Somazina 100 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Somazina 100 mg/ml oral solution

Citicoline

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

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

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

This medicine has been prescribed for you; do not give it 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 100 mg/ml oral solution is and what it is used for.
2. Before you take Somazina 100 mg/ml oral solution.
3. How to take Somazina 100 mg/ml oral solution.
4. Possible side effects.
5. How to store Somazina 100 mg/ml oral solution.
6. Further information.

1. What SOMAZINA 100 mg/ml ORAL SOLUTION is and what it is used for

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

Somazina is used to treat memory and behavioral disturbances due to:

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

2. Before taking SOMAZINA 100 mg/ml ORAL SOLUTION

Do not take Somazina

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

Take special care with Somazina

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

Other medicines and Somazina

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 simultaneously with medications containing L-Dopa unless approved by your doctor. Medications containing L-Dopa are commonly used to treat Parkinson's disease.

Somazina should not be administered concomitantly with medications containing meclofenoxate, a cerebral stimulant.

Taking Somazina with food and drinks

Somazina may be taken with or without food.

Pregnancy and breast-feeding

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

Driving and using machines

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

Somazina contains sorbitol (E-420), carmine 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 informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor before taking this medicine.

This medicine may cause allergic reactions because it contains carmine red (Ponceau 4R, E-124). It may trigger 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 discomfort and diarrhea because it contains formaldehyde.

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

3. How to take SOMAZINA 100 mg/ml ORAL SOLUTION

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

The usual dose is 500 mg (5 ml) to 2,000 mg (20 ml) per day, depending on the severity of your condition. It can be taken directly or diluted 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 your doctor considers it necessary.

If you take more Somazina than you should

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

If you forget to take Somazina

Take the missed dose as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Somazina

Your doctor will advise you on 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 may have adverse effects, although not everyone experiences 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 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 experience to be severe, or if you notice any adverse effect not listed 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 expiry date stated on the container.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Information for the User

Composition of Somazina

• The active substance is citicoline. Each ml contains 100 mg of citicoline (as the sodium salt).
• The other components (excipients) are: sodium saccharin (E954), liquid sorbitol (E420),
  glycerol (E422), methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216),
  sodium citrate (E331), glycerol formaldehyde, potassium sorbate (E202), strawberry flavour,
  Ponceau 4R red colour (E124), citric acid (E330) and purified water.

Appearance of the medicinal product and contents of the pack

Somazina is a pink, transparent oral solution with strawberry odour and flavour. It contains 100 mg of citicoline per millilitre of solution.

It is available in a 30 ml glass bottle. The package also includes an oral 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 most recent revision of this leaflet: May 2021