Product Information

Product Description
Gelclair is a viscous gel specially formulated to aid in the management of lesions of the oral mucosa. It forms a protective film that, by adhering to the mucosa of the oropharyngeal cavity, can prevent further irritations thus contributing to the rapid relief of pain. It is presented as a concentrated gel in sachets for dilution with water.

Indications
Gelclair helps in the management of lesions of the oropharyngeal cavity. Gelclair forms a protective film that helps to provide pain relief, soothing mouth lesions including those caused by medication, disease, radiotherapy, chemotherapy, oral surgery, traumatic ulcers caused by dental braces and dentures and ageing.

Ingredients
Deionised water, polyvinylpyrrolidone (PVP), maltodextrin, propylene glycol, PEG-40 hydrogenated castor oil, potassium sorbate, sodium benzoate, hydroxyethylcellulose, benzalkonium chloride, flavouring, disodium edetate, saccharin sodium, sodium hyaluronate, glycyrrhetinic acid.

Instructions for use
Gelclair should be used 3 times a day or as needed. Avoid eating or drinking for at least one hour following treatment. Pour the entire contents of the single-dose Gelclair sachet into a glass and add approximately 40ml of water (3 tablespoonfuls). Stir mixture well and use at once.
Rinse around the mouth for at least one minute or as long as possible to coat tongue, palate, throat, inside of cheeks and all oral tissue thoroughly. Gargle and spit out. If water is not available, the product may be used undiluted. Discard any unused mouthwash.

Contra-indications
The use of Gelclair is contra-indicated in any patient with a known history of hypersensitivity to any of the ingredients.

Precautions and Warnings
Avoid eating or drinking for at least one hour after each treatment.
Do not use the product if the sachet is damaged or has reached its expiry date.
The gel may become a little darker and thicker on storage but this does not affect its efficacy or safety. Store at room temperature, out of direct sunlight. Do not refrigerate.
If no improvement is seen after 7 days treatment, consult your doctor.

Interactions with medicaments and other forms of interaction - There are no known interactions with medicinal or other products.
Pregnancy and lactation - May be used during pregnancy and lactation.
Effects on ability to drive and use machines - None.

Undesirable Effects
No undesirable effects have been reported to date. Use of the product is not, however, advisable for individuals known to be hypersensitive to any of its ingredients.

Accidental Ingestion / Overdose
At the time of producing this leaflet no cases of overdose have been reported. Whilst no adverse effects would be expected from accidental ingestion of Gelclair, ingestion is not recommended.

KEEP OUT OF THE REACH OF CHILDREN.

Packaging
Pack containing 21 x 15ml sachets to be diluted before use.

Regulatory Status
ΠMedical Device Class 1.

Manufacturer:
Helsinn Birex Pharmaceuticals Limited, Damastown, Mulhuddart, Dublin 15, Republic or Ireland.

Distributed in UK & Eire by:
Cambridge Laboratories Limited, Deltic House, Kingfisher Way, Silverlink Business Park, Wallsend, Tyne & Wear, NE28 9NX, UK
Under license of Helsinn Healthcare SA, Lugano, Switzerland

Date of Preparation of Text
April 2004.