Shelf life
4 years.
Incompatibilities
Not applicable.
List of excipients
Mannitol
Calcium Hydrogen Phosphate dihydrate
Red Iron Oxide (E172)
Maize Starch
Pregelatinised Starch
Magnesium Stearate
Date of revision of the text
5th October 2017
Marketing authorisation holder
AstraZeneca UK Limited,
600 Capability Green,
Luton, LU1 3LU, UK.
Special precautions for storage
Do not store above 30°C
Nature and contents of container
5 mg Tablets:
Aluminium/PVC-PVDC or Aluminium/PVC foil blister packs of 14, 20, 28, 28x1, 30, 42, 50, 56, 60, 84, 98, 100, 400 and 500 tablets.
Aluminium/PVC-PVDC or Aluminium/PVC foil blister calendar packs of 14, 28, 42, 56, 84 and 98 tablets.
HDPE bottle packs of 20, 30, 50, 100 and 400 tablets.
10 mg Tablets:
Aluminium/PVC-PVDC or Aluminium/PVC foil blister packs of 14, 20, 28, 30, 50, 56, 84, 98, 100 and 400 tablets.
Aluminium/PVC-PVDC or Aluminium/PVC foil blister calendar packs of 14, 28, 56, 84 and 98 tablets.
HDPE bottle packs of 20, 30, 50, 100 and 400 tablets.
20 mg Tablets:
Aluminium/PVC-PVDC or Aluminium/PVC foil blister packs of 14, 20, 28, 30, 42, 50, 56, 56x1, 60, 84, 98, 100, 400 and 500 tablets.
Aluminium/PVC-PVDC or Aluminium/PVC foil blister calendar packs of 14, 28, 42, 56, 84 and 98 tablets.
HDPE bottle packs of 20, 30, 50, 100 and 400 tablets.
Not all pack sizes may be marketed.
Marketing authorisation number(s)
| 5 mg:
| PL 17901/0061
|
| 10 mg:
| PL 17901/0062
|
| 20 mg:
| PL 17901/0063
|
Special precautions for disposal and other handling
No special requirements.
Date of first authorisation/renewal of the authorisation
Date of first authorisation: 8 June 2000
Date of first renewal: 1 August 2010