SOMAZINA 100 mg/ml ORAL SOLUTION

Introduction

Somazina 100 mg/ml oral solution

Citicolina

Read the entire leaflet carefully before starting to take the medicine.

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

If you have any doubts, 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 100 mg/ml oral solution is and what it is used for.
2. Before taking Somazina 100 mg/ml oral solution.
3. How to take Somazina 100 mg/ml oral solution.
4. Possible adverse effects.
5. Storage of Somazina 100 mg/ml oral solution.
6. Additional information

1. What is SOMAZINA 100 mg/ml ORAL 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 for the treatment of memory and behavioral disorders due to:

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

2. Before taking SOMAZINA 100 mg/ml ORAL SOLUTION

Do not takeSomazina

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

Be careful with Somazina

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

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.

Taking Somazina with food and drinks

Somazina can be taken 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 have been observed on the ability to drive and use machinery.

Somazina contains sorbitol (E-420), cochineal red (Ponceau 4R, E-124), propyl parahydroxybenzoate (E-216), methyl parahydroxybenzoate (E-218), formaldehyde, and sodium

This medicine contains 2000 mg of sorbitol in each 10 ml of oral solution. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

This medicine may cause allergic reactions because it contains cochineal red (Ponceau 4R, E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

It may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218).

This medicine may cause stomach upset and diarrhea because it contains formaldehyde.

This medicine contains 61.4 mg of sodium (main component of table salt/cooking salt) in each 10 ml of oral solution. This is equivalent to 3% of the maximum daily sodium intake recommended for an adult.

3. How to take SOMAZINA 100 mg/ml ORAL 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 (5 ml) to 2000 mg (20 ml) per day, depending on the severity of your disease. It 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 take moreSomazinathan 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 takeSomazina

Take your dose as soon as you remember. Do not take a double dose to make up for forgotten 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 doubts 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 all people suffer from them.

The adverse 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 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.

5. Storage of SOMAZINA 100 mg/ml ORAL 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 disposed of through wastewater or household waste. 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 citicolina. Each ml contains 100 mg of citicolina (as sodium salt).
• The other components (excipients) are: sodium saccharin (E954), liquid sorbitol (E420),

glycerol (E422), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),

sodium citrate (E331), glycerol formaldehyde, potassium sorbate (E-202), strawberry flavor,

red Ponceau 4R color (E124), citric acid (E330), and purified water.

Appearance of the product and packaging content

Somazina is a clear, pink-colored oral solution with a strawberry flavor and odor. It contains 100 mg of citicolina per milliliter of solution.

It is presented in a 30 ml glass bottle. The packaging also includes a dosing syringe.

Marketing authorization holder

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

FERRER INTERNACIONAL, S.A.

Joan Buscallá, 1-9

08173-Sant Cugat del Vallés, Barcelona (Spain)

FERRER INTERNACIONAL, S.A.

Joan XXIII, 10

08950-Esplugues del Llobregat

Barcelona (Spain)

Date of the last revision of this leaflet:May 2021