Fenotropil (Tablets) Instructions for Use

Marketing Authorization Holder

Valenta-Intellect, LLC (Russia)

Manufactured By

Valenta Pharm, JSC (Russia)

Contact Information

VALENTA PHARM, JSC (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substance

Fonturacetam (Rec.INN)

Dosage Forms

	Fenotropil	Tablets 50 mg: 10 or 30 pcs.
		Tablets 100 mg: 10, 20, 30, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a yellowish tint, round, flat-cylindrical, with a bevel.

Excipients: lactose monohydrate, potato starch, povidone K-25, croscarmellose sodium, calcium stearate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Tablets from white to white with a yellowish tint, round, flat-cylindrical, with a bevel.

Excipients: lactose monohydrate, potato starch, povidone K-25, croscarmellose sodium, calcium stearate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Clinical-Pharmacological Group

Nootropic drug

Pharmacotherapeutic Group

Psychoanaleptics; psychostimulants, agents used in attention deficit hyperactivity disorder, and nootropic agents; other psychostimulants and nootropic agents

Pharmacological Action

Fenotropil has a pronounced anti-amnesic effect, has a direct activating effect on the integrative activity of the brain, promotes memory consolidation, improves concentration and mental activity, facilitates the learning process, increases the speed of information transfer between the cerebral hemispheres, increases the resistance of brain tissue to hypoxia and toxic effects, has an anticonvulsant effect and anxiolytic activity, regulates the processes of activation and inhibition of the central nervous system, improves mood.

Fenotropil has a positive effect on metabolic processes and cerebral circulation, stimulates redox processes, increases the body’s energy potential through glucose utilization, improves regional blood flow in ischemic areas of the brain.

Fenotropil does not affect the respiratory and cardiovascular systems, exhibits a mild diuretic effect, and has anorexigenic activity with course use.

The stimulating effect of the drug Fenotropil is manifested in its ability to exert a moderately pronounced effect on motor reactions, in increasing physical performance, in a pronounced antagonism to the cataleptic effect of neuroleptics, as well as in reducing the severity of the hypnotic effect of ethanol and hexenal.

The psychostimulating effect of the drug Fenotropil predominates in the ideational sphere.

The moderate psychostimulating effect of the drug is combined with anxiolytic activity, improves mood, exerts some analgesic effect, increasing the pain sensitivity threshold.

The adaptogenic effect of the drug Fenotropil is manifested in increasing the body’s resistance to stress under conditions of excessive mental and physical stress, fatigue, hypokinesia and immobilization, and at low temperatures.

Against the background of taking the drug Fenotropil, an improvement in vision was noted, which is manifested in an increase in acuity, brightness and visual fields.

Fenotropil improves blood supply to the lower extremities.

Fenotropil stimulates the production of antibodies in response to antigen administration, which indicates its immunostimulating properties, but at the same time does not contribute to the development of immediate hypersensitivity and does not alter the allergic inflammatory skin reaction caused by the introduction of a foreign protein.

With course use of the drug Fenotropil, drug dependence, tolerance, and withdrawal syndrome do not develop.

The effect of the drug Fenotropil manifests itself from a single dose, which is important when using the drug in extreme conditions.

Fenotropil does not have teratogenic, mutagenic, carcinogenic, or embryotoxic properties. Toxicity is low, the lethal dose in an acute experiment is 800 mg/kg.

Preclinical safety data

The drug Fenotropil does not have teratogenic, mutagenic, carcinogenic, or embryotoxic properties. Toxicity is low, the lethal dose in an acute experiment is 800 mg/kg.

Pharmacokinetics

Absorption

Rapidly absorbed. The absolute bioavailability of the drug when taken orally is 100%.

Distribution

Penetrates into various organs and tissues, easily passes through the BBB. C_max in blood is reached after 1 hour.

Metabolism

Not metabolized in the body.

Excretion

T_1/2 is 3-5 hours. Excreted unchanged. Approximately 40% of the drug is excreted in the urine, 60% of the drug is excreted in bile and sweat.

Indications

Adults aged 18 years and older

• Diseases of the central nervous system of various origins, mainly associated with vascular diseases and metabolic disorders in the brain, intoxication, including post-traumatic conditions and chronic cerebrovascular insufficiency, accompanied by deterioration of intellectual and mnestic functions, decreased motor activity;
• Neurotic conditions, manifested by lethargy, increased exhaustion, decreased psychomotor activity, impaired attention, memory deterioration;
• Learning disorders;
• Obesity (alimentary-constitutional genesis);
• Prevention of hypoxia, increasing resistance to stress, correction of the functional state of the body in extreme conditions of professional activity in order to prevent the development of fatigue and to increase mental and physical performance, increasing the level of wakefulness;
• Chronic alcoholism (to reduce the phenomena of asthenia, intellectual and mnestic disorders).

ICD codes

Dosage Regimen

Adults

The dose of the drug and the duration of treatment should be determined by the doctor. Doses vary depending on the characteristics of the patient’s condition.

The average single dose is 150 mg (from 100 mg to 250 mg); the average daily dose is 250 mg (from 200 mg to 300 mg). The maximum allowable dose is 750 mg/day.

It is recommended to divide the daily dose into 2 doses. A daily dose of up to 100 mg should be taken once a day in the morning, and a dose over 100 mg should be divided into 2 doses. The duration of treatment can vary from 2 weeks to 3 months. The average duration of treatment is 30 days. If necessary, the course can be repeated after one month.

For increasing performance, 100-200 mg is prescribed once a day in the morning, for 2 weeks (for athletes – 3 days).

For alimentary-constitutional obesity – 100-200 mg once a day in the morning for 30-60 days.

Children

The drug is contraindicated for use in children under 18 years of age.

Method of administration

Orally. Take immediately after meals. It is not recommended to take the drug later than 3 PM.

Adverse Reactions

According to WHO, adverse reactions are classified according to their frequency of occurrence as follows: very common (≥1/10); common (≥1/100, but <1/10), uncommon (≥1/1000, but <1/100), rare (≥1/10000, but <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).

* in case of taking the drug later than 3 PM;

** these adverse reactions are possible in some patients during the first 1-3 days of administration.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk ratio of the medicinal product. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to fonturacetam or to any of the excipients;
• Children under 18 years of age;
• Pregnancy;
• Breastfeeding period.

With caution use in patients with severe organic liver and kidney damage, severe arterial hypertension, in patients with atherosclerosis, also in patients who have previously experienced panic attacks, acute psychotic conditions occurring with psychomotor agitation – due to the possibility of exacerbation of anxiety, panic, hallucinations and delusions, as well as in patients prone to allergic reactions to nootropic drugs of the pyrrolidone group.

Use in Pregnancy and Lactation

Pregnancy

There are no data from randomized clinical trials of fonturacetam in pregnant women, therefore the use of the drug Fenotropil during pregnancy is contraindicated.

Breastfeeding period

The use of the drug during breastfeeding is contraindicated. If it is necessary to use the drug during lactation, breastfeeding should be discontinued during treatment.

Use in Hepatic Impairment

The drug Fenotropil should be prescribed with caution to patients with severe organic liver damage.

Use in Renal Impairment

The drug Fenotropil should be prescribed with caution to patients with severe organic kidney damage.

Pediatric Use

The drug is contraindicated for use in children under 18 years of age.

Special Precautions

In case of excessive psycho-emotional exhaustion against the background of chronic stress and fatigue, chronic insomnia, a single dose of the drug Fenotropil on the first day can cause a sharp need for sleep. Such patients in outpatient settings should be recommended to start a course of the drug on non-working days.

Excipients

Sodium

The drug contains less than 1 mmol (23 mg) of sodium per one tablet, i.e., it is essentially sodium-free.

Lactose

The drug Fenotropil contains lactose. Patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take the drug Fenotropil.

Effect on ability to drive vehicles and machinery

Caution should be exercised when driving vehicles and machinery, especially in the first days of administration, taking into account the possible occurrence of drowsiness (see section “Special Precautions”).

Overdose

Symptoms of overdose have not been reported.

Treatment symptomatic therapy.

Drug Interactions

Fenotropil may enhance the effect of drugs that stimulate the central nervous system, antidepressants and nootropic drugs.

Storage Conditions

The drug should be stored in a place protected from light, out of the reach of children, at a temperature not exceeding 30°C (86°F).

Shelf Life

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

Dispensing Status

The drug is dispensed by 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.