Gliatilin - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Choline (choline alfoscerate

GLIATILIN 400 mg capsules
GLIATILIN solution for injection 1000 mg / 4 ml

Gliatilin package inserts are available for pack sizes:
  • GLIATILIN 400 mg capsules, GLIATILIN solution for injection 1000 mg / 4 ml
  • GLIATILIN 600 mg capsules, GLIATILIN 600 mg vials

Why is Gliatilin used? What is it for?

PHARMACO-THERAPEUTIC CATEGORY

Psychostimulant, activating the Central Nervous System of the elderly patient.

THERAPEUTIC INDICATIONS

Psychoorganic cerebral degenerative-involutional syndromes or secondary to cerebrovascular insufficiency, that is, primary or secondary cognitive disorders of the elderly characterized by memory deficits, confusion and disorientation, a decrease in motivation and initiative and a reduction in attention skills. of senile behavior: emotional lability, irritability, indifference to the surrounding environment. Pseudodepression of the elderly.

Contraindications When Gliatilin should not be used

Individual hypersensitivity to closely related components or substances from a chemical point of view.

Contraindicated in pregnancy.

Precautions for use What you need to know before taking Gliatilin

None.

Interactions Which drugs or foods can modify the effect of Gliatilin

There are no known interactions of the product with other drugs.

Warnings It is important to know that:

Keep this medicine out of the reach of children.

Dose, Method and Time of Administration How to use Gliatilin: Posology

Ampoules: one ampoule per day intramuscularly or intravenously. IV administration is recommended. slowly.

Capsules: one capsule two to three times a day.

These dosages can be increased at the discretion of the treating physician.

Overdose What to do if you have taken too much Gliatilin

There are no known cases of overdose.

Side Effects What are the side effects of Gliatilin

As precursor of biological constituents, choline alfoscerate, even for prolonged administration, generally does not pose problems of tolerability.

The possible onset of nausea (probably attributable to a secondary dopaminergic activation) could require a reduction in the dosage.

If, after the administration of the drug, undesirable effects appear even if not described in the package leaflet, they must be communicated to your doctor.

Expiry and Retention

Do not use the medicine after the expiry date indicated on the package.

Other information

COMPOSITION

Vials:

Each 4ml vial contains:

  • Active ingredient: choline alfoscerate 1000 mg
  • Excipients: water for injections.

Capsules:

Each soft gelatin capsule contains:

  • Active ingredient: choline alfoscerate 400 mg
  • Excipients: purified water, glycerol.
  • Capsule constituents: gelatin, hexitol, sorbitans, sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, titanium dioxide (E 171), iron oxide (E 172).

PHARMACEUTICAL FORMS

5 ampoules of solution for injection intramuscularly or intravenously of 1000 mg / 4ml.

14 soft gelatin capsules for oral use of 400 mg.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Gliatilin can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

GLIATILIN

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

GLIATILIN solution for injection 1000mg / 4ml

Each 4ml vial contains:

Active principle:

choline alfoscerate 1000 mg.

GLIATILIN 400 mg capsules

One soft gelatin capsule contains:

Active principle:

choline alfoscerate 400 mg.

03.0 PHARMACEUTICAL FORM

Solution for injection i.m./e.v.

Soft gelatin capsules

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Psychoorganic cerebral degenerative-involutional syndromes or secondary to cerebrovascular insufficiency, ie primary or secondary cognitive disorders of the elderly characterized by memory deficits, confusion and disorientation, decreased motivation and initiative and reduced attention skills.

Alterations of the affective sphere and of senile behavior: emotional lability, irritability, indifference to the surrounding environment.

Pseudodepression of the elderly.

04.2 Posology and method of administration

Ampoules: one ampoule per day intramuscularly or intravenously. IV administration is recommended. slowly.

Capsules: one capsule two to three times a day.

These dosages can be increased at the discretion of the treating physician.

04.3 Contraindications

Known individual hypersensitivity to components or strictly correlated substances from a chemical point of view.

Contraindicated in pregnancy.

04.4 Special warnings and appropriate precautions for use

Keep out of reach of children.

04.5 Interactions with other medicinal products and other forms of interaction

None.

04.6 Pregnancy and breastfeeding

The use of Gliatilin is contraindicated in pregnancy.

However, specific studies have highlighted the lack of embryotoxic and teratogenic effects.

04.7 Effects on ability to drive and use machines

Nobody.

04.8 Undesirable effects

As precursor of biological constituents, even prolonged administration of choline alfoscerate does not generally pose problems of tolerability.

The possible onset of nausea (probably due to a secondary dopaminergic activation) could require a reduction of the dosage.

04.9 Overdose

See point 4.8.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: psychostimulant, activating the nervous system

Central of the elderly patient.

ATC code N07AX02.

Choline alfoscerate as a carrier of choline and precursor of phosphatidylcholine, has the potential to carry out a preventive and corrective action on biochemical lesions, which is recognized as having particular value among the pathogenetic factors of the involutional psychoorganic syndrome, namely on the reduced cholinergic tone and on the "altered composition phospholipid of neuronal membranes.

The chemical structure of choline alfoscerate (containing 40.5% of choline) and the chemical-physical properties related to it guarantee a significant supply of active and metabolically protected substance to the brain tissue.

The results of the experimental tests of preclinical pharmacology and of clinical studies have validated the ability of choline alfoscerate to intervene advantageously on cognitive and memory functions, as well as on the affective and behavioral sphere compromised by the involutional brain pathology.

05.2 Pharmacokinetic properties

The pharmacokinetic characteristics, determined by administration of the labeled compound, similar in the different animal species used (rat, dog, monkey), are the following: rapid and complete gastrointestinal absorption; rapid uptake and distribution in different tissues and organs, including the brain; renal excretion only (about 10%, in 96 hours of the administered dose of radioactivity); higher availability in the brain than 3H-choline.

05.3 Preclinical safety data

In rodents, the LD50 is greater than 1 g / kg parenterally and 10 g / kg orally. A daily oral dose of 300 mg / kg and 150 mg / kg administered for 6 months to rats and dogs, respectively, does not give rise to clinical signs of toxicity or to alterations in haematological, haematochemical or urinary parameters.

The drug was not mutagenic or teratogenic and did not modify the reproductive capabilities of the rat and rabbit.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Injectable solution

water for injections.

Soft gelatin capsules

purified water, glycerol

Capsule constituents: gelatin, hexitol, sorbitans, sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, titanium dioxide (E171), iron oxide (E172).

06.2 Incompatibility

None.

06.3 Period of validity

Vials: 60 months.

Capsules: 36 months.

06.4 Special precautions for storage

None.

06.5 Nature of the immediate packaging and contents of the package

GLIATILIN vials

lithographed cardboard box containing 5 vials of 4 ml colorless neutral glass, housed in a plastic box.

GLIATILIN 400 capsules

lithographed cardboard box containing 14 yellow opaque ovoid soft gelatin capsules, contained in PVC / Al blisters.

06.6 Instructions for use and handling

None.

07.0 MARKETING AUTHORIZATION HOLDER

ITALFARMACO S.p.A. - Viale Fulvio Testi, 330 - 20126 MILAN

08.0 MARKETING AUTHORIZATION NUMBER

GLIATILIN solution for injection 1000 mg / 4 ml 5 ampoules A.I.C. n. 025937071

GLIATILIN 400 mg capsules 14 capsules A.I.C. n. 025937020

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

Authorization: 27/07/1987

Renewal: 01/06/2010

10.0 DATE OF REVISION OF THE TEXT

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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