Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Carbomer
Bausch + Lomb Ireland Limited
S01XA; S01XA20
Carbomer
Eye gel
Other ophthalmologicals; artificial tears and other indifferent preparations
Marketed
2002-03-22
Package leaflet: Information for the user Bausch & Lomb LIPOSIC ® 2 MG/G, EYE GEL CARBOMER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. -- 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 Liposic ® 2 mg/g Eye Gel is and what it is used for 2. What you need to know before you use Liposic ® 2 mg/g Eye Gel 3. How to use Liposic ® 2 mg/g Eye Gel 4. Possible side effects 5. How to store Liposic ® 2 mg/g Eye Gel 6. Contents of the pack and other information 1. WHAT LIPOSIC ® 2 MG/G EYE GEL IS AND WHAT IT IS USED FOR Liposic ® 2 mg/g Eye Gel is a whitish highly viscous gel which contains a lubricant that is used as a substitute for natural 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. Liposic ® 2 mg/g Eye Gel, will help keep your eyes comfortable. Liposic ® 2 mg/g Eye Gel, is a highly viscous gel that forms a protective layer over the eye, which keeps the surface of the eye moist. It is easy and comfortable to use, and is particularly suitable for the symptomatic treatment of severe dry eye symptoms. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LIPOSIC ® 2 MG/G EYE GEL DO NOT USE Liposic ® 2 mg/g Eye Gel: -- if you are allergic to Carbomer or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Liposic ® 2 mg/g E Baca dokumen lengkapnya
Health Products Regulatory Authority 29 July 2022 CRN00CTSL Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Liposic 2 mg/g eye gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 g of eye gel contains 2mg of carbomer. For a full the list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye gel White, turbid, highly viscous, gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of dry eye syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Therapy of dry eye conditions requires an individual dosage regimen. According to the severity and intensity of the symptoms, instill one drop into the conjunctival sac 3‑5 times daily; and approximately 30 minutes before going to bed (otherwise there is a risk of sticky eyelids). Children and adolescents aged to 18 years The safety and efficacy ofLiposic ® 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 Ocular use. Generally, an ophthalmologist should be consulted when treating keratoconjunctivitis sicca, which normally turns out to be long-term or permanent therapy. An appropriate drop size is obtained when the tube is held in a vertical position above the eye during instillation. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contact lenses should be removed prior to administration, and may be inserted again 30 minutes after Liposic2 mg/g Eye gel has been instilled. Liposic 2 mg/g Eye gel may prolong the contact-time of topically applied drugs in ophthalmology. Concomitant ocular medication should be administered 15 minutes prior to instillation of Liposic 2 mg/g Eye gel (see section 4.5). If the symptoms of the dry eye continue or worsen, treatment should be stopped and an ophthalmologist should be consulted. Health Products Regulatory Authority 29 July 2022 CRN00C Baca dokumen lengkapnya