KETESSE Film-coated tablets Ref.[50355] Active ingredients: Dexketoprofen

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2021  Publisher: LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville, 7551

Product name and form

Ketesse 25 mg film coated tablets.

Pharmaceutical Form

Film coated tablets.

Ketesse 25 mg: White film coated tablets, scored on both sides, with convex sides.

The tablets can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains: dexketoprofen 25 mg (as dexketoprofen trometamol).

Sugar free.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dexketoprofen

Dexketoprofen belongs to the non-steroidal anti-inflammatory group of drugs. The mechanism of action of Dexketoprofen is related to the reduction of prostaglandin synthesis by the inhibition of cyclooxygenase pathway. Furthermore, the inhibition of the synthesis of prostaglandins could affect other inflammation mediators such as kinins, causing an indirect action which would be additional to the direct action.

List of Excipients

Maize starch
Microcrystalline cellulose
Sodium starch glycollate
Glycerol distearate
Hypromellose
Titanium dioxide
Propylene glycol
Macrogol 6000

Pack sizes and marketing

Opaque white or transparent PVC/aluminium or aluminium/aluminium blister strips in an outer carton.

Pack sizes: 4, 10, 20, 30, 50 or 500 film coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville, 7551

Marketing authorization dates and numbers

54/2.7/0536

27 July 2021

Drugs

Drug Countries
KETESSE Austria, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Lithuania, Nigeria, Poland, Singapore, South Africa

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