REMETHAN Gastro-resistant tablet Ref.[28321] 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 25 mg gastro-resistant tablets.

Remethan 50 mg gastro-resistant tablets.

Pharmaceutical Form

Remethan 25 mg & 50 mg:

Gastro-resistant tablet.

Yellow, round, enteric-coated tablets.

Qualitative and quantitative composition

Remethan 25 mg gastro-resistant tablets: Each gastro-resistant tablet contains 25 mg diclofenac sodium.

Remethan 50 mg gastro-resistant tablets: Each gastro-resistant tablet contains 50 mg diclofenac sodium.

Excipient(s) with known effect:

Remethan 25 mg gastro-resistant tablets contain 52.8 mg lactose.

Remethan 50 mg gastro-resistant tablets contain 73.1 mg lactose.

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

Remethan 25 mg & 50 mg gastro-resistant tablets

Core:

Povidone
Lactose monohydrate
Maize starch
Cellulose, microcrystalline
Starch, pregelatinised
Silica, colloidal anhydrous
Magnesium stearate
Talc

Coating:

Methacrylic acid – ethyl acrylate copolymer (1:1) dispersion (30%)
Macrogol 6000
Titanium dioxide
Ferric oxide yellow E172
Simeticone
Polysorbate 80
Talc

Pack sizes and marketing

Remethan 25 mg gastro-resistant tablets:

PVC-PE-PVDC/Aluminium blisters. Pack sizes of 30, 100 and 1000 tablets.

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

Remethan 50 mg gastro-resistant tablets:

PVC-PE-PVDC/Aluminium blisters. Pack sizes of 20, 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

Remethan 25 mg gastro-resistant tablets: 10334
Remethan 50 mg gastro-resistant tablets: 19633

Remethan 25 mg gastro-resistant tablets:

Date of first authorization: 02 December 1985
Date of latest renewal: 04 September 2012

Remethan 50 mg gastro-resistant tablets:

Date of first authorization: 04 August 2004
Date of latest renewal: 29 September 2010

Drugs

Drug Countries
REMETHAN Cyprus, Hong Kong, Malta, Singapore

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