MARKETING AUTHORIZATION NO.

12313/2019/01-02-03-04-05-06 Annex 3
Labelling information

DIFLEX 50 mg/g gel

Diclofenac Sodium

INFORMATION TO BE INCLUDED ON SMALL PRIMARY PACKAGING

Aluminium tube

1.COMMERCIAL NAME OF THE MEDICINE

DIFLEX 50 mg/g gel

Diclofenac Sodium

Dermal administration

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

4. MANUFACTORING SERIES

Series:

5. CONTENT ON WEIGHT, VOLUME OF UNIT OF DOSE

25 g gel
45 g gel
100 g gel
175 g gel
45 g gel
100 g gel

5. OTHER INFORMATION

S.C. Fiterman Pharma S.R.L.

It also contains hydroxyethyl cellulose, l-menthol, propylene glycol, ethanol 96%, diethylene glycol
monoethyl ether, methyl p-hydroxybenzoate (E218), n-propyl p-hydroxybenzoate (E216), polysorbate
80, and purified water.