Citicoline Teva-Ratiopharm 1000 mg oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Citicolina Teva-ratiopharm 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Citicolina Teva-ratiopharm belongs to a group of medicines called psychostimulants and nootropics, which work by improving brain function.

Citicolina Teva-ratiopharm 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
• traumatic brain injury, which is a blow to the head.

2. What you need to know before taking Citicolina Teva-ratiopharm

Do not take Citicolina Teva-ratiopharm

• 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, pharmacist, or nurse before taking Citicolina Teva-ratiopharm

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

Children

Citicolina Teva-ratiopharm has not been adequately studied in children and should only be administered if your doctor considers it necessary.

Taking Citicolina Teva-ratiopharm with other medicines

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

Citicolina Teva-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 Teva-ratiopharm should not be taken together with medicines containing meclofenoxate, a central nervous system stimulant.

Taking Citicolina Teva-ratiopharm with food and drinks

Citicolina Teva-ratiopharm 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 Teva-ratiopharm, 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 and use machinery have been observed.

Citicolina Teva-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 patient cannot metabolize fructose, consult your doctor (or your child’s doctor) before taking this medicine.

Citicolina Teva-ratiopharm contains carmine red

May cause allergic-type reactions.

Citicolina Teva-ratiopharm contains parahydroxybenzoates

May cause allergic reactions (possibly delayed).

Citicolina Teva-ratiopharm contains formaldehyde

May cause stomach discomfort and diarrhea.

Citicolina Teva-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 recommended sodium intake for an adult.

3. How to take Citicolina Teva-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 Teva-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 Teva-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 Teva-ratiopharm

Your doctor will determine the duration of your treatment with Citicolina Teva-ratiopharm. 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 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 Teva-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 or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, 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 CiticolinaTeva-ratiopharm

• 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), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium citrate (E-331), glycerol formal, potassium sorbate (E-202), strawberry flavouring, red colour Ponceau 4R (E-124), citric acid (E-330) and purified water.

Appearance of the product and contents of the pack

Citicolina Teva-ratiopharm is a pink, transparent oral solution with a strawberry odour and flavour, supplied in sachets.

It is available in packs containing 10 sachets or 30 sachets (3 units of 10 sachets each) with 10 ml of oral solution in each sachet.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

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

Crta 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 review of this leaflet: February 2014

Other sources of information

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

You can access detailed information about this medicine by scanning the QR code included on the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78263/P_78263.html

QR Code + URL