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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
CE Medical Device Class 2a.
Manufacturer:
Helsinn Birex Pharmaceuticals Limited, Damastown, Mulhuddart,
Dublin 15, Republic or Ireland.
Distributed in UK & Eire by:
Cambridge Laboratories, A division of Alliance Pharmaceuticals Limited, Avon Bridge Houe, Bath road,
Chippenham, Wiltshire, SN15 2BB, UK
Under license of Helsinn Healthcare SA, Lugano, Switzerland
Date of Preparation of Text
April 2004.
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