GLYCINE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLYCINE

(GLYCINE)

Composition:

Active substance: glycine;

1 tablet contains 100 mg of glycine;

Excipients: povidone, magnesium stearate.

Pharmaceutical form. Sublingual tablets.

Main physico-chemical properties: white or almost white, round-shaped tablets with a flat surface and beveled edges.

Pharmacotherapeutic group. Agents acting on the nervous system. ATC code N07XX.

Pharmacological Properties.

Pharmacodynamics.

Glycine (aminoacetic acid) has properties of a metabolic regulator and is a non-essential amino acid (a natural metabolite). It acts as an inhibitory-type neurotransmitter and regulates metabolic processes in the central nervous system.

The drug exerts glycine- and GABA-ergic, α-adrenoblocking, antioxidant, and antitoxic effects, and modulates the activity of glutamate receptors, thereby capable of:

• reducing psychoemotional tension, aggression, and conflict behavior, while improving social adaptation;
• improving mood;
• facilitating sleep onset and normalizing sleep;
• enhancing mental performance;
• reducing the severity of vegetovascular disorders;
• decreasing the extent of cerebral disturbances in ischemic stroke and traumatic brain injury;
• reducing the toxic effects of alcohol.

The drug does not cause dependence.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

Reduced mental performance.

In stressful situations and psychoemotional tension (during examination periods, in conflict situations).

Deviant behavior in children and adults.

Functional and organic disorders of the nervous system (neuroses, neurosis-like conditions, vegetovascular dystonia, consequences of neuroinfection, traumatic brain injury, perinatal and other forms of encephalopathy, including those of alcoholic origin), accompanied by increased excitability, emotional instability, reduced mental performance, and sleep disturbances.

Ischemic stroke and cerebral circulation disorders.

As an adjunct in the treatment of alcoholism.

Contraindications.

Individual intolerance to the drug and increased sensitivity to its individual components; arterial hypotension. Children under 3 years of age.

Interaction with other medicinal products and other types of interactions.

Glycine reduces the toxicity of anticonvulsants, antipsychotics, and antidepressants. When combined with sedatives, tranquilizers, and antipsychotic agents, the central nervous system depressant effect is enhanced.

Special precautions.

Patients predisposed to arterial hypotension should have their arterial blood pressure monitored, and dose adjustment may be necessary: Glycine should be administered in lower doses with regular monitoring of arterial blood pressure. If arterial blood pressure decreases below the usual level, administration of the drug should be discontinued.

Use during pregnancy or breastfeeding.

The effect of the drug on the body during pregnancy or breastfeeding has not been thoroughly studied; therefore, use of the drug during these periods is not recommended.

Ability to influence reaction rate when driving or operating machinery.

Caution should be exercised when driving vehicles or operating machinery, as well as when engaging in other potentially hazardous activities.

Method of administration and dosage.

The drug is administered transbuccally or sublingually (as tablets or as a powder after crushing the tablet).

For children aged 3 years and older, and adults: for decreased cognitive performance, memory, attention, mental retardation, psychoemotional stress, and deviant behavior forms, Glycine is prescribed at 1 tablet (100 mg) 2–3 times daily; treatment course – 14–30 days.

Maximum daily dose – 300 mg.

For children aged 3 years and older, and adults with increased excitability and emotional lability: 1 tablet 2–3 times daily; treatment course – 7–14 days. If necessary, the treatment course may be repeated.

For sleep disorders, 100 mg should be administered 20 minutes before bedtime or immediately before sleep.

In ischemic stroke and cerebral circulation disorders: 1 g of the drug should be administered transbuccally or sublingually (if necessary, the tablet may be crushed) within the first 3–6 hours after stroke onset, followed by 1 g daily for the next 1–5 days, then 1–2 tablets 3 times daily for 6–30 days.

In the treatment of alcoholism: the drug is used as an adjunctive agent at 1 tablet 2–3 times daily for 14–30 days. If necessary, the treatment course may be repeated 4–6 times per year.

Children. The drug is indicated for children aged 3 years and older.

Overdose.

There is no information available on clinical manifestations of overdose.

Side effects.

In individual cases, with increased individual sensitivity, allergic reactions may develop, including rhinitis, conjunctivitis, urticaria, sore throat, weakness, rash, and itching.

Gastrointestinal side effects may include dyspeptic symptoms such as epigastric pain and nausea. Nervous system side effects have included isolated cases of impaired concentration, headache, tension, and irritability.

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 tablets in a blister; 5 blisters in a cardboard box.

50 tablets in a blister; 1 blister in a cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA"

Manufacturer's address and place of business.

1, Gordienkovska Street, Kharkiv, Kharkiv region, 61010, Ukraine.