ETHOSUXIMIDE NEURAXPHARMA Oral solution Ref.[8336] Active ingredients: Aethosuximide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str. 23, 40764, Langenfeld, Germany

Product name and form

Ethosuximide neuraxpharm 50 mg/ml oral solution.

Pharmaceutical Form

Oral solution.

Clear, colourless to slightly yellow solution.

Qualitative and quantitative composition

1 ml oral solution contains 50 mg ethosuximide.

Excipients with known effect: 1 ml oral solution contains 0.6 mg Methyl-4-hydroxybenzoate (E218).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Aethosuximide

Ethosuximide is an anti-epileptic of the class of succinimides that apparently exerts multiple mechanisms of action. The activity of ethosuximide in absence type epilepsy seems to rely primarily on the inhibition of T-type calcium channels in the thalamus.

List of Excipients

Methyl-4-hydroxybenzoate (E218)
Hypromellose
Macrogol 300
Sodium citrate dihydrate
Citric acid monohydrate
Saccharin sodium
Cream caramel flavour (contains propylene glycol and vanillin)
Purified water

Pack sizes and marketing

Brown glass bottle (glass type III) with screw cap (polypropylene/polyethylene).

Packs of 125 ml or 250 ml (2 × 125 ml) oral solution in a carton containing also a 10 ml graduated oral syringe, graduated in 0.5 ml steps and an adapter for the oral syringe.

Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str. 23, 40764, Langenfeld, Germany

Marketing authorization dates and numbers

PL 48035/0024

21/06/2018

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