ng doses 25 fold higher than the maximum recommended dose in humans.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
CALCIUM HYDROGEN PHOSPHATE DIHYDRATE,
MALTODEXTRIN,
HYPROMELLOSE,
MAGNESIUM STEARATE,
ANHYDROUS COLLOIDAL SILICA.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 112, 120, 180 and 500 tablets in Aluminium/Poly(vinylchloride) blister, packed in cardboard boxes.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex – France
8. MARKETING AUTHORISATION NUMBER(S)
PA 568/13/1
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 24th November 2000
Date of last renewal: 29th March 2010
10. DATE OF REVISION OF THE TEXT
November 2011
