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CELLUVISC 1% W/V EYE DROPS

Active substance(s): CARMELLOSE SODIUM

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Celluvisc ® 1% w/v Eye Drops

Ref: 1090/090715/1/F

(carmellose sodium)
Patient Information Leaflet
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.
Your medicine is called Celluvisc 1% w/v Eye Drops
but will be referred to as Celluvisc throughout the
leaflet.

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

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.

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.

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.

How to store Celluvisc

5

• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.

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.

• Do not store above 25°C.
• Use immediately after opening. Any unused

If you have any further questions on the use of this
product, ask your doctor or pharmacist.



4

Possible side effects

solution should be discarded.

• Remember this medicine is for you. Never give



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.

6

your medicine to other people. It may harm them,
even if their symptoms are the same as yours.
This leaflet does not tell you everything about your
medicine. If you have any questions or are not
sure about anything, ask your doctor or
pharmacist. He/she will have additional
information about this medicine and will be able to
advise you.
Do not use this medicine after the expiry date
shown on the vial label or carton label. Do not use
the product if you notice that the vial cap has
already broken-off. If your doctor tells you to stop
using this medicine, return any unused medicine
to your pharmacist for safe disposal. Only keep
this medicine, if your doctor tells you to. If your
eye drops show any signs of deterioration consult
your pharmacist for advice.

Contents of the pack and other
information

What Celluvisc contains
Each ml of soultion contains 10mg of carmellose
sodium as the active ingredient. Celluvisc also
contains the following inactive ingredients; sodium
chloride, sodium lactate, potassium chloride,
calcium chloride dihydrate and purified water.
What Celluvisc looks like and contents of the
pack
Celluvisc is a clear, colourless viscous solution in a
small, plastic and see-through (bubble-like) casing
(known as a vial). Each vial contains 0.4ml of
solution and has a twist-off cap. Each vial also has a
plastic tab telling you the name of the product on
one side and the expiry/use by date on the other.
Celluvisc is available in packs of 30 or 60 x 0.4ml
single-use vials.
Manufacturer and Licence Holder
Celluvisc is manufactured by Allergan
Pharmaceuticals Ireland, Westport, County Mayo,
Ireland and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
Celluvisc is a registered trademark of Allergan Inc.

P

PL 15184/1090

Leaflet revision date: 09/07/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 1090/090715/1/B

Ref: 1090/090715/2/F

Carmellose Sodium 1% w/v Eye Drops
Patient Information Leaflet
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.
Your medicine is called Carmellose sodium 1% w/v
Eye Drops but will be referred to as Carmellose sodium throughout the leaflet.

What is in this leaflet:
1 What Carmellose sodium is and what it is
used for
2 What you need to know before you use
Carmellose sodium
3 How to use Carmellose sodium
4 Possible side effects
5 How to store Carmellose sodium
6 Contents of the pack and other information

1

Pregnancy and breast-feeding
Celluvisc can be used during pregnancy and breastfeeding.
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 Carmellose sodium

Carmellose 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 Carmellose
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.

What Carmellose sodium is and what it
is used for

Carmellose 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
Carmellose sodium

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 Carmellose
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 Carmellose.

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 Carmellose sodium 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 Carmellose sodium
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
product, ask your doctor or pharmacist.

4

Possible side effects

5

How to store Carmellose sodium

• KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.

• Do not store above 25°C.
• Use immediately after opening. Any unused
solution should be discarded.

• Remember this medicine is for you. Never give




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.

your medicine to other people. It may harm them,
even if their symptoms are the same as yours.
This leaflet does not tell you everything about your
medicine. If you have any questions or are not
sure about anything, ask your doctor or
pharmacist. He/she will have additional
information about this medicine and will be able to
advise you.
Do not use this medicine after the expiry date
shown on the vial label or carton label. Do not use
the product if you notice that the vial cap has
already broken-off. If your doctor tells you to stop
using this medicine, return any unused medicine
to your pharmacist for safe disposal. Only keep
this medicine, if your doctor tells you to. If your
eye drops show any signs of deterioration consult
your pharmacist for advice.

6
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

Contents of the pack and other
information

What Carmellose sodium contains
Each ml of soultion contains 10mg of carmellose
sodium as the active ingredient. Carmellose sodium
also contains the following inactive ingredients;
sodium chloride, sodium lactate, potassium chloride,
calcium chloride dihydrate and purified water.
What Carmellose looks like and contents of the
pack
Carmellose sodium is a clear, colourless viscous
solution in a small, plastic and see-through
(bubble-like) casing (known as a vial). Each vial
contains 0.4ml of solution and has a twist-off cap.
Each vial also has a plastic tab telling you the name
of the product on one side and the expiry/use by
date on the other. Carmellose sodium is available in
packs of 30 or 60 x 0.4ml single-use vials.
Manufacturer and Licence Holder
Carmellose sodium is manufactured by Allergan
Pharmaceuticals Ireland, Westport, County Mayo,
Ireland and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.

P

PL 15184/1090

Leaflet revision date: 09/07/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 1090/090715/2/B

Expand view ⇕

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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