Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
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. |
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 tabletsCore: Povidone Coating: Methacrylic acid – ethyl acrylate copolymer (1:1) dispersion (30%) |
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.
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
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
| Drug | Countries | |
|---|---|---|
| REMETHAN | Albania, Cyprus, Hong Kong, Malta, Singapore |
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