Somazina 1000 mg solucion oral

Somazina 1000 mg oral solution

Citicolina

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

2.Before taking Somazina 1000 mg oral solution.

3.How to take Somazina 1000 mg oral solution.

4.Possible adverse effects.

5.Storage of Somazina 1000 mg oral solution.

6.Additional information

Somazina belongs to a group of medications 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 cranial trauma, which is a blow to the head.

Children

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

Do not takeSomazina

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

- if you have hyperparasympathetic nervous system hypertension, a severe condition with 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 obtained 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 central nervous system 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 contains 2000 mg of sorbitol in each sachet. 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 (or your child) before taking this medication.

This medication may cause allergic reactions because it contains cochineal red A (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 sachet. This is equivalent to 3% 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 1 to 2 packets 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 without them.

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 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 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 the 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 containers and medicines you no longer need. This will help protect the environment.

Composition of Somazina

- The active ingredient is citicoline. Each package contains 1000 mg of citicoline (as sodium salt).

- The other components (excipients) are: sodium saccharin (E-954), liquid sorbitol (E-420),

glycerol(E-422), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216),

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

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

Appearance of the product and contents of the packaging

Somazina is a transparent oral solution of pink color, with strawberry smell and taste, packaged in sachets.

It is presented in packaging containing 10 and 30 sachets with 10 ml of oral solution each.

Marketing Authorization Holder

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)

or

Joan XXIII, 10

08950-Esplugues del Llobregat

Barcelona (Spain)

Last review date of this leaflet:May 2021.