MOTIFENE Capsule, hard Ref.[50029] Active ingredients: Diclofenac

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: PL 08265/0003Daiichi Sankyo UK Ltd., 1<sup>st</sup> Floor, Building 4, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH

Product name and form

Motifene 75 mg Capsules.

Pharmaceutical Form

Capsule, hard.

Size 2 hard gelatin capsule with a light blue opaque cap and colourless transparent body, containing white to cream-coloured pellets. The capsules are printed “D75M” in white.

Qualitative and quantitative composition

Each capsule contains 75 mg diclofenac sodium (25 mg as gastro-resistant pellets and 50 mg as prolonged release pellets).

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

Gastro-resistant pellets:

Microcrystalline cellulose
Povidone K25
Colloidal anhydrous silica
Methacrylic acid ethyl acrylate copolymer
Propylene glycol
Talc

Prolonged release pellets:

Microcrystalline cellulose
Povidone K25
Colloidal anhydrous silica
Ammonio methacrylate copolymer A and B
Triethyl citrate
Talc

Capsule shell:

Indigocarmine E132
Titanium dioxide E171
Gelatin

Capsule body:

Gelatin
Ink, containing:
Shellac
Propylene glycol
Titanium dioxide E171

Pack sizes and marketing

The capsules are blister packed in PVC/PDVC and aluminium foil and are packed into folding cardboard cartons.

Motifene is available in packs of 2, 4, 28 and 56 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

PL 08265/0003Daiichi Sankyo UK Ltd., 1st Floor, Building 4, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH

Marketing authorization dates and numbers

PL 08265/0003

Date of first authorisation: 5 August 1994
Date of latest renewal: 9 September 2004

Drugs

Drug Countries
MOTIFENE Finland, United Kingdom
 
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