Somazina 500 mg solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Somazina 500 mg injectable solution

Citicoline

Read the entire leaflet carefully before you start using this medicine.

Keep this leaflet, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Somazina 500 mg injectable solution is and what it is used for
2. Before using Somazina 500 mg injectable solution
3. How to use Somazina 500 mg injectable solution
4. Possible side effects
5. How to store Somazina 500 mg injectable solution
6. Further information

1. What SOMAZINA 500 mg INJECTABLE SOLUTION is and what it is used for

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

Somazina is used to treat memory and behavioral disturbances associated with:

• stroke, which is an interruption of blood supply to the brain due to a blood clot or rupture of a blood vessel, in the acute and subacute phases.
• head trauma, which is a blow to the head.

2. BEFORE USING SOMAZINA 500 mg INJECTABLE SOLUTION

Do not use Somazina

• if you are allergic to citicoline or to any of the other components of Somazina.
• if you suffer from parasympathetic nervous system hyperactivity, a serious condition characterized by low blood pressure, sweating, tachycardia, and fainting.

Take special care with Somazina

• When administered in cases of persistent intracranial hemorrhage, no more than 1000 mg should be given per day, by very slow intravenous infusion (30 drops/minute).

Use with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Somazina enhances the effects of L-Dopa; therefore, it should not be administered concomitantly with medicines containing L-Dopa without first consulting your doctor. Medicines containing L-Dopa are commonly used to treat Parkinson's disease.

Somazina should not be administered together with medicines containing meclofenoxate, a cerebral stimulant.

Use of Somazina with food and drink

As directed by your doctor, Somazina may be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine. Somazina, like most medicines, should not be administered during pregnancy, if you suspect you may be pregnant, or during breastfeeding, unless considered necessary by your doctor.

Driving and using machines

No effects on the ability to drive or operate machinery have been observed.

3. HOW TO USE SOMAZINA 500 mg INJECTABLE SOLUTION

Follow exactly the administration instructions for Somazina given by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual dose is 500 mg to 2,000 mg per day, depending on the severity of your condition.

Somazina may be administered by intramuscular route, slow intravenous injection (over 3 to 5 minutes, depending on the dose), or by intravenous infusion (40 to 60 drops per minute).

Somazina is compatible with all isotonic intravenous solutions. It may also be mixed with hypertonic glucose serum.

If directed by your doctor, this medicine may be administered orally. The contents of the ampoule may be taken directly or dissolved in half a glass of water (120 ml), with or without food.

Use in children

Somazina has not been adequately studied in children and should only be administered if considered necessary by your doctor.

If you use more Somazina than you should

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

If you forget to use Somazina

If you miss a dose, wait until the next scheduled dose. Do not use a double dose to make up for missed doses.

If you stop using Somazina

Your doctor will determine the duration of your treatment with Somazina. Do not discontinue treatment before consulting your doctor.

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

4. Possible adverse effects

Like all medicines, Somazina can have adverse effects, although not everyone will experience them.

The adverse effects of this medicine are very rare (less than 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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, tell your doctor or pharmacist.

5. Storage of SOMAZINA 500 mg INJECTABLE SOLUTION

Keep out of the reach and sight of children.

Do not use Somazina after the expiry date stated on the container.

Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Somazina

• The active substance is citicoline. Each ml of solution contains 125 mg of citicoline.
• The other components (excipients) are: water for injectable preparations and hydrochloric acid to adjust pH.

Appearance of the product and contents of the container

Ampoules containing a transparent, colorless, and odorless liquid.

Each glass ampoule contains 4 ml.

Packaged in packs containing 5 or 10 ampoules.

Marketing Authorization Holder

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

FERRER INTERNACIONAL, S.A.

Buscallá, 1-9

08190-Sant Cugat del Vallés, Barcelona (Spain)

or

FAMAR HEALTH CARE SERVICES MADRID, S.A.U

Avenida de Leganés, 62

28923 Alcorcón (MADRID)

This patient information leaflet was approved in January 2006

August 2010 version

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