MARKETING AUTHORIZATION NO.

12313/2019/01-02-03-04-05-06 Annex 4
Data on the qualitative and quantitative composition of the medicine

DIFLEX 50mg/g gel

Diclofenac Sodium

Qualitative and quantitative composition

One gram of gel contains:

Diclofenac Sodium 50.00 mg
Hydroxyethyl cellulose 11.00 mg

L-menthol 10.00 mg

Propylene glycol 25.00 mg

Ethanol 96% 200.00 mg

Diethylene glycol monoethyl ether 100.00 mg

Methyl p-hydroxybenzoate (E218) 0.60 mg

N-propyl p-hydroxybenzoate (E216) 0.40 mg

Polysorbate 80 15.00 mg

Purified water 588.00 mg

Description of the authorized medicine

Homogenous gel, transparent, yellowish, with a strong odor of menthol.