Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
CARBOMER
PCO Manufacturing
S01XA20
CARBOMER
0.2 %w/w
Eyegel
Product not subject to medical prescription
Other ophthalmologicals
Authorised
2013-10-11
PACKAGE LEAFLET: INFORMATION FOR THE USER VIDISIC® _0.2% W/W EYE GEL _ CARBOMER The name of your medicine is Vidisic 0.2 % w/w Eye Gel and it is called Vidisic in this leaflet. PLEASE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However you still need to use Vidisic carefully to get the best results from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - You must contact a doctor if your symptoms worsen or do not improve. - If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. _IN THIS LEAFLET: _ 1. What Vidisic is and what it is used for 2. What you need to know before you use Vidisic 3. How to use Vidisic 4. Possible side effects 5. How to store Vidisic 6. Contents of the pack and other information 1. WHAT VIDISIC IS AND WHAT IT IS USED FOR Your gel contains the active ingredient carbomer, which acts as a lubricant to treat symptoms of dry eye. It is a soothing gel that is used as an artificial tear when the eyes are lacking in tears. Your eyes will normally produce just enough natural tears to allow them to move easily and comfortably. If your eyes do not produce enough tears they can become dry, red and painful. Your gel keeps the surface of the eye lubricated when production of tears is less than normal, and has a refreshing, cooling action. The carbomer in this gel holds moisture and releases this onto the surface of the eye to help relieve the feeling of dryness. This gel can be used by children, adults and the elderly. 2. WHAT YOU NEED TO KNOW Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vidisic 0.2 % w/w Eye Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The product contains carbomer 0.2 % w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye gel. _Product imported from Germany:_ Sterile, colourless, clear, aqueous eye gel, without visible particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For symptomatic relief of dry eyes associated with the sicca syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.2.1 DOSAGE One drop into the conjunctive sac 3-5 times per day. 4.2.2 ADMINISTRATION For ocular use 4.3 CONTRAINDICATIONS Use in patients hypersensitive to the constituents. Should not be used for undiagnosed conjunctivitis. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Wearers of contact lenses should remove their lenses before Vidisic is instilled and should wait for 15 minutes before they insert them again. Intolerance reactions to one of the ingredients may be seen in isolated cases. Vidisic gel contains cetrimide as a preservative which, particularly when used frequently or for a long period, may cause ocular irritation (burning, redness, foreign body sensation) and may damage the corneal epithelium. Preservative-free medicinal products should therefore be preferred for long-term treatment of chronic keratoconjuctivitis sicca. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Vidisic may prolong the contact-time of topically applied drugs in ophthalmology. Concomitant ocular medication should be administered 15 minutes prior to the instillation of Vidisic. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/10/2013_ _CRN 2133177_ _page number: 1_ Vidisic shoul Preberite celoten dokument