Patient leaflet - CELLUVISC 1.0% W/V EYE DROPS SOLUTION UNIT DOSE
obbvie
Package leaflet:
Information for the user
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.
on the single-dose container tab, the foil pouch and the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
CELLUVISC®
1.0% w/v Eye drops, solution, unit dose
Carmellose sodium
Keep the single dose containers in the pouch and place the pouch back in the outer carton. Pouch is required to prevent moisture loss.
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.
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.
Do not re-use the single-dose container even if there is some
Ask your pharmacist if you n
eed 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.
solution left. It is most important not keep it.
that you throw it away and do
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.
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
If you use more Celluvisc tha
It will not cause you any harm. If doctor or pharmacist.
If you forget to use Celluvisc
n you should
you are worried, talk to your
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).
Warnings and precautions
If you wear contact lenses, t before using Celluvisc. Thehese should be removed 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.
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 affected eyes as needed.
Make sure that the single-dose
drops of Celluvisc in the
container is intact before use.
The solution should be used immediately after opening.
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.
Do not use if the packaging shows evidence of tampering. Do not use if solution changes colour or becomes cloudy. 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 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 10, 20, 30, 40, 60 or 90 foil-pouched single-dose containers.
Each foil pouch contains 10 single-dose containers.
4. Possible side effects
Like all medicines, this medicine although not everybody gets the
can cause side effects, m.
Not all pack sizes may be market
Marketing Authorisation Hold
AbbVie Ltd
Maidenhead
ed.
r
events were reported during clin
Common side effects (occurri 10 patients in every 100) are: Eye irritation (including burning itchy eyes, visual disturbance.
Post-Marketing Data
The following adverse reactions events have been reported sinc
Uncommon side effects (occur in every 1000) are:
Allergic reactions (including eye of vision, increase in tear produ sticky eye, crusting of the eyelid that something is in your eye, re eyesight worsening, eye injury t the tip of the vial touching the ey
If any of the side effects gets se
ical trials:
ng in between 1 and
and discomfort), eye pain,
or medically relevant adverse e the drug has been marketed:
ring in between 1 and 10 patients
or eyelid swelling), blurring ction (also known as tearing), and/or drug residue, a feeling dness of the eye/eyelid, o the surface of the eye due to e during use.
rious, or if you notice any
SL6 4UB
UK
AbbVie Limited
Citywest Business Campus
Dublin 24
Ireland
Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
Co. Mayo
Ireland
For any information about this me local representative of the Marke
AbbVie Ltd.
UK
Tel: 01628 561090
dicine, please contact the ting Authorisation Holder.
side effects not listed in this leaf pharmacist.
Reporting of side effects
If you get any side effects, talk t nurse. This includes any possibl leaflet. You can also report side
UK
Yellow Card Scheme
Website:
Ireland
Website:
let, please tell your doctor or
o your doctor, pharmacist or e side effects not listed in this effects directly via:
wcard
obbvie
Package leaflet:
Information for the user
CELLUVISC®
1.0% w/v Eye drops, solution, unit dose Carmellose sodium
By reporting side effects you can help provide more information on the safety of this medicine. ।
5. How to store Celluvisc
obbvie
Package leaflet:
Information for the user
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.
on the single-dose container tab, the foil pouch and the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
CELLUVISC®
1.0% w/v Eye drops, solution, unit dose
Carmellose sodium
Keep the single dose containers in the pouch and place the pouch back in the outer carton. Pouch is required to prevent moisture loss.
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.
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.
Do not re-use the single-dose container even if there is some
Ask your pharmacist if you n
eed 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.
solution left. It is most important not keep it.
that you throw it away and do
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.
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
If you use more Celluvisc tha
It will not cause you any harm. If doctor or pharmacist.
If you forget to use Celluvisc
n you should
you are worried, talk to your
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).
Warnings and precautions
If you wear contact lenses, t before using Celluvisc. Thehese should be removed 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.
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 affected eyes as needed.
Make sure that the single-dose
drops of Celluvisc in the
container is intact before use.
The solution should be used immediately after opening.
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.
Do not use if the packaging shows evidence of tampering. Do not use if solution changes colour or becomes cloudy. 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 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 10, 20, 30, 40, 60 or 90 foil-pouched single-dose containers.
Each foil pouch contains 10 single-dose containers.
4. Possible side effectsLike all medicines, this medicine although not everybody gets the | can cause side effects, m. | Not all pack sizes may be market Marketing Authorisation Hold AbbVie Ltd Maidenhead | ed. r |
| events were reported during clin Common side effects (occurri 10 patients in every 100) are: Eye irritation (including burning itchy eyes, visual disturbance. Post-Marketing Data The following adverse reactions events have been reported sinc Uncommon side effects (occur in every 1000) are: Allergic reactions (including eye of vision, increase in tear produ sticky eye, crusting of the eyelid that something is in your eye, re eyesight worsening, eye injury t the tip of the vial touching the ey If any of the side effects gets se | ical trials: ng in between 1 and and discomfort), eye pain, or medically relevant adverse e the drug has been marketed: ring in between 1 and 10 patients or eyelid swelling), blurring ction (also known as tearing), and/or drug residue, a feeling dness of the eye/eyelid, o the surface of the eye due to e during use. rious, or if you notice any | SL6 4UB UK AbbVie Limited Citywest Business Campus Dublin 24 Ireland Manufacturer Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo Ireland For any information about this me local representative of the Marke AbbVie Ltd. UK Tel: 01628 561090 | dicine, please contact the ting Authorisation Holder. |
| side effects not listed in this leaf pharmacist. Reporting of side effects If you get any side effects, talk t nurse. This includes any possibl leaflet. You can also report side UK Yellow Card Scheme Website: Ireland Website: | let, please tell your doctor or o your doctor, pharmacist or e side effects not listed in this effects directly via: wcard | obbvie Package leaflet: Information for the user CELLUVISC® 1.0% w/v Eye drops, solution, unit dose Carmellose sodium |
By reporting side effects you can help provide more information on the safety of this medicine. ।
5. How to store Celluvisc
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
73715MD028P
This medicinal product is authorised in the Member
States of the EEA under the
following names:
| Denmark | Celluvisc | |
| Finland | Celluvisc 1.0% S | lmatipat, liuos |
| Germany | Celluvisc 1% Auc | lentropfen |
| Greece | Celluvisc 1.0% w 6iaXu|ia | /v O$9aX|JiK£c; OTaYbvec;, |
| Ireland | Celluvisc 1.0% w | /v Eye drops, solution, unit dose |
| Portugal | Celluvisc, colu-io, | solugao a 1,0%. |
| Spain | Viscofresh 10 mc | i/ml Colirio en solucion |
| UK | Celluvisc 1.0% w | /v Eye drops, solution, unit dose |
This leaflet was last revised
in 02/2022
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, fr 0800 198 5000 (UK
ee of charge: only).
Please be ready to give the following
information: Carme
lose sodium 1.0%
reference number PL 41042/0061.
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