GLIATILIN 400 mg Capsules

Зміст інструкції

1. Gliatilin 1000 mg/4 ml injectable solution
   1. What Gliatilin is and what it is used for
   2. What you need to know before using Gliatilin
   3. How to use Gliatilin
   4. Possible side effects
   5. How to store Gliatilin
   6. Contents of the pack and other information
2. Gliatilin 600 mg capsules
   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
3. Gliatilin 400 mg capsules
   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

Gliatilin 1000 mg/4 ml injectable solution

choline alfoscerate

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Gliatilin is and what it is used for
• 2. What you need to know before you use Gliatilin
• 3. How to use 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 ingredient choline alfoscerate which is used to stimulate brain functions.
In particular, it is used for the treatment of the following conditions:
symptoms and signs of degenerative brain diseases of the elderly, also caused by insufficient
blood circulation in the brain, or to treat cognitive disorders and disorientation that manifest with:
memory loss
confusion and loss of orientation
decrease in motivation and initiative
reduction of attention.
It is also indicated for treating behavioral and emotional relationship problems in the elderly such as:
emotionality,
irritability,
indifference to the surrounding environment
passivity.

2. What you need to know before using Gliatilin

Do not use Gliatilin

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using 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 of Gliatilin with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
You should not take Gliatilin during pregnancy (see ”Do not use Gliatilin”).

Driving and operating machinery
There is no data available on the effects of the product on the ability to drive.

3. How to use Gliatilin

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.

The recommended doseis one vial per day intramuscularly (into the muscle) or intravenously
(into the vein). The doctor will administer the intravenous administration slowly.
If deemed necessary, the doctor may decide to increase the dosage.

If you use more Gliatilin than you should
In case of accidental ingestion/administration of an excessive dose of Gliatilin, immediately inform your
doctor or go to the nearest hospital.

If you forget to use Gliatilin
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since it is naturally present in the human body, even long-term administration of
choline alfoscerate generally does not create tolerability problems.
During treatment with Gliatilin, you may experience the following side effects:

• nausea.

This side effect may require a dose reduction.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects 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 which is stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the drain or with household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gliatilin contains

• The active ingredient is choline alfoscerate. Each 4 ml vial contains 1000 mg of choline alfoscerate.
• The other component is water for injections.

Description of the appearance of Gliatilin and contents of the pack
Gliatilin is presented as an injectable solution for intramuscular or intravenous use.
The pack contains 5 vials of 4 ml each.

Marketing authorisation holder and manufacturer
Italfarmaco S.p.A. - Viale Fulvio Testi, 330 - 20126 Milano

Gliatilin 600 mg capsules

Gliatilin 600 mg vials
choline alfoscerate

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 ingredient choline alfoscerate which is used to stimulate brain functions.
In particular, it is used for the treatment of the following conditions:

• symptoms and signs of degenerative brain diseases of the elderly, also caused by insufficient blood circulation in the brain, or to treat cognitive disorders and disorientation that manifest with:
• memory loss
• confusion and loss of orientation
• decrease in motivation and initiative
• reduction of attention. It is also indicated for treating behavioral and affective relationship problems in the elderly such as:
• emotionality,
• 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 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 of Gliatilin with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not take Gliatilin during pregnancy (see “Do not take Gliatilin”).

Driving and operating machinery
There is no data available on the effects of the product on the ability to drive.

Gliatilin 600mg capsulescontains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Gliatilin 600mg capsules contains 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 vialscontains 23.04 mg of alcohol (ethanol) in each vial, which is 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 contains methyl parahydroxybenzoate, propyl parahydroxybenzoate 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 following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
The recommended doseis 1 capsule or 1 vial twice a day.
If deemed necessary, your doctor may increase the dosage.

If you take more Gliatilin than you should
In case of accidental ingestion/intake of an excessive dose of Gliatilin, immediately inform your
doctor 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

As a precursor of biological constituents, choline alfoscerate, even with prolonged administration,
generally does not pose tolerability problems.
Like all medicines, this medicine can cause side effects although not all people will experience them.
Given that it is naturally present in the human body, the administration even for long periods of
choline alfoscerate generally does not create tolerability problems.
During treatment with Gliatilin, the following side effects may manifest, for which it is not possible
to estimate the frequency:

• nausea.

This side effect may require a dose reduction.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor
or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects 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 which is stated on the packaging after “Exp”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
Gliatilin 600mg capsules: Store at a temperature below 30°C.

6. Contents of the pack and other information

What Gliatilin
Capsules contain:

• The active ingredient is choline alfoscerate. Each soft gelatin capsule contains 600 mg of choline alfoscerate.
• The other ingredients are: purified water, glycerol. The capsule components are: gelatin, sorbitol, sorbitans, sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, titanium dioxide (E 171), ferric oxide (E 172).

Vials:

• The active ingredient is choline alfoscerate. Each 7 ml vial contains 600 mg of choline alfoscerate.
• The other ingredients 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 presented in the form of soft gelatin capsules for oral use or in the form of vials for oral
use.
The pack contains 10 capsules of 600 mg or 10 vials of 600 mg.

Marketing Authorisation Holder
Italfarmaco S.p.A. - Viale Fulvio Testi, 330 - 20126 Milan

Manufacturer
Capsules:Italfarmaco S.p.A. - Viale F. Testi, 330 - 20126 Milan

Vials: -Italfarmaco S.A. - Alcobendas (Madrid) – Spain

• ABC Farmaceutici S.p.A. - Via Cantone Moretti, 29
• 10090 - San Bernardo d’Ivrea (TO)

Gliatilin 400 mg capsules

choline alfoscerate

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 ingredient choline alfoscerate which is used to stimulate brain functions.
In particular, it is used for the treatment of the following conditions:

• symptoms and signs of degenerative brain diseases of the elderly, also caused by insufficient blood circulation in the brain, or to treat cognitive and disorientation disorders that manifest with:
• memory loss
• confusion and loss of orientation
• decrease in motivation and initiative
• reduction of attention. It is also indicated for treating behavioral and affective problems in the elderly such as:
• emotionality,
• 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 any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant (see section “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 medicine.
No interactions of Gliatilin with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
You must not take Gliatilin during pregnancy (see ”Do not take Gliatilin”).

Driving and operating machinery
There is no data available on the effects of the product on the ability to drive.
This medicine contains 41 mg of sorbitol per capsule.
This medicine contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate
which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially
‘sodium-free’.

3. How to take Gliatilin

Take this medicine following the instructions of your doctor or pharmacist exactly as given. If you have
any doubts, consult your doctor or pharmacist.

The recommended doseis 1 capsule two to three times a day.
If deemed necessary, your doctor may decide to increase the dosage.

If you take more Gliatilin than you should
In case of accidental ingestion/intake of an excessive dose of Gliatilin, immediately notify your
doctor 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since it is naturally present in the human body, even long-term administration of
choline alfoscerate generally does not create tolerability problems.
During treatment with Gliatilin, the following side effects may occur, the frequency of which cannot be
estimated.

• nausea.

This side effect may require a dose reduction.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor
or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects 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 which is stated on the packaging after “Exp”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
Store at a temperature below 30°C.

6. Contents of the pack and other information

What Gliatilin contains

• The active ingredient is choline alfoscerate. Each soft gelatin capsule contains 400 mg of choline alfoscerate.
• The other ingredients are: purified water, glycerol. The capsule components are: gelatin, xylitol, sorbitans, sodium ethyl p-hydroxybenzoate,sodium propyl p-hydroxybenzoate, titanium dioxide (E171), ferric oxide (E172).

Description of the appearance of Gliatilin and contents of the pack
Gliatilin is presented in the form of soft gelatin capsules for oral use.
The pack contains 14 capsules of 400 mg.

Marketing authorisation holder and manufacturer
Italfarmaco S.p.A. - Viale Fulvio Testi, 330 - 20126 Milan