Somazina 100 mg/ml oral solution

Citicolina

1.What Somazina 100 mg/ml oral solution is and for what it is used.

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

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 due to:

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

Do not takeSomazina

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

- if you have autonomic nervous system hypertension, a serious condition with low blood pressure, sweating, tachycardia, and fainting.

arterial low blood pressure, sweating, tachycardia, and fainting.

Be especially careful with Somazina

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

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, which is a cerebral stimulant.

Taking Somazina with food and beverages

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

This medication contains2000mg 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 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 (or your child) before taking this medication.

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

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

This medication may cause stomach discomfort and diarrhea because it contains formaldehyde.

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

Follow exactly the administration instructions for Somazina as indicated 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 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 take moreSomazinathan 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 takeSomazina

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

If you interrupt treatment with Somazina

Your doctor will indicate the duration of your treatment with Somazina. Do not discontinue treatment without consulting your doctor.

If you have any other questions 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. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Somazina

- The active ingredient is citicoline. Each ml contains 100 mg of citicoline (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 essence,

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

Appearance of the product and contents of the packaging

Somazina is a transparent oral solution of pink color, with a strawberry smell and taste. It contains 100 mg of citicoline per milliliter of solution.

It is presented in a 30 ml glass vial. The packaging also contains a dosing syringe.

Holder of the marketing authorization

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028Barcelona (Spain)

Responsible for manufacturing

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)

Revision date of this leaflet:May 2021