Citicoline Pensapharma 1000 mg oral solution EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Citicolina Pensa Pharma is and what it is used for
- 2. What you need to know before starting to take Citicolina Pensa Pharma
- 3. How to take Citicoline Pensa Pharma
- 4. Possible adverse effects
- 5. Storage of Citicoline Pensa Pharma
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Citicoline Pensa Pharma 1000 mg oral solution EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Citicoline Pensa Pharma is and what it is used for
- What you need to know before taking Citicoline Pensa Pharma
- How to take Citicoline Pensa Pharma
- Possible side effects
- How to store Citicoline Pensa Pharma
- Contents of the pack and other information
1. What Citicolina Pensa 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 disturbances due to:
- a stroke, which is an interruption of blood supply to the brain caused by a blood clot or rupture of a blood vessel.
a head injury, which is a blow to the head.
2. What you need to know before starting to take Citicolina Pensa Pharma
Do not take Citicolina Pensa Pharma
- if you are allergic to the active substance citicoline or to any of the other components of this medicine (listed in section 6).
- if you suffer from parasympathetic nervous system hypertonia, 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 Citicolina Pensa Pharma
- if you are allergic to acetylsalicylic acid, as it may trigger asthma.
Children
Citicolina has not been adequately studied in children and should only be administered if considered necessary by your doctor.
Other medicines and Citicolina Pensa 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. Medications containing L-Dopa are commonly used to treat Parkinson's disease.
Citicoline should not be administered concomitantly with medications containing meclofenoxate, a central nervous system stimulant.
Taking Citicolina Pensa Pharma with food and drinks
This medicine may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may 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 Pensa 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 (the main component of table/cooking salt) per sachet. This corresponds to 3.85% of the maximum daily recommended sodium intake for an adult.
This medicine contains 2 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 metabolize fructose, consult your doctor before taking this medicine. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
This medicine may cause allergic reactions as 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. If the infant is less than 4 weeks old, consult your doctor or pharmacist, especially if the infant has been given other medicines containing propylene glycol or alcohol.
3. How to take Citicoline Pensa Pharma
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
The usual 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 along the arrows indicated on the package |
directly from the sachet or |
half a glass of water (120 ml) and drink it |
If you take more Citicolina Pensa Pharma than you should
Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Citicolina Pensa Pharma
Take your dose as soon as you remember. Do not take a double dose to make up for the forgotten dose.
If you stop taking Citicolina Pensa Pharma
Your doctor will determine the duration of your treatment with Citicolina Pensa Pharma. Do not discontinue 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Citicoline Pensa Pharma
Keep this medicine out of 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. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, 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 Citicolina Pensa Pharma
- The active substance is citicoline. Each sachet contains 1000 mg of citicoline (as sodium salt).
- The other components (excipients) are: sodium saccharin (E-954), liquid sorbitol (E-420), glycerol (E-422), methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), sodium citrate (E-331), glycerinformaldehyde, potassium sorbate (E-202), strawberry flavour (containing propylene glycol (E-1520)), carmine red A (Ponceau 4R) (E-124), citric acid (E-330) and purified water.
Appearance of the product and contents of the pack
Citicolina Pensa Pharma is a pink, transparent oral solution with strawberry odour and flavour, supplied in sachets.
It is available in packs containing 10 or 30 sachets, each with 10 ml of oral solution. Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (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 leaflet: July 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/