Esto

Patient Information Leaflet

ESTO 500 mg tablets, 500 mg oral solution in sachet

L-alpha-glycerylphosphoryl-ethanolamine monohydrate

Please read all of 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ESTO is and what it is used for

This medicinal product contains L-alpha-glycerylphosphorylethanolamine, an active substance that stimulates brain cognitive functions such as: memory, perception, recognition, and understanding of information from the external world.
ESTO is used, in combination with other medicinal products (as an adjunctive treatment), to improve brain cognitive functions that are impaired due to aging (cerebral involutive syndromes).

2. What you should know before taking ESTO

Do not take ESTO if you are allergic to L-alpha-glycerylphosphorylethanolamine or to any of the other
components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking ESTO.
There are no specific warnings or precautions for the use of this medicine.
Other medicines and ESTO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
No interactions with other drugs have been reported.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
ESTO should be administered during pregnancy and breastfeeding only if clearly needed and under the direct supervision of a physician.
Driving and using machines
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ESTO does not impair the ability to drive or operate machinery.
ESTO oral solution in sachet contains:

• methyl p-hydroxybenzoate and propyl p-hydroxybenzoate: may cause allergic reactions (including delayed reactions);
• sodium: This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially ‘sodium-free’. The raspberry flavour also contains:
• ethanol: This medicine contains 2.068 mg of alcohol (ethanol) per sachet (5 ml), equivalent to 0.42 mg/ml (0.042% w/v). The amount in each 5 ml sachet of this medicine is equivalent to 0.052 ml of beer or 0.021 ml of wine. The small amount of alcohol in this medicine will not produce any significant effects.

ESTO tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take ESTO

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
ESTO tablets
The recommended dose is 1 tablet, taken twice daily by mouth (oral use).
The score line on the tablet is not intended to divide the tablet into equal doses, but to facilitate breaking it for easier swallowing.
ESTO oral solution in sachet
The recommended dose is 1 sachet twice daily.
Once the sachet is opened, squeeze the contents directly into the mouth without drinking water, gently pressing from the bottom to ensure complete expulsion.
If you take more ESTO than you should:
Overdose symptoms have not been reported.
If you forget to take ESTO
Do not take a double dose to make up for the forgotten 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.
Nausea, vomiting or mild drowsiness have very rarely been reported. These side effects tend to resolve
spontaneously.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You
can also report side effects directly via 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.
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5. How to store ESTO

Keep this medicine out of the sight and reach of children.
Store ESTO tablets at a temperature not exceeding 30°C.
No special storage precautions are required for ESTO 500 mg oral solution in sachets.
Do not use this medicine after the expiry date stated on the packaging. 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 ESTO contains
The active substance is: L-alpha-glycerylphosphoryl-ethanolamine monohydrate.
ESTO tablets
1 tablet of 500 mg contains 500 mg of L-alpha-glycerylphosphoryl-ethanolamine monohydrate.
The other components are: pregelatinized starch; microcrystalline cellulose; precipitated silica; croscarmellose
sodium; magnesium stearate.
ESTO oral solution in single-dose sachet
1 sachet contains 500 mg of L-alpha-glycerylphosphoryl-ethanolamine monohydrate.
The other components are: glycerol; sodium citrate; citric acid monohydrate; saccharin sodium; methyl
parahydroxybenzoate; propyl parahydroxybenzoate; raspberry flavour (contains ethanol); demineralized water.
Description of the appearance of ESTO and contents of the pack
ESTO tablets are white, shiny, oblong tablets, available in a box containing 14 tablets.
ESTO oral solution in single-dose sachet is available in boxes containing 10 single-dose sachets or 30 single-dose sachets, each of 5 ml.
Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy.
Manufacturer
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy.
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