Viscotears Liquid Gel
S144 LEAFLET Viscotears 20150901
PACKAGE LEAFLET: INFORMATION FOR THE USER
VISCOTEARS® LIQUID GEL
(carbomer)
Your medicine is known as Viscotears Liquid Gel but will be referred to as Viscotears throughout the following 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.
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.
Viscotears contains cetrimide
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.
If you are not sure ask your doctor or pharmacist.
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. Hold the tube vertically (see figure 1).
4. Tilt your head backwards (see figure 2).
5. Rest one hand on your cheek and gently pull down your lower eye lid.
6. Look upwards.
7. Insert one drop by squeezing the tube gently (see figure 3).
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. Repeat for your 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. Follow the instructions carefully.
If there is anything you don't understand, ask your pharmacist or doctor.
Do not use Viscotears Liquid Gel later than four weeks after first opening.
Figure 1 Figure 2 Figure 3
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).
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 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.
5. HOW TO STORE VISCOTEARS
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Viscotears should not be stored above 25°C. Discard 28 days after first opening.
• Do not use after the expiry date printed on the carton or tube label.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Viscotears contains
• Each gram of eye gel contains 2mg of carbomer.
• Viscotears also contains the following inactive ingredients: sorbitol, sodium hydroxide, purified water and cetrimide.
What Viscotears looks like and contents of the pack
Viscotears is a colourless liquid eye gel.
Viscotears is available in tubes of 10g in a carton.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Dr Winzer Pharma GmbH, 13581 Berlin, Germany.
[P] PL No: 19488/0144
Leaflet revision date: 01 September 2015
Viscotears is a registered trade mark of Novartis AG, Switzerland.
S144 LEAFLET Viscotears 20150901
S144 LEAFLET Carbomer 20150901
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBOMER 0.2%w/w EYE GEL
(carbomer)
Your medicine is known as Carbomer 0.2%w/w Eye Gel but will be referred to as Carbomer Gel throughout the following leaflet.
Please read this leaflet carefully before you start to use Carbomer Gel.
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 Carbomer Gel is and what it's used for
2. Things to consider before you start to use Carbomer Gel
3. How to use Carbomer Gel
4. Possible side effects
5. How to store Carbomer Gel
6. Further information
1. WHAT CARBOMER GEL IS AND WHAT IT’S USED FOR
Carbomer Gel contains the active ingredient, carbomer (polyacrylic acid).
Carbomer Gel 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 CARBOMER GEL
DO NOT use Carbomer Gel 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 Carbomer Gel at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.
Warnings and precautions
• Only use Carbomer Gel 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 Carbomer Gel.
• 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 Carbomer Gel
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. Carbomer Gel 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.
Carbomer Gel contains cetrimide
If you wear contact lenses, you should remove them before using Carbomer Gel 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 Carbomer Gel. If affected, wait until your vision clears before you drive or use machinery.
3. HOW TO USE CARBOMER GEL
If your doctor has prescribed Carbomer Gel 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 Carbomer Gel in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.
If you are not sure ask your doctor or pharmacist.
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. Hold the tube vertically (see figure 1).
4. Tilt your head backwards (see figure 2).
5. Rest one hand on your cheek and gently pull down your lower eye lid.
6. Look upwards.
7. Insert one drop by squeezing the tube gently (see figure 3).
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. Repeat for your 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 Carbomer Gel 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. Follow the instructions carefully.
If there is anything you don't understand, ask your pharmacist or doctor.
Do not use Carbomer Liquid Gel later than four weeks after first opening.
Figure 1 Figure 2 Figure 3
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).
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 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.
5. HOW TO STORE CARBOMER GEL
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Carbomer Gel should not be stored above 25°C. Discard 28 days after first opening.
• Do not use after the expiry date printed on the carton or tube label.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Carbomer Gel contains
• Each gram of eye gel contains 2mg of carbomer.
• Carbomer Gel also contains the following inactive ingredients: sorbitol, sodium hydroxide, purified water and cetrimide.
What Carbomer Gel looks like and contents of the pack
Carbomer Gel is a colourless liquid eye gel.
Carbomer Gel is available in tubes of 10g in a carton.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Dr Winzer Pharma GmbH, 13581 Berlin, Germany.
[P] PL No: 19488/0144
Leaflet revision date: 01 September 2015
S144 LEAFLET Carbomer 20150901