DICLAC Enteric-coated tablet Ref.[49609] Active ingredients: Diclofenac

Source: Υπουργείο Υγείας (CY)  Revision Year: 2014  Publisher: HEXAL AG, Industriestraße 25, D-83607 Holzkirchen, Telephone: +49 (0) 80 24 / 908-0, Telefax: +49 (0) 80 24 / 908-1290, e-mail: service@hexal.de <u>Distributor in Cyprus:</u> P.T.Hadjigeorgiou Co Ltd, ...

Product name and form

Diclac 50 HEXAL Enteric-Coated Tablets.

Pharmaceutical Form

Diclac 50 HEXAL: Enteric-coated tablets.

Qualitative and quantitative composition

Pharmacologically active ingredients:

One Diclac 50 HEXAL enteric-coated tablet contains: 50 mg diclofenac sodium.

Additional inactive ingredients: see point 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

Diclac 50 HEXAL enteric-coated tablet

Lactose 1H2O
Calcium hydrogen phosphate 2H2O
Microcrystalline cellulose
Maize starch
Sodium starch glycollate
Magnesium stearate
Colloidal silicon dioxide

Film-coating:

Eudragit L 30 D
Triethyl citrate
Talc
Titanium dioxide (E171)
Yellow ferric oxide (E172)

Advice to diabetics:

The tablet contains less than 0.01 carbohydrate exchange units.

Pack sizes and marketing

Original package containing 10, 20, 30, 50 and 60 enteric-coated tablets.

Marketing authorization holder

HEXAL AG, Industriestraße 25, D-83607 Holzkirchen, Telephone: +49 (0) 80 24 / 908-0, Telefax: +49 (0) 80 24 / 908-1290, e-mail: service@hexal.de

Distributor in Cyprus:

P.T.Hadjigeorgiou Co Ltd, P.O.Box 53158-3301, Limassol, Cyprus, Tel: 25372425, Fax: 25376400, e-mail: hapanicos@cytanet.com.cy

Marketing authorization dates and numbers

19654

30/04/04

Drugs

Drug Countries
DICLAC Brazil, Cyprus, Germany, Estonia, Croatia, Ireland, Lithuania, Malta, Poland, Romania

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