Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Carmellose sodium
Allergan Pharmaceuticals Ireland
S01XA; S01XA20
Carmellose sodium
0.5 percent weight/volume
Eye drops, solution
Product not subject to medical prescription
Other ophthalmologicals; artificial tears and other indifferent preparations
Marketed
2006-11-10
PACKAGE LEAFLET: INFORMATION FOR THE USER CELLUVISC ® 0.5% 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 from pharmacies. 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 substitute for tears, 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) caused by you not producing enough tears to keep the eye wet. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CELLUVISC ® DO NOT USE CELLUVISC ® If you are hypersensitive (allergic) to carmellose sodium or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS If irritation, pain, redness or changes in vision occur or if you feel your condition is getting worse, stop taking this medicine and consult your doctor or pharmacist. 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 between putting in the other drops and CELLUVISC ® . PREGN Baca dokumen lengkap
Health Products Regulatory Authority 10 September 2019 CRN0099LK Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celluvisc 0.5 %w/v eye drops solution, unit dose 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 5mg carmellose sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution in single-dose container. Clear, colourless to slightly yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tear substitute. Treatment of the symptoms of dry eye. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Instil 1-2 drops in the affected eye/s 4 times a day or as needed. Ensure that the single-dose container is intact before use. The eye drop solution should be used immediately after opening. To avoid contamination or possible eye injury, do not touch tip of the bottle or vial to any surface and avoid contact with the eye. If Celluvisc is concomitantly used with other ocular eye medications there must be an interval of at least 15 minutes between the two medications (as displacement of a medication may occur). The eye drops may be used with contact lenses. _Paediatric population _ The safety and efficacy of Celluvisc in children and adolescents have been established by clinical experience, but no clinical trial data are available. The posology recommended in adults is recommended in the paediatric population. 4.3 CONTRAINDICATIONS Hypersensitivity to carmellose sodium or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If irritation, pain, redness or changes in vision occur or if the patient’s condition worsens, treatment discontinuation should be considered and a new assessment made. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known. For the use of concomitant ocular products, see section 4.2. 4.6 FERTILITY, PREGNANCY AND LACTATION Health Products Regulatory Authority 10 September 2019 CRN0099LK Page 2 of 4 Pregnancy and Breast-feeding Due to the negligibl Baca dokumen lengkap