Viscotears Liquid Gel
Viscotears® Liquid Gel Ref: 1230/180216/1/F
carbomer (polyacrylic acid)
Patient Information Leaflet
for
use
How to use Viscotears Possible side effects How to store Viscotears Further information
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:
^ What Viscotears is and what it's used ^ Things to consider before you start to Viscotears
a a
s
[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
A preservative in Visoctears (cetrimide) may cause eye irritation and is also known to discolour soft contact lenses.
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.
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
^ 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 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.
Keep all medicines out of the sight and reach of children.
Do not store above 25°C.
Do not use the drops for longer than 28 days after first opening the tube.
Do not use the eye drops after the expiry date shown on the tube (EXP).
If your medicines become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
Take any unused Viscotears back to your pharmacist to be destroyed.
Do not throw it away with your normal household water or waste. This will help to protect the environment.
Further Information
What Viscotears contains
Each gram of gel contains 2mg carbomer (polyacrylic acid) as the active ingredient.
Viscotears also contains the inactive ingredients cetrimide (as a preservative), sorbitol, sodium hydroxide and water for injection.
What Viscotears looks like and contents of the pack
Viscotears is a clear sterile liquid gel.
Viscotears comes in 10g and 3 x 10g tubes.
Manufacturer and Licence Holder
Viscotears is manufactured by Dr Winzer Pharma GmbH, Brunsbutteler Damm 165-173, Berlin, 13581 Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE Viscotears is a registered trademark of Novartis AG.
[P| PL 15184/1230
Leaflet revision date: 18/02/2016
Viscotears is a registered trademark of Novartis AG.
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Visc-Ophtal 'Liquid Gel carbomer (polyacrylic acid) Patient Information Leaflet
This product will be called Visc-ophtal in this leaflet.
Please read this leaflet carefully before you start to use Visc-ophtal . 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:
What Visc-ophtal is and what it's used for ™ Things to consider before you start to use Visc-ophtal
.3 How to use Visc-ophtal [3 Possible side effects [3 How to store Visc-ophtal .6 Further information
M What Visc-ophtal is and what it’s used for
Visc-ophtal contains the active ingredient, carbomer (polyacrylic acid). Visc-ophtal is used to make your eyes more comfortable when they feel dry. It is one of a group of eye drops called ‘artificial tears'.
™ Things to consider before you start to use Visc-ophtal
DO NOT use Visc-ophtal 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 Visc-ophtal at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.
Warnings and precautions
• Only use Visc-ophtal 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 Visc-ophtal.
• 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 Visc-ophtal
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. Visc-ophtal 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
A preservative in Visc-ophtal (cetrimide) may cause eye irritation and is also known to discolour soft contact lenses.
If you wear contact lenses, you should remove them before using Visc-ophtal 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 Visc-ophtal. If affected, wait until your vision clears before you drive or use machinery.
^ How to use Visc-ophtal
If your doctor has prescribed Visc-ophtal 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 Visc-ophtal 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.
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 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.
Keep all medicines out of the sight and reach of children.
Do not store above 25°C.
Do not use the drops for longer than 28 days after first opening the tube.
Do not use the eye drops after the expiry date shown on the tube (EXP).
If your medicines become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
Take any unused Visc-ophtal back to your pharmacist to be destroyed.
Do not throw it away with your normal household water or waste. This will help to protect the environment.
^ Further Information
What Visc-Ophtal contains
Each gram of gel contains 2mg carbomer (polyacrylic acid) as the active ingredient. Visc-Ophtal also contains the inactive ingredient cetrimide (as a preservative), sorbitol, sodium hydroxide and water for injection.
What Visc-Ophtal looks like and contents of the pack
Visc-Ophtal is a clear sterile liquid gel.
Visc-Ophtal comes in 10g and 3 x 10g tubes.
Manufacturer and Licence Holder
Visc-Ophtal is manufactured by Dr Winzer Pharma GmbH, Brunsbutteler Damm 165-173, Berlin, 13581 Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE Visc-Ophtal is a registered trademark of Novartis AG
|~F| PL 15184/1230
Leaflet revision date: 18/02/2016
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Carbomer Liquid Gel
carbomer (polyacrylic acid)
Patient Information Leaflet
This product will be called Carbomer in this leaflet.
Please read this leaflet carefully before you start to use Carbomer . 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:
What Carbomer is and what it's used for ™ Things to consider before you start to use Carbomer
.3 How to use Carbomer [3 Possible side effects [3 How to store Carbomer .6 Further information
" What Carbomer is and what it’s used for
Carbomer contains the active ingredient, carbomer (polyacrylic acid). Carbomer is used to make your eyes more comfortable when they feel dry. It is one of a group of eye drops called ‘artificial tears'.
Things to consider before you start to use Carbomer
DO NOT use Carbomer 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 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 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.
• 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. Carbomer 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 contains cetrimide
A preservative in Carbomer (cetrimide) may cause eye irritation and is also known to discolour soft contact lenses.
If you wear contact lenses, you should remove them before using Carbomer 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. If affected, wait until your vision clears before you drive or use machinery.
^ How to use Carbomer
If your doctor has prescribed Carbomer 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 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 Carbomer Liquid Gel later than four weeks after first opening
Figure 1 Figure 2 Figure 3
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 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.
Keep all medicines out of the sight and reach of children.
Do not store above 25°C.
Do not use the drops for longer than 28 days after first opening the tube.
Do not use the eye drops after the expiry date shown on the tube (EXP).
If your medicines become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
Take any unused Carbomer back to your pharmacist to be destroyed.
Do not throw it away with your normal household water or waste. This will help to protect the environment.
Further Information
What Carbomer contains
Each gram of gel contains 2mg carbomer (polyacrylic acid) as the active ingredient.
Carbomer also contains the inactive ingredients cetrimide (as a preservative), sorbitol, sodium hydroxide and water for injection.
What Carbomer looks like and contents of the pack
Carbomer is a clear sterile liquid gel.
Carbomer comes in 10g and 3 x 10g tubes.
Manufacturer and Licence Holder
Carbomer is manufactured by Dr Winzer Pharma GmbH, Brunsbutteler Damm 165-173, Berlin, 13581 Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE
|~F| PL 15184/1230
Leaflet revision date: 18/02/2016
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
Ref: 1230/180216/3/B