Glycine-darnitsa

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT Glycine-Darnytsia (Glycine-Darnytsia)

Composition:

Active substance: glycine;

1 tablet contains glycine (calculated as 100% dry substance) 100 mg;

Excipients: povidone, ammonium methacrylate copolymer dispersion (type A), ammonium methacrylate copolymer dispersion (type B), magnesium stearate.

Pharmaceutical form. Sublingual tablets.

Main physicochemical properties: tablets are white or almost white, flat cylindrical in shape, with bevel and score line.

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

Pharmacological Properties

Pharmacodynamics

Glycine (aminoacetic acid) has properties as 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-adrenergic blocking, antioxidant, and antitoxic effects, and modulates the activity of glutamate receptors, thereby enabling it to:

• reduce psychoemotional tension, aggression, and conflict behavior, while improving social adaptation;
• improve mood;
• facilitate falling asleep and normalize sleep;
• enhance mental performance;
• reduce vegetative-vascular disorders, including those occurring during the climacteric period;
• decrease the severity of cerebral disorders associated with ischemic stroke and traumatic brain injury;
• reduce the toxic effects of alcohol.

The drug does not cause dependence.

Pharmacokinetics

The drug readily 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.

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

Deviant forms of behavior in children and adults.

Functional and organic diseases of the nervous system (neuroses, astheno-neurotic syndrome, somatoform dysfunction of the nervous system, consequences of neuroinfection, traumatic brain injury, perinatal and other forms of encephalopathy, including alcohol-induced), accompanied by increased excitability, emotional instability, reduced mental performance, and sleep disturbances.

Ischemic stroke and cerebral circulation disorders.

As an auxiliary agent 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-Darnitsia reduces the toxicity of anticonvulsants, antipsychotic agents, antidepressants, and antiseizure drugs. When combined with sedatives, tranquilizers, and antipsychotic agents, the inhibitory effect on the central nervous system is enhanced.

Special precautions for use.

In patients prone to arterial hypotension, blood pressure levels should be monitored and, if necessary, dosage adjustment of the medicinal product should be performed. Glycine should be administered in lower doses and with regular monitoring of blood pressure. If blood pressure decreases below the usual level, administration of the medicinal product should be discontinued.

Use during pregnancy or breastfeeding.

The effects of glycine on the body during pregnancy or breastfeeding have not been thoroughly studied; therefore, the use of the medicinal product is not recommended.

Ability to affect reaction rate when driving or operating machinery.

Caution should be exercised when driving or operating machinery, as well as during potentially hazardous activities.

Dosage and Administration

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

Children from 3 years of age, adolescents, adults: For impaired cognitive performance, memory, attention, mental retardation, psychoemotional stress, and deviant behavioral patterns, the medicinal product Glycine-Darnytsia is prescribed at a dose of 1 tablet (100 mg) 2–3 times daily for 14–30 days.

Maximum daily dose — 300 mg.

Children from 3 years of age and adults: For functional and organic disorders of the nervous system (neuroses, astheno-neurotic syndrome, somatoform dysfunction of the nervous system, sequelae of neuroinfection, traumatic brain injury, perinatal and other forms of encephalopathy, including alcohol-induced) the recommended dose is 1 tablet 2–3 times daily for 7–14 days. If necessary, the treatment course may be repeated.

Sleep disorders: 50–100 mg should be administered 20 minutes before bedtime or immediately before sleep.

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

Treatment of alcoholism: The medicinal product is prescribed as an adjunctive therapy at a dose of 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 medicinal product is indicated for children aged 3 years and older.

Overdose

There is no information available on clinical manifestations of overdose.

Adverse reactions.

The medicinal product is generally well tolerated. In individual cases, with individual hypersensitivity, allergic reactions may occur, including rhinitis, conjunctivitis, rash, pruritus, urticaria, irritation (scalp pruritus) in the throat, weakness.

Gastrointestinal disorders, including epigastric pain and nausea, are possible. Nervous system disorders: isolated cases of impaired concentration, headache, tension, irritability have been observed.

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and/or lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: 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 of children.

Packaging.

10 tablets in a blister pack; 3 or 6 blisters per carton.

Availability. Over-the-counter.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and location of its business activities.

13, Borispilska Street, Kyiv, 02093, Ukraine.