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CELLUVISC 0.5% W/V EYE DROP SOLUTION UNIT DOSE

Active substance(s): CARMELLOSE SODIUM

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Insert - CELLUVISC® 0.5% - Ireland - MoH Submission

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody
gets them.

Package leaflet:
Information for the user

The side effects are classified into the following categories, depending on how often
they occur:

CELLUVISC®

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 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® 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

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 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
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 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®.
If you are unsure about anything, discuss it with 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.

3.

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 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 medicine, ask your doctor,
pharmacist or nurse.

Artwork created at 100%
Drop keylines and notes before printing
Part Number: 71855MD311F
Drawing Number: 0152202

The following side effects may be seen with CELLUVISC®:
Common

Not known

Eye irritation (including burning and discomfort), eye pain, itchy eyes,
visual disturbance.
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.

UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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.

may affect more than 1 in 10 people
may affect up to 1 in 10 people
may affect up to 1 in 100 people
may affect up to 1 in 1,000 people
may affect up to 1 in 10,000 people
frequency cannot be estimated from the available data

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:

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

1.

Very common
Common
Uncommon
Rare
Very rare
Not known

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.
5. How to store CELLUVISC®

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date (use by date) which is stated on the singledose container tab and the carton after EXP:. The expiry date refers to the last day of
that month.
Do not use if CELLUVISC® packaging shows evidence of tampering. Do not use if
solution changes colour or becomes cloudy. 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).
6. Contents of the pack and other 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 eye drops solution in a small seethrough (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 eye drops
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 medicine 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: uk_medinfo@allergan.com

This leaflet was last revised in 11/2014.

71855MD311F

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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