VOLTAROL PAIN-EZE EMULGEL Gel for topical administration

Active ingredients: Diclofenac

Product name and form

Voltarol Pain-eze Emulgel.

Voltarol Back and Muscle Pain Relief 1.16% Gel.

Pharmaceutical Form

Gel for topical administration.

Qualitative and quantitative composition

Diethylammonium-{o[2,6-dichlorophenyl)-amino]-phenyl}-acetate.

100g of this medicine contains 1.16g of the active substance diclofenac diethylammonium, which corresponds to 1g diclofenac sodium.

For excipients, see section 6.1.

Active Ingredient
Description

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

Diethylamine
Carbomers
Cetomacrogol
Cocoyl caprylocaprate
Isopropyl alcohol
Liquid paraffin
Perfume creme 45 (containing benzyl benzoate)
Propylene glycol
Purified water

Pack sizes and marketing

Sealed aluminium tubes with protective inner coating, closed with a polypropylene screw cap.

Packaging available in packs of 10g, 30g, 40g and 50g.

Aluminium laminated tube (low density polyethylene/aluminium/high density polyethylene (internal layer)) fitted with a high density polyethylene shoulder and closed by a moulded seal. The tube is closed with a polypropylene screw cap, incorporating a moulded feature used to insert, twist and remove the seal before first use or a push/pull cap applicator, which is designed to facilitate hand-free application of the product, available for 100g pack only

Packaging available in packs of 30g, 50g, 60g, 100g and 120g.

Marketing authorization holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Marketing authorization dates and numbers

PL 44673/0156

Date of first authorisation: 22 November 2004.

Date of latest renewal: 24 February 2011.

Drugs

Drug
Countries
Ireland, United Kingdom