REMETHAN Prolonged-release tablet Ref.[28323] Active ingredients: Diclofenac

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Remethan 100 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

Peach, round, film-coated tablets.

Qualitative and quantitative composition

Each prolonged-release tablet contains 100 mg diclofenac sodium.

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

Core:

Calcium hydrogen phosphate
Hydroxypropylcellulose
Povidone
Sodium starch glycolate
Colloidal silicon dioxide
Magnesium stearate
Talc

Coating :

Titanium dioxide E171
Yellow ferric oxide E172
Hypromellose
Polyethylene glycol 400
Red ferric oxide E172

Pack sizes and marketing

PVC/Aluminium blisters. Pack sizes of 10, 30, 100 and 1000 tablets.

PP containers with PE closure. Pack sizes of 100 and 1000 tablets.

Not all pack-sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

12480

Date of first authorization: 05 October 1989
Date of latest renewal: 30 September 2011

Drugs

Drug Countries
REMETHAN Albania, Cyprus, Hong Kong, Malta, Singapore

© 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.