Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
CARBOMER
Bausch & Lomb UK Limited
S01XA20
CARBOMER
0.2 %w/w
Eyegel
Product not subject to medical prescription
artificial tears and other indifferent preparations
Marketed
2001-12-14
1 2 3 PACKAGE LEAFLET: INFORMATION FOR THE USER Vidisic ® _Preservative Free Single Dose Unit_ Carbomer The name of your medicine is Vidisic Preservative Free Single Dose Unit and it is called Vidisic Preservative Free in this leaflet. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. This medicine is available without prescription. However you still need to use Vidisic Preservative Free 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. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse. _What is in this leaflet:_ 1. What Vidisic Preservative Free is and what it is used for 2. What you need to know before you use Vidisic Preservative Free 3. How to use Vidisic Preservative Free 4. Possible side effects 5. How to store Vidisic Preservative Free 6. Contents of the pack and other information 1. WHAT VIDISIC PRESERVATIVE FREE 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 BEFORE YOU USE VIDISIC PRESERVATIVE FREE Do NOT use Vidisic Preservative Free • If you are allergic to Carb Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vidisic Preservative Free Single Dose Unit 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Carbomer 0.2% w/w. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye gel. Colourless, clear, aqueous eye gel, without visible particles for single use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for symptomatic relief of dry eyes associated with the sicca syndrome. Vidisic Preservative Free Single Dose Unit is indicated in adults and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY One drop into the conjunctive sac 3-5 times per day. CHILDREN AND ADOLESCENTS AGED TO 18 YEARS: The safety and efficacy of Vidisic eye gel in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available. METHOD OF ADMINISTRATION For ocular use. 4.3 CONTRAINDICATIONS Use in patients hypersensitive to the active substance or to any of the excipients listed in section 6.1. 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 l5 minutes before they insert them again. Discontinuation of the treatment is advised in cases of irritation of the eyes, persistent redness, or if the condition worsens or persists. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Vidisic Preservative Free Single Dose Unit may prolong the contact-time of topically applied drugs in ophthalmology. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Baca dokumen lengkap