Medine.co.uk

Celluvisc 0.5%W/V Eye Drop Solution Unit Dose

Document: leaflet MAH GENERIC 5 and 90 packs_PL 41443-0011 change

UK/lreland CELLUVISC® 0.5% Insert 0.4 ml

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PACKAGE LEAFLET:

INFORMATION FOR THE USER

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Carmellose sodium 0.5% w/v

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription from pharmacies. Please use CELLUVISC® carefully according to the instructions below to get the best results.

   Keep this leaflet. You may need to read it again.

   Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve.

this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What CELLUVISC® is and what it is used for

2.    Before you use CELLUVISC®

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4.    Possible side effects

5.    How to store CELLUVISC®

6.    Further 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 your not producing enough tears to keep the eye wet.

2. BEFORE YOU USE CELLUVISC®

Do not use CELLUVISC®

CELLUVISC®. These are listed at the end of this leaflet in section 6 “Further information". Take special care with CELLUVISC®

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.

Using other medicines

Please tell your doctor or pharmacist it you a relating or "Rave recently taken 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®.

3regnancy and breast-feeding

You can use CELLUVISC® if you are pregnant and when you are breast-feeding.

Driving and using machines

CELLUVISC® does not usually cause blurred (unclear) 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®.

If you are unsure about anything, discuss it with your doctor, nurse or pharmacist.

3. HOW TO USE CELLUVISC®

Follow these instructions unless the pharmacist or your doctor gave you different advice.

The usual 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®.

Vlake sure that the single-dose container is intact before use. The solution should be used mmediately after opening. To avoid contamination, do not let the open-end of the single-dose container touch your eye or anything else. Wash your hands before use.

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-    Artwork is actual size.

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-    Drawing Number 0106901 -Part Number 71859GB10T

6. FURTHER INFORMATION What CELLUVISC® contains

•    The active ingredient is carmellose sodium 5 mg/ml.

•    The other ingredients are sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, and purified water. Small amounts

of sodium hydroxide or hydrochloric acldTnayireatffletfTo bring the solution to the correct pH (a measure of the acidity or alkalinity of the solution).

The ingredients and the amount used in CELLUVISC® were chosen to match what appears in tears produced naturally by the eye.

What CELLUVISC® looks like and contents of the pack

CELLUVISC® is a clear, colourless to Dale vellow solution in a small see-throuah fbubble-likel

^ °ne sn^e "^ose conta'ner ^rom l^e str'P-

casing (known as a 'single-dose container'). The single-dose container has a twist-off top. Each single-dose container contains 0.4 ml of solution.

Each pack contains 5, 30 or 90 single-dose containers. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Allergan Pharmaceuticals Ireland Castlebar Road

Westport —-

County Mayo Ireland

For any further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

^%L' Hold the single-dose container upright (with the top uPPermost)andtwistoff^etop.

Afiergan Limited

1st Floor Marlow International

The Parkway

Marlow

Buckinghamshire, SL71YL, United Kingdom Tel. 01628 494026

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E-mail: uk_medlnfo@affeTgaiT.COm

This leaflet was last approved on 2006-08-22

//£yi Turn the single-dose container upside downand squeeze it to (cJ5'\s 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

worried, talk to your doctor or pharmacist.

If you forqet to use CELLUVISC®, use a sinqle drop in each eve 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

gets them.

You may have a feeling of burning, for a short time.

if this side effect goes on for some time or worries you, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CELLUVISC®

<eep out of the reach and sight of children.

Do not store above 25°C.

Do not use CELLUVISC® after the expiry date (use by 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.

Used CELLUVISC® eye drop containers can be disposed of as household waste. Any unused containers can be returned to the pharmacist or he can tell you how to dispose of them safely (in order to protect the environment).

-== ALLERGAN

® Marks owned by Allergan Inc.

© 2006 Allergan, Inc., Irvine, CA 92612

71859GB10T


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