TRILASYM Oral solution Ref.[8673] Active ingredients: Amantadine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Fontus Health Ltd, 60 Lichfield Street, Walsall, WS4 2BX, United Kingdom

Product name and form

Trilasym 50 mg/5 ml Oral Solution.

Pharmaceutical Form

Oral Solution.

Clear, colourless, raspberry-flavoured liquid.

Qualitative and quantitative composition

Each 5 ml of Oral Solution contains 50 mg of amantadine hydrochloride.

Excipient(s) with known effect:

Each 5 ml also contains:

3250 mg of sorbitol (E420)

10 mg of sodium benzoate (E211)

6.5 mg raspberry flavour containing ethanol, propylene glycol (E 1520) and benzyl alcohol

For the full list of excipients, see section 6.1.

Active Ingredient Description
Amantadine

Amantadine has been shown to be a low affinity antagonist at the N-methyl-D-aspartate (NMDA) subtype of glutamate receptors. Overactivity of glutamatergic neurotransmission has been implicated in the generation of parkinsonian symptoms. In addition, amantadine specifically inhibits the replication of influenza A viruses at low concentrations.

List of Excipients

Sodium benzoate (E211)
Sorbitol (E420)
Raspberry flavour – containing ethanol, propylene glycol (E1520) and benzyl alcohol
Citric acid monohydrate
Purified Water

Pack sizes and marketing

Type III amber glass bottle with a tamper evident polypropylene child-resistant screw cap with a polyethylene inner liner containing 150ml of solution with a polypropylene dosing cup.

Pack size: 150 ml.

Marketing authorization holder

Fontus Health Ltd, 60 Lichfield Street, Walsall, WS4 2BX, United Kingdom

Marketing authorization dates and numbers

PL 42924/0020

03/05/2019

© 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.