CATAFLAM Sugar coated tablet Ref.[28178] Active ingredients: Diclofenac

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland <u>Marketing License Holder Representative in Cyprus:</u> Novartis Pharma Services Inc., Methonis Tower, 73 Arch. Makarios ...

Product name and form

CATAFLAM Sugar Coated Tablets 50mg.

Pharmaceutical Form

Sugar coated tablet.

Qualitative and quantitative composition

Each tablet contains 50 mg of diclofenac potassium.

Chemical name: Potassium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate

Excipient(s) with known effect:

Sodium starch glycolate.

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

Silica, colloidal anhydrous (Aerosil 200)
Calcium phosphate
Magnesium stearate
Maize starch
Povidone (Polyvinylpyrrolidone K30 PH)
Sodium starch glycollate (Sodium carboxymethyl starch)
Cellulose, microcrystalline (Avicel PH 101)
Iron oxide, red 17266 (E.172)
Macrogol 8000 (Polyethylene glycol 8000)
Sucrose, cryst
Talc PH
Titanium dioxide PH (E.171)
Each tablet contains 0.1496 mmol of potassium.

Pack sizes and marketing

PVC/PE/PVDC blister strips containing 20 tablets.

(PVC 190-275 micron, PE20-40 micron, PVDC 32-59 micron, aluminium foil 26-34 micron).

Marketing authorization holder

Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing License Holder Representative in Cyprus:

Novartis Pharma Services Inc., Methonis Tower, 73 Arch. Makarios ΙΙΙ Avenue, 1070 Nicosia, Cyprus

P.O.Box 23917, 1687 Nicosia

Marketing authorization dates and numbers

18492

Date of first authorisation: 08 March 1991
Date of latest renewal: 26 September 2011

Drugs

Drug Countries
CATAFLAM Brazil, Cyprus, Ecuador, Estonia, Hong Kong, Ireland, Israel, Lithuania, Malta, Mexico, Netherlands, Poland, Singapore, Tunisia, Turkey, South Africa

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