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CARMELLOSE SODIUM 0.5% W/V EYE DROPS SOLUTION

Active substance(s): CARMELLOSE SODIUM

PDF Transcript

Celluvisc ® 0.5% w/v Eye Drops Solution

Ref: 0107/230916/1/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 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.
Your medicine is called Celluvisc 0.5% w/v Eye
Drops Solution, however thorughout the rest of this
leaflet it will be referred to as Celluvisc
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

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.

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 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

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

1. Tear one single-dose container from the strip.

Pregnancy and breast-feeding
You can use Celluvisc if you are pregnant and when
you are breast-feeding.

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.

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.

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

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.

4 Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The side effects are classified into the following
categories, depending on how often they occur:
Very common

may affect more than
1 in 10 people

Common

may affect up to
1 in 10 people

Uncommon

may affect up to
1 in 100 people

Rare

may affect up to
1 in 1,000 people

Very rare

may affect up to
1 in 10,000 people

Not known

frequency cannot be
estimated from
the available data

The following side effects may be seen with
Celluvisc.
Common

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

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

How to store Celluvisc

5

Keep out of the sight and reach of children.
Do not store above 25oC
Do not use Celluvisc 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.

6

Contents of the pack and other
information

What Celluvisc contains
The active ingredient is called carmellose sodium
5mg/ml.
The other ingredients are sodium chloride, sodium
lactate, potassium chloride, calcium chloride,
magnesium chloride and purified water.
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 eye drop solution, in a
single-dose container. The single-dose container
has a twist off top.
Each single-dose container contains 0.4ml of
solution.
Each pack contains 30 single-dose containers.
Manufacturer and Licence Holder
This medicine is manufactured by Allergan
Pharmaceuticals Ireland, Westport, County Mayo,
Ireland and is procured from within the EU. Product
Licence Holder LTT Pharma Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE. Repackaged by Lexon
(UK) Limited, B98 0RE, UK.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine and
will be able to advise you.

P

PL 33723/0107

Revision date: 23/09/16
Not known

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.

Celluvisc is a registered tradmark of Allergan, Inc.

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

Ref: 0107/230916/1/B

Carmellose sodium

Ref: 0107/230916/2/F

0.5% w/v Eye Drops Solution
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 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.
Your medicine is called Carmellose sodium 0.5%
w/v Eye Drops Solution, however thorughout the
rest of this leaflet it will be referred to as Carmellose
sodium
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

Driving and using machines
Carmellose sodium 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
Carmellose sodium.
If you are unsure about anything, discuss it with your
doctor, nurse or pharmacist.

3 How to use Carmellose sodium
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 eye/each affected eye, 4
times a day or as often as needed.
You do not need to remove contact lenses before
using Carmellose sodium.
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.

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 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

What you need to know before you
use Carmellose sodium

Do not use Carmellose sodium
* 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 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 between putting in the other drops and
Carmellose sodium
Pregnancy and breast-feeding
You can use Carmellose sodium if you are pregnant
and when you are breast-feeding.

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 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 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
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.

4

Possible side effects

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

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

How to store Carmellose sodium

5

Keep out of the sight and reach of children.
Do not store above 25oC
Do not use Carmellose sodium 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.

The side effects are classified into the following
categories, depending on how often they occur:
6
Very common

may affect more than
1 in 10 people

Common

may affect up to
1 in 10 people

Uncommon

may affect up to
1 in 100 people

Rare

may affect up to
1 in 1,000 people

Very rare

may affect up to
1 in 10,000 people

Not known

frequency cannot be
estimated from
the available data

The following side effects may be seen with
Carmellose sodium.
Common

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

Contents of the pack and other
information

What Carmellose sodium contains
The active ingredient is called carmellose sodium
5mg/ml.
The other ingredients are sodium chloride, sodium
lactate, potassium chloride, calcium chloride,
magnesium chloride and purified water.
The ingredients and the amount used in Carmellose
sodium were chosen to match what appears in tears
produced naturally by the eye.
What Carmellose sodium looks like and contents
of the pack
Carmellose sodium is a clear colourless eye drop
solution, in a single-dose container. The single-dose
container has a twist off top.
Each single-dose container contains 0.4ml of
solution.
Each pack contains 30 single-dose containers.
Manufacturer and Licence Holder
This medicine is manufactured by Allergan
Pharmaceuticals Ireland, Westport, County Mayo,
Ireland and is procured from within the EU. Product
Licence Holder LTT Pharma Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE. Repackaged by Lexon
(UK) Limited, B98 0RE, UK.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine and
will be able to advise you.

P

PL 33723/0107

Revision date: 23/09/16

Not known

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.

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

Ref: 0107/230916/2/B

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.