Glycine-Bio Pharmaplant^® (Tablets) Instructions for Use

Marketing Authorization Holder

Ozon, LLC (Russia)

ATC Code

N06BX (Other psychostimulants and nootropic drugs)

Active Substance

Glycine (Rec.INN registered by WHO)

Dosage Form

Glycine-Bio Pharmaplant®

Sublingual tablets 100 mg: 50 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – contour cell packs (5) – cardboard packs.
50 pcs. – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves brain metabolism

Pharmacotherapeutic Group

Metabolic agent

Pharmacological Action

Glycine is a non-essential amino acid and a central inhibitory neurotransmitter. It improves metabolic processes in brain tissues and has antidepressant and sedative effects.

The drug possesses GABA-ergic, alpha-adrenoblocking, antioxidant, and antitoxic actions; it regulates the activity of glutamate (NMDA) receptors, thereby reducing psycho-emotional stress, aggressiveness, and conflict; improves social adaptation and mood; facilitates falling asleep and normalizes sleep; increases mental performance.

It reduces the severity of vegetative-vascular disorders (including during menopause) and general brain disorders in ischemic stroke and traumatic brain injury. It reduces the toxic effects of ethanol on the central nervous system.

Pharmacokinetics

It easily penetrates into most biological fluids and body tissues, including the brain, and does not accumulate. It is rapidly broken down in the liver by glycine oxidase to water and carbon dioxide.

Indications

• Stressful situations – psycho-emotional stress in stressful situations (including exams, conflict situations);
• Reduced mental performance;
• Deviant forms of behavior in children and adolescents;
• Functional and organic diseases of the nervous system, accompanied by increased excitability, emotional instability, decreased mental performance, and sleep disorders (autonomic dystonia syndrome, neuroses, neurosis-like states, consequences of neuroinfections and traumatic brain injuries, perinatal and other forms of encephalopathy (including those of alcoholic genesis));
• Cerebral infarction;
• In narcology – as a drug that increases mental performance and reduces psycho-emotional stress during remission in cases of encephalopathy, organic lesions of the central and peripheral nervous system.

ICD codes

Dosage Regimen

Sublingually or buccally, 100 mg (in tablets or as a powder after crushing the tablet). In children under 3 years of age, the drug must be crushed into a powder and dissolved in a small amount of water.

For children, adolescents, and adults with psycho-emotional stress, decreased memory, attention, mental performance, and with deviant forms of behavior, Glycine is prescribed 100 mg 2-3 times a day for 14-30 days.

For functional and organic lesions of the nervous system, accompanied by increased excitability, emotional lability, and sleep disorders, children under 3 years are prescribed 50 mg 2-3 times a day for 7-14 days, then 50 mg once a day for 7-10 days. The daily dose is 100-150 mg, the course dose is 2-2.6 g. Children over 3 years and adults are prescribed 100 mg 2-3 times a day, the course of treatment is 7-14 days, it can be increased to 30 days; if necessary, the course is repeated after 30 days.

For sleep disorders, it is prescribed 20 minutes before sleep or immediately before sleep, 50-100 mg (depending on age).

For cerebral infarction, within the first 3-6 hours from the onset of stroke, 1 g (10 tablets) is administered buccally or sublingually with 1 teaspoon of water, then 1 g/day for 1-5 days, then for the next 30 days, 100-200 mg 3 times a day.

In narcology — 100 mg 2-3 times a day for 14-30 days.

If necessary, the courses are repeated 4-6 times a year.

Adverse Reactions

Allergic reactions.

Contraindications

• Hypersensitivity to glycine or other components of the drug.

With caution arterial hypotension.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and breastfeeding due to the lack of sufficient data.

Special Precautions

In patients prone to arterial hypotension, Glycine-Bio is taken in smaller doses and under blood pressure control; if it decreases below the usual level, administration is discontinued.

Effect on the ability to drive vehicles and operate machinery

When taking Glycine-Bio, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, taking into account the profile of side effects.

Overdose

No overdose data available.

Drug Interactions

It reduces the severity of side effects of antipsychotic drugs (neuroleptics), anxiolytics, antidepressants, hypnotics, and anticonvulsants.

Storage Conditions

In a dry, light-protected place at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

Over-the-counter.

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.