DICLOFLEX Prolonged-release tablet Ref.[28016] Active ingredients: Diclofenac

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Dexcel-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire NN11 8PB, UK

Product name and form

Dicloflex 75 mg SR.

Pharmaceutical Form

Prolonged-release tablet.

Pink, round, biconvex tablet, marked “DICL 75” on one side.

Qualitative and quantitative composition

Diclofenac sodium 75 mg.

Excipients(s) with known effect:

Each tablet contains approximately 86 mg Sucrose.

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

Granulating fluid:

Cetostearyl Alcohol

Core:

Colloidal Silicon Dioxide
Compressible Sugar
Talc
Povidone
Magnesium Stearate

Subcoat:

Copovidone
Sucrose

Pigmented film coat:

Hydroxypropylmethylcellulose
Polyethylene glycol
Iron oxide red (E172)
Titanium dioxide (E171)
Gum acasia

Polish:

Carnauba Wax

Pack sizes and marketing

The tablets are presented in aluminium/PVC or PVDC-coated-PVC blisters, strips of which are contained within a printed cardboard carton. Cartons of 28 and 56 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Dexcel-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire NN11 8PB, UK

Marketing authorization dates and numbers

PL 14017/0009

30 January 1997 / 18 February 2003

Drugs

Drug Countries
DICLOFLEX Estonia, Lithuania, United Kingdom
 
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