Viscotears Liquid Gel

Document: leaflet MAH BRAND_PLPI 06464-1923 change

VISCOTEARS® LIQUID GEL

(carbomer 980)

Patient Information Leaflet

'Your medicine is called Viscotears Liquid Gel but will be referred to as Viscotears throughout the remainder of 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 4. Possible side effects

2. Things to consider before you start to use Viscotears 5. How to store Viscotears

3. How Viscotears is used 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).

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.

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.

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.

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.

Figure 3

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 30 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. 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

z' '

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. 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 reactions, eyelid swelling, eye redness, swelling, pain and itching following the use of Viscotears.

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.

5. HOW TO STORE VISCOTEARS

• Viscotears liquid gel should not be stored above 25°C. Store with the cap tightly closed. The tube should be discarded one month after opening.

• 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.

6. FURTHER INFORMATION

Your medicine is called Viscotears liquid gel. Each gram of liquid gel contains 2mg of the active ingredient carbomer 980 in a colourless and translucent gel.

Viscotears liquid gel also contains the following: cetrimide, sorbitol, sodium hydroxide and purified water.

Viscotears liquid gel are available as tubes of 10g.

[p] PL No: 6464/1923

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

Leaflet revision and issue date (Ref.) 12.08.2014

Viscotears is a registered trademark of NOVARTIS AG

CARBOMER 0.2% w/w LIQUID GEL (carbomer 980)

Patient Information Leaflet

Your medicine is called Carbomer 0.2% w/w liquid Gel but will be referred to as Carbomer throughout the remainder of 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:

1. What Carbomer is and what it's used for 4. P_ossibl_{e s}id_{e e}ffe_cts

2. Things to consider before you start to use Carbomer 5. H_ow to _st_ore C_arb_0mer

³. ^{How Carbomer is used} 6. Further information

1. 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'.

2. THINGS TO CONSIDER BEFORE YOU START TO USE CARBOMER DO NOT use Carbomer if:

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

Take special care:

• In children and adolescents aged to 18 years, the safety and efficacy of Carbomber at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.

You should also ask yourself these questions before starting to use Carbomer:

• 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 Carbomer.

• Are you using any other eye drops? If you need to use more than one kind of eye drops wait 5 minutes between treatments. Carbomer should always be the last of the eye drops used.

• Are you pregnant or breast-feeding? Discuss whether you should use Carbomer with your doctor.

Will there be any problems with driving or using machinery?

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.

3. 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 30 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.

Do not use Carbomer Liquid Gel later than four weeks after first opening.

z' '

4. POSSIBLE SIDE EFFECTS

Carbomer 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. Carbomer 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 reactions, eyelid swelling, eye redness, swelling, pain and itching following the use of Carbomer.

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

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CARBOMER

• Carbomer 0.2% w/w liquid gel should not be stored above 25°C. Store with the cap tightly closed. The tube should be discarded one month after opening.

• 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.

6. FURTHER INFORMATION

Your medicine is called Carbomer 0.2% w/w liquid gel. Each gram of liquid gel contains 2mg of the active ingredient carbomer 980 in a colourless and translucent gel.

Carbomer 0.2% w/w liquid gel also contains the following: cetrimide, sorbitol, sodium hydroxide and purified water.

Carbomer 0.2% w/w liquid gel are available as tubes of 10g. p] PL No: 6464/1923

This product is manufactured by Dr Winzer Pharma GmbH, Berlin, Germany and procured within the EU and repackaged by the Product Licence holder:

Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

Leaflet revision and issue date (Ref.) 12.08.2014