inical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use in the product and which have not already been mentioned elsewhere in this Summary.
6. Pharmaceutical particulars
6.1 List of excipients
Core:
Microcrystalline cellulose
Stearic acid
Povidone
Film Coat:
Hypromellose
Polyethylene glycol
6.2 Incompatibilities
None known
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Child Resistant PVC/Al blister.
Pack sizes: 8 and 16 tablets.
6.6 Special precautions for disposal and other handling
None
7. Marketing authorisation holder
Wrafton Laboratories Limited (T/A Perrigo)
Braunton
Devon
EX33 2DL
8. Marketing authorisation number(s)
PL 12063/0112
9. Date of first authorisation/renewal of the authorisation
27/04/2011
10. Date of revision of the text
02/03/2016
