Delecit

Package leaflet: Information for the patient

Delecit 600 mg/7 ml oral solution

Choline alfoscerate
Please read all of 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Delecit is and what it is used for

Delecit belongs to a group of medicines called psychostimulants because the active substance it contains, choline alfoscerate, is used to stimulate brain functions in elderly patients.
Delecit is used to treat the symptoms and signs of degenerative brain diseases in the elderly, including those caused by inadequate blood circulation in the brain, or to treat cognitive disturbances and disorientation manifested by:

• memory loss
• confusion and loss of orientation
• reduced motivation and initiative
• decreased attention

It is also indicated for the treatment in the elderly of behavioural and emotional relationship problems such as:

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

2. What you should know before taking Delecit

Do not take Delecit

• if you are allergic to choline alfoscerate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Delecit.
Other medicines and Delecit
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions of this product with other drugs are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should not take Delecit during pregnancy, as the use of this medicine is not recommended in this condition. However, specific studies have shown the absence of adverse toxic effects.
Driving and using machines
Delecit does not impair the ability to drive or operate machinery.
Delecit contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate
These may cause allergic reactions (including delayed reactions).
This medicine contains 23.04 mg of alcohol (ethanol) in each 7 ml vial or sachet, equivalent to 3.29 mg/ml. The amount in 7 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains less than 1 mmol (23 mg) of sodium per 7 ml of solution (one vial/sachet), i.e. essentially 'sodium-free'.

3. How to take Delecit

Take this medicine exactly as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 bottle or 1 sachet taken twice daily.
If necessary, your doctor may increase your dose.
If you take more Delecit than you should
In case of overdose, contact your doctor immediately or go to the nearest hospital,
where you will be given appropriate treatment.
If you forget to take Delecit
Do not take a double dose to make up for the missed dose.
If you stop treatment with Delecit
If you have any questions about using this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone experiences them.
Since it is naturally present in the human body, administration of alfoscerate choline, even
over long periods, is generally well tolerated.
During treatment with Delecit, the following side effects may occur,
the frequency of which cannot be estimated, and your doctor may therefore reduce your
dose:
Effects related to the stomach:

• nausea

Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, consult your doctor or pharmacist. You may also report side effects
directly via the national reporting system at the website
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 Delecit

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after
Exp.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any changes in the appearance of the solution, which should be clear and colourless.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Delecit contains

• The active substance is: Choline alfoscerate. One single-dose container or sachet of 7 ml contains 600 mg of choline alfoscerate.
• The other components are: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate (see section 2), sodium saccharin, orange flavour, purified water.

Description of the appearance of Delecit and package contents
Oral solution
Carton pack containing 10 single-dose containers of 7 ml in brown glass.
Carton pack containing 14 single-dose sachets of 7 ml made of polyester, aluminium and polyethylene.

Marketing Authorization Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milano, Italy

Manufacturer
Oral solution – 10 single-dose containers:
Mipharm S.p.A.
Via B. Quaranta, 12
20141 Milano (MI), Italy
Or
Italfarmaco S.A.
San Rafael 3,
28108 Alcobendas, Madrid, Spain
Or
Lachifarma S.p.A. Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Zona industriale
73010 Zollino (LE), Italy

Oral solution – 14 single-dose sachets:
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR), Italy

Patient Information Leaflet

Delecit 400 mg soft capsules

Choline alfoscerate
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 other people, even if they have the same symptoms as you, 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 Delecit is and what it is used for
2. What you need to know before taking Delecit
3. How to take Delecit
4. Possible side effects
5. How to store Delecit
6. Contents of the pack and other information

1. What Delecit is and what it is used for

Delecit belongs to a group of medicines called psychostimulants because the active substance it contains, choline alfoscerate, is used to stimulate brain functions in elderly patients.
Delecit is used to treat the symptoms and signs of degenerative brain diseases in the elderly, including those caused by inadequate blood circulation in the brain, or to treat cognitive disorders and disorientation manifested by:

• memory loss,
• confusion and loss of orientation,
• reduced motivation and initiative,
• decreased attention.

It is also indicated for the treatment in the elderly of behavioural and emotional relationship problems such as:

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

2. What you need to know before taking Delecit

Do not take Delecit

• if you are allergic to choline alfoscerate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Delecit.
Other medicines and Delecit
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. No interactions of this product with other drugs are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should not take Delecit during pregnancy because use of this medicine is not recommended in this situation. However, specific studies have shown no negative toxic effects.
Driving and using machines
Delecit does not affect the ability to drive or operate machinery.
Delecit contains sodium ethyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate
These 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 Delecit

Take this medicine exactly as instructed by your doctor or
pharmacist. If you have any doubts, consult your doctor or
pharmacist.
The recommended dose is 1 capsule 2-3 times daily.
If necessary, your doctor may increase your dose.
If you take more Delecit than you should
In case of overdose, contact your doctor immediately or go to
the nearest hospital, where you will receive appropriate medical care.
If you forget to take Delecit
Do not take a double dose to make up for the forgotten dose.
If you stop treatment with Delecit
If you have any questions about using this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone experiences them.
Since it is naturally present in the human body, administration of alfoscerate choline,
even over long periods, generally does not cause tolerability issues.
During treatment with Delecit, the following side effects may occur,
for which the frequency cannot be estimated, and your doctor may therefore reduce
your dose:
Effects related to the stomach:

• nausea

Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, consult your doctor or pharmacist. You may also report side effects
directly via the national reporting system at the following website
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 Delecit

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
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 via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help
protect the environment.

6. Package contents and other information

What Delecit contains

• The active substance is: Choline alfoscerate. Each soft gelatin capsule contains 400 mg of choline alfoscerate.
• The other components are: purified water, glycerol.

Components of the capsule shell: gelatin, partially dehydrated liquid sorbitol,
sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate (see
section 2), titanium dioxide (E 171), iron oxide (E 172), glycerol.
Description of the appearance of Delecit and package contents
Opaque yellow ovoid soft gelatin capsules, in opaque PVC/Al blisters.
Carton box containing 14 capsules.
Marketing Authorization Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milan
Manufacturer
Italfarmaco S.p.A.
Viale Fulvio Testi, 330
20126 Milan

Patient Information Leaflet

Delecit 1g/4ml injectable solution

Choline alfoscerate
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, consult 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, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Delecit is and what it is used for

Delecit belongs to a group of medicines called psychostimulants because the active substance it contains, choline alfoscerate, is used to stimulate brain functions in elderly patients.
Delecit is used to treat the symptoms and signs of degenerative brain diseases in the elderly, including those caused by inadequate blood circulation in the brain, or to treat cognitive disturbances and disorientation manifested by:

• memory loss
• confusion and disorientation
• lack of motivation and initiative
• reduced attention

It is also indicated in the elderly for behavioural and emotional relationship problems such as:

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

2. What you need to know before taking Delecit

Do not take Delecit

• if you are allergic to choline alfoscerate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Delecit.
Other medicines and Delecit
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. No interactions of this product with other drugs are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Delecit during pregnancy, as the use of this medicine is not indicated in this condition. However, specific studies have shown the absence of negative toxic effects.
Driving and using machines
Delecit does not impair the ability to drive vehicles or operate machinery.

3. How to take Delecit

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 one vial per day by intramuscular or intravenous administration.
Your doctor will administer the intravenous dose slowly.
If necessary, your doctor may increase your dosage.
Instructions for opening the vials
To properly open the vials, follow these instructions:

If you take more Delecit than you should
In case of overdose, contact your doctor immediately or go to the nearest hospital, where you will receive appropriate medical care.
If you forget to take Delecit
Do not take a double dose to make up for the forgotten dose.
If you stop treatment with Delecit
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Since it is naturally present in the human body, administration of alfoscerate choline, even over long periods, generally does not cause tolerability problems.
During treatment with Delecit, the following side effects may occur, for which the frequency cannot be estimated, and therefore your doctor might reduce your dose:
Effects related to the stomach:

• nausea

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: 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 Delecit

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 use this medicine if you notice any changes in the appearance of the solution, which should be clear and colourless.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Delecit contains

• The active substance 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 Delecit and contents of the pack
Delecit injectable solution is available in cardboard boxes containing 3 or 5 colourless glass vials of 4 ml, housed in a plastic tray.

Marketing Authorization Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milan

Manufacturer
ITALFARMACO S.p.A.
Viale Fulvio Testi, 330 - 20126 Milan (MI)