CELLUVISC 1.0% W/V EYE DROPS SOLUTION

Active substance: CROSCARMELLOSE SODIUM

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Insert - CELLUVISC® 1.0% 30 x 0.4 ml - UK, Ireland - MoH Submission

2. What you need to know before you use Celluvisc

Package leaflet:
Information for the user

Celluvisc®

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: 71688MD126F
Drawing Number: 0238501

Do not use Celluvisc
• If you are allergic (hypersensitive) to carmellose sodium or any of
the other ingredients of this medicine (listed in section 6).
Warnings and precautions
• 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.
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
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2 
Tel: +353 1 6764971 
Fax: +353 1 6762517 
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.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 June 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.

71688MD126F

Insert - CELLUVISC® 1.0% 60 x 0.4 ml - UK, Ireland - MoH Submission

Package leaflet:
Information for the user

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

1.0 % w/v Eye drops, solution, unit dose

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.

CELLUVISC®
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.
2. What you need to know before you use Celluvisc
Do not use Celluvisc
• If you are allergic (hypersensitive) to carmellose sodium or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
• 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.
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

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
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2 
Tel: +353 1 6764971 
Fax: +353 1 6762517 
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.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.

Celluvisc is for ocular use (applied on the eye).

Marketing Authorisation Holder and Manufacturer
Allergan Pharmaceuticals Ireland, Westport, Co. Mayo, Ireland.

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.

For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.

The recommended dose is 1-2 drops of Celluvisc in the affected eyes as needed.

Allergan Ltd
The Parkway,
Marlow,
Bucks, SL7 1YL
United Kingdom
Tel: +44 (0)1628 494026 
e-mail: uk_medinfo@allergan.com

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.

This medicinal product is authorised in the Member States of the EEA under the
following names:
Denmark
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.

Celluvisc

Germany

Celluvisc 1% Augentropfen

Finland

Celluvisc 1.0% Silmätipat, liuos

Greece

Celluvisc 1.0% w/v Οφθαλμικές σταγόνες, διάλυμα

Portugal

Celluvisc, colírio, solução a 1,0%.

Ireland

Spain
UK

Celluvisc 1.0% w/v Eye drops, solution, unit dose

Viscofresh 10 mg/ml Colirio en solución

Celluvisc 1.0% w/v Eye drops, solution, unit dose
This leaflet was last revised in June 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.

Artwork created at 100%
Drop keylines and notes before printing
Part Number: 71938MD127F
Drawing Number: 0152202

71938MD127F

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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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