Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Carmellose sodium
PCO Manufacturing Ltd.
S01XA20
Carmellose sodium
1 percent weight/volume
Eye drops, solution
Product not subject to medical prescription
artificial tears and other indifferent preparations
Authorised
2011-04-15
_ _ 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 Lire le document complet
Health Products Regulatory Authority 10 June 2022 CRN00CZ7G Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Celluvisc 1.0 % 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 a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. _Product imported from France;_ A clear, colourless to slightly yellow viscous solution. 4 CLINICAL PARTICULARS As per PA1824/016/001 5 PHARMACOLOGICAL PROPERTIES As per PA1824/016/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium chloride Sodium lactate Potassium chloride Calcium chloride Purified water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. The eye drop solution should be used immediately after opening. Any unused solution should be discarded. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25ºC. Keep the single dose containers in the pouch and place back in the outer carton. Pouch is required to prevent moisture loss. 6.5 NATURE AND CONTENTS OF CONTAINER Clear, single-dose containers made from low density polyethylene formed with a twist-off tab. Health Products Regulatory Authority 10 June 2022 CRN00CZ7G Page 2 of 2 Each unit is filled with 0.4 ml of solution. Pack sizes: 30 or 60 foil pouched single-dose containers. Each foil pouch contains 10 single-dose containers. Not all pack size may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT Ensure that the single dose container is intact before use. Discard any unused solution (i.e. once opened do not re-use container for subsequent doses). 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath As Lire le document complet