Celluvisc 0.5% W/V Eye Drops Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available as Celluvisc 0.5% w/v Eye Drops Solution, but will be referred to as Celluvisc 0.5% throughout this 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 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 0.5% is and what it is used for
2. What you need to know before you use Celluvisc 0.5%
3. How to use Celluvisc 0.5%
4. Possible side effects
5. How to store Celluvisc 0.5%
6. Contents of the pack and other information
1. WHAT CELLUVISC 0.5% IS AND WHAT IT IS USED FOR
Celluvisc 0.5% 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 0.5%
Do not use Celluvisc 0.5%
• 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 0.5%
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 0.5%.
Pregnancy and breast-feeding
You can use Celluvisc 0.5% if you are pregnant and when you are breast-feeding.
Driving and using machines
Celluvisc 0.5% may cause temporary blurring of vision. If you do experience temporary blurring, do not drive or use machines until your sight is clear.
Read all the information in this leaflet before using Celluvisc 0.5%.
If you are unsure about anything, discuss it with your doctor, nurse or pharmacist.
3. HOW TO USE CELLUVISC 0.5%
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 0.5% in the affected eye/each affected eye, 4 times a day or as often as needed.
You do not need to remove contact lenses before using Celluvisc 0.5%.
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.
1. Tear one single-dose container from the strip.
2. Hold the single-dose container upright (with the top uppermost) and twist off the top.
3. 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 you use more Celluvisc 0.5% 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 0.5%
Use a single drop in each eye that needs treatment as soon as you remember, and then go back to your regular routine. Do not use a large number of drops to make up for forgetting to put drops in your eye or eyes earlier.
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 side effects are classified into the following categories, depending on how often they occur:
|
Very common |
may affect more than 1 in 10 people |
|
Common |
may affect up to 1 in 10 people |
|
Uncommon |
may affect up to 1 in 100 people |
|
Rare |
may affect up to 1 in 1,000 people |
|
Very rare |
may affect up to 1 in 10,000 people |
|
Not known |
frequency cannot be estimated from the available data |
The following side effects may be seen with Celluvisc 0.5%:
|
Common |
Eye irritation (including burning and discomfort), eye pain, itchy eyes, visual disturbance. |
|
Not known |
Allergic reactions (including eye allergy), blurred vision, sticky eye, watery eye, redness of the eye, eye injury to the surface of the eye due to the tip of the vial touching the eye during use. |
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:
Yellow Card Scheme
Website: 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 0.5%
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use Celluvisc 0.5% after the expiry date which is stated on the single-dose container tab and the carton after 'EXP:'. The expiry date refers to the last day of that month.
If your medicine appears to be discoloured or shows any other signs of deterioration please return it to your pharmacist who will advise you further.
If your doctor tells you to stop using the medicine, please take it back to the pharmacist. Only keep the medicine if your doctor tells you to.
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 0.5% contains
• The active substance is carmellose sodium.
Each 1ml of solution contains 5mg of carmellose sodium
• The other ingredients are: sodium chloride, sodium lactate, potassium chloride, calcium chloride, magnesium chloride and purified water. Small amounts of sodium hydroxide or hydrochloric acid may de added to bring the solution to the correct pH (a measure of the acidity or alkalinity of the solution).
The ingredients in Celluvisc 0.5% were designed to match your natural tear composition.
What Celluvisc 0.5% looks like and contents of the pack
Celluvisc 0.5% is a clear, colourless to slightly yellow solution in a small see-through (bubblelike) casing (known as a "single-dose container"). The single-dose container has a twist-off cap. Each single-dose container contains 0.4ml of eye drop solution.
Each pack contains 30 single-dose vials.
Manufacturer
Celluvisc 0.5% is manufactured by:
Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, County Mayo, Ireland.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
Leaflet issue and revision date (Ref): 29.03.16 CELLUVISC® is a registered trademark of Allergan, Inc.
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