Nanotropil^® novo (Tablets) Instructions for Use

Marketing Authorization Holder

Valenta Pharm, JSC (Russia)

Manufactured By

OHFK, JSC (Russia)

Or

Valenta Pharm, JSC (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substance

Fonturacetam (Rec.INN registered by WHO)

Dosage Forms

	Nanotropil® novo	Tablets 50 mg: 10, 20, 30, 40 or 50 pcs.
		Tablets 100 mg: 10, 20, 30, 40 or 50 pcs.

Dosage Form, Packaging, and Composition

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

Excipients: povidone K-17, microcrystalline cellulose, sodium carboxymethyl starch, magnesium 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 (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

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

Excipients: povidone K-17, microcrystalline cellulose, sodium carboxymethyl starch, magnesium 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 (4) – cardboard packs.
10 pcs. – contour cell packs (5) – 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

Nootropic agent. It has a pronounced anti-amnesic effect, activates the integrative activity of the brain, promotes memory consolidation, improves concentration and mental activity, facilitates learning processes, accelerates the transfer of information 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.

It has a positive effect on the metabolic processes and blood circulation of the brain, stimulates redox processes, increases the energy potential of the body through glucose utilization, improves regional blood flow in ischemic areas of the brain. It increases the content of norepinephrine, dopamine and serotonin in the brain.

It does not affect the GABA level, does not bind to GABA_A and GABA_B receptors, and does not have a noticeable effect on the spontaneous bioelectrical activity of the brain.

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

It has a moderately activating effect on motor reactions, increases physical performance, has a pronounced antagonism to the cataleptic effect of neuroleptics, and reduces the severity of the hypnotic effect of ethanol and hexenal.

The psychostimulating effect predominates in the ideational sphere. The moderate psychoactivating effect of the drug is combined with anxiolytic activity; it improves mood, has an analgesic effect, increasing the pain sensitivity threshold.

It has an adaptogenic effect, increasing the body’s resistance to stress under conditions of increased mental and physical stress, fatigue, hypokinesia and immobilization, and at low temperatures.

Against the background of the drug use, an improvement in vision is noted (increase in acuity, brightness and visual fields); blood supply to the lower extremities improves.

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

The effect manifests itself after a single dose, which is important for use in extreme conditions.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract, distributed in various organs and tissues, and easily penetrates the blood-brain barrier. The absolute bioavailability of the drug when taken orally is 100%. C_max in blood is reached after 1 hour. It is not metabolized in the body and is excreted unchanged. About 40% is excreted in the urine, 60% – in bile and sweat. T_1/2 is 3-5 hours.

Indications

Diseases of the central nervous system of various origins, especially vascular diseases or those associated with disorders of metabolic processes in the brain and intoxication (in particular, in post-traumatic conditions and phenomena of 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; mild and moderate depression; psycho-organic syndromes manifested by intellectual and mnestic disorders and apathetic-abulic symptoms, as well as lethargic-apathic conditions in schizophrenia; convulsive conditions; obesity (alimentary-constitutional origin); prevention of hypoxia, increasing resistance to stress; correction of the functional state of the body in extreme conditions of professional activity to prevent the development of fatigue and increase mental and physical performance; correction of the daily biorhythm, regulation of the sleep-wake cycle; chronic alcoholism (to reduce the symptoms of asthenia, depression, intellectual and mnestic disorders).

ICD codes

Dosage Regimen

Administer orally. The dosage regimen is individual and must be strictly tailored to the indication, patient age, and clinical situation.

For adults, initiate treatment with a dose of 50 mg to 100 mg taken two to three times daily. The maximum daily dose should not exceed 600 mg.

For the management of chronic conditions, a course of treatment lasting 2 to 4 weeks is typical. A second course may be prescribed after a 1-month interval, based on clinical evaluation.

To prevent the development of insomnia, administer the last dose of the day no later than 3 PM.

In elderly patients and those with severe hepatic or renal impairment, initiate therapy at the lower end of the dosage range and titrate cautiously.

For the correction of the sleep-wake cycle, take the total daily dose as a single morning administration.

In cases of excessive psycho-emotional exhaustion, be aware that the initial dose may induce a sudden need for sleep.

Discontinue the drug gradually to avoid potential withdrawal symptoms.

Adverse Reactions

From the central nervous system insomnia (when taking the drug after 3 PM).

In some patients during the first 3 days of administration – psychomotor agitation, skin hyperemia, feeling of heat, increased blood pressure.

Contraindications

Childhood, pregnancy, lactation (breastfeeding), hypersensitivity to fonturacetam.

Use in Pregnancy and Lactation

Should not be prescribed during pregnancy and lactation (breastfeeding) due to the lack of clinical study data; it does not have teratogenic, mutagenic or embryotoxic effects.

Use in Hepatic Impairment

With caution in patients with severe organic liver lesions.

Use in Renal Impairment

With caution in patients with severe organic kidney lesions.

Pediatric Use

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

Geriatric Use

Use with caution in elderly patients to avoid worsening the course of concomitant diseases.

Special Precautions

Should be used with caution in patients with severe organic lesions of the liver and kidneys, severe arterial hypertension, with pronounced atherosclerosis; in patients who have previously experienced panic attacks, acute psychotic conditions accompanied by psychomotor agitation (since exacerbation of anxiety, panic, hallucinations and delusions is possible); in patients prone to allergic reactions to nootropic drugs of the pyrrolidone group.

It should be taken into account that with excessive psycho-emotional exhaustion against the background of chronic stress and fatigue, chronic insomnia, a single dose of fonturacetam on the first day may cause a sharp need for sleep.

Drug Interactions

May enhance the effect of drugs stimulating the central nervous system, antidepressants and nootropic drugs.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.