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CARMELLOSE SODIUM 1% W/V EYE DROPS SOLUTION

Active substance(s): CARMELLOSE SODIUM

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S0870 LEAFLET Celluvisc 20150629

PACKAGE LEAFLET: INFORMATION FOR THE USER

CELLUVISC 1% w/v EYE DROPS, SOLUTION
(Carmellose Sodium)
Your medicine is known as Celluvisc 1% w/v Eye Drops, Solution
but will be referred to as Celluvisc throughout the following 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.

What is in this leaflet:
1. What Celluvisc is and what it is used for

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.

Tear one single-dose container from the strip.

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

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

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.

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).

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

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.

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.

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.

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.

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.

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:

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Celluvisc contains


Each ml contains 10mg of the active ingredient, carmellose
sodium.



Celluvisc also contains the following inactive ingredients:
Sodium chloride, sodium lactate, potassium chloride, calcium
chloride and purified water.

What Celluvisc looks like and contents of the pack
Celluvisc is a clear, colourless to slightly yellow viscous solution in a
small see-through (bubble-like) casing (known as a ‘single-dose
container’). The single-dose container has a twist-off cap.
Celluvisc is available as single-dose containers containing 0.4 mls
of solution in packs of 30.

UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.

Product Licence holder
Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines, Alperton Lane, Wembley, HA0 1DX.
Manufacturer

5. HOW TO STORE CELLUVISC

This product is manufactured by Allergan Pharmaceuticals Ireland,
Castlebar Road, Westport, Co Mayo, Ireland.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Protect from light.

P



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.

Leaflet revision date: 29 June 2015



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.



Do not use if the packaging shows evidence of tampering. Do
not use if solution changes colour or becomes cloudy. You
should seek the advice of your pharmacist who will tell you what
to do.

PL: 19488/0870

Celluvisc is a registered trade mark of Allergan, Inc, USA.
S0870 LEAFLET Celluvisc 20150629

S0870 LEAFLET Carmellose Sodium 20150629

PACKAGE LEAFLET: INFORMATION FOR THE USER

CARMELLOSE SODIUM 1% w/v EYE DROPS, SOLUTION
Your medicine is known as Carmellose Sodium 1% w/v Eye Drops,
Solution but will be referred to as Carmellose Sodium throughout
the following 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.

What is in this leaflet:
1. What Carmellose Sodium is and what it is used for

3. HOW TO USE CARMELLOSE SODIUM
Carmellose Sodium 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 Sodium 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.

Tear one single-dose container from the strip.

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

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. WHAT CARMELLOSE SODIUM IS AND WHAT IT IS USED
FOR
Carmellose Sodium 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 Carmellose Sodium


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 Carmellose Sodium. The lenses can be put back again 15
minutes after you have applied your drops.

Other medicines and Carmellose Sodium
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 Sodium.
Pregnancy and breast-feeding
Carmellose Sodium can be used during pregnancy and breastfeeding.

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 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

Driving and using machines
Carmellose Sodium 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.

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:

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Carmellose Sodium contains


Each ml contains 10mg of the active ingredient, carmellose
sodium.



Carmellose Sodium also contains the following inactive
ingredients: Sodium chloride, sodium lactate, potassium
chloride, calcium chloride and purified water.

What Carmellose Sodium looks like and contents of the pack
Carmellose Sodium is a clear, colourless to slightly yellow viscous
solution in a small see-through (bubble-like) casing (known as a
‘single-dose container’). The single-dose container has a twist-off
cap.

UK

Carmellose Sodium is available as single-dose containers
containing 0.4 mls of solution in packs of 30.

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

Product Licence holder

By reporting side effects you can help provide more information on
the safety of this medicine.

Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines, Alperton Lane, Wembley, HA0 1DX.

5. HOW TO STORE CARMELLOSE SODIUM

Manufacturer



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.

This product is manufactured by Allergan Pharmaceuticals Ireland,
Castlebar Road, Westport, Co Mayo, Ireland.



Protect from light.



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.





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.
Do not use if the packaging shows evidence of tampering. Do
not use if solution changes colour or becomes cloudy. You
should seek the advice of your pharmacist who will tell you what
to do.

P

PL: 19488/0870

Leaflet revision date: 29 June 2015
S0870 LEAFLET Carmellose Sodium 20150629

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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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