Source: Medicines Authority (MT) Revision Year: 2015 Publisher: Ferrer Internacional, S.A, Gran Via de Carlos III, 94, 08028, Barcelona
Hypersensitivity to citicoline or to any of the excipients.
It is contraindicated for patients with hypertonia of the parasympathetic nervous system.
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).
Citicoline potentiates the effects of the medicines containing L-Dopa.
It must not be administered concomitantly with medicines containing Meclofenoxate.
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).
Somazina has no influence on the ability to drive and use of machines.
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
Not applicable.
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