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HYPROMELLOSE 3.2 MG/ML EYE DROPS SOLUTION

Active substance(s): HYPROMELLOSE

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504402/PL1c

PACKAGE LEAFLET: INFORMATION FOR THE USER

Artelac® 3.2 mg/ml eye drops, solution
Hypromellose
The name of your medicine is Artelac 3.2 mg/ml eye drops, solution and it is called Artelac in this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
-

Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet
1. What Artelac is and what it is used for
2. What you need to know before you use Artelac
3. How to use Artelac
4. Possible side effects
5. How to store Artelac
6. Contents of the pack and other information
1. WHAT ARTELAC IS AND WHAT IT IS USED FOR
Artelac contains the active ingredient hypromellose which acts as a lubricant to treat symptoms of dry eye. It is a
soothing solution that is used as an artificial tear when the eyes are lacking in tears.
Your eyes will normally produce just enough natural tears to allow them to move easily and comfortably. If your
eyes do not produce enough tears they can become dry, red and painful.
Your drops keep the surface of the eye lubricated (moist) when production of tears is less than normal, and has a
refreshing, cooling action. The hypromellose in these drops increases the thickness of the solution which has a
moisturising effect and helps the solution to stay in contact with your eye for a longer period of time.
Artelac can be used by children, adults and the elderly.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ARTELAC
Do NOT use Artelac


If you are allergic to hypromellose or any of the ingredients of this medicine (listed in Section 6).

Warnings and precautions




Talk to your doctor or pharmacist before using Artelac.
If you wear soft contact lenses – take out your lenses before using Artelac and then wait for at least 15
minutes after using these drops before putting your lenses back in.
If your eyes continue to feel dry and sore, stop using your drops and tell your doctor.

Other medicines and Artelac


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility


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.

Driving and using machines


All eye drops can cause a short term blurring of vision when first used, so you should wait until your eyes are
clear before driving or using machines.

3. HOW TO USE ARTELAC
Always use your solution exactly as your doctor or pharmacist has told you to. Check with your doctor or
pharmacist if you are not sure.
This medicine is only to be used as drops applied into one or both eye(s).
The recommended dose is
The usual dose is to apply 1 drop in the corner of the eye, nearest the nose, 3 to 5 times each day or as required to
give enough lubrication. Ensure the dropper tip does not touch any surface including the eye surface.
Dry eye is a condition that varies from person to person. Use the drops as often as you think necessary.

continued overleaf

Directions for use










Wash your hands before using your drops
Sit down in front of a mirror so that you can see what you are doing
Wipe your eyes to clear any residual wateriness or discharge
Unscrew the cap from the bottle and check the dropper is clean
Pull your lower eyelid gently down, and then carefully place one drop
inside the lower eyelid, in the corner nearest the nose (see picture)
Take care not to touch the dropper with your eye or fingers
Release the lower eyelid, and blink a few times to make sure the eye is
covered by the liquid
Repeat the procedure for your other eye
When you have finished, put the cap back on the bottle tightly

If you use more Artelac than you should
If you accidentally use a larger dose than recommended, this may cause some blurring of vision,
which will soon pass.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you forget to take Artelac
Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Artelac can cause side effects, although not everybody gets them.
In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have
developed cloudy patches on the cornea due to calcium build-up during treatment.
You may briefly have blurred vision or a slight stinging feeling after using your drops. Frequency cannot be
estimated from the available data.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
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 ARTELAC
• Keep out of the sight and reach of children.
• Do not use this medicine after its expiry date.
Check the expiry date on the label before you begin to use your medicine.
The expiry date refers to the last day of that month.
If the expiry date has passed, take the medicine back to your pharmacist.
• Do not store above 25ºC.
• Keep container in the outer carton. Protect from light.
• Your eye drops are sterile until first opened. It is important to keep the drops as clean
as possible during use. Do not touch the dropper tip on the eye or any other surface.
• Your drops come in a bottle, which should be thrown away 6 weeks after first opening.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
• If you notice any sign of discolouration or deterioration of your medicine, please tell your pharmacist
immediately.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Artelac contains



Each 1 ml of solution contains 3.2 mg of hypromellose.
The other ingredients are sorbitol (E420), disodium phosphate dodecahydrate, sodium dihydrogen phosphate
dihydrate, disodium edetate, cetrimide and water for injections. The preservative in your eye drops is
cetrimide. Artelac is therefore suitable for patients who are hypersensitive to benzalkonium chloride.

What Artelac looks like and contents of the pack
Artelac is a colourless, sterile, clear solution supplied in 10 ml plastic eye drop bottles.
This medicine is for you, never give it to anyone else, even if they appear to have the same symptoms as you.
Return any unused medicine to your pharmacist.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd, repackager Ginova UK Ltd, both of St James'
House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Bausch & Lomb Pharma NV, Lambermontlaan 430, 1030 Brussels, Belgium.
®

Artelac 3.2 mg/ml eye drops, solution
PL No: 18067/0461

P

®

Artelac is a registered trademark.
This leaflet was last approved on 1st April 2016.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

504402/PL1c

500000/PL1c

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hypromellose 3.2 mg/ml eye drops, solution
The name of your medicine is Hypromellose 3.2 mg/ml eye drops, solution and it is called Hypromellose in this
leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
-

Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet
1. What Hypromellose is and what it is used for
2. What you need to know before you use Hypromellose
3. How to use Hypromellose
4. Possible side effects
5. How to store Hypromellose
6. Contents of the pack and other information
1. WHAT HYPROMELLOSE IS AND WHAT IT IS USED FOR
Hypromellose contains the active ingredient hypromellose which acts as a lubricant to treat symptoms of dry eye.
It is a soothing solution that is used as an artificial tear when the eyes are lacking in tears.
Your eyes will normally produce just enough natural tears to allow them to move easily and comfortably. If your
eyes do not produce enough tears they can become dry, red and painful.
Your drops keep the surface of the eye lubricated (moist) when production of tears is less than normal, and has a
refreshing, cooling action. The hypromellose in these drops increases the thickness of the solution which has a
moisturising effect and helps the solution to stay in contact with your eye for a longer period of time.
Hypromellose can be used by children, adults and the elderly.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HYPROMELLOSE
Do NOT use Hypromellose


If you are allergic to hypromellose or any of the ingredients of this medicine (listed in Section 6).

Warnings and precautions




Talk to your doctor or pharmacist before using Hypromellose.
If you wear soft contact lenses – take out your lenses before using Hypromellose and then wait for at least 15
minutes after using these drops before putting your lenses back in.
If your eyes continue to feel dry and sore, stop using your drops and tell your doctor.

Other medicines and Hypromellose


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility


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.

Driving and using machines


All eye drops can cause a short term blurring of vision when first used, so you should wait until your eyes are
clear before driving or using machines.

3. HOW TO USE HYPROMELLOSE
Always use your solution exactly as your doctor or pharmacist has told you to. Check with your doctor or
pharmacist if you are not sure.
This medicine is only to be used as drops applied into one or both eye(s).
The recommended dose is
The usual dose is to apply 1 drop in the corner of the eye, nearest the nose, 3 to 5 times each day or as required to
give enough lubrication. Ensure the dropper tip does not touch any surface including the eye surface.
Dry eye is a condition that varies from person to person. Use the drops as often as you think necessary.

continued overleaf

Directions for use










Wash your hands before using your drops
Sit down in front of a mirror so that you can see what you are doing
Wipe your eyes to clear any residual wateriness or discharge
Unscrew the cap from the bottle and check the dropper is clean
Pull your lower eyelid gently down, and then carefully place one drop
inside the lower eyelid, in the corner nearest the nose (see picture)
Take care not to touch the dropper with your eye or fingers
Release the lower eyelid, and blink a few times to make sure the eye is
covered by the liquid
Repeat the procedure for your other eye
When you have finished, put the cap back on the bottle tightly

If you use more Hypromellose than you should
If you accidentally use a larger dose than recommended, this may cause some blurring of vision,
which will soon pass.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you forget to take Hypromellose
Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Hypromellose can cause side effects, although not everybody gets them.
In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have
developed cloudy patches on the cornea due to calcium build-up during treatment.
You may briefly have blurred vision or a slight stinging feeling after using your drops. Frequency cannot be
estimated from the available data.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
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 HYPROMELLOSE
• Keep out of the sight and reach of children.
• Do not use this medicine after its expiry date.
Check the expiry date on the label before you begin to use your medicine.
The expiry date refers to the last day of that month.
If the expiry date has passed, take the medicine back to your pharmacist.
• Do not store above 25ºC.
• Keep container in the outer carton. Protect from light.
• Your eye drops are sterile until first opened. It is important to keep the drops as clean
as possible during use. Do not touch the dropper tip on the eye or any other surface.
• Your drops come in a bottle, which should be thrown away 6 weeks after first opening.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
• If you notice any sign of discolouration or deterioration of your medicine, please tell your pharmacist
immediately.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Hypromellose contains



Each 1 ml of solution contains 3.2 mg of hypromellose.
The other ingredients are sorbitol (E420), disodium phosphate dodecahydrate, sodium dihydrogen phosphate
dihydrate, disodium edetate, cetrimide and water for injections. The preservative in your eye drops is
cetrimide. Hypromellose is therefore suitable for patients who are hypersensitive to benzalkonium chloride.

What Hypromellose looks like and contents of the pack
Hypromellose is a colourless, sterile, clear solution supplied in 10 ml plastic eye drop bottles.
This medicine is for you, never give it to anyone else, even if they appear to have the same symptoms as you.
Return any unused medicine to your pharmacist.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd, repackager Ginova UK Ltd, both of St James'
House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Bausch & Lomb Pharma NV, Lambermontlaan 430, 1030 Brussels, Belgium.
Hypromellose 3.2 mg/ml eye drops, solution
PL No: 18067/0461

P

This leaflet was last approved on 1st April 2016.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

500000/PL1c

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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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