Patient leaflet - Viscotears single dose unit 2.0 mg/g eye gel
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.
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.
carbomer (polyacrylic acid)
Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A. ULOTKA PIL
Nazwa produktu
Product Name
Viscotears gel 0.2%
(single dose unit) 0.6ml
Kolor nadruku Colours | Dane techniczne Technical data (do not print)
Black Cutting
Kraj
Country (ISO) UK Nr wykrojnika
Spec No 14821
Opracowane przez
Designed by - Kod Wytwórcy
Manufacturer code 42543PB285/3-UK
PIL size 148 x 210 mm
Krój czcionki
Font used
NewsGoth BT font family Gramatura papieru
Paper weight
- g/m2
Komentarze Comments (Reason for the change)
PMR_ICN-18-0173-A Factory (Packing site): DMP Berlin
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
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.
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:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Viscotears
Keep all medicines out of the sight and reach of children.
Do not store the drops above 25ºC. Keep the single-dose 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
Viscotears is a trademark of Bausch & Lomb Incorporated or its affiliates.
© Bausch & Lomb Incorporated
This leaflet was revised in March 2018.
P9UK03 42543PB285/3-UK