DIFFLAM Lozenge

Active ingredients: Benzydamine

Product name and form

Difflam 3 mg Lozenges, mint flavour.

Pharmaceutical Form

Lozenge.

Green square-shaped lozenges, with a central cavity.

Qualitative and quantitative composition

Each lozenge contains 3 mg of benzydamine hydrochloride equivalent to 2.68 mg benzydamine.

Excipients with known effects: each lozenge contains 3183 mg of Isomalt (E953) and 3.5 mg of Aspartame (E951).

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Benzydamine exerts an anti-inflammatory and analgesic action by stabilising the cellular membrane and inhibiting prostaglandin synthesis.

List of Excipients

Isomalt (E953)
Aspartame (E951)
Levomenthol
Citric acid, monohydrate
Lemon flavour
Mint flavour
Quinoline yellow (E104)
Indigotin dye (E132)

Pack sizes and marketing

Lozenge is wrapped in paraffin paper.

Ten lozenges are wrapped together in printed polyethylene-paper-aluminium trilaminated material.

Each pack contains 20 or 30 lozenges (two or three packets of ten lozenges each).

Not all pack size may be marketed.

Marketing authorization holder

Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK

Marketing authorization dates and numbers

PL 46302/0095

Date of first authorisation: 30/01/2001
Date of latest renewal: 06/08/2010

Drugs

Drug
Countries
Australia, Cyprus, Hong Kong, Ireland, Singapore, United Kingdom