Find here answers to the most Frequently Asked Questions about Gelclair®.
Gelclair® is a concentrated oral gel classified as a Type IIa medical device.
Being a medical device, Gelclair® has no “active ingredient”; however, it contains two barrier-forming substances:
- polyvinylpyrrolidone (PVP)
- sodium hyaluronate
The pH of Gelclair® is between 5.5 and 6.5.
When Gelclair® is rinsed around the mouth, PVP and sodium hyaluronate create a barrier over the oral mucosa.
This barrier can reduce pain and enable patients to eat and drink more easily, as it shields the nerve endings underneath.
Gelclair® comes in 15ml sachets or as a bottle of 180ml. Pour the entire contents of the single dose sachet, or 15ml from the bottle into a glass and add approximately 40ml of water. Stir mixture well and use at once. Rinse around the mouth for at least one minute or as long as possible to coat the tongue, palate, throat, inside of cheeks and all oral tissue thoroughly. Gargle and spit out. Use 3 times a day or as needed, 30-60 minutes before meals.
Gelclair® may be used undiluted if patients are unable to rinse and gargle or if water is not available. It may be applied undiluted with a syringe or sponge.
It is not recommended to dilute the product and store it for use. Each sachet should be used individually as required.
Gelclair® should be used in conjunction with a good oral hygiene regimen.
Gelclair® is registered for use in patients of all ages.
A limiting factor may be that children under the age of 6 may not be able to rinse and gargle. In these patients, Gelclair® may be applied directly in the mouth by using a sponge or swab.
There are no cases to date of overdosing.
No serious adverse effects should be affected from ingestion of several sachets of Gelclair®.
Gelclair® should not be swallowed.
However, if Gelclair® is accidentally swallowed, no adverse events would be expected.
There are no known interactions with medicinal or other products.
- Gelclair® should be used at least 1 hour apart from other mouth rinses, and immediately after oral hygiene
- It could reduce sublingual drug delivery