Citicoline Pharmacare

Package leaflet: Information for the user

Citicolina Pharmacare

1 000 mg oral solution
cytidine 5'-triphosphate
Equivalent medicine
Please read all of this leaflet carefully before you take 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, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Citicolina Pharmacare is and what it is used for

Citicolina Pharmacare belongs to a group of medicines called psychostimulants and nootropics that improve brain function.
Citicolina Pharmacare is used in the treatment of memory and behavioural disorders caused by:

• stroke, when blood flow to the brain is interrupted by a blood clot or rupture of a blood vessel in the brain
• head injuries, a severe blow to the head.

2. What you need to know before taking Citicolina Pharmacare

Do not take Citicolina Pharmacare
if you are allergic to citicoline or to any of the other ingredients of this medicine (listed in
section 6).

• if you suffer from parasympathetic nervous system hypertonia, a serious condition associated with low blood pressure, sweating, tachycardia, and fainting.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citicolina Pharmacare

• if you are allergic to acetylsalicylic acid, as it may cause asthma.

Children
Studies on Citicolina Pharmacare in children are insufficient. This medicine should only be
administered when the doctor considers it necessary.
Other medicines and Citicolina Pharmacare
Tell your doctor or pharmacist if you are using, have recently used, or might use any other
medicines, including over-the-counter medicines.
Citicolina Pharmacare enhances the effects of medicines containing L-dopa. You must not take Citicolina
Pharmacare together with medicines containing L-dopa without consulting your doctor. Medicines containing L-
dopa are generally used to treat Parkinson's disease.
Citicolina Pharmacare must not be taken together with medicines containing meclofenoxate, a medicine
that stimulates the brain.
Citicolina Pharmacare with food and drink
Citicolina Pharmacare can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Citicolina Pharmacare must not be administered if you are pregnant or breastfeeding unless your doctor considers it necessary.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Citicolina Pharmacare contains Ponceau 4R (E124)
This medicine may cause allergic reactions.
Citicolina Pharmacare contains sorbitol (E420)
Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain
sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which
patients are unable to metabolize fructose, speak with your doctor before you (or the child) take
this medicine.
Citicolina Pharmacare contains parahydroxybenzoates
This medicine contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) and may
cause allergic reactions (including delayed reactions).
Citicolina Pharmacare contains sodium
This medicine contains 80.8 mg of sodium (the main component of table salt) per 10 mL sachet. This corresponds to 4% of the maximum daily recommended dietary intake for an adult.

3. How to take Citicolina Pharmacare

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The usual dose is 1 to 2 sachets per day, depending on the severity of your condition. The medicine can be
taken directly from the sachet or dissolved in half a glass of water (120 mL), with meals or at other times.

1. Hold firmly 2. With the other hand 3. You can take the 4. Alternatively, dissolve the Citicolina Pharmacare sachet and shake. pull along the area the medicine directly from the sachet. in half a glass of water indicated by the arrows. (120 mL) and drink.

If you take more Citicolina Pharmacare than you should
Contact your doctor or pharmacist immediately, stating the name of the medicine and the amount taken.
If you forget to take Citicolina Pharmacare
Take the missed dose as soon as you remember. Do not take a double dose to make up for the forgotten dose.
If you stop treatment with Citicolina Pharmacare
Your doctor will inform you about the duration of treatment with Citicolina Pharmacare. Do not stop treatment before speaking with your doctor.
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.
The side effects of this medicine are very rare (may affect up to 1 in 10,000 people).
You may experience hallucinations, headache, dizziness, shortness of breath, nausea, vomiting, occasional diarrhoea, facial flushing, hives, skin rash, red spots on the skin, tremors, swelling of the extremities, and changes in blood pressure. If you experience any of these or other symptoms, inform your doctor.
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.

5. How to store Citicoline Pharmacare

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.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Citicolina Pharmacare contains

• The active substance is citicoline. Each sachet contains 1,000 mg of citicoline (as sodium salt). The other components are: sodium saccharin (see section 2 “Citicolina Pharmacare contains sodium”), sorbitol liquid (non-crystallizable) (E420) (see section 2 “Citicolina Pharmacare contains sorbitol”), glycerol (E422), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) (see
  section 2 “Citicolina Pharmacare contains parahydroxybenzoates”), sodium citrate, formaldehyde glycerol, potassium
  sorbate (E202), strawberry flavour (containing propylene glycol (E1520)), Ponceau 4R red dye (E124),
  citric acid and purified water.

Description of the appearance of Citicolina Pharmacare and package contents

Citicolina Pharmacare is a pink, transparent solution with strawberry odour and taste.

It is available in packs containing 10, 30 or 30 (3x10) heat-sealed sachets in PET 23µm /PE Ext.
White 12gsm /Aluminium 9µm /Extruded Copolymer 25gsm, each containing 10 mL of oral solution.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Pharmacare srl
Via Marghera, 29
20149 Milan,
Italy

Manufacturer
Galenicum Health, S.L.U. (Physical-chemical control)
Sant Gabriel, 50
Esplugues de Llobregat, 08950, Barcelona, Spain
or
SAG Manufacturing SLU (Physical-Chemical & Microbial)
Crta N-I, Km 36
28750 San Agustin de Guadalix, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Citicolina Pharmacare
Spain: Citicolina Pharmacare 1,000 mg oral solution EFG