Celluvisc 0.5%W/V Eye Drop Solution Unit Dose
®
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 prescriptio n 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.
better or if you feel worse.
de effects, although not everybody g categories, depending on how often
The side effects are classified into the followin they occur:
|
Very common |
may affect more than 1 in |
10 people |
|
Common |
may affect up to 1 in 10 p |
eople |
|
Uncommon |
may affect up to 1 in 100 |
people |
|
Rare |
may affect up to 1 in 1,00 |
0 people |
|
Very rare |
may affect up to 1 in 10,0 |
00 people |
|
Not known |
frequency cannot be esti |
mated from the available data |
You must talk to a doctor if you do not feel 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 vis ion 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®
Pregnancy and breast-feeding
You can use CELLUVISC® if you are pregnant and when you are breast-feeding.
Driving and using machines
CELLUVISC® may cause temporary blurring ef 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 u sing CELLUVISC®
If you are unsure about anything, discuss it w th your doctor, nurse or pharmacist.
3. How to use CELLUVISC®
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 eye/each affected eye, 4 times a day or as often as needed.
You do not need to remove contact lenses before using CELLUVISC®
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 singledose 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® than you should
It will not cause you any harm. If you are worri ed, talk to your doctor or pharmacist. If you forget to use CELLUVISC®
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.
The following side effects may be seen with C ELLUVISC®:
|
Common |
Eye irritation (including bi visual disturbance. |
jrning and discomfort), eye pain, itchy eyes, |
|
Not known |
Allergic reactions (includi watery eye, redness of th due to the tip of the vial to |
ng eye allergy), blurred vision, sticky eye, e eye, eye injury to the surface of the eye uching the eye during use. |
Reporting of side effects
If you get any side effects, talk to your doctor, possible side effects not listed in this leaflet. 'Vi
UK
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.
pharmacist or nurse. This includes any ou can also report side effects directly via:
Keep this medicine out of the sight and reach Do not store above 25°C.
Do not use this medicine after the expiry date ( dose container tab and the carton after EXP: iat month.
of children.
use by date) which is stated on the single-The expiry date refers to the last day of
Do not use if CELLUVISC® packaging shows solution changes colour or becomes cloudy. can be disposed of as household waste. Any the pharmacist or he can tell you how to dispo environment).
evidence of tampering. Do not use if Used CELLUVISC® eye drop containers unused containers can be returned to se of them safely (in order to protect the
6. Contents of the pack and other information
What CELLUVISC® contains
• The active ingredient is carmellose sodiu
• The other ingredients are sodium chloride, calcium chloride dihydrate, magnesium chl amounts of sodium hydroxide or hydrochloi to the correct pH (a measure of the acidity
The ingredients and the amount used in CEL appears in tears produced naturally by the ey e.
What CELLUVISC® looks like and content
CELLUVISC® is a clear, colourless to pale ye through (bubble-like) casing (known as a ‘sini container has a twist-off top. Each single-dose solution.
Each pack contains 5, 30 or 90 single-dose c marketed.
Marketing Authorisation Holder and Manufacturer
Allergan Pharmaceuticals Ireland Castlebar Road Westport County Mayo Ireland
5 mg/ml.
sodium lactate, potassium chloride, oride hexahydrate and purified water. Small ric acid may be added to bring the solution or alkalinity of the solution).
LUVISC® were chosen to match what
s of the pack
low eye drops solution in a small see-gle-dose container’). The single-dose container contains 0.4 ml of eye drops
ontainers. Not all pack sizes may be
For any further information about this mi representative of the Marketing Authi
Allergan Limited 1 st Floor Marlow International The Parkway, Marlow Buckinghamshire SL7 1YL United Kingdom Tel. 01628 494026 E-mail: uk_medinfo@allergan.com
This leaflet was last revised in 11/2014
edicine product, please contact the local orisation Holder:
71855MD311F
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Artwork created at 100% Drop keylines and notes before printing Part Number: 71855MD311F |
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