Cikappa

Italy
Brand name Cikappa
Form solution, oral
Active substance / Dosage
SODIUM CITICOLINE
Prescription type Prescription only
ATC code
N06BX06
Registration number 051607
Manufacturer I.B.N. SAVIO S.R.L

Table of Contents

Package leaflet: Information for the user

CIKAPPA 1 000 mg oral solution

Citicoline
Generic medicine
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 pass it on 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 CIKAPPA is and what it is used for
  2. What you need to know before taking CIKAPPA
  3. How to take CIKAPPA
  4. Possible side effects
  5. How to store CIKAPPA
  6. Contents of the pack and other information

1. What CIKAPPA is and what it is used for

CIKAPPA belongs to a group of medicines called psychostimulants and nootropics that improve neuronal membrane function.
CIKAPPA is used to treat memory and behavioural disorders caused by:

  • stroke, due to interruption of blood flow to the brain caused by a blood clot or rupture of a blood vessel.
  • head trauma, a severe blow to the head.

2. What you need to know before taking CIKAPPA

Do not take CIKAPPA:

  • if you are allergic to citicoline or to any of the other ingredients of this medicine (listed in section 6).
  • if you have 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 CIKAPPA:

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

Children
Studies on the use of CIKAPPA in children are insufficient. Therefore, this medicine should only be administered when the doctor considers it necessary.
Other medicines and CIKAPPA
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
CIKAPPA enhances the effects of L-Dopa. Therefore, you should not take CIKAPPA together with other medicines containing L-Dopa without informing your doctor. Medicines containing L-Dopa are often used to treat Parkinson's disease.
CIKAPPA must not be taken together with medicines containing meclofenoxate, a drug that stimulates brain activity.
CIKAPPA with food and drink
CIKAPPA can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
CIKAPPA must not be administered during pregnancy or while breastfeeding unless your doctor considers it necessary.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
CIKAPPA contains Ponceau 4R (E124)
This medicine may cause allergic reactions.
CIKAPPA contains sorbitol (E420)
Sorbitol is a source of fructose. If your doctor has diagnosed you (or the child) with intolerance to certain sugars, or if you have hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, consult your doctor before you (or the child) take this medicine.
CIKAPPA contains parahydroxybenzoates
This medicine contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), which may cause allergic reactions (including delayed reactions).
CIKAPPA 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 CIKAPPA

Take this medicine exactly as stated in this leaflet or as instructed by your doctor. 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. This medicine can be taken directly from the sachet or dissolved in half a glass of water (120 mL), with meals or at other times.

Three line drawings show the A hand holds an open sachet and pours the liquid contents into
  1. Hold the CIKAPPA sachet firmly. 2. With the other hand, tear along the line indicated by the arrows. 3. You can take this medicine directly. Shake the sachet well. 4. Alternatively, dissolve it in half a glass of water (120 mL) and drink.

If you take more CIKAPPA than you should
Contact your doctor or pharmacist immediately, stating the name of the medicine and the amount taken.
If you forget to take CIKAPPA
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 taking CIKAPPA
Your doctor will advise you on how long your treatment with CIKAPPA should last. Do not stop treatment without consulting your doctor.
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 everybody will experience them.
The side effects of this medicine are very rare (occurring in fewer than 1 in 10,000 people). You may experience hallucinations, headache, dizziness, shortness of breath, nausea, vomiting, occasional diarrhoea, hot flushes, urticaria, skin rash, purple spots on the skin, tremors, swelling of the extremities, and changes in blood pressure. If you experience any of these or other side effects, 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 may 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 CIKAPPA

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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CIKAPPA contains

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

Description of the appearance of CIKAPPA and pack contents
CIKAPPA 1,000 mg is a pink, transparent solution with a strawberry odour and taste.
It is packaged in cartons containing 10, 30 or 30 (3x10) single-dose sachets, heat-sealed in PET 23µm /
white PE outer layer 12g /AL 9µm /extruded copolymer 25g, each containing 10 mL of oral solution per single-dose sachet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
I.B.N Savio S.r.l.
Via del Mare, 36
00071 Pomezia (RM)
Italy

Manufacturers
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat, 08950, Barcelona, Spain
SAG Manufacturing SLU
Crta N-I, Km 36
28750 San Agustin de Guadalix, Madrid, Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:
Italy: CIKAPPA
Spain: CIKAPPA