Label: information for the user

Somazina 1000 mg injectable solution

Citicolina

Read this label carefully before starting to use the medication.

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

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

This medication 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 that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

1. What Somazina 1000 mg injectable solution is and for what it is used

2. Before using Somazina 1000 mg injectable solution

3. How to use Somazina 1000 mg injectable solution

4. Possible adverse effects

5. Storage of Somazina 1000 mg injectable solution

6. Additional information

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

Somazina is used for the treatment of memory and behavior alterations associated with:

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

Do not use Somazina

- if you are allergic to citicoline or any of the other components of Somazina.

- if you have hypertonia of the parasympathetic nervous system, a severe condition with low blood pressure, sweating, tachycardia, and fainting.

Be especially careful with Somazina

- When administered in case of persistent intracranial hemorrhage, do not administer more than 1000 mg per day, in very slow intravenous administration (30 drops/minute).

Other medications and Somazina

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

Somazina potentiates 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 concurrently with medications containing meclofenoxate, a central nervous system stimulant.

Use of Somazina with food and beverages

If your doctor instructs you to do so, Somazina can be used with meals or without 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, if you think you may be pregnant, or during breastfeeding, unless your doctor considers it necessary.

Driving and operating machinery

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

Somazina contains sodium

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

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

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

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

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

If your doctor instructs you to do so, this medication can be administered orally. The contents of the ampule can be taken directly or dissolved in half a glass of water (120 ml) with meals or without 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used.

If you forgot to use Somazina

In case of forgotten dose, wait for the next one. Do not use a double dose to compensate for the missed doses.

If you interrupt the treatment with Somazina

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

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

Like all medications, Somazina may have adverse effects, although not everyone will experience them.

The adverse effects of this medication are very rare (less than 1 in 10,000 patients). It may cause headache, dizziness, nausea, occasional diarrhea, facial flushing, swelling of the extremities, 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 are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Do not use Somazina after the expiration date that appears on the packaging.

Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Somazina

- The active ingredient is citicoline. Each ml of solution contains 250 mg of citicoline.

- The other components (excipients) are: water for injection preparations and hydrochloric acid to adjust the pH.

Appearance of the product and contents of the package

Flint ampoules containing a transparent, colorless, and odorless liquid.

Each glass ampoule contains 4 ml.

It is presented in packages containing 3 or 10 ampoules.

Marketing Authorization Holder

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for Manufacturing

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)

Last review date of this leaflet:April 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es.