SOMAZINA 1g INJECTABLE SOLUTION

Introduction

Leaflet: information for the user

Somazina 1000 mg injectable solution

Citicoline

Read the entire leaflet carefully before starting to use the 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 to you and should not be given to others, even if they have the same symptoms, as it may harm them.

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What Somazina 1000 mg injectable solution is and what it is used for
2. Before using Somazina 1000 mg injectable solution
3. How to use Somazina 1000 mg injectable solution
4. Possible side effects
5. Storage of Somazina 1000 mg injectable solution
6. Additional information

1. What is SOMAZINA 1000 mg INJECTABLE SOLUTION and what is it used for

Somazina belongs to a group of medicines called psychostimulants and nootropics, which act by improving brain function.

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

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

2. BEFORE USING SOMAZINA 1000 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 serious condition with low blood pressure, sweating, tachycardia, and fainting.

Be careful with Somazina

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

Other medicines and Somazina

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

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

Somazina should not be administered together with medicines containing meclofenoxate, which is a brain stimulant.

Using 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 medicine. Somazina, like most medicines, 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.

Somazina contains sodium

This medicine contains 45 mg of sodium (main component of table salt/cooking salt) in each 4ml ampoule. This is equivalent to 2.25% of the maximum daily sodium intake recommended for an adult.

3. HOW TO USE SOMAZINA 1000 mg INJECTABLE SOLUTION

Follow exactly the administration instructions of Somazina indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

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 administration (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 medicine 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 medicine 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 forgotten doses.

If you stop 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 the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Somazina can have side effects, although not everyone gets them.

The side effects of this medicine are very rare (less than 1 in 10,000 patients). Headache, dizziness, nausea, occasional diarrhea, facial flushing, swelling of the limbs, 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 suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of SOMAZINA 1000 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.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines 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 250 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 content

Ampoules containing a clear, colorless, and odorless liquid.

Each glass ampoule contains 4 ml.

It is presented in packaging containing 3 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 (Spain)

Date of the last revision of this leaflet:April 2021

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