Source: Medicines Authority (MT) Revision Year: 2023 Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg
Keral 25 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film coated tablet. White, round, scored film-coated tablet, with convex sides. The tablets can be divided into equal doses. |
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 Film-coating: Dry laquer composed of: Hypromellose Propylene glycol |
Tablets are provided in blister packs (PVC-aluminium blister or Aclar-aluminium blister or aluminium-aluminium blister).
Keral 25 mg tablets – 4, 10 or 20 film-coated tablets/pack.
Keral 25 mg tablets – 30, 50 or 500 film-coated tablets/pack.
Not all pack sizes may be marketed.
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg
Keral 25 mg tablets, 10 or 20 film-coated tablets – MA204/00107
Keral 25 mg tablets, 30, 50 or 500 film-coated tablets – MA204/00101
MA204/00101:
Date of first authorisation: 21st March 2006
Date of latest renewal: 29th July 2006
MA204/00107:
Date of first authorisation: 27th September 2013
| Drug | Countries | |
|---|---|---|
| KERAL | Ireland, Malta, United Kingdom, South Africa |
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