on available data).Meldonium Blood and lymphatic system disorders Frequency unknown: eosinophilia. Immune system disorders Rare: allergic reactions (skin redness, skin rash, urticaria, itching, swelling, angioedema). Heart disorders Very rare: tachycardia. Vascular disorders Rare: decreased or increased blood pressure. Gastrointestinal disorders Common: dyspeptic phenomena. Nervous system disorders Common: headaches; Frequency unknown: agitation. General disorders Frequency unknown: general weakness.Ethylmethylhydroxypyridine succinate Immune system disorders: Very rare: angioedema, urticaria. Gastrointestinal disorders: Very rare: dry mouth, nausea, pain, burning and discomfort in the epigastric region, heartburn, flatulence, diarrhea. Nervous system disorders: Very rare: headache. Skin and subcutaneous tissue disorders: Very rare: rash, itching, hyperemia. Psychiatric disorders: Very rare: drowsiness.If you notice any other side effects not listed in the instructions, please inform your doctor.The drug is low in toxicity and does not cause severe adverse reactions. Symptoms: decreased blood pressure, accompanied by headache, tachycardia, dizziness, and general weakness. Drowsiness, insomnia. Treatment: treatment is usually not required; symptoms resolve on their own within 24 hours. In cases of severe manifestations, supportive and symptomatic treatment is administered.Meldonium Enhances the action of coronary dilators, certain antihypertensive agents, and cardiac glycosides. Can be combined with prolonged forms of nitrates, other antianginal agents, anticoagulants, antiplatelet agents, antiarrhythmic agents, diuretics, and bronchodilators. Due to the possible development of tachycardia and arterial hypotension, caution should be exercised when combining with nitroglycerin (for sublingual use) and antihypertensive agents (especially alpha-adrenergic blockers and short-acting forms of nifedipine). Simultaneous use of the drug with other preparations containing meldonium is not allowed, as it may increase the risk of adverse reactions.Ethylmethylhydroxypyridine succinate Ethylmethylhydroxypyridine succinate can be combined with all medications used for the treatment of somatic diseases. Enhances the action of benzodiazepine medications, antidepressants, anxiolytics, antiepileptic agents (carbamazepine), and antiparkinsonian agents (levodopa), as well as nitrates. Reduces the toxic effects of ethanol.

Meldonium (trimethylhydrazinium propionate) is a structural analogue of the carnitine precursor gamma-butyrobetaine, a substance found in every cell of the human body.
Trimethylhydrazinium propionate restores the balance of oxygen delivery and consumption processes in cells under ischemic conditions, prevents the disruption of adenosine triphosphate (ATP) transport; at the same time, it activates glycolysis, which occurs without additional oxygen consumption.
Ethylmethylhydroxypyridine succinate, by blocking the process of lipid peroxidation, reduces the number of free radicals, improves the structure and function of cell membranes, neurotransmitter transport, and signal transmission in synapses.
The use of the combination of trimethylhydrazinium propionate and ethylmethylhydroxypyridine succinate leads to a synergistic pharmacodynamic interaction of the two components in the form of conformationally selective agonism to receptors, which enhances the neuroprotective activity of the drug. Under hypoxic conditions, the BRAYNMAX® drug activates energy production in mitochondria, and under reduced blood supply, it helps maintain the structure and viability of cells, particularly neurons and cardiomyocytes.
When using the BRAYNMAX® drug, the antioxidant, anti-hypoxic, membrane- and stress-protective, anticonvulsant, anxiolytic, nootropic, and anti-ischemic effects of the two active substances exceed the pharmacological effect of each component used separately, leading to a reduction in clinical manifestations of cerebrovascular insufficiency, an increase in patient mobility, improvement in cognitive functions, enhancement of memory and attention, normalization of emotional state, reduction of symptoms of mental and physical strain, increased work capacity, increased tolerance to mental and physical loads, improved blood supply to organs and tissues, cardioprotective action, and improvement of neurological status.
The BRAYNMAX® drug under ischemic conditions slows the formation of necrotic zones and myocardial cell damage, reduces platelet aggregation, promotes faster rehabilitation after cardiovascular events, supports the energy metabolism of the heart, which increases tolerance to physical loads and helps reduce the frequency of angina attacks in heart failure. It has a hypolipidemic effect, reducing total cholesterol and low-density lipoprotein levels. It aids in detoxification and improves the condition of the nervous system in cases of alcoholism and withdrawal syndrome.
In a clinical placebo-controlled study, the effectiveness of the BRAYNMAX® drug was demonstrated for the treatment of patients with post-COVID asthenic syndrome and symptoms characteristic of conditions following viral infections, such as asthenia, sleep disturbances, headaches, dizziness, chronic fatigue syndrome, cognitive function impairments, and feelings of anxiety.

Meldonium
After oral administration, meldonium is rapidly absorbed from the gastrointestinal tract. Bioavailability is 78%. The time to reach maximum plasma concentration is 1-2 hours after ingestion. It is primarily metabolized in the liver, resulting in the formation of two main metabolites, which are excreted by the kidneys. The half-life (T1/2) after oral administration depends on the dose and ranges from 3 to 6 hours. Trace concentrations of the drug are maintained in the body for an extended period.
Ethylmethylhydroxypyridine succinate
Rapidly absorbed after oral administration. The maximum concentration (Cmax) at doses of 400-500 mg is 3.5-4.0 mcg/ml. It is quickly distributed in organs and tissues. The mean residence time (MRT) of the drug in the body after oral administration is 4.9-5.2 hours. It is metabolized in the liver through glucuronidation. Five metabolites have been identified: 3-hydroxypyridine phosphate is formed in the liver and, with the involvement of alkaline phosphatase, breaks down into phosphoric acid and 3-hydroxypyridine; the second metabolite is pharmacologically active, formed in large quantities, and detected in urine 1-2 days after administration; the third is excreted in large amounts in urine; the fourth and fifth are glucuronides. The half-life (T1/2) after oral administration is 2.0-2.6 hours. It is rapidly excreted in urine mainly as metabolites and to a lesser extent in unchanged form. The most intense excretion occurs within the first 4 hours after drug administration. The excretion rates of unchanged drug and metabolites show individual variability.