DICLODENT Oromucosal solution (Mouthwash)

Active ingredients: Diclofenac

Product name and form

Diclodent 0.74 mg/ml Mouthwash (Oromucosal Solution).

Diclofenac 0.74 mg/ml Mouthwash.

Pharmaceutical Form

Oromucosal solution (Mouthwash).

Qualitative and quantitative composition

100 ml of the solution contains:

Active substance: 0.074 %w/v Diclofenac free acid.

Excipients with known effect:

Sorbitol (E420) 50% w/v
Sodium Benzoate (E211) 1% w/v
Ponceau Red E124 0.005% w/v

For a full list of excipients, see section 6.1.

Active Ingredient

Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac in AK may be related to the inhibition of the cycloxygenase pathway leading to reduced prostaglandin E2 (PGE2) synthesis. In addition, immunohistochemistry (IHC) from skin biopsies ac revealed that the clinical effects of diclofenac in AK are primarily due to anti-inflammatory, anti-angiogenic and possibly anti-proliferative effects and apoptosis-inducing mechanisms.

List of Excipients

Sorbitol liquid non crystallising (E420)
Sodium benzoate (E211)
Disodium edetate
Acesulfame potassium (E950)
Peppermint oil
Peach flavour
Ponceau red E124
Purified water

Pack sizes and marketing

200ml amber (type III) glass bottle with child resistance polypropylene closure.

Marketing authorization holder

Morningside Healthcare Ltd, 115 Narborough Road, Leicester, LE3 0PA, UK

Marketing authorization dates and numbers

PL 20117/0112