Gliatilin

Package leaflet: Information for the patient

Gliatilin 600 mg capsules, 600 mg vials

alphoscerate choline
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Gliatilin is and what it is used for
2. What you need to know before taking Gliatilin
3. How to take Gliatilin
4. Possible side effects
5. How to store Gliatilin
6. Contents of the pack and other information

1. What Gliatilin is and what it is used for

Gliatilin contains the active substance choline alfoscerate, which is used to stimulate brain functions.
In particular, it is used to treat the following conditions:

• symptoms and signs of degenerative brain diseases in the elderly, also caused by insufficient blood circulation in the brain, or to treat cognitive disorders and disorientation manifested by:
  • memory impairment
  • confusion and loss of orientation
  • lack of motivation and initiative
  • reduced attention.

It is also indicated for treating behavioral and emotional relationship problems in the elderly, such as:

• emotional lability
• irritability
• indifference to the surrounding environment
• passivity.

2. What you need to know before taking Gliatilin

Do not take Gliatilin

• if you are allergic to choline alfoscerate or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking Gliatilin.
Other medicines and Gliatilin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between Gliatilin and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Gliatilin during pregnancy (see "Do not take Gliatilin").
Driving and using machines
There are no data available on the effects of this product on the ability to drive.
Gliatilin 600 mg capsules contain sodium ethyl para-hydroxybenzoate and sodium propyl para-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Gliatilin 600 mg capsules contain 28 mg of sorbitol per capsule.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.
Gliatilin 600 mg vials contain 23.04 mg of alcohol (ethanol) in each vial, equivalent to 3.29 mg/ml. The amount in each vial of this medicine is equivalent to less than 1 ml of beer.
The small amount of alcohol in this medicine will not produce significant effects.
Gliatilin 600 mg vials contain methyl para-hydroxybenzoate and propyl para-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

3. How to take Gliatilin

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule or 1 bottle twice daily.
If necessary, your doctor may increase your dose.
If you take more Gliatin than you should
In case of accidental ingestion/overdose of Gliatilin, inform your doctor immediately or go to the nearest hospital.
If you forget to take Gliatilin
Do not take a double dose to make up for a missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

As a precursor of biological components, alfoscerate choline is generally well tolerated, even with prolonged administration.
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Since it occurs naturally in the human body, alfoscerate choline administration over long periods is generally not associated with tolerability issues.

During treatment with Gliatilin, the following adverse reaction may occur, for which the frequency cannot be estimated:

• nausea.

This adverse reaction may require dose reduction.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Gliatilin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Gliatilin 600mg capsules: Store below 30°C.

6. Package contents and other information

What Gliatilin contains
Capsules:

• The active substance is choline alfoscerate. Each soft gelatin capsule contains 600 mg of choline alfoscerate.
• The other components are: purified water, glycerol. Components of the capsule shell are: gelatin, xylitol, sorbitans, sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, titanium dioxide (E 171), iron oxide (E 172).

Vials:

• The active substance is choline alfoscerate. Each 7 ml vial contains 600 mg of choline alfoscerate.
• The other components are: sodium methyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, sodium saccharin, orange flavour (containing ethanol), purified water.

Description of the appearance of Gliatilin and contents of the pack
Gliatilin is available as soft gelatin capsules for oral use or as oral solution in vials.
Pack contents: 10 capsules of 600 mg or 10 vials of 600 mg.

Marketing Authorization Holder
Italfarmaco S.p.A.
Viale Fulvio Testi, 330
20126 Milan,
Italy

Manufacturer
Capsules:
Catalent Italy S.p.A.
Via Nettunense,
Aprilia (Latina),
Italy
Controlled by:
Italfarmaco S.p.A.
Viale F. Testi, 330
20126 Milan,
Italy

Vials:
Italfarmaco S.A.
Alcobendas (Madrid)
Spain
ICE S.p.A.
Cantone Moretti, 29
10015 Ivrea (TO),
Italy