Citicoline Tecnigen 1000 mg oral solution EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Citicolina TecniGen is and what it is used for
- 2. What you need to know before taking Citicolina TecniGen
- 3. How to take Citicoline TecniGen
- 4. Possible adverse effects
- 5. Storage of Citicoline TecniGen
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Citicoline TecniGen 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, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4. >
Leaflet contents
- What Citicoline TecniGen is and what it is used for
- What you need to know before taking Citicoline TecniGen
- How to take Citicoline TecniGen
- Possible adverse effects
- How to store Citicoline TecniGen
- Contents of the pack and other information
1. What Citicolina TecniGen is and what it is used for
Citicolina TecniGen belongs to a group of medicines called psychostimulants and nootropics, which work by improving brain function.
Citicolina TecniGen 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 taking Citicolina TecniGen
Do not take Citicolina TecniGen
- 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 hyperactivity, a serious condition characterized by low blood pressure, sweating, tachycardia, and fainting.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Citicolina TecniGen
- if you are allergic to acetylsalicylic acid, as it may trigger asthma.
Children
Citicolina TecniGen has not been adequately studied in children and should only be administered if considered necessary by your doctor.
Taking Citicolina TecniGen with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Citicolina TecniGen 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.
Citicolina TecniGen should not be administered concomitantly with medicines containing meclofenoxate, a central nervous system stimulant.
Taking Citicolina TecniGen with food and drinks
Citicolina TecniGen 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.
Citicolina TecniGen, like most medicines, should not be administered during pregnancy, suspected pregnancy, or breastfeeding unless considered necessary by your doctor.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Citicolina TecniGen contains sorbitol, carmine red, and parahydroxybenzoates
This medicine contains sorbitol (E-420). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine may cause allergic reactions as it contains carmine red (Ponceau 4R or 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-217) and methyl parahydroxybenzoate (E-218).
3. How to take Citicoline TecniGen
Follow exactly the instructions for use of this medicine as given by your doctor. If you have any doubts, 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 meals.
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tear the sachet along the arrows indicated |
directly from the sachet or |
half a glass of water (120 ml) and drink it |
If you take more CiticolinaTecniGen than you should
Contact your doctor, 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 CiticolinaTecniGen
Take your dose as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stop using CiticolinaTecniGen
Your doctor will advise you on the duration of your treatment with CiticolinaTecniGen. Do not discontinue the 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 everybody gets 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 extremities, 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 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 TecniGen
Keep 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 is the last day of the month indicated.
Store in the original packaging.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Citicolina TecniGen
- The active substance is citicoline. Each sachet contains 1000 mg of citicoline (as the sodium salt).
- The other components (excipients) are: sodium saccharin (E-954), liquid sorbitol (E-420), glycerol (E-422), methylparaben (E-218), propylparaben (E-217), disodium citrate dihydrate (E-331), formaldehyde glycerin, potassium sorbate (E-202), strawberry flavor, Ponceau 4R red dye (E-124), citric acid (E-330), and purified water.
Appearance of the product and contents of the pack
Citicolina TecniGen is a pink, transparent oral solution with strawberry odor and flavor, packaged in sachets.
It is presented in a pack containing 10 sachets, each with 10 ml of oral solution.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Tecnimede España Industria Farmacéutica, S.A.
Avda. Bruselas, 13
28108 Alcobendas (Madrid), Spain.
Manufacturer
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)
Date of latest review of this leaflet: December 2015
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/