Citicoline Kern Pharma 1,000 mg oral solution EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Citicolina Kern Pharma is and what it is used for
- 2. What you need to know before starting to take Citicolina Kern Pharma
- 3. How to take Citicoline Kern Pharma
- 4. Possible adverse effects
- 5. Storage of Citicoline Kern Pharma
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Citicolina Kern Pharma 1.000 mg oral solution EFG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further 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, because it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. See section 4.
Contents of this leaflet
- What Citicolina Kern Pharma is and what it is used for
- What you need to know before taking Citicolina Kern Pharma
- How to take Citicolina Kern Pharma
- Possible side effects
- How to store Citicolina Kern Pharma
- Contents of the pack and other information
1. What Citicolina Kern Pharma is and what it is used for
Citicolina belongs to a group of medicines called psycho-stimulants and nootropics, which work by improving brain function.
Citicolina is used to treat memory and behavioural disorders caused by:
- a stroke, which is an interruption of blood supply to the brain due to a blood clot or rupture of a blood vessel.
- head trauma, which is a blow to the head.
2. What you need to know before starting to take Citicolina Kern Pharma
Do not take Citicolina Kern Pharma
- if you are allergic to the active substance citicoline or to any of the other ingredients of this medicine (listed in section 6).
- if you have parasympathetic nervous system hyperactivity, a serious condition characterized by low blood pressure, sweating, tachycardia, and fainting.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take citicoline:
- if you are allergic to acetylsalicylic acid, as it may trigger asthma.
Children
Citicoline has not been adequately studied in children, so it should only be administered if your doctor considers it necessary.
Other medicines and Citicolina Kern Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Citicoline enhances the effects of L-Dopa; therefore, it should not be administered simultaneously with medications containing L-Dopa without consulting your doctor. Medicines containing L-Dopa are commonly used to treat Parkinson's disease.
Citicoline should not be administered together with medicines containing meclofenoxate, a cerebral stimulant.
Taking Citicolina Kern Pharma with food and drinks
This medicine can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Citicolina Kern Pharma contains sorbitol (E-420), carmine red A (Ponceau 4R) (E-124), parahydroxybenzoates (E-216 and E-218), propylene glycol (E-1520), and sodium
This medicine contains 78.76 mg of sodium (a main component of table/cooking salt) per sachet. This corresponds to 3.94% of the maximum daily sodium intake recommended for an adult.
This medicine contains 1.4 g of sorbitol (E-420) per sachet. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
This medicine may cause allergic reactions because it contains carmine red A (Ponceau 4R) (E-124). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.
It may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218).
This medicine contains 2.58 mg of propylene glycol (E-1520) per sachet.
3. How to take Citicoline Kern Pharma
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is 1 to 2 sachets per day, depending on the severity of your condition. It can be taken directly or dissolved in half a glass of water (120 ml), with or without food.
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tear the sachet at the location indicated by the arrows |
directly from the sachet or |
half a glass of water (120 ml) and drink it |
If you take more Citicoline Kern Pharma than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Citicoline Kern Pharma
Take your dose as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stop using Citicoline Kern Pharma
Your doctor will advise you on how long you should take citicoline. Do not stop treatment before consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects of this medicine are very rare (may affect up to 1 in 10,000 patients). These may include headache, dizziness, nausea, occasional diarrhoea, facial flushing, swelling of the limbs, and changes in blood pressure. If you experience any of these or other symptoms, inform your doctor.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Citicoline Kern Pharma
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 the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Citicoline Kern Pharma
- The active substance is citicoline. Each sachet contains 1,000 mg of citicoline (as the sodium salt).
- The other components (excipients) are: sodium saccharin (E-954), non-crystallizable liquid sorbitol (E-420), glycerol (E-422), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium citrate (E-331), glycerol formal, potassium sorbate (E-202), strawberry flavouring (containing propylene glycol (E-1520)), cochineal red A (Ponceau 4R) (E-124), anhydrous citric acid (E-330) and purified water.
Appearance of the product and contents of the pack
Citicoline Kern Pharma is a pink, transparent oral solution with strawberry odour and flavour, packed in sachets.
It is available in packs containing 10 or 30 sachets (3 units of 10 sachets) with 10 ml of oral solution per sachet.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Kern Pharma, S.L.
Venus, 72 – Pol. Ind. Colón II
08228 Terrassa – Barcelona
Spain
Manufacturer
Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
08950 Barcelona (Spain)
or
SAG Manufacturing SLU
Crta N-I, Km 36
28750 San Agustin de Guadalix,
Madrid (Spain)
Date of the most recent revision of this package leaflet: March 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/