NEOFORDEX Tablet

Active ingredients: Dexamethasone

Product name and form

Neofordex 40 mg tablets.

Pharmaceutical Form

Tablet.

White, oblong (11 mm × 5.5 mm) tablet with a score-line on one face.

The tablet can be divided for administration of a 20 mg dose (see section 4.2).

Qualitative and quantitative composition

Each tablet contains dexamethasone acetate, equivalent to 40 mg dexamethasone.

Excipient with known effect: Each tablet contains 98.1 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response.

List of Excipients

Lactose monohydrate
Microcrystalline cellulose
Magnesium stearate
Colloidal anhydrous silica

Pack sizes and marketing

10 × 1 tablets in OPA/Aluminium/PVC-Aluminium perforated unit dose blister. Pack size of 10 tablets.

Marketing authorization holder

Laboratoires CTRS, 63, rue de l’Est, 92100 Boulogne-Billancourt, France, Email: ctrs@ctrs.fr

Marketing authorization dates and numbers

EU/1/15/1053/001

Date of first authorisation: 16 March 2016

Drugs

Drug
Countries
Austria, Estonia, Finland, France, Ireland, Lithuania, Poland