Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CARBOMER
Chauvin Pharmaceuticals Limited
0.2 %w/w
Eyegel
1997-02-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Geltears 0.2% w/w Carbomer Eye Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 0.2% w/w carbomer . Excipients contains 0.01% w/w Benzalkonium chloride. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye gel. Homogeneous, colourless, gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Substitution of tear fluid in the management of dry eye conditions, including keratoconjunctivitis sicca and unstable tear film. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the elderly) and children: One drop to be instilled into the conjunctival fold of each affected eye 3 - 4 times daily or as required, depending on the degree of discomfort. 4.3 CONTRAINDICATIONS Use in patients with a known hypersensitivity to any component of the preparation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Blurred vision can occur if too much gel is instilled at one time, or if the gel is used too frequently. This effect can last for up to an hour. Recovery can be aided by blinking vigorously for a few seconds. If this fails, the lower eyelid should be manipulated until the gel returns to the lower fornix and normal vision is restored. Contact lenses should be removed during treatment with GelTears. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No significant interactions have been reported. 4.6 FERTILITY, PREGNANCY AND LACTATION Safety for use in pregnancy and lactation has not been established, therefore, GelTears should not be used in these circumstances. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/04/2011_ _CRN 2072600_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE Read the complete document