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

Product name and form

Somazina 100 mg/ml oral solution.

Pharmaceutical Form

Oral solution.

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

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.

Active Ingredient Description
Citicoline

Citicoline stimulates the biosynthesis of structural phospholipids of the neuronal membrane. 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.

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

Pack sizes and marketing

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.

Marketing authorization holder

Ferrer Internacional, S.A, Gran Via de Carlos III, 94, 08028, Barcelona

Marketing authorization dates and numbers

MA130/00201

29th September 2005 / 30th November 2015

Drugs

Drug Countries
SOMAZINA Ecuador, Spain, Hong Kong, Malta, Mexico

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.