DIFENE Modified‑release capsule Ref.[49772] Active ingredients: Diclofenac

Source: Υπουργείο Υγείας (CY)  Revision Year: 2016  Publisher: Medililink Pharmaceuticals Ltd, 30 Armenias Street, 2003 Strovolos, Nicosia, Cyprus, Tel.: +357 22319282, Fax: +357 22319290

Product name and form

Difene Dual Release.

100 mg modified‑release capsule, hard.

Diclofenac sodium.

Pharmaceutical Form

Modified‑release capsule, hard.

Hard gelatine capsule, size 1, with a blue opaque capsule cap and colourless transparent body and white print “D100M”, filled with white to cream-coloured pellets.

Qualitative and quantitative composition

Each modified‑release capsule, hard contains 100 mg diclofenac sodium (25 mg diclofenac sodium in gastroresistant form, 75 mg diclofenac sodium in prolonged‑release form).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Diclofenac

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

Talc,
Microcrystalline cellulose,
Povidone K 25,
Colloidal anhydrous silica,
Propylene glycol,
Ammonio methacrylate copolymer (type A),
Ammonio methacrylate copolymer (type B),
Methacrylic acid ethyl acrylate copolymer (1:1) (Ph.Eur.),
Triethylcitrate,
Gelatin,
Indigo carmine (E 132),
Titanium dioxide (E 171),
Sodium lauryl sulphate,
Printing ink

Pack sizes and marketing

Blister packs of PVC/PVDC foil and aluminium foil.

Original pack of 10, 20, 50, 100 modified‑release capsules, hard.

Hospital pack of 500 (10 × 50) modified‑release capsules, hard.

Marketing authorization holder

Medililink Pharmaceuticals Ltd, 30 Armenias Street, 2003 Strovolos, Nicosia, Cyprus, Tel.: +357 22319282, Fax: +357 22319290

Marketing authorization dates and numbers

19430

05 December 2002

Drugs

Drug Countries
DIFENE Cyprus, Ireland
 
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