Gliatilin (Capsules, Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

N07AX02 (Choline alfoscerate)

Active Substance

Choline alfoscerate (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Nootropic drug. Central-acting cholinomimetic

Pharmacotherapeutic Group

Other agents for the treatment of nervous system diseases; parasympathomimetics; other parasympathomimetics

Pharmacological Action

Cholinomimetic. It is a precursor of acetylcholine. It acts primarily on cholinergic receptors in the CNS.

Glycerophosphate, which is formed during the breakdown of choline alfoscerate, is a precursor of neuronal membrane phospholipids (phosphatidylcholine).

It facilitates the transmission of nerve impulses in cholinergic neurons, improves the plasticity of neuronal membranes and receptor function.

Pharmacokinetics

After oral administration, an average of about 88% of the choline alfoscerate dose is absorbed, with rapid distribution in organs and tissues.

It penetrates the blood-brain barrier. It accumulates mainly in the brain (the concentration in the brain reaches 45% of that in plasma), lungs and liver.

85% is excreted by the lungs as carbon dioxide, the remaining amount (15%) is excreted through the kidneys and through the intestines.

Indications

Cerebrovascular accidents of the ischemic type (acute and recovery period) and hemorrhagic type (recovery period); psycho-organic syndrome against the background of involutional and degenerative processes of the brain; consequences of cerebrovascular insufficiency or primary and secondary cognitive impairments in the elderly, characterized by memory impairment, confusion, disorientation, decreased motivation and initiative, decreased concentration; behavioral and affective disorders in old age – emotional lability, increased irritability, decreased interest; senile pseudomelancholia; multi-infarct dementia.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F01	Vascular dementia
F03	Unspecified dementia
F07	Personality and behavioral disorders due to disease, damage or dysfunction of the brain
G93.4	Unspecified encephalopathy
I61	Intracerebral hemorrhage (cerebrovascular accident of hemorrhagic type)
I63	Cerebral infarction
I69	Sequelae of cerebrovascular diseases

ICD-11 code	Indication
6D81	Dementia due to cerebrovascular disease
6D8Z	Dementia, unknown or unspecified cause
6E68	Secondary emotionally labile personality disorder
6E6Z	Unspecified secondary mental or behavioral syndromes
8B00.Z	Intracerebral hemorrhage of unspecified site, unspecified
8B11	Cerebral ischemic stroke
8B25.Z	Sequelae of cerebrovascular disease, unspecified
8E47	Encephalopathy, not elsewhere classified
8E4A.0	Paraneoplastic or autoimmune disorders of the central nervous system, including brain and spinal cord
8E63	Post-cardiopulmonary bypass encephalopathy

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally, intramuscularly, or intravenously. Set the dosage regimen individually based on the clinical picture, indication, and patient tolerance.

For chronic cerebrovascular insufficiency and cognitive decline, take 400 mg orally three times daily. The typical oral maintenance dose is 400 mg once or twice daily.

For the acute phase of ischemic or hemorrhagic stroke, administer 1000 mg intravenously or intramuscularly once daily. Initiate treatment as early as possible.

During the recovery period following a stroke, use a dose of 400 mg intramuscularly or intravenously twice daily. Continue therapy for the duration established by the treating physician.

Subsequently, transition to oral administration for maintenance therapy. The total daily therapeutic course typically ranges from 600 mg to 2000 mg.

The duration of treatment is determined by the physician based on the patient’s response. Therapy may extend for several months.

If nausea occurs, which may result from dopaminergic activation, reduce the dose. Do not abruptly discontinue treatment without medical supervision.

Adverse Reactions

From the digestive system nausea, abdominal pain.

From the nervous system short-term confusion.

Contraindications

Hypersensitivity to choline alfoscerate; pregnancy, breastfeeding period; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated.

Special Precautions

Nausea may be a consequence of dopaminergic activation. If nausea occurs, the dose of choline alfoscerate should be reduced.

Effect on ability to drive vehicles and operate machinery

During the use of choline alfoscerate, patients should exercise caution when driving vehicles and operating machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Gliatilin [Italfarmaco, S.p.A. (Italy)]
Oral solution 600 mg: 7 ml bottle 10 pcs.

Marketing Authorization Holder

Italfarmaco, S.p.A. (Italy)

Manufactured By

Mipharm S.p.A. (Italy)

Dosage Form

Gliatilin

Oral solution 600 mg: 7 ml bottle 10 pcs.

Dosage Form, Packaging, and Composition

Oral solution transparent, colorless.

	1 fl.
Choline alfoscerate	600 mg

Excipients : methylparahydroxybenzoate 8 mg, propylparahydroxybenzoate 2.4 mg, sodium saccharinate 3 mg, orange flavor 29 mg, purified water up to 7 ml.

7 ml – brown glass bottles (10) – cardboard packs.

Gliatilin [Italfarmaco, S.p.A. (Italy)]
Solution for infusion and intramuscular injection 1 g/3 ml: amp. 3 pcs.

Marketing Authorization Holder

Italfarmaco, S.p.A. (Italy)

Dosage Form

Gliatilin

Solution for infusion and intramuscular injection 1 g/3 ml: amp. 3 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion and intramuscular injection transparent, colorless.

	1 amp.
Choline alfoscerate	1 g

Excipients : water for injections – up to 3 ml.

4 ml – ampoules of colorless glass (3) – contour cell packs (1) – cardboard packs.
4 ml – ampoules of colorless glass (3) – contour cell packs (2) – cardboard packs.
4 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.
4 ml – ampoules of colorless glass (6) – contour cell packs (1) – cardboard packs.

Gliatilin [Italfarmaco, S.p.A. (Italy)]
Capsules 400 mg: 14 pcs.

Marketing Authorization Holder

Italfarmaco, S.p.A. (Italy)

Dosage Form

Gliatilin

Capsules 400 mg: 14 pcs.

Dosage Form, Packaging, and Composition

Capsules soft gelatin, oval, yellow, opaque; capsule contents – a viscous colorless solution.

	1 caps.
Choline alfoscerate	400 mg

Excipients : glycerol, purified water.

Capsule shell composition gelatin, ezitol, sorbitan, ethylparahydroxybenzoate sodium, propylparahydroxybenzoate sodium, titanium dioxide (E171), iron (III) meta-hydroxide (E172).

14 pcs. – blisters (1) – cardboard packs.

Gliatilin [Italfarmaco, S.p.A. (Italy)]
Solution for intravenous and intramuscular injection 1 g/4 ml: amp. 3 pcs.