K-FENAK Film-coated tablet Ref.[115344] Active ingredients: Diclofenac

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: CIPLA MEDPRO (PTY) LTD, Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA

Product name and form

K-FENAK OTC (Tablets).

Pharmaceutical Form

White, circular, biconvex, film-coated tablets plain on both sides.

Qualitative and quantitative composition

Each film-coated tablet contains 50 mg diclofenac potassium.

Contains sugar (lactose monohydrate 81,00 mg/tablet).

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

Colloidal anhydrous silica
Crospovidone
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Opadry white [containing lecithin (soya), partially hydrolysed polyvinyl alcohol, talc, titanium dioxide and xanthan gum]
Povidone

Pack sizes and marketing

Aluminium blister strip-packed cartons of 9 tablets.

Marketing authorization holder

CIPLA MEDPRO (PTY) LTD, Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA

Marketing authorization dates and numbers

A38/3.1/0651

Drugs

Drug Countries
K-FENAK South Africa
 
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