KERAL Film coated tablet Ref.[7936] Active ingredients: Dexketoprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: MENARINI INTERNATIONAL O.L.S.A., 1, Avenue de la Gare, L-1611, Luxembourg

Product name and form

Keral 25 mg film-coated tablets.

Pharmaceutical Form

Film coated tablet.

Keral 25 mg: white, round, scored film-coated tablet. The tablets can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains: dexketoprofen 25 mg as dexketoprofen trometamol.

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

Tablet core:

Maize starch
Microcrystalline cellulose
Sodium starch glycollate
Glycerol distearate

Film-coating:

Dry laquer composed of:

Hypromellose
Titanium dioxide
Macrogol 6000
Propylene glycol

Pack sizes and marketing

Tablets are provided in blister packs (PVC-aluminium blister or Aclar-aluminium blister).

Keral 25 mg tablets – 4, 10, 20, 30, 50 or 500 film-coated tablets/pack

Not all pack sizes may be marketed.

Marketing authorization holder

MENARINI INTERNATIONAL O.L.S.A., 1, Avenue de la Gare, L-1611, Luxembourg

Marketing authorization dates and numbers

PL 16239/0007

Date of first authorisation: 14 January 1998
Date of latest renewal: 25 April 2006

Drugs

Drug Countries
KERAL Ireland, Malta, United Kingdom, South Africa

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