Citicoline Stada 1000 mg oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

CiticolinaSTADA 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, as 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, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Citicolina STADA belongs to a group of medicines called psycho-stimulants and nootropics, which work by improving brain function.

Citicolina STADA is used to treat memory and behavioural disturbances due to:

• stroke, which is an interruption of blood supply to the brain caused by 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 STADA

Do not take Citicolina STADA

• 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 characterized by low blood pressure, sweating, tachycardia, and fainting.

Warnings and precautions

Talk to your doctor or pharmacist 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.

Taking Citicolina STADA with other medicines

Tell 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 medicines containing L-Dopa without consulting your doctor. Medicines containing L-Dopa are commonly used to treat Parkinson's disease.

Citicoline should not be administered concomitantly with medicines containing meclofenoxate, a central nervous system stimulant.

Taking Citicolina STADA with food and drinks

Citicoline 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.

Citicoline, like most medicines, should not be administered during pregnancy, if you suspect you may be pregnant, or during 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 STADA contains sodium, sorbitol, propyl parahydroxybenzoate, methyl parahydroxybenzoate, and cochineal red

This medicine contains 77 mg of sodium (a main component of table 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 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.

It may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate (E-217) and methyl parahhydroxybenzoate (E-218).

This medicine may cause allergic reactions because it contains cochineal red (Ponceau 4R) (E-124). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Citicolina STADA

Follow exactly the instructions for use of this medicine as indicated by your doctor. 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.

If you take more Citicolina STADA than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Citicolina STADA

Take your dose as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Citicolina STADA

Your doctor will advise you on the duration of your treatment with citicoline. Do not stop treatment before consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citicoline STADA

Keep this medicine out of the sight and reach of children.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Citicolina STADA

• 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), liquid sorbitol (E-420), glycerol (E-422), methylparaben (E-218), propylparaben (E-217), sodium citrate (E-331), glycerin formaldehyde, potassium sorbate (E-202), strawberry flavour (containing propylene glycol (E-1520), red colour Ponceau 4R (E-124)), citric acid (E-330), and purified water.

Nature of the product and contents of the pack

Citicolina STADA is a pink, transparent oral solution with strawberry odour and flavour, packed 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 commercially available.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Galenicum Health, S.L.U.

Sant Gabriel, 50

08950 Esplugues de Llobregat

Barcelona (Spain)

or

SAG Manufacturing, S.L.U.

Crta N-I, Km 36

28750 San Agustín de Guadalix

Madrid (Spain)

Date of the most recent revision of this leaflet: December 2013

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/