MOTIFINE Capsule, hard Ref.[50530] Active ingredients: Diclofenac

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Biotech Laboratories (Pty) Ltd, Ground Floor, Block K West, Central Park, 400 16th Road, Randjespark, Midrand 1685, South Africa

Product name and form

MOTIFINE 75 mg capsules.

Pharmaceutical Form

Capsules, hard.

Hard gelatine capsules (size 2) with light blue opaque cap and colourless transparent body marked in white print “D75M”.

Qualitative and quantitative composition

Each capsule contains 75 mg diclofenac sodium (25 mg as enteric coated pellets and 50 mg as sustained release pellets).

Sugar free.

For the 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

Enteric coated pellets:

Microcrystalline cellulose
Povidone
Colloidal anhydrous silica
Methacrylic acid ethyl acrylate copolymer
Propylene glycol
Talc

Sustained release pellets:

Microcrystalline cellulose
Povidone
Colloidal anhydrous silica
Ammonio methacrylate copolymer
Triethylcitrate
Talc.

Capsule shell:

Indigocarmine (E132)
Titanium dioxide (E171)
Gelatine.

Capsule body:

Gelatine
Ink (containing shellac, propylene glycol, titanium dioxide [E171])

Pack sizes and marketing

The capsules are blister packed in white opaque PVC/PVDC and silver aluminium foil and packed into outer cardboard cartons.

Pack size: 6 capsules.

Marketing authorization holder

Biotech Laboratories (Pty) Ltd, Ground Floor, Block K West, Central Park, 400 16th Road, Randjespark, Midrand 1685, South Africa

Marketing authorization dates and numbers

45/3.1/1150

Drugs

Drug Countries
MOTIFINE South Africa
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈