Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Carmellose sodium
AbbVie Limited
S01XA; S01XA20
Carmellose sodium
Eye drops, solution
Other ophthalmologicals; artificial tears and other indifferent preparations
Marketed
1997-04-23
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CELLUVISC ® 1.0 % W/V EYE DROPS, SOLUTION, UNIT DOSE Carmellose sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. Always use this medicine exactly as described in this leaflet or as your pharmacist or nurse has 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, pharmacist or nurse. 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 CELLUVISC is and what it is used for 2. What you need to know before you use CELLUVISC 3. How to use CELLUVISC 4. Possible side effects 5. How to store CELLUVISC 6. Contents of the pack and other information 1. WHAT CELLUVISC IS AND WHAT IT IS USED FOR CELLUVISC is a tear substitute and contains the lubricant called carmellose sodium. It is used for the treatment of the symptoms of dry eye (such as soreness, burning, irritation or dryness). 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 CELLUVISC DO NOT USE CELLUVISC If you are allergic (hypersensitive) to carmellose sodium or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS If you wear contact lenses, these should be removed before using CELLUVISC . The lenses can be put back again 15 minutes after you have applied your drops. OTHER MEDICINES AND CELLUVISC Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription. If you are using other eye drops, leave at least 15 minutes before putting in CELLUVISC . PREGNANCY AND BREAST-FEEDING CELLUVISC can be used during pregnancy and bre Läs hela dokumentet
Health Products Regulatory Authority 01 April 2022 CRN00CNH9 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celluvisc 1% w/v Eye drops, solution, unit dose 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 10 mg carmellose sodium. One drop (» 0.05 ml) contains 0.5 mg of carmellose sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution A clear, colourless to slightly yellow viscous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the symptoms of dry eye. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Instil one or two drops in the affected eye/s as needed. Ensure that the single-dose container is intact before use. The eye drop solution should be used immediately after opening. _Paediatric population_ The safety and efficacy of Celluvisc in Paediatric population have not been established. No data are available. 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 If irritation, pain, redness and changes in vision occur or worsen, treatment should be discontinued and a new assessment considered. Contact lenses should be removed before each application and may be inserted after 15 minutes. Concomitant ocular medication should be administered 15 minutes prior to the instillation of Celluvisc. To avoid contamination or possible eye injury, do not touch the tip to the bottle or vial to any surface and avoid contact with the eye. Discard open single dose container after use. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS No interaction studies have been performed 1. No interactions have been observed with Celluvisc. Given the formulation of Celluvisc, no interactions are anticipated. 2. If this product is used concomitantly with other topical eye medications there must be an interval of at least 15 minutes between the two medications. 4.6 FERTILITY, PREGNANCY AND LACTATION Health Pr Läs hela dokumentet