Tenoten^® (Tablets) Instructions for Use

Marketing Authorization Holder

Materia Medica Holding NPF, LLC (Russia)

Contact Information

MATERIA MEDICA HOLDING NPF LLC (Russia)

ATC Code

N05BX (Other anxiolytics)

Dosage Form

Tenoten®

Sublingual tablets: 40 pcs.

Dosage Form, Packaging, and Composition

Sublingual tablets from white to almost white in color, flat-cylindrical in shape, with a score and a bevel; on the flat side with the score, the inscription MATERIA MEDICA is printed, on the other flat side the inscription TENOTEN is printed; the break line (score) is not intended for breaking the tablet.

* EMD – units of modifying action.

Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.

20 pcs. – blister packs (2) – cardboard cartons.

Clinical-Pharmacological Group

Anxiolytic drug

Pharmacotherapeutic Group

Psycholeptics; anxiolytics; other anxiolytics

Pharmacological Action

The drug has a calming, anti-anxiety (anxiolytic) effect without causing undesirable hypnotic and muscle relaxant effects.

It improves tolerance to psychoemotional stress. It has stress-protective, nootropic, anti-amnesic, anti-hypoxic, neuroprotective, anti-asthenic, and antidepressant effects.

Under conditions of intoxication, hypoxia, and after acute cerebrovascular accidents, it exerts a neuroprotective effect, limits the area of brain damage, and normalizes learning and memory processes.

It inhibits lipid peroxidation processes.

It modifies the functional activity of the S-100 protein, which couples synaptic (informational) and metabolic processes in the central nervous system (CNS). By exerting a GABA-mimetic and neurotrophic action, it increases the activity of stress-limiting systems and promotes the restoration of neuronal plasticity processes.

Clinical efficacy and safety

The drug Tenoten^® is an effective and safe means for treating anxiety disorders of various origins, as confirmed by a significant reduction in the total score on the Hamilton Anxiety Scale (HAM-A).

After 12 weeks of therapy with Tenoten^®, a statistically significant decrease in the mean HAM-A score by 11.25 points was observed when treated at a dose of 4 tablets/day and by 11.91 points on the regimen of 8 tablets/day compared to 9.71 points in the placebo group.

The superiority of therapy with Tenoten^® over placebo was manifested in a significant reduction in the mean HAM-A score compared to the baseline when using Tenoten^® according to the regimen of 8 tablets/day after 4 and 8 weeks of therapy.

A clinically significant reduction in anxiety severity by 50% or more after 12 weeks of therapy was achieved in 69.8% of patients taking Tenoten^® at a daily dose of 4 tablets and in 73.8% of participants on the regimen of 8 tablets/day compared to 53.9% in the placebo group, which was confirmed by the analysis of the overall odds ratio for achieving a clinical effect.

Therapy with Tenoten^® at a dose of 8 tablets/day for 12 weeks contributed to a significant increase in the proportion of patients up to 96.2% with no anxiety (compared to 86.7% in the placebo group) according to the HAM-A scale testing results.

Dynamically, under the influence of the therapy, an improvement in the quality of life indicators of the study participants was noted.

Data from the statistical analysis of changes in the total scores of quality of life questionnaires confirmed the significant advantage of therapy with Tenoten^® over placebo.

The efficacy of Tenoten^® in neurotic disorders is due to both the anxiolytic and antidepressant effects of the drug.

Tenoten^® is an effective means of treating neurotic disorders of the anxiety spectrum against the background of somatic pathology, including neurological, cardiovascular, and gastrointestinal diseases; moreover, the inclusion of Tenoten^® in the complex therapy of these disorders helps to increase the effectiveness of the main treatment and improve the quality of life of patients.

The drug Tenoten^® has a favorable safety profile, confirmed by the absence of adverse reactions.

Preclinical safety data

Preclinical safety studies, including assessment of toxicity after single and repeated (multiple) administration, genotoxicity, reproductive toxicity, immunotoxicity, as well as sensitizing and local irritant properties, did not reveal the presence of toxic or potentially hazardous effects of the drug Tenoten^® for humans.

Pharmacokinetics

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

Indications

The drug Tenoten^® is indicated for use in adults

• For anxiety states in neurological disorders of dyscirculatory origin and psychosomatic diseases, accompanied by emotional lability, irritability, memory impairment, autonomic disorders, as part of complex therapy;
• To reduce the severity of stress disorders, improve concentration and performance.

ICD codes

Dosage Regimen

The score is not intended for breaking the tablet.

The recommended dose for adults is 1-2 tablets per dose, not during meals. The tablet should be held in the mouth until completely dissolved.

Take 2 times/day; if necessary – up to 4 times/day.

The course of treatment is 1-3 months; if necessary, the course of treatment can be extended to 6 months or repeated after 1-2 months.

Children

The safety and efficacy of the drug Tenoten^® in children aged 0 to 18 years have not been established to date. Data are lacking.

Adverse Reactions

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

Contraindications

• Hypersensitivity to the active substance or to any of the excipients included in the drug.

Use in Pregnancy and Lactation

Pregnancy

The safety of using the drug Tenoten^® in pregnant women has not been studied. During pregnancy, the drug should be used only if the intended benefit to the mother outweighs the potential risk to the fetus. The “benefit-risk” ratio is determined by the attending physician.

Lactation period

The safety of using the drug Tenoten^® during lactation has not been studied. During lactation, the drug should be used only if the intended benefit to the mother outweighs the potential risk to the child. The “benefit-risk” ratio is determined by the attending physician.

Pediatric Use

The use of the drug is contraindicated in children and adolescents under 18 years of age.

Special Precautions

Due to the presence of activating properties in the action of Tenoten^®, the last dose should be taken no later than 2 hours before bedtime.

Does not cause drug dependence.

Excipients

The drug contains lactose, therefore patients with rare hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this drug.

Effect on ability to drive vehicles and machinery

The drug does not affect the ability to drive vehicles and other potentially dangerous machinery.

Overdose

In case of overdose, dyspeptic phenomena are possible, due to the excipients included in the drug.

Drug Interactions

No cases of incompatibility with other medicinal products have been identified to date.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). During the period of use, store the blister pack in the cardboard carton provided by the manufacturer.

Shelf Life

The shelf life is 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.