VOLTAROL Suppositories

Active ingredients: Diclofenac

Product name and form

Voltarol Suppositories 12.5mg, 25mg, 50mg and 100mg.

Pharmaceutical Form

Suppositories.

Qualitative and quantitative composition

The active substance is sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac sodium).

Each suppository contains 12.5mg, 25mg, 50mg and 100mg diclofenac sodium Ph.Eur.

For a full list of 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

Voltarol suppositories also contain suppository mass 5 (a waxy base composed of hard fat).

Pack sizes and marketing

The suppositories are white to yellowish, torpedo-shaped, with smooth or slightly rough surfaces and a slightly fatty odour, and are sealed in a composite foil made of polyvinylchloride (PVC) laminated with low-density polyethylene (LD-PE).

They come in packs of 10.

Marketing authorization holder

Novartis Pharmaceuticals UK Ltd., Trading as Geigy Pharmaceuticals, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Marketing authorization dates and numbers

12.5mg: PL 00101/0472
25mg: PL 00101/0473
50mg: PL 00101/0474
100mg: PL 00101/0475

11 July 1997 / 29 July 2007

Drugs

Drug
Countries
Ireland, United Kingdom