CELLUVISC 1.0% W/V EYE DROPS SOLUTION

Active substance: CROSCARMELLOSE SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
Insert - CELLUVISC® 1% 30 x 0.4 ml - UK, Ireland - MoH Submission

2.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Celluvisc®

1% w/v Eye drops, solution, unit dose
Carmellose sodium

Read all of this leaflet carefully because it contains important
information for you.
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.
2.
3.
4.
5.
6.
1.

What Celluvisc is and what it is used for
Before you use Celluvisc
How to use Celluvisc
Possible side effects
How to store Celluvisc
Further information
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).

Artwork is created at 100%
Drop keylines and notes before printing
Part Number: 71688MD004E
Drawing Number: 0238501

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).

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.

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.
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.

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.
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).

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.

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.

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

5.

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

HOW TO STORE CELLUVISC

Keep out of the reach and sight of children.
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.
Do not store above 25°C.
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.

FURTHER 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.

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.

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

Celluvisc®

Germany

Celluvisc® 1% Augentropfen

Ireland

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

Finland

Greece

Portugal
Spain

UK

Celluvisc® 1.0% Silmätipat, liuos

Celluvisc® 1.0% w/v Οφθαλμικές σταγόνες, διάλυμα
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 approved in Ireland in February 2009 and
last revised for the UK in January 2013.

© 2013 Allergan, Inc., Irvine CA 92612
® marks owned by Allergan, Inc.

71688MD004E

Insert - CELLUVISC® 1% 60 x 0.4 ml - UK, Ireland - MoH Submission

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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.

CELLUVISC®

Keep out of the reach and sight of children.
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.
Do not store above 25°C.

1% w/v Eye drops, solution, unit dose
Carmellose sodium

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

5.

HOW TO STORE CELLUVISC

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.

FURTHER 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.

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).

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

2.

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

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.
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.

1.
2.
3.

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

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

Celluvisc®

Finland

Celluvisc® 1.0% Silmätipat, liuos

Germany

Celluvisc® 1% Augentropfen

Greece

Celluvisc® 1.0% w/v Οφθαλμικές σταγόνες, διάλυμα

Ireland

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

Portugal

Celluvisc®, colírio, solução a 1,0%.

Spain

Viscofresh® 10 mg/ml Colirio en solución

UK

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

This leaflet was last approved in Ireland in February 2009 and last revised for the UK in
January 2013.

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.

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).
© 2013 Allergan, Inc., Irvine CA 92612
® marks owned by Allergan, Inc.

Artwork is created at 100%
Drop keylines and notes before printing
Part Number: 71938MD005E
Drawing Number: 0152202

71938MD005E

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.

Hide
(web5)