GLYCISED

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

Composition:

active substance: glycine;

1 tablet contains glycine equivalent to 100% substance 100 mg;
excipients: ammonium methacrylate copolymer dispersion, glycol montanic wax, povidone, calcium stearate.

Medicinal form. Tablets.

Main physicochemical properties: tablets are nearly white or white with a creamy tint, round-shaped with a flat surface and beveled edges. The surface of the tablets may have a marbled appearance.

Pharmacotherapeutic group. Agents affecting the nervous system.

ATC code N07X X.

Pharmacological properties.

Glycine is an amino acid (a natural metabolite) that acts as an inhibitory-type neurotransmitter and regulator of metabolic processes in the central nervous system. It reduces psycho-emotional tension, enhances mental performance, exerts neuroprotective, anti-stress, and sedative effects, improves brain metabolism, normalizes sleep, and reduces the toxic effects of alcohol. It does not cause dependence.

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

Clinical characteristics.

Indications.

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

Ischemic stroke and cerebral circulation disorders.

As an adjunctive agent in the treatment of alcoholism.

Contraindications.

Individual hypersensitivity to the drug or increased sensitivity to any of its components; arterial hypotension. Children under 3 years of age.

Special precautions.

In patients predisposed to arterial hypotension, blood pressure should be monitored, and, if necessary, dosage adjustment should be performed: Glycised® should be administered in lower doses with regular monitoring of blood pressure. If blood pressure decreases below the usual level, administration of the drug should be discontinued.

Interaction with other medicinal products and other forms of interactions.

Glycised® reduces the toxicity of anticonvulsants, antipsychotics, antidepressants, and antiseizure agents. When used concomitantly with sedatives, tranquilizers, and antipsychotics, the central nervous system depressant effect is enhanced.

Special precautions.

Use during pregnancy or breastfeeding.

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

Ability to affect reaction speed when driving vehicles or operating machinery.

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

Method of Administration and Dosage

The medicinal product Glycised® is administered in tablet form or as a powder obtained by crushing the tablet, transbuccally (by placing in the mouth or between the cheek and gum) or sublingually (under the tongue). The tablet should be held in the oral cavity until completely dissolved.

For children aged 3 years and older, adolescents, and adults with decreased mental performance, Glycised® is prescribed at a dose of 1 tablet (100 mg) 2--3 times daily for 14--30 days. The maximum daily dose is 300 mg.

For children aged 3 years and older and adults with increased excitability and emotional lability, the recommended dose is 1 tablet 2--3 times daily for 7--14 days. If necessary, the treatment course may be repeated.

For sleep disorders, 50--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 (the tablet may be crushed if necessary) within the first 3--6 hours after stroke onset, followed by 1 g daily for the next 1--5 days, and then 1--2 tablets 3 times daily for days 6--30.

In the treatment of alcoholism, the drug is prescribed as an adjunctive agent 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 drug is indicated for use in children aged 3 years and older.

Adverse reactions.

The drug is usually well tolerated. In cases of individual hypersensitivity, allergic reactions may occur, as well as skin rash, itching, urticaria, rhinitis, sore throat, conjunctivitis, and weakness. Gastrointestinal side effects, including epigastric pain and nausea, are possible. Isolated cases of impaired attention, headache, tension, and irritability have been observed in connection with the nervous system.

Overdose.

There is no information on clinical manifestations of overdose.

Shelf life.

3 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 per blister. 5 blisters per pack.

Release category.

Over-the-counter.

Manufacturer.

PJSC "Kyivmedpreparat".

Manufacturer's location and address of place of business.

139 Saksahanskoho Street, Kyiv, 01032, Ukraine.

INSTRUCTION

for medical use of medicinal product

GLICISED

(GLICISED®)

Composition:

Active ingredient: glycine;

1 tablet contains glycine, recalculated to 100% substance, 100 mg;

Excipients: ammonium-methacrylate copolymer dispersion, montan wax glycolic, povidone, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: tablets are nearly white or white with a creamy tint, round-shaped with a flat surface and beveled edges. The surface of the tablets may have a marbled appearance.

Pharmacotherapeutic group. Drugs affecting the nervous system.

ATC code N07XX.

Pharmacological properties.

Glycine is a replaceable amino acid (a natural metabolite) that acts as an inhibitory neurotransmitter and regulator of metabolic processes in the central nervous system. It reduces psycho-emotional tension, enhances mental performance, exerts neuroprotective, anti-stress, and sedative effects, improves brain metabolism, normalizes sleep, and reduces the toxic effects of alcohol. It does not cause dependence.

Glycine easily penetrates most biological fluids and tissues, including the brain. It is rapidly broken down in the liver by glycine oxidase into water and carbon dioxide. There is no accumulation of glycine in tissues.

Clinical characteristics.

Indications.

Functional and organic disorders of the nervous system (neuroses, neurosis-like conditions, vegetative-vascular 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 adjunctive agent in the treatment of alcoholism.

Contraindications.

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

Special precautions.

In patients prone to arterial hypotension, blood pressure should be monitored. If necessary, the dose should be adjusted: Glicised should be administered in lower doses with regular monitoring of arterial pressure. If blood pressure drops below normal levels, administration of the drug should be discontinued.

Interaction with other medicinal products and other types of interactions.

Glicised reduces the toxicity of anticonvulsants, antipsychotics, antidepressants, and antiseizure drugs. When used in combination with hypnotics, tranquilizers, and antipsychotics, the central nervous system depressant effect is enhanced.

Special instructions.

Use during pregnancy or breastfeeding.

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

Ability to affect reaction speed when driving or operating machinery.

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

Administration and dosage.

The medicinal product Glicised® is administered as tablets or as a powder after tablet grinding, via transbuccal (placed in the cheek or oral cavity) or sublingual (under the tongue) route. The tablet should be held in the mouth until completely dissolved.

For children over 3 years of age, adolescents, and adults with reduced mental performance: Glicised is administered at 1 tablet (100 mg) 2**─3 times daily for 14─**30 days.

Maximum daily dose ─ 300 mg.

For children over 3 years of age and adults with increased excitability and emotional lability: 1 tablet 2**─3 times daily; treatment course ─ 7─**14 days. If necessary, the course may be repeated.

For sleep disorders: 50**─**100 mg is administered 20 minutes before bedtime or immediately before sleep.

For ischemic stroke and cerebral circulation disorders: 1 g of the drug is 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.

For the treatment of alcoholism: as an adjunctive agent, 1 tablet 2**─3 times daily for 14─30 days. If necessary, the course may be repeated 4─**6 times per year.

Children.

The drug is indicated for children over 3 years of age.

Adverse reactions.

The drug is usually well tolerated. In cases of individual hypersensitivity, allergic reactions may occur, as well as skin rash, itching, urticaria, rhinitis, sore throat, conjunctivitis, and weakness. Gastrointestinal side effects, including epigastric pain and nausea, are possible. Isolated cases of impaired attention, headache, tension, and irritability have been observed in connection with the nervous system.

Overdose.

There is no information on clinical manifestations of overdose.

Shelf life.

3 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 per blister. 5 blisters per pack.

Release category.

Over-the-counter.

Manufacturer.

PJSC "Kyivmedpreparat".

Manufacturer's location and address of place of business.

139 Saksahanskoho Street, Kyiv, 01032, Ukraine.