Emolait®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EMOLIGHT® (EMOLIGHT)

Composition:

Active ingredient: phenibut;

1 tablet contains 250 mg of phenibut;

Excipients: lactose monohydrate; potato starch; calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: tablets from white to white with a yellowish tint, oval-shaped with a biconvex surface.

Pharmacotherapeutic group. Other psychostimulants and nootropics.

ATC code N06B X22.

Pharmacological Properties

Pharmacodynamics

Phenibut is a derivative of γ-aminobutyric acid and phenethylamine.

Its primary effects are anti-hypoxic and anti-amnestic. Phenibut improves memory and attention, facilitates learning processes, and enhances both physical and mental performance. Psychological parameters (attention, memory, speed and accuracy of sensorimotor reactions) improve under the influence of phenibut. It has been established that phenibut increases the energy potential of neurons by improving mitochondrial function.

Phenibut also has tranquilizer properties: it reduces psychoemotional tension, anxiety, fear, emotional lability, and irritability, improves sleep, and prolongs and enhances the effects of hypnotics, narcotic agents, neuroleptics, and anticonvulsants. Phenibut binds exclusively to GABA-β receptors in the brain, thus exerting a moderate calming effect without causing undesirable sedative effects such as drowsiness, dizziness, or reduced attention and performance. The drug prolongs the latent period and reduces the duration and intensity of nystagmus, exerting an antiepileptic effect. It does not affect cholinergic or adrenergic receptors.

The medicinal product EMO-LIGHT® significantly reduces manifestations of asthenia and vasovegetative symptoms, including headache and a sensation of heaviness in the head. In patients with asthenia and emotionally labile individuals, phenibut improves well-being without causing excitation.

Pharmacokinetics

Absorption and Distribution

Phenibut is well absorbed after oral administration and readily penetrates all tissues of the body, effectively crossing the blood-brain barrier (approximately 0.1% of the administered dose penetrates into brain tissue, and to a significantly greater extent in both young and elderly individuals). The highest binding of phenibut occurs in the liver (80%), and this binding is nonspecific.

Biotransformation and Excretion

80–95% of phenibut is metabolized in the liver; the metabolites are pharmacologically inactive.

Distribution in the liver and kidneys is close to uniform, while in the brain and blood it is lower than uniform. A significant amount of administered phenibut can be detected in urine within 3 hours; simultaneously, the concentration of the drug in brain tissue does not decrease—phenibut is still detectable in the brain after 6 hours. The following day, phenibut can only be detected in urine; it remains detectable in urine for up to 2 days after administration, but the amount detected constitutes only 5% of the administered dose. With repeated administration, no accumulation was observed.

Clinical characteristics.

Indications.

Asthenic and anxiety-neurotic conditions: restlessness, fear, anxiety.

Insomnia, nocturnal restlessness in elderly people.

For prevention of stress conditions prior to surgeries or painful diagnostic procedures.

Meniere’s disease, dizziness associated with vestibular analyzer dysfunction of various origins.

For prevention of kinetosis (a specific condition characterized by nausea, vomiting, prostration, and vestibular dysfunction caused by being in a moving object such as a ship or airplane).

Stuttering, tics in children aged 8 to 14 years.

As an adjunctive agent in the treatment of alcohol withdrawal syndrome.

Contraindications.

Hypersensitivity to the components of the drug.

Acute renal failure.

Pregnancy and breastfeeding.

Interaction with other medicinal products and other types of interactions.

The medicinal product EMO-LIGHT® can be combined with other psychotropic medicinal products, reducing the doses of phenibut and concomitantly administered drugs.

Phenibut enhances and prolongs the effects of hypnotics, narcotics, neuroleptics, and anti-parkinsonian drugs.

Special precautions for use.

The medicinal product EMO-LIGHT® should be used with caution in patients with gastric or intestinal pathology. In order to protect the mucosa from the irritating effect of phenibut, lower doses should be prescribed to these patients.

In case of prolonged treatment, blood and liver parameters should be monitored.

The medicinal product contains lactose and therefore should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

Animal studies have not revealed mutagenic, teratogenic, or embryotoxic effects of phenibut. There are insufficient and poorly controlled studies on the safety of phenibut use in pregnant women. Therefore, the use of the medicinal product EMO-LIGHT® during pregnancy or breastfeeding is contraindicated.

Ability to affect reaction rate when driving or operating machinery.

Patients who experience drowsiness, dizziness, or other central nervous system disorders during treatment with this medicinal product should refrain from driving or operating machinery.

Method of Administration and Dosage

The medicinal product EMO-LYTE® is taken orally before meals. The tablet should be swallowed whole with a sufficient amount of water.

For asthenic and anxiety-neurotic conditions in adults: 250–500 mg (1–2 tablets) three times daily. Maximum single doses: for adults – 750 mg, for elderly patients – 500 mg.

The treatment course lasts 2–3 weeks. If necessary, the treatment course may be extended to 4–6 weeks.

Children aged 8 to 14 years: 250 mg (1 tablet) three times daily.

Meniere’s disease, dizziness associated with vestibular dysfunction of various origins

In cases of infectious vestibular dysfunction and Meniere’s disease during exacerbation, the medicinal product EMO-LYTE® is prescribed at 750 mg (3 tablets) three times daily for 5–7 days; once vestibular symptoms subside – 250–500 mg (1–2 tablets) three times daily for 5–7 days, followed by 250 mg once daily for 5 days. In cases of milder disease course, EMO-LYTE® is administered at 250 mg (1 tablet) twice daily for 5–7 days, then 250 mg once daily for 7–10 days.

For relief of dizziness due to vestibular dysfunction of vascular or traumatic origin: the medicinal product EMO-LYTE® is prescribed at 250 mg three times daily for 12 days.

For prevention of kinetosis: the medicinal product should be taken at a single dose of 250–500 mg one hour before the expected onset of motion sickness or upon the appearance of first symptoms of motion discomfort.

For management of alcohol withdrawal syndrome: during the initial days of treatment, EMO-LYTE® is prescribed at 250–500 mg three times daily and 750 mg at night, with gradual reduction of the daily dose to the standard adult dose.

Patients with hepatic insufficiency

High doses of the drug may cause hepatotoxicity in patients with hepatic insufficiency. Lower doses should be prescribed for this patient group.

Patients with renal insufficiency

There are no data regarding adverse effects of the medicinal product EMO-LYTE® on patients with impaired renal function when therapeutic doses are administered.

Drug dependence and withdrawal syndrome have not been observed during use of this medicinal product.

Isolated cases of tolerance to phenibut have been reported (as found in literature sources).

Children

The medicinal product may be used in children aged 8 years and older.

Overdose

Data on overdose are lacking. EMO-LYTE® is a low-toxicity medicinal product; however, daily doses of 7–14 g over prolonged periods may be hepatotoxic. These doses significantly exceed the recommended average therapeutic doses according to patient age (the average therapeutic dose is 500–2000 mg).

Symptoms: drowsiness, nausea, vomiting, dizziness.

Prolonged use of high doses of phenibut may lead to arterial hypotension, acute renal failure, eosinophilia, and fatty liver degeneration.

Treatment: gastric lavage. Symptomatic therapy.

There is no specific antidote.

Adverse Reactions

EMOLAYT®, like other medicinal products, may cause adverse reactions, although they do not occur in all patients.

Classification of adverse reactions by frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); frequency not known (cannot be estimated from available data).

Central and peripheral nervous system disorders: frequency not known — drowsiness (at the beginning of treatment), headache and dizziness (when doses above 2000 mg per day are used; the intensity of these adverse effects decreases with dose reduction).

Gastrointestinal disorders: frequency not known — nausea (at the beginning of treatment), vomiting, diarrhea, epigastric pain.

Hepatobiliary disorders: frequency not known — hepatotoxicity (with prolonged use of high doses).

Immune system disorders: frequency not known — hypersensitivity reactions, including urticaria, erythema, rash, angioneurotic edema, facial swelling, tongue swelling.

Skin and subcutaneous tissue disorders: rare — allergic reactions (rash, pruritus).

Psychiatric disorders: frequency not known — emotional lability, sleep disturbances (these adverse reactions may occur in children if instructions for medical use of the medicinal product are not followed).

If any adverse reactions not listed in this instruction occur, or if any of the listed adverse reactions are particularly severe, medical advice should be sought immediately.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 10 tablets in a blister pack. 2 blisters per cardboard box.

Prescription status. Prescription only.

Manufacturer. ASTRAFARM LLC.

Manufacturer's address and location of business activity.

6 Kyivska Street, city of Vyshneve, Bucha District, Kyiv Oblast, 08132, Ukraine.