Prospekta^® (Tablets) Instructions for Use

Marketing Authorization Holder

Materia Medica Holding NPF, LLC (Russia)

Contact Information

MATERIA MEDICA HOLDING NPF LLC (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Dosage Form

Prospekta®

Lozenges: 40 or 100 pcs.

Dosage Form, Packaging, and Composition

Lozenges from white to almost white in color, flat-cylindrical in shape, with a score and a bevel; on the flat side with a score, the inscription MATERIA MEDICA is applied, on the other flat side, the inscription PROSPEKTA is applied.

* EMD – units of modifying action.

Excipients: lactose monohydrate (lactose), microcrystalline cellulose, magnesium stearate.

20 pcs. – blister packs (2) – cardboard boxes.
20 pcs. – blister packs (5) – cardboard boxes.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Nootropic agent

Pharmacological Action

Mechanism of action

The target of the action of the drug Prospekta^® is the brain-specific Ca²⁺-binding protein S-100 (S100B), widely represented in the CNS.

S100B regulates the following fundamental processes in the brain: generation and conduction of nerve impulses, synaptic signal transmission; stimulation of neuronal differentiation and proliferation; at the systemic level, S100B modifies the ratio of activation and inhibition processes, positively influencing the integrative activity of the brain.

Due to this, S100B has stress-protective, including anti-anxiety, neuroprotective, and nootropic effects.

In studies of the mechanism of action using cell membranes expressing human GABA, serotonin, and dopamine receptors (GABA_B1A/B2, 5-HT_2B, 5-HT_2C, 5-HT₃ and D₃, respectively), a change in the number of “ligand-receptor” complexes was shown, i.e., the ability, through action on S100B, to influence both inhibitory and activating neurotransmitter systems, restoring the balance of the levels of the main neurotransmitters.

Pharmacodynamic effects

By modifying the functional activity of S100B, the drug Prospekta^® improves the integrative activity of the brain at all levels of organization of neural systems (cellular, intercellular, structural, and systemic). The drug changes the spectral power of the bioelectrical activity of the cerebral cortex, hippocampus, and hypothalamus, including in animals with hereditary anxiety and depression-like behavior against the background of deviations in the neurochemical profile and synaptic plasticity.

It has been experimentally shown that the drug

• Normalizes emotional state and behavior in animals (reduces somatovegetative manifestations of stress, eliminates signs of anxious behavior, restores locomotor-exploratory activity);

• Exhibits nootropic activity by improving the formation of a memory trace in a model of conditioned reflex amnesia; compensating for age-related weakening of short-term memory mechanisms; enhancing long-term synaptic plasticity (the basis of cellular mechanisms of memory and learning).

It has also been shown that the drug has neuroprotective and neuroreparative effects: it increases the resistance of brain tissue to hypoxia and toxic effects, has membrane-stabilizing and antioxidant effects. In the post-stroke or post-traumatic period, it mobilizes intracellular compensatory reserves functionally associated with the S100B protein in damaged and healthy neurons, as well as in glial cells located in the damaged area.

Due to changes in the bioelectrical activity of the brain, it can influence the structure of sleep.

Clinical efficacy and safety

It has been clinically proven that the drug has anti-anxiety and anti-asthenic effects in a wide range of diseases.

Against the background of treatment with Prospekta^®, the level of anxiety significantly decreased in patients with vascular diseases of the brain and various somatic diseases.

In a clinical study on the treatment of patients in the early recovery period of ischemic stroke, normalization of patient behavior and mood was shown in the form of reduced irritability, increased level of self-care, reduced difficulties in performing daily housework, increased social role in the family, including those due to a reduction in asthenic manifestations such as fatigue and weakness, improvement of patients’ cognitive functions according to the Montreal Cognitive Assessment (MoCA), restoration of activity in daily living according to the Barthel scale. According to testing on the Stroke-Specific Quality of Life Scale (SS-QOL), patients showed improvement in most indicators (mood, speech, vision, thinking, mobility, etc.).

It has been clinically proven that after a novel coronavirus infection, the use of the drug helps reduce the severity of asthenia (weakness), feelings of constant fatigue, and tiredness.

It has been clinically proven that in most children with attention deficit hyperactivity disorder (ADHD), against the background of taking Prospekta^®, the severity of inattention and hyperactivity symptoms decreases by 25% or more. The average total score on the ADHD-RS-V scale decreases by 10.2 points. A course of taking Prospekta^® leads to improved concentration when performing tasks or during games, sustained attention to details, the ability to follow given instructions and fully complete school homework, housework, and adult assignments.

In studies of elderly and senile patients, the anxiolytic effect of the drug was shown. The severity of anxiety according to the “Anxiety” domain of the NPI-C scale decreased by 2.3 points.

Pharmacokinetics

Pharmacokinetic studies are impossible due to the complex composition of the drug.

Indications

The drug Prospekta^® is indicated for use in adults for the treatment of the following disorders

• Anxiety states, emotional lability, irritability; asthenic conditions manifested by increased fatigue and weakness, including those of dyscirculatory origin;

• Cognitive (decreased memory and concentration) impairments of various origins, including after acute cerebrovascular accidents, as well as in elderly and senile persons;
• Asthenic conditions in the post-infectious period, including after a coronavirus infection (COVID-19).

The drug Prospekta^® is indicated for use in children aged 7 years and older

• Treatment of attention deficit hyperactivity disorder.

ICD codes

Dosage Regimen

The score is not intended for dividing the tablet into parts.

Orally. One tablet per dose. The drug is taken between meals (in the interval between meals or 15 minutes before a meal or fluid intake). Keep the tablets in the mouth, without swallowing, until completely dissolved.

For the treatment of anxiety states and asthenia

Take 1 tablet 2 times/day. The course of treatment is 1 month; if necessary, the course can be repeated after 1-2 months.

For the treatment of cognitive impairments of various origins

Take 1 tablet 2 times/day. The course of treatment is 6 months; if necessary, the course of treatment can be repeated after 1-2 months.

For the treatment of post-infectious asthenic conditions

Take 1 tablet 2 times/day. The course of treatment is 1 month; if necessary, the course of treatment can be repeated after 1-2 months.

If there is no improvement in the condition within 4 weeks after starting treatment, it is necessary to consult a doctor.

For the treatment of attention deficit hyperactivity disorder

Take 1 tablet 2 times/day (approximately at the same time). The course of treatment is 8 weeks; if necessary, the course of treatment can be repeated.

Adverse Reactions

Possible reactions of increased individual sensitivity to the components of the drug.

Contraindications

• Increased individual sensitivity to the components of the drug;
• Children under 7 years of age;
• Lactase deficiency, hereditary galactose intolerance, glucose-galactose malabsorption;

Use in Pregnancy and Lactation

The safety of using the drug Prospekta^® in pregnant women and during breastfeeding has not been studied. If it is necessary to take the drug, the risk/benefit ratio should be considered.

Pediatric Use

Contraindicated for use in children under 7 years of age.

Special Precautions

The drug contains lactose, therefore it is not recommended to prescribe it to patients with congenital galactosemia, glucose or galactose malabsorption syndrome, or congenital lactase deficiency.

Effect on ability to drive vehicles and machinery

In rare cases, drowsiness may occur during the first dose of the drug, so driving vehicles should be avoided for several hours after the first dose of the drug.

Overdose

In case of overdose, dyspeptic phenomena are possible, caused by the excipients included in the drug.

Drug Interactions

No cases of incompatibility with other drugs have been reported to date.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.