Package insert
Intended use:
Rhinix nasal filter for patients aged 6 years and older, with properties that allow unimpeded nasal breathing, is for the prevention or alleviation of seasonal allergic rhinitis (hay fever) and for seasonal or perennial allergies to other airborne allergens with a similar size fraction to grass pollen allergens.
Rhinix nasal filters: Over the counter use.
How to use it
Recommendation: The rhinix nasal filter will be most effective if you start using it before you experience symptoms. If you start using it after your symptoms have begun, the effect may be delayed.
Before insertion, blow your nose and make sure that it is dry.
Insert the nasal filter as illustrated: Make sure that the pointy end of the nasal filter is directed towards the front of your nose (see illustrations above). Use a mirror until you are comfortable with the process of inserting the nasal filter. Use a mirror to check that the device is positioned correctly (see illustrations above). The height of the nasal filter can be adjusted using the crossbar. When inserted correctly, you should be able to touch the side of your nostrils without experiencing discomfort (see illustration above). You may need to use both hands to insert the device until you are comfortable with the method.
You can remove the nasal filter and reinsert it within the same 24 hours (e.g. if you need to blow your nose or want to eat a meal without the nasal filter inserted, simply take it out and reinsert it again afterwards).You do not have to breathe solely through your nose when using the nasal filter. You should simply breathe as you normally would in any given situation.
Best way to remove the nasal filter: Pull the nasal filter’s crossbar outwards in the opposite direction to the illustration shown for insertion.
Size guide:
Use the size guide above to choose your filter size. If the nasal filter is too big, it may be uncomfortable and we suggest that you try a smaller size. Use the right size for optimum results. The nasal filter does not necessarily have to be completely tight against the edges of your nose to be effective. The nasal filter will gradually adapt its shape to the proportions of your nasal cavity whereby you should feel it less and less.
Warnings:
Single and individual use only. A nasal filter must be changed at least once a day, though it can be removed and reinserted within each 24-hour period.
Caution: Do not use over sores, sunburnt or irritated skin. Not for children under 6 years of age. Do not use the same nasal filter for more than 24 hours. Do not use during sleep. Disposable. During exercise of moderate intensity you may experience that your nasal breathing becomes laboured. If this is too uncomfortable, remove the nasal filter while exercising. If you feel that the nasal filter gets blocked or if you experience laboured breathing you should remove the nasal filter and insert a new one.
Adverse reactions: Application site reactions or hypersensitivity to RHINIX™ nasal filters i.e. irritation of skin. If a rash or skin irritation occurs, discontinue use. If the nasal filter comes into continuous contact with the mucosal membrane, discontinue use, switch to a smaller size or use the crossbar to lower the nasal filter to a position where it does not touch your mucosal membrane.
Avoid transportation at extreme temperatures (>60°C) and do not store in direct sunlight, as this will change the properties of the nasal filter. Keep in original packaging until use. Please inspect the nasal filter prior to use to ensure that it appears intact with the membrane attached to the frame (see photo for comparison).
Manufactured by:
Rhinix ApS, Tulipanvej 8, DK-8240 Risskov.
RHINIX™ is a registered trademark of the Rhinix ApS.
Last update of package insert: January 2019.