Celluvisc 1.0% W/V Eye Drops Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER Celluvisc® 1.0% w/v Eye Drops, Solution
(carmellose sodium)
This product is available using the above name but will be referred to as Celluvisc throughout the following leaflet.
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 FO
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 breast-feeding.
Driving and using machines
Celluvisc may cause short-lasting blurring of vision typically lasting 1 - 15 minutes. If you do experience temporary blurring, do not drive or use machines until your sight is clear.
3. HOW TO USE CELLUVISC
Celluvisc is for ocular use (applied on the eye).
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The recommended dose is 1-2 drops of Celluvisc in the affected eyes as needed.
Make sure that the single-dose container is intact before use. The solution should be used immediately after opening. To avoid contamination or possible eye injury, do not let the open-end of the single-dose container touch your eye or anything else. Wash your hands before use.
Tear one single-dose container from the strip.
Hold the single-dose container upright (with the cap uppermost) and twist off the cap.
Gently pull down the lower eyelid to form a pocket.
Turn the single-dose container upside down and squeeze it to release one drop into each eye. Blink your eyes a few times.
Do not re-use the single-dose container even if there is some solution left. It is most important that you throw it away and do not keep it.
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.
If you use more Celluvisc than you should
It will not cause you any harm. If you are worried, talk to your doctor or pharmacist.
If you forget to use Celluvisc
Apply your next dose as required or at the normal time as directed by your pharmacist or doctor. Do not take a double dose to make up for forgotten individual doses.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following adverse reactions or medically relevant adverse events were reported during clinical trials:
Common side effects (occurring in between 1 and 10 patients in every 100) are: Eye irritation (including burning and discomfort), eye pain, itchy eyes, visual disturbance.
Post-Marketing Data
The following adverse reactions or medically relevant adverse events have been reported since the drug has been marketed:
Uncommon side effects (occurring in between 1 and 10 patients in every 1000) are:
Allergic reactions (including eye or eyelid swelling), blurring of vision, increase in tear production (also known as tearing), sticky eye, crusting of the eyelid and/or drug residue, a feeling that something is in your eye, redness of the eye/eyelid, eyesight worsening, eye injury to the surface of the eye due to the tip of the vial touching the eye during use.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CELLUVISC
Keep all medicines out of the sight and reach of children.
Do not store above 25°C.
Once the vial has been opened the solution should be used immediately, any remaining solution should be discarded.
Do not use this medicine after the expiry date which is stated on the vial tab/carton after EXP. The expiry date refers to the last day of the month.
Do not use the product if you notice that the vial cap has already broken-off.
If the eye drops become discoloured or show any other signs of deterioration, you should ask your doctor or pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6.CONTENTS OF THE PACK AND OTHER INFORMATION
What Celluvisc contains
The active substance is: carmellose sodium 10mg/ml.
Other ingredients: sodium chloride, sodium lactate, potassium chloride, calcium chloride and purified water.
Celluvisc® 1.0% w/v Eye Drops, Solution is a clear colourless to pale yellow solution in individual 0.4ml single dose vials with a twist off tab.
Each pack contains 30 vials with 0.4ml of solution in each vial and has a twist-off cap. Each vial also has a plastic ‘tab’ telling you the name of the product.
PL No: 17805/0383 P
This product is manufactured by Allergan Pharmaceuticals Ireland, Westport, Co. Mayo, Ireland. It is procured from within the EU by the Product Licence holder: Delta Pharma (Europe), Limited,1 Colonial Way, Watford, Herts WD24 4EW and repackaged by OPD Laboratories Limited, 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 08.12.2014.
Celluvisc is a registered trade mark of Allergan, Inc., United States of America.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.