CELLUVISC 1.0% W/V EYE DROPS SOLUTION UNIT DOSE/CARMELLOSE SODIUM 1.0% W/V EYE DROPS SOLUTION UNIT

Active substance: CARMELLOSE SODIUM

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S0862LEAFLET Celluvisc 20131015

PACKAGE LEAFLET: INFORMATION FOR USER

CELLUVISC 1% w/v EYE DROPS, SOLUTION,
UNIT DOSE
(Carmellose Sodium)
Your medicine is known as Celluvisc 1% w/v Eye Drops, Solution,
Unit Dose but will be referred to as Celluvisc throughout the
following leaflet.
Read all of this leaflet carefully because it contains important
information for you.

3. HOW TO USE CELLUVISC
Celluvisc is for ocular use (applied on the eye).
Follow these instructions unless the pharmacist or your doctor gave
you different advice.
The usual 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, do not let the open-end of the single-dose container
touch your eye or anything else. Wash your hands before use.

This medicine is available without prescription. However, you still
need to use Celluvisc carefully to get the best results from it.


Keep this leaflet. You may need to read it again.



Ask your pharmacist if you need more information or advice.



You must contact a doctor if your symptoms worsen or do not
improve.



If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Celluvisc is and what it is used for
2. Before you use 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.

3. How to use Celluvisc
4. Possible side effects
5. How to store Celluvisc
6. Further 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).
2. BEFORE YOU USE CELLUVISC
Do not use Celluvisc


If you are allergic (hypersensitive) to carmellose sodium or any
of the other ingredients of Celluvisc (see section 6 for a full list
of ingredients).

Take special care with 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.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken 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.

Do not re-use the single-dose container even if there is some
solution left.
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 product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Celluvisc can cause side effects, although not
everybody gets them.
The following side affects are known to occur, but the number of
people likely to be affected is unknown:


Eye irritation, burning or stinging sensation,



Blurring of vision,



Increase in tear production (also known as tearing).

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.

5. HOW TO STORE CELLUVISC

6. FURTHER INFORMATION



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

What Celluvisc contains



Do not store above 25°C.





Do not use Celluvisc after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.

Each ml contains 10mg of the active ingredient, carmellose
sodium 1% (w/v).



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






Do not use the product if you notice that the vial cap has
already broken-off.
You may have completed your course of treatment as directed
by your pharmacist or doctor and still have some unused vials
remaining. These may be returned to your pharmacy for safe
disposal.

What Celluvisc looks like and contents of the pack

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Celluvisc is available as ampoules in packs of 30.

A clear, colourless to slightly yellow viscous solution in a small,
plastic and see-through (bubble-like) casing (known as a ‘vial’).
Each vial contains 4ml of the solution.

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

PL No: 19488/0862

Leaflet revision date: 15 October 2013
Celluvisc is a registered trade mark of Allergan, Inc, USA.
S0862LEAFLET Celluvisc 20131015

S0862 LEAFLET Carmellose Sodium 20131015

PACKAGE LEAFLET: INFORMATION FOR USER

CARMELLOSE SODIUM 1% w/v EYE DROPS,
SOLUTION, UNIT DOSE

3. HOW TO USE CARMELLOSE SODIUM
Carmellose Sodium is for ocular use (applied on the eye).
Follow these instructions unless the pharmacist or your doctor gave
you different advice.

Your medicine is known as Carmellose Sodium 1% w/v Eye Drops,
Solution, Unit Dose but will be referred to as Carmellose Sodium
throughout the following leaflet.

The usual dose is 1-2 drops of Carmellose Sodium in the affected
eyes as needed.

Read all of this leaflet carefully because it contains important
information for you.

Make sure that the single-dose container is intact before use.
The solution should be used immediately after opening. To avoid
contamination, do not let the open-end of the single-dose container
touch your eye or anything else. Wash your hands before use.

This medicine is available without prescription. However, you still
need to use Carmellose Sodium carefully to get the best results
from it.


Keep this leaflet. You may need to read it again.



Ask your pharmacist if you need more information or advice.



You must contact a doctor if your symptoms worsen or do not
improve.



If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Carmellose Sodium is and what it is used for
2. Before you use Carmellose Sodium
3. How to use Carmellose Sodium

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.

4. Possible side effects
5. How to store Carmellose Sodium
6. Further 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).
2. 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 Carmellose Sodium (see section 6 for
a full list of ingredients).

Do not re-use the single-dose container even if there is some
solution left.
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.

Take special care with Carmellose Sodium


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.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken 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.
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Carmellose Sodium can cause side effects,
although not everybody gets them.
The following side affects are known to occur, but the number of
people likely to be affected is unknown:


Eye irritation, burning or stinging sensation,



Blurring of vision,



Increase in tear production (also known as tearing).

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.

5. HOW TO STORE CARMELLOSE SODIUM

6. FURTHER INFORMATION



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

What Carmellose Sodium contains



Do not store above 25°C.





Do not use Carmellose Sodium after the expiry date which is
stated on the carton and blister strip. The expiry date refers to
the last day of that month.

Each ml contains 10mg of the active ingredient, carmellose
sodium 1% (w/v).



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






Do not use the product if you notice that the vial cap has
already broken-off.
You may have completed your course of treatment as directed
by your pharmacist or doctor and still have some unused vials
remaining. These may be returned to your pharmacy for safe
disposal.

What Carmellose Sodium looks like and contents of the pack

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Carmellose Sodium is available as ampoules in packs of 30.

A clear, colourless to slightly yellow viscous solution in a small,
plastic and see-through (bubble-like) casing (known as a ‘vial’).
Each vial contains 4ml of the solution.

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

PL No: 19488/0862

Leaflet revision date:15 October 2013
S0862 LEAFLET Carmellose Sodium 20131015

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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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