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VISCOTEARS SDU EYE GEL

Active substance(s): CARBOMER

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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 Viscotears is used
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:
• you think you may be allergic to any of the ingredients. (These are listed at the end of the leaflet).

WARNING!

You should also ask yourself these questions before starting to use Viscotears:
• Do you wear contact lenses? Take your lenses out before you put the drops in your eyes. Don’t put
the lenses back in for at least 30 minutes.
• Do you have problems with your eyes apart from sore or dry eyes? Talk to your doctor before you
start to use Viscotears.
• Are you using any other eye drops? If you need to use more than one kind of eye drops wait 5
minutes between treatments. Viscotears should always be the last of the eye drops used.
• Are you pregnant or breast-feeding? Discuss whether you should use Viscotears with your doctor.

DATE:

CUSTOMER
APPROVED:

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.

Will there be any problems with driving or using machinery?
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.

The usual dosage is:
Adults (including the elderly): One drop in each affected eye, three or four times a day.
DATE:
12/08/14

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.

UK PIL DATED MARCH 2013
REPORTING OF SIDE EFFECTS

6464/2255A
CODE:

TVT CHECKED

DT

DATE OF PROOF:

If you are not sure ask your doctor or pharmacist.

Viscotears Single Dose eye Gel

ARTWORKER:

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.

PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

05-0440

Q.A.
APPROVED:

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.

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 30
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.

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 148 x 317

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.

PROOF HISTORY:
v.1 - waymade - 12/08/14

«PAdBì

27mm

VISCOTEARS® SINGLE DOSE UNIT EYE GEL
(carbomer)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000A

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

4. Possible side effects
Viscotears is suitable for most people, but, like all medicines, it can sometimes cause side effects.
Sometimes people notice that the drops make their eyes burn or sting slightly. This usually quickly passes.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

These effects are often mild. If they are severe, or if you notice anything else not mentioned here,
please go and see your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.




WARNING!

5. How to store Viscotears
Do not use after the expiry date printed on the tube or carton.
Viscotears single dose unit eye gel should not be stored above 25°C.
Store in the outer carton.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop using the drops, please take them back to the pharmacist for safe
disposal. Only keep the medicine if your doctor tells you to.
If the drops become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist who will tell you what to do.
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
Your medicine is called Viscotears single dose unit eye gel. Each gram of unpreserved eye gel contains 2mg
of the active ingredient carbomer in a colourless and translucent gel.

Viscotears single dose unit eye gel are available as packs of 30 and 60 single dose units.
Each single dose unit contains 0.6ml of eye gel.
Viscotears single dose unit eye gel belongs to a group of medicines called artificial tears.
P

PL No: 6464/2255

This product is manufactured by Dr. Winzer Pharma GmbH, Berlin, Germany and is procured within the EU
and repackaged by the Product Licence Holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR.

12/08/14

Viscotears is a registered trademark of NOVARTIS AG

ARTWORKER:
Viscotears Single Dose eye Gel

6464/2255A

PRODUCT:

CODE:

UK PIL DATED MARCH 2013
REPORTING OF SIDE EFFECTS

TVT CHECKED

PRE-PRESS NO.:

DATE OF PROOF:

DT

DATE:

Leaflet revision and issue date (Ref.) 12.08.2014

CUSTOMER: Waymade

05-0440

Q.A.
APPROVED:

This leaflet only applies to Viscotears single dose unit eye gel and not to any other artificial tears product.

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

Viscotears single dose unit eye gel also contains the following:
sorbitol, sodium hydroxide and water for injections.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Leaflet Flat Size = 148 x 317

Viscotears can make your eyelids feel sticky.
Sometimes your vision may be blurred for a short time. This will gradually clear (but do not drive or operate
machinery while affected).
There have been reports of allergic reaction, eyelid swelling, eye redness, swelling, pain and itching following
the use of Viscotears.

PROOF HISTORY:
v.1 - waymade - 12/08/14

«PAdBì

27mm

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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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