Somazina 1000 mg oral solution

Package leaflet: Information for the user

Introduction

Somazina 1000 mg 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 and should not be given 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 severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Somazina 1000 mg oral solution is and what it is used for.
2. Before taking Somazina 1000 mg oral solution.
3. How to take Somazina 1000 mg oral solution.
4. Possible side effects.
5. How to store Somazina 1000 mg oral solution.
6. Further information

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

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

Somazina is used to treat memory and behavioral disturbances caused by:

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

2. Before taking SOMAZINA 1000 mg ORAL SOLUTION

Children

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

Do not take Somazina

• if you are allergic to citicoline or to any of the other components of Somazina.
• if you have parasympathetic nervous system hyperactivity, 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 potentiates the effects of L-Dopa; therefore, it should not be administered concomitantly with medications containing L-Dopa without consulting your doctor. Medications containing L-Dopa are commonly used to treat Parkinson's disease.

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

Taking Somazina with food and drink

Somazina may be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine. Somazina, like most medicines, should not be administered during pregnancy, if you suspect you might be pregnant, or during breastfeeding, unless your doctor considers it necessary.

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 per sachet. Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with intolerance to certain sugars, or with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor (or your child’s doctor) before taking this medicine.

This medicine may cause allergic reactions because it contains carmine red A (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 discomfort and diarrhea because it contains formaldehyde.

This medicine contains 61.4 mg of sodium (the main component of table/cooking salt) per sachet. This corresponds to 3% of the maximum daily recommended sodium intake for an adult.

3. How to take SOMAZINA 1000 mg ORAL SOLUTION

Follow exactly the administration instructions for Somazina provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

The usual dose is 1 to 2 sachets per day, depending on the severity of your condition. It can be taken directly or dissolved in half a glass of water (120 ml), with or without food.

If you take more Somazina than you should

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

If you forget to take Somazina

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

If you stop taking Somazina

Your doctor will determine 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). Headache, dizziness, nausea, occasional diarrhoea, 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 any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, please inform your doctor or pharmacist.

5. STORAGE OF SOMAZINA 1000 mg 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 down the drain or with household waste. Ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Information provided

Composition of Somazina

• The active substance is citicoline. Each sachet contains 1000 mg of citicoline (as the sodium salt).
• The other components (excipients) are: sodium saccharin (E-954), liquid sorbitol (E-420),

glycerol (E-422), methylparaben (E-218), propylparaben (E-216),

sodium citrate (E-331), glycerol formaldehyde, potassium sorbate (E-202), strawberry flavor,

cochineal red A (Ponceau 4R) (E-124), citric acid (E-330) and purified water.

Appearance of the product and contents of the pack

Somazina is a transparent pink oral solution with a strawberry odor and flavor, packed in sachets.

It is available in packs containing 10 and 30 sachets, each with 10 ml of oral solution.

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)

or

Joan XXIII, 10

08950-Esplugues del Llobregat

Barcelona (Spain)

Date of the most recent review of this leaflet: May 2021.