Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
ADENURIC 80 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “80” on one side and a score line on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. |
Each tablet contains 80 mg of febuxostat.
Excipient(s) with known effects: Each tablet contains 76.50 mg of lactose (as monohydrate)
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Febuxostat |
Uric acid is the end product of purine metabolism in humans and is generated in the cascade of hypoxanthine → xanthine → uric acid. Both steps in the above transformations are catalyzed by xanthine oxidase (XO). Febuxostat is a 2-arylthiazole derivative that achieves its therapeutic effect of decreasing serum uric acid by selectively inhibiting XO. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Tablet coating: Opadry II, Yellow, 85F42129 containing: Polyvinyl alcohol |
Clear (Aclar/PVC/Aluminium or PVC/PE/PVDC/Aluminium) blister of 14 tablets.
ADENURIC 80 mg is available in pack sizes of 14, 28, 42, 56, 84 and 98 film-coated tablets.
Not all pack sizes may be marketed.
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
EU/1/08/447/001
EU/1/08/447/002
EU/1/08/447/005
EU/1/08/447/006
EU/1/08/447/007
EU/1/08/447/008
EU/1/08/447/013
EU/1/08/447/014
EU/1/08/447/015
EU/1/08/447/016
EU/1/08/447/017
EU/1/08/447/018
Date of first authorisation: 21 April 2008
Date of latest renewal: 20 December 2012
| Drug | Countries | |
|---|---|---|
| ADENURIC | Austria, Australia, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom |
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