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VISCOTEARS SINGLE DOSE UNIT 2.0MG/G EYE GEL

Active substance(s): CARBOMER / CARBOMER

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carbomer (polyacrylic acid)
Patient Information Leaflet
This product will be called Viscotears in
this leaflet.
Please read this leaflet carefully before you start
to use Viscotears. It contains important
information. Keep the leaflet in a safe place
because you may want to read it again.
Do not share these eye drops with anyone
else just in case you have an eye infection which
you could pass on.
If you have any other questions, or if there is
something you don’t understand, please ask your
pharmacist.
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.
In this leaflet:
1. What Viscotears is and what it’s used for
2. Things to consider before you start to
use Viscotears
3. How to use Viscotears
4. Possible side effects
5. How to store Viscotears
6. Further information
1. What Viscotears is and what it’s used for
Viscotears contains the active ingredient, carbomer
(polyacrylic acid). Viscotears is used to make your
eyes more comfortable when they feel dry. It is one
of a group of eye drops called ‘artificial tears’.
2. Things to consider before you start
to use Viscotears
DO NOT use Viscotears if:
•• If you are allergic to carbomer or any of the
other ingredients of this medicine (listed in
section 6).
Take special care:
•• in children and adolescents aged to 18 years,
the safety and efficacy of Viscotears at the
posology recommended in adults has been
established by clinical experience, but no
clinical trial data are available.

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Warnings and precautions
•• Only use Viscotears in your eye(s).
•• If you have problems with your eyes apart from
sore or dry eyes talk to your doctor or pharmacist
before you start to use Viscotears.
•• If you experience eye pain, vision changes,
irritation of the eyes, persistent redness, or if the
condition worsens or persists, discontinue use
and consult your doctor.
•• If you are taking other medicines. Please, also
read the section “Using other medicines”.
Other medicines and Viscotears
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines.
If you are using other eye drop or eye ointment
medicines, wait at least 5 minutes between each
medicine. Viscotears should always be the last eye
drops used.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
If you wear contact lenses, you should remove
them before using Viscotears and wait at least 15
minutes before putting your lenses back in.
Driving and using machines
Some people may find that their vision is blurred
immediately after using Viscotears. If affected, wait
until your vision clears before you drive or use
machinery.
3. How to use Viscotears
If your doctor has prescribed Viscotears he/ she
will tell you how and when to use it and the dose
will be on the pharmacist’s label.
The usual dosage is:
Adults (including the elderly): One drop in each
affected eye, three or four times a day.
Children and adolescents aged to 18 years:
The safety and efficacy of Viscotears in children
and adolescents at the posology recommended in
adults has been established by clinical experience,
but no clinical trial data are available.

2016-10-21 14:34:03

If you are not sure ask your doctor or pharmacist.
Each Viscotears Single Dose Unit (SDU) should
only be used once. Use immediately after you open
it. Follow these instructions carefully and ask your
pharmacist if there is anything you do not
understand.
How to use your eye drops
1 Wash your hands
2 If you wear contact lenses, remove them before
using the drops and do not replace for at least
15 minutes.
3 Remove one SDU from the strip, shake
the gel to the tip of the SDU and twist off the
cap.
4 Tilt your head backwards.
5 Rest one hand on your cheek and gently pull
down your lower lid.
6 Look upwards.
7 Gently squeeze the SDU to insert one drop in
your eye.
8 Blink a few times to spread the liquid gel
evenly over your eye.
9 Wipe away any excess gel from around
the eyelids.
10 Take another SDU and repeat for the other eye
if required.
NOTE: Do not touch your eye or the surrounding
area with the tip of the dropper as this may cause
injury to the eye and contaminate the gel.
If you use more Viscotears than you should,
it is not expected that you will suffer any side
effects from this, however, should you notice any
problems you think are related, seek medical
attention.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
You may experience the following reactions in your
eyes:
Very common side effects (may affect more than
1 in 10 people): blurred vision
Common side effects (may affect up to 1 in 10
people): eye discomfort, eyelid crusting, eye
irritation.
Uncommon side effects (may affect up to 1 in
100 people): eye swelling, eye pain, itchy eye, eye
redness, increased tear production.
Or, reactions in other parts of your body:
Uncommon side effects (may affect up to 1 in
100 people): skin inflammation.

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Additional side effects from post-marketing
experience that have been reported for which the
frequency is not known: Allergic reactions
(symptoms may include itching, redness, swelling,
or pain of the eye or redness, swelling or rash of
the skin around the eye).
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the national reporting system
(see details below). By reporting side effects you
can help provide more information on the safety of
this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. How to store Viscotears
Keep all medicines out of the reach and sight of
children.
Do not store the drops above 25ºC. Keep the singledose units inside the carton.
Do not use the eye drops after the expiry date
shown on the pack.
Take any unused Viscotears back to your pharmacist
to be destroyed. Do not throw them away with your
normal household water or waste. This will help to
protect the environment.
6. Further information
Viscotears contains 2.0 mg/g of the active
ingredient, carbomer (polyacrylic acid).
The gel also contains the inactive ingredients
sorbitol, sodium hydroxide and water.
Each single-dose unit contains 0.6 ml of gel.
Each pack contains 5, 10, 15, 20 or 30 units.
Some of the pack sizes may not be marketed.
The product licence holder and manufacturer
responsible for release on to the market is
Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173,
13581 Berlin, Germany
This leaflet was revised in October 2016.

P9UK02
42543PB285/2-UK

2016-10-21 14:34:03

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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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