Citicoline Ratiopharm 1000 mg oral solution EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Citicolina ratiopharm 1,000 mg oral solution EFG

Read this 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 may 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

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

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

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

Citicolina ratiopharm 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 ratiopharm

Do not take Citicolina ratiopharm

• if you are allergic to citicoline or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from parasympathetic nervous system hypertension, 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 ratiopharm

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

Children

Citicolina ratiopharm has not been adequately studied in children, and should therefore only be administered if considered necessary by your doctor.

Taking Citicolina ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Citicolina ratiopharm 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.

Citicolina ratiopharm should not be taken together with medicines containing meclofenoxate, a cerebral stimulant.

Taking Citicolina ratiopharm with food and drinks

Citicolina ratiopharm can 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 ratiopharm, like most medicines, should not be administered during pregnancy, if you suspect you might 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 ratiopharm contains sorbitol

Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with intolerance to certain sugars, or with hereditary fructose intolerance (HFI), a rare genetic disorder in which the body cannot break down fructose, you (or your child) should consult your doctor before taking this medicine.

Citicolina ratiopharm contains carmine red

It may cause allergic-type reactions.

Citicolina ratiopharm contains parahydroxybenzoates

It may cause allergic reactions (possibly delayed).

Citicolina ratiopharm contains formaldehyde

It may cause stomach discomfort and diarrhea.

Citicolina ratiopharm contains sodium

This medicine contains 83.83 mg of sodium (main component of table/cooking salt) per sachet. This corresponds to 4.19% of the maximum daily sodium intake recommended for an adult.

3. How to take Citicolina ratiopharm

Follow exactly the instructions for use of this medicine as given 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 ratiopharm than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Citicolina ratiopharm

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 ratiopharm

Your doctor will determine the duration of your treatment with Citicolina ratiopharm. Do not discontinue treatment without 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 may cause adverse effects, although not everyone experiences 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 via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citicoline ratiopharm

Keep 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.

Store in the original packaging.

No special storage conditions are required.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 Citicolinaratiopharm

• 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-216), sodium citrate (E-331), glycerinformaldehyde, potassium sorbate (E-202), strawberry flavoring, red color Ponceau 4R (E-124), citric acid (E-330), and purified water.

Appearance of the product and contents of the pack

Citicolina ratiopharm is a pink, transparent oral solution with strawberry odor and flavor, packed in sachets.

It is available in a pack containing 10 sachets or 30 sachets in a multiple pack (3 subunits of 10 sachets), each containing 10 ml of oral solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid, Spain

Manufacturer

STE PHARMA SYSTEMS, S.L.

Avda. Universitat Autònoma, 13

Parc Tecnològic del Vallès,

Cerdanyola del Vallès,

08290 Barcelona (Spain)

Or

Galenicum Health, S.L.U.

Sant Gabriel, 50
Esplugues de Llobregat

08950 Barcelona (Spain)

Or

SAG Manufacturing, SLU

Ctra. N-I, Km 36

28750 San Agustin de Guadalix, Madrid (Spain)

Or

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial Urtinsa II.

Alcorcón

28923, Madrid (Spain)

Date of the most recent revision of this leaflet: February 2014

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/