Faa use of sedating antihistamines
Astelin (Azelastine), Dymista (Azelastine HCl / Fluticasone propionate), Claritin (Loratadine), Clarinex (Desloratadine) and Allegra (Fexofenadine) are acceptable to the FAA provided there are no adverse effects.
APPROVED INHALERS Sedating medications are not acceptable.
Through the consultation process, the TGA is requesting comments that will help ensure that the wording of the proposed advisory statements is appropriate and supports the quality use of the medicines; and that the label changes that would be required for these medicines are made in the most convenient, efficient and cost-effective way.
The Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) sets out the level of control on the availability of medicines in Australia.
Medicines that are unscheduled or included in Schedules 2 or 3 of the SUSMP are collectively referred to either as ‘non-prescription medicines’, ‘over-the-counter medicines’ or 'OTC medicines'.
Consumers rely on information from their health practitioner, pharmacist and medicine label in order to use medicines safely and effectively.
Therefore, the TGA proposes that the RASML should now be updated to ensure that the warning appears more consistently on all of these products.
In particular: Enquiries should be directed via email to [email protected] All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).
The TGA also proposed to take this opportunity to make some editorial changes in order to harmonise the entries for each of these medicines as far as possible, to reduce the total number of entries needed to cover all eventualities, and to more clearly specify which substances are affected by these entries.
The proposed amended RASML class entries, showing the new RASML requirements in red text, are set out in Table 1, below (editorial changes are not tracked in this Table - for a full ‘tracked-changes’ version see Table 2 at the end of this document): The associated individual substance entries will also be updated accordingly. Interested parties should respond by close of business Thursday, 21 June 2018.
However, the enhanced access and availability of OTC medicines means that consumers may not always receive comprehensive advice from a practitioner or pharmacist.
In the context of self-medication, the medicine label is the primary source of information for the consumer; so the label must contain the directions and advisory statements that are needed for safe and effective use of these medicines.