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CELLUVISC 1.0% W/V EYE DROPS SOLUTION UNIT DOSE

Active substance: CARMELLOSE SODIUM

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Insert - CELLUVISC® 1% Unit Dose - UK, Ireland - MoH Submission

2. What you need to know before you use Celluvisc

1.

2.

3.

Do not use Celluvisc

Package leaflet:
Information for the user

• If you are allergic (hypersensitive) to carmellose sodium or any of
the other ingredients of this medicine (listed in section 6).

Celluvisc®

• If you wear contact lenses, these should be removed before using
Celluvisc. The lenses can be put back again 15 minutes after you
have applied your drops.

1.0% 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. 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
1. What Celluvisc is and what it is used for

Celluvisc is a tear substitute 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).
You must talk to a doctor if you do not feel better or if you feel worse.

Artwork is created at 100%
Drop keylines and notes before printing
Part Number: 71688MD313F
Drawing Number: 0238501

Warnings and precautions

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 before
putting in Celluvisc.
Pregnancy and breast-feeding
Celluvisc can be used during pregnancy and breast-feeding.
Driving and using machines
Celluvisc may cause short-lasting blurring of vision typically lasting
1 - 15 minutes. If you do experience temporary blurring, do not drive
or use machines until your sight is clear.
3. How to use Celluvisc
Celluvisc is for ocular use (applied on the eye).
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
eyes as needed.
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 cap uppermost)
and twist off the cap.
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 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.
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

Apply your next dose as required or at the normal time as directed
by your pharmacist or doctor. Do not take a double dose to make
up for forgotten individual doses.
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 following adverse reactions or medically relevant adverse
events were reported during clinical trials:

Common side effects (occurring in between 1 and 10 patients in
every 100) are:
Eye irritation (including burning and discomfort), eye pain, itchy
eyes, visual disturbance.

Post-Marketing Data

The following adverse reactions or medically relevant adverse
events have been reported since the drug has been marketed:

Uncommon side effects (occurring in between 1 and 10 patients
in every 1000) are:
Allergic reactions (including eye or eyelid swelling), blurring
of vision, increase in tear production (also known as tearing),
sticky eye, crusting of the eyelid and/or drug residue, a feeling
that something is in your eye, redness of the eye/eyelid, eyesight
worsening, eye injury to the surface of the eye due to the tip of the
vial touching the eye during use.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
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:
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.
5. How to store Celluvisc

Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.

Do not store above 25°C.

Do not use if the packaging shows evidence of tampering. Do not
use if solution changes colour or becomes cloudy.
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 contains

• The active substance is carmellose sodium 10 mg/ml.
• The other ingredients are sodium chloride, sodium lactate,
potassium chloride, calcium chloride and purified water.

The ingredients in Celluvisc were designed to match your natural
tear composition.
What Celluvisc looks like and contents of the pack

Celluvisc is an eye drop solution. It is presented as 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 cap. Each single-dose container contains
0.4 ml of solution.
Each pack contains 5, 10, 20, 30, 40, 60 or 90 single-dose
containers. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Allergan Pharmaceuticals Ireland,
Westport,
Co. Mayo,
Ireland.

For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder.
Allergan Ltd
The Parkway,
Marlow,
Bucks, SL7 1YL
United Kingdom
Tel: +44 (0)1628 494026
e-mail: uk_medinfo@allergan.com

This medicinal product is authorised in the Member States
of the EEA under the following names:
Denmark
Finland
Germany
Greece
Ireland
Portugal
Spain
UK

Celluvisc
Celluvisc 1.0% Silmätipat, liuos
Celluvisc 1% Augentropfen
Celluvisc 1.0% w/v Οφθαλμικές σταγόνες, διάλυμα
Celluvisc 1.0% w/v Eye drops, solution, unit dose
Celluvisc, colírio, solução a 1,0%.
Viscofresh 10 mg/ml Colirio en solución
Celluvisc 1.0% w/v Eye drops, solution, unit dose

This leaflet was last revised in 11/2014.

To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge: 0800 198 5000 (UK only).
Please be ready to give the following
information: Carmellose sodium 1.0%
reference number PL 41443/0001.
This is a service provided by the
Royal National Institute of Blind People.

© 2014 Allergan, Inc., Irvine CA 92612
® marks owned by Allergan, Inc.

71688MD313F

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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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