Patient leaflet - Celluvisc 1.0% w/v eye drops solution unit dose
1. What Celluvisc is and wh
Celluvisc is a tear substitute a carmellose sodium. It is used f of dry eye (such as soreness, b You must talk to a doctor if you
lk to your doctor, pharmacist or sible side effects not listed in ou do not feel better or if you it is used for re you use Celluvisc her information at it is used for nd contains the lubricant called or the treatment of the symptoms urning, irritation or dryness). do not feel better or if you feel worse.
2. What you need to know b
Do not use Celluvisc
If you are allergic (hypersen
or any of the other ingredien section 6).
Warnings and precautions
If you wear contact lenses, t
before using Celluvisc. The 15 minutes after you have a
Other medicines and Celluvi
Please tell your doctor or phar recently used or might use any medicines obtained without a p If you are using other eye drop before putting in Celluvisc.
efore you use Celluvisc sitive) to carmellose sodium ts of this medicine (listed in hese should be removed lenses can be put back again pplied your drops.
sc macist if you are using, have other medicines, including rescription.
s, leave at least 15 minutes
Pregnancy and breast-feedi
Celluvisc can be used during
Driving and using machines
Celluvisc may cause short-las lasting 1 - 15 minutes. If you do do not drive or use machines u
3. How to use Celluvisc
Celluvisc is for ocular use (ap Always use this medicine exac as your doctor, pharmacist or n your doctor, pharmacist or nurs
The recommended dose is 1-2 affected eyes as needed.
Make sure that the single-dose The solution should be used im
ng pregnancy and breast-feeding.
ting blurring of vision typically experience temporary blurring, ntil your sight is clear.
plied on the eye).
tly as described in this leaflet or urse has told you. Check with e if you are not sure.
drops of Celluvisc in the container is intact before use. mediately after opening.
To avoid contamination or possi open-end of the single-dose co anything else. Wash your hands
- 1. 2.
- 1. Tear one single-dose contain
- 2. Hold the single-dose contain uppermost) and twist off the
- 3. Gently pull down the lower ey the single-dose container up release one drop into each e
Do not re-use the single-dose c solution left. It is most important
ble eye injury, do not let the ntainer touch your eye or before use.
3.
er from the strip.
er upright (with the cap cap.
elid to form a pocket. Turn side down and squeeze it to ye. Blink your eyes a few times.
ontainer even if there is some that you throw it away and do not keep it.
If irritation, pain, redness or cha feel your condition is getting wo and consult your doctor or phar
If you use more Celluvisc tha
It will not cause you any harm. If doctor or pharmacist.
If you forget to use Celluvisc
Apply your next dose as require directed by your pharmacist or d dose to make up for forgotten in
If you have any further question ask your doctor, pharmacist or n
4. Possible side effects
Like all medicines, this medicine although not everybody gets the
nges in vision occur or if you rse, stop taking this medicine macist.
n you should you are worried, talk to your d or at the normal time as octor. Do not take a double dividual doses.
s on the use of this medicine, urse.
can cause side effects, m.
The following adverse reactions 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
or medically relevant adverse 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 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: www.mhra.gov.uk/yello
Ireland
Website: www.hpra.ie
By reporting side effects you ca on the safety of this medicine.
5. How to store Celluvisc
Keep this medicine out of the si Do not use this medicine after th
let, please tell your doctor or
o your doctor, pharmacist or e side effects not listed in this effects directly via:
wcard n help provide more information ght and reach of children. e expiry date which is stated
on the single-dose container tab, after EXP. The expiry date refers
Do not store above 25°C.
Keep the single dose containers pouch back in the outer carton. P moisture loss.
Do not use if the packaging show Do not use if solution changes co Medicines should not be dispose household waste. Ask your phar medicines no longer required. Th protect the environment.
6. Contents of the pack and ot
What Celluvisc contains
The active substance is carme
the foil pouch and the carton to the last day of that month.
in the pouch and place the ouch is required to prevent s evidence of tampering. lour or becomes cloudy. d of via wastewater or macist how to dispose of ese measures will help to her information llose sodium 10 mg/ml.
- The other ingredients are sodi potassium chloride, calcium c
The ingredients in Celluvisc wer natural tear composition.
What Celluvisc looks like and
Celluvisc is an eye drop solution. colourless to pale yellow solution (bubble-like) casing (known as a ‘ The single-dose container has a t container contains 0.4 ml of soluti Each pack contains 10, 20, 30, 4 single-dose containers.
Each foil pouch contains 10 singl
Not all pack sizes may be market
Marketing Authorisation Hold
AbbVie Ltd
Maidenhead
um chloride, sodium lactate, hloride and purified water.
e designed to match your contents of the pack
It is presented as a clear, in a small see-through single-dose container’). wist-off cap. Each single-dose on.
0, 60 or 90 foil-pouched e-dose containers.
ed.
er
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 uk_medinfo@abbvie.com
dicine, please contact the ting Authorisation Holder.
Package leaflet:
Information for the user
CELLUVISC®
1.0% w/v Eye drops, solution, unit dose
Carmellose sodium
73715MD028P
This medicinal product is au States of the EEA under the Denmark Celluvisc Finland Celluvisc 1.0% S Germany Celluvisc 1% Aug Greece Celluvisc 1.0% w διάλυμα Ireland Celluvisc 1.0% w Portugal Celluvisc, colírio, Spain Viscofresh 10 mg UK Celluvisc 1.0% w This leaflet was last revised To listen to or reque this leaflet in Braille | |||||||||
thorised in the Member following names: ilmätipat, liuos entropfen /v Οφθαλμικές σταγόνες, /v Eye drops, solution, unit dose solução a 1,0%. /ml Colirio en solución /v Eye drops, solution, unit dose in 02/2022 st a copy of , large print or | |||||||||
| audio please call, fr 0800 198 5000 (UK Please be ready to information: Carmel reference number P This is a service pr Royal National Insti | ee of charge: only). give the following lose sodium 1.0% L 41042/0061. ovided by the tute of Blind People. | ||||||||