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Celluvisc 0.5%W/V Eye Drop Solution Unit Dose

Document: leaflet MAH GENERIC 30 pack_PL 41443-0011 change

UK/Ireland CELLUVISC® 0.5% Insert 0.4 ml

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.

•    If any of the side effects gets serious, or if you notice any side effect    not listed in

this leaflet, please tell your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

CELLUVISC® 0.5% w/v, eye drops, solution, unit dose Carmellose sodium 0.5% w/v

in this leaflet:

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

2.    Before you use CELLUVISC1 2 3 4 5 6 7

3.    How to use CELLUVISC®

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.

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 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, CELLUVISC® can cause side (unwanted) effects, although not everybody 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®

Keep 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).

2. BEFORE YOU USE CELLUVISC®

Do not use CELLUVISC®

•    If you are hypersensitive (allergic) to carmellose sodium or any of the other ingredients of 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 if you are taking or have 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®'.

Pregnancy 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 (uhclear) 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.

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 acid may be added to 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 pale yellow solution in a small see-through (bubble-like) 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:

Allergan Limited

1st Floor Marlow International

The Parkway

Marlow

Buckinghamshire, SL7 1YL,

United Kingdom

Tel. 01628 494026

E-mail: ukjnedinfo@allergan.com

This leaflet was last approved on 2006-08-22

Tear one single-dose container from the strip.


Hold the single-dose container upright (with the top uppermost) and twist off the top.

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 youreyesafewltimes.


e ALLERGAN

| ® Marks are owned by Allergan Inc.

© 2006 Allergan, Inc., Irvine, CA 92612

71855GB10T


-    All copy prints Black.

-    Artwork is actual size.

-    Drop keylines before processing.

-    Drawing Number 0152202 -Part Number 71855GB10T




1

HOW TO USE CELLUVISC®

2

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

3

The usual dose is 1-2 drops of CELLUVISC® in the affected eye/each affected eye, 4 times a

4

day or as often as needed.

5

You do not need to remove contact lenses before using CELLUVISC®.

6

Make sure that the single-dose container is intact before use. The solution should be used

7

immediately 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.