SOMAZINA 500 mg Injectable Solution

2. BEFORE USING SOMAZINA 500 mg INJECTABLE SOLUTION

Do not use Somazina

• if you are allergic to citicoline or any of the other components of Somazina.
• if you have parasympathetic nervous system hypertonia, which is a severe condition with low blood pressure, sweating, tachycardia, and fainting.

Be careful when using Somazina

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

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Somazina enhances the effects of L-Dopa, so it should not be administered at the same time as medications containing L-Dopa, without consulting your doctor. Medications containing L-Dopa are usually used to treat Parkinson's disease.

Somazina should not be administered in conjunction with medications containing meclofenoxate, which is a brain stimulant medication.

Use of Somazina with food and drinks

If your doctor indicates, Somazina can be used with meals or outside of them.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication. Somazina, like most medications, should not be administered if you are pregnant, think 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.

3. HOW TO USE SOMAZINA 500 mg INJECTABLE SOLUTION

Follow your doctor's instructions for administering Somazina exactly. Consult your doctor or pharmacist if you have any questions.

The normal dose is 500 mg to 2000 mg per day, depending on the severity of your illness.

Somazina can be administered intramuscularly, by slow intravenous infusion (3 to 5 minutes, depending on the dose), or by intravenous drip infusion (40 to 60 drops per minute).

Somazina is compatible with all isotonic intravenous solutions. It can also be mixed with hypertonic glucose solution.

If your doctor indicates, this medication can be administered orally. The contents of the ampoule can be taken directly or dissolved in half a glass of water (120 ml) with meals or outside of them.

Use in children

Somazina has not been adequately studied in children, so it should only be administered if your doctor considers it necessary.

If you use more Somazina than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to use Somazina

In case of forgetting a dose, wait for the next one. Do not use a double dose to make up for the missed doses.

If you interrupt treatment with Somazina

Your doctor will indicate the duration of your treatment with Somazina. Do not stop treatment before consulting your doctor.

If you have any other questions about using this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Somazina can have side effects, although not everyone experiences them.

The side effects of this medication are very rare (less than 1 in 10,000 patients). Headache, dizziness, nausea, occasional diarrhea, facial flushing, swelling of the extremities, and changes in blood pressure may occur. If you experience any of these or other symptoms, inform your doctor.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform 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 expiration date shown on the packaging.

Store in the original packaging.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Somazina

• The active ingredient 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 the pH.

Appearance of the product and packaging contents

Ampoules containing a clear, colorless, and odorless liquid.

Each glass ampoule contains 4 ml.

It is presented in packaging 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 package leaflet was approved in January 2006

Version August 2010

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es.