SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Somazina 100 mg/ml oral solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Somazina 100 mg/ml oral solution is packaged in glass bottles containing 30 ml. Each ml contains
100 mg of citicoline (as sodium salt).

Excipients:
Both formats contain per ml of solution: 0.005 mg of Ponceau 4-R red colour; 0.4 mg of propyl
parahydroxybenzoate; 1.6 mg of methyl parahydroxybenzoate; 200 mg of liquid sorbitol and other
excipients in q.s.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral solution.

Somazina 100 mg/ml oral solution: Glass bottle containing 30 ml of a transparent and pink-
coloured solution, with strawberry smell and taste.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

 Treatment of cognitive and neurological disorders associated with acute and sub-acute
stroke.

 Treatment of cognitive and neurological disorders associated with traumatic brain injuries.

4.2 Posology and method of administration

Posology

Adults:
The recommended dose is from 500 to 2,000 mg/day, depending on the severity of the symptoms
to be treated.

Older people:

Somazina does not need any specific dose adjustment for this age group.

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Children:

The experience in children is limited; therefore it may only be administered when the expected
therapeutical benefit is higher than any possible risk.

Method of administration

See the instructions for preparation of the medicine in section 6.6.

4.3 Contraindications

Hypersensitivity to citicoline or to any of the excipients.

It is contraindicated for patients with hypertonia of the parasympathetic nervous system.

4.4 Special Warnings and precautions for use

Due to cochineal red (Ponceau 4-R or E-124) it may cause allergic reactions.

It may cause asthma, especially in patients with allergy to acetylsalicylic acid.

Somazina contains Sorbitol (E-420) as excipient, because of that, patients with hereditary
problems of fructose intolerance should not take this medicine.

Somazina contains parahydroxybenzoates in the form of propyl (E-217) and methyl (E-218) esters,
therefore, it may cause allergic reactions (possibly delayed).

4.5 Interaction with other medicinal products and other forms of interaction

Citicoline potentiates the effects of the medicines containing L-Dopa.

It must not be administered concomitantly with medicines containing Meclofenoxate.

4.6 Pregnancy and lactation

There are no adequate data from the use of Citicoline in pregnant women.

Somazina should not be used during pregnancy unless clearly necessary. That is, only when the
expected therapeutic benefit is higher than any possible risk (see section 5.3).

4.7 Effects on the ability to drive and use machines

Somazina has no influence on the ability to drive and use of machines.

4.8 Undesirable effects

Very rare (<1/10,000) (include individual notifications)

Psychiatric disorders: hallucinations
Nervous system disorders: cephalea, vertigo
Vascular disorders: arterial hypertension, arterial hypotension
Respiratory, thoracic and mediastinal disorders: dyspnoea
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Gastrointestinal disorders: nausea, vomiting, occasional diarrhoea
Skin and subcutaneous tissue disorders: blush, hives, exanthemas, purple
General disorders and administration site conditions: shiver, oedema

4.9 Overdose

No case of overdose has been reported

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other psychostimulants and nootropics.

ATC code: N06BX06

Citicoline stimulates the biosynthesis of structural phospholipids of the neuronal membrane as it is

demonstrated in the magnetic resonance spectroscopy studies. Citicoline, through this action,
improves the function of the membrane mechanisms, such as the functioning of the ionic exchange
pumps and receptors inserted in the latter, the modulation of which is indispensable in the
neurotransmission.

Citicoline due to its membrane stabilising activity has properties which favour brain oedema
reabsorption.

Experimental studies showed that Citicoline inhibits the activation of some phospholipases (A1,
A2, C and D), reducing the formation of free radicals, avoiding the destruction of membranous
systems and preserving antioxidant defence systems as glutation.

Citicoline preserves the neuronal energetic reserve, inhibits apoptosis and stimulates acetylcholine
synthesis

It has been experimentally shown that Citicoline also exerts a prophylactic neuroprotective effect
in focal brain ischemic models.

Clinical trials showed that Citicoline significantly increases the functional evolution of patients
with acute ischemic cerebrovascular accident, coinciding with a lower growth of the brain
ischemic injury in neuroimaging tests.

In patients with craniocerebral traumatisms, citicoline speeds up their recuperation and reduces the
duration and intensity of the post-concussional syndrome.

Citicoline improves the level of attention and consciousness and acts favourably over amnesia and
cognitive and neurological disorders associated to brain ischemia.

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5.2 Pharmacokinetic properties

Citicoline is well absorbed after oral, intramuscular or intravenous administration. Plasma choline
levels significantly increase through the aforementioned routes. Oral absorption is nearly complete
and its bioavailability is approximately the same as the intravenous route. The medicine is
metabolized in the intestine wall and in the liver to choline and cytidine. The administered
citicoline is widely distributed in brain structures, with a quick incorporation of the choline
fraction in structural phospholipids and the cytidine fraction in cytidinic nucleotides and nucleic
acids. Citicoline reaches the brain and it is actively incorporated to cellular, cytoplasmatic and
mitochondrial membranes, taking part of the structural phospholipids fraction.

Only a small amount of the dose appears in urine and faeces (less than 3 %). Approximately 12 %
of the dose is eliminated via expired CO 2. In the urinary excretion of the drug, two phases can be
distinguished: a first phase, around 36 hours, where the excretion speed rapidly decreases, and a
second phase where excretion speed decreases much slower. The same happens with expired CO 2 ,
the elimination speed rapidly decreases after approximately 15 hours and later it decreases much
slower.

5.3 Preclinical safety data

Oral (1.5 g/kg/day during 6 months in dogs) and intraperitoneal (1g/kg/day during 12 weeks in
rats) chronic toxicity studies did not show significant abnormalities related with the administration
of the drug. Intravenous administration of 300-500 mg/kg/day of citicoline during 3 months in
dogs only produced toxic signs immediately after the injection, such as occasional vomiting,
diarrhoea and hyper-salivation.

800 mg/kg of Citicoline was administered to albino rabbits during the organogenesis phase, that is,
from 7th to 18th gestation day. The animals were sacrificed on the 29th day and a detailed exam of
foetus and their mothers was carried out. No maternal or embryo-foetal toxicity signs were
observed. The effects over organogenesis were inappreciable, only 10 % of the treated foetus
showed a slight delay in brain osteogenesis.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Both Somazina 100 mg/ml oral solution (30 ml bottles) contains the following excipients:

Sodium saccharin ( E-954)

Liquid sorbitol (E-420)
Glycerol (E-422)
Methyl parahydroxybenzoate (E-218)
Propyl parahydroxybenzoate ( E-217)
Sodium citrate (E-331)
Glycerol formal
Potassium sorbate ( E-202)
Strawberry essence
Ponceau 4-R red colour ( E-124)
Citric acid (E-330)
Purified water

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6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Somazina 100 mg/ ml oral solution: 3 years.

6.4 Special precautions for storage

Store in the original package.

6.5 Nature and contents of the container

Somazina 100 mg/ml oral solution is supplied in a pack containing a 30 ml glass bottle with sealed
plastic cap and a syringe graduated in ml.

6.6 Special precautions for disposal and other handling

Handling instructions for the medicinal product are the following:

Somazina 100 mg/ml oral solution

The product is administered with the aid of the dosing syringe, according to the following scheme:

1 -Introduce the dosing syringe with the piston pressing to the bottom.

2 -Aspirate the indicated dose making the piston turn, taking into account that the liquid contained
in the syringe coincides exactly with the prescribed level.

3 - Administer the preparation directly or dissolved in half a glass of water (120 ml).

After each administration, it is recommended to wash the dosing syringe with water.

7. MARKETING AUTHORISATION HOLDER

Ferrer Internacional, S.A

Gran Via de Carlos III, 94
08028 – Barcelona

8. MARKETING AUTHORISATION NUMBERS

MA130/00201

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORIZATION

29th September 2005 / 30th November 2015

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10. DATE OF REVISION OF THE TEXT

30th November 2015

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