In the event of an inadvertent temperature excursion the following data may be used:
In-house stability data from the manufacturer for this product support, that continuous or episodic exposure to temperatures stated below does not affect the quality of the product nor will the exposure reduce the total shelf life of the products.
-20°C to 2°C for a period of time up to 7 days
8°C to 15°C for a period of time up to 7 days
15°C to 25°C for a period of time up to 3 days
20 January 2022
London MI Service
Medicine Compliance Aid Stability
Recordati Rare Diseases UK Ltd · Orphan Europe UK Ltd
Orphan Europe UK Ltd
Recordati Rare Diseases UK Ltd
Tablets dispersible 200mg
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Dispersible tablet so unsuitable. One month expiry once removed from 2-8 deg C and container opened