SOMAZINA Oral solution Ref.[51153] Active ingredients: Citicoline

Source: Medicines Authority (MT)  Revision Year: 2015  Publisher: Ferrer Internacional, S.A, Gran Via de Carlos III, 94, 08028, Barcelona

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 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

Gastrointestinal disorders: nausea, vomiting, occasional diarrhoea

Skin and subcutaneous tissue disorders: blush, hives, exanthemas, purple

General disorders and administration site conditions: shiver, oedema

6.2. Incompatibilities

Not applicable.

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