Please be informed of a recent update to the product information for Zaponex 25mg and 100mg tablets.
Zaponex Summary of Product Characteristics (SPC):
Section 6.3: Shelf-life
- Shelf-life for Zaponex 25mg tablets in blister packs and for the Zaponex 25 and 100mg tablets in HDPE container has been extended to 5 years, in line with shelf-life for Zaponex 100mg tablets in blister packs. For all Zaponex tablet formulations, a 5-year shelf-life period is applicable.
Section 6.4: Special Precautions for Storage
- For the Zaponex 25 and 100mg tablets in HDPE container, special storage conditions are no longer necessary.
- For the Zaponex 25mg and 100mg tablets in blister packs, the storage temperature limits have been extended from 25 to 30 degrees celsius.
The Zaponex Patient Information Leaflet (PIL) has been updated accordingly (Section 5 – How to store Zaponex)
The updated leaflet (PIL) will be included in the packaging of Zaponex products as soon as possible. It may however take a few months before new Zaponex stock with the updated product information is delivered to your hospital or retail pharmacies.
Please note that the new product information is available via the ZTAS website, as well as from the electronic Medicines Compendium (eMC) website.
We trust that you will find this information useful,
Yours sincerely,
Leyden Delta B.V.
Zaponex Treatment Access System
