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ARTELAC 3.2 MG/ML EYE DROPS SOLUTION

Active substance(s): HYPROMELLOSE

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500000/PL1a

PACKAGE LEAFLET: INFORMATION FOR THE USER

ARTELAC®
HYPROMELLOSE

3.2 mg/ml
eye drops, solution

The name of your medicine is Artelac 3.2 mg/ml eye drops, solution and it is called Artelac in this leaflet.
Please read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription, as an over the counter item only in a pharmacy. However, you
still need to use Artelac carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Artelac is and what it is used for
2. Before you use Artelac
3. How to use Artelac
4. Possible side effects
5. How to store Artelac
6. Further information
1. WHAT ARTELAC IS AND WHAT IT IS USED FOR
Your drops contain hypromellose as the active ingredient, which is a form of cellulose.
Your drops are used as a tear substitute and lubricant when applied to the eye.
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 the eye for a longer period of time.
These drops work by soothing the eye and giving tear-like lubrication to the eyes and eye lids.
They are used to treat the symptoms of “dry eye”, which is a dehydration of the surface of the eye because no
natural tears are being produced. Dry eye can also be caused if it is not possible to close your eyelids partly or
completely.
2. BEFORE YOU USE ARTELAC
Do not use these drops
 if you have been told, or know, that you are allergic (hypersensitive) to any of its ingredients
(see section 6).
Take special care with these drops
 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.
Pregnancy and breast-feeding
 These drops can be used if you are pregnant or breast-feeding.
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 drops exactly as your doctor or pharmacist has told you to. You should check with your
doctor or pharmacist if you are not sure.
The medicine is to be used only as drops applied into one or both eye(s).
Dosage
The usual dose is to apply one drop in the corner of the eye, nearest the nose, 3 to 5 times each day or as required
to give enough lubrication.
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
– 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
– 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, replace the protective cap tightly to avoid
spillage or spoilage
Always read the label before using this medicine.
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.
Make sure you know how and when to use your medicine. If you are not sure about using your drops,
ask your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Artelac can cause some side effects, although not everybody gets them. If you experience any
difficulty stop using your drops and talk to your doctor or pharmacist.
Like all eye drops you may briefly have blurred vision or a slight stinging feeling after using your drops.
There is also a slight possibility that irritation or itching of the eye may occur in a very small number of people.
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. FURTHER 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 and Manufacturer
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.
The manufacturer is: 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.
th

This leaflet was last approved on 4 June 2014.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

50****/PL1*

500000/PL1a

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.
Please read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription, as an over the counter item only in a pharmacy. However, you
still need to use Hypromellose carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Hypromellose is and what it is used for
2. Before you use Hypromellose
3. How to use Hypromellose
4. Possible side effects
5. How to store Hypromellose
6. Further information
1. WHAT HYPROMELLOSE IS AND WHAT IT IS USED FOR
Your drops contain hypromellose as the active ingredient, which is a form of cellulose.
Your drops are used as a tear substitute and lubricant when applied to the eye.
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 the eye for a longer period of time.
These drops work by soothing the eye and giving tear-like lubrication to the eyes and eye lids.
They are used to treat the symptoms of “dry eye”, which is a dehydration of the surface of the eye because no
natural tears are being produced. Dry eye can also be caused if it is not possible to close your eyelids partly or
completely.
2. BEFORE YOU USE HYPROMELLOSE
Do not use these drops
 if you have been told, or know, that you are allergic (hypersensitive) to any of its ingredients
(see section 6).
Take special care with these drops
 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.
Pregnancy and breast-feeding
 These drops can be used if you are pregnant or breast-feeding.
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 drops exactly as your doctor or pharmacist has told you to. You should check with your
doctor or pharmacist if you are not sure.
The medicine is to be used only as drops applied into one or both eye(s).
Dosage
The usual dose is to apply one drop in the corner of the eye, nearest the nose, 3 to 5 times each day or as required
to give enough lubrication.
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
– 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
– 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, replace the protective cap tightly to avoid
spillage or spoilage
Always read the label before using this medicine.
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.
Make sure you know how and when to use your medicine. If you are not sure about using your drops,
ask your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Hypromellose can cause some side effects, although not everybody gets them. If you
experience any difficulty stop using your drops and talk to your doctor or pharmacist.
Like all eye drops you may briefly have blurred vision or a slight stinging feeling after using your drops.
There is also a slight possibility that irritation or itching of the eye may occur in a very small number of people.
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. FURTHER 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 and Manufacturer
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.
The manufacturer is: Bausch & Lomb Pharma NV, Lambermontlaan 430, 1030 Brussels, Belgium.
®

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

P

th

This leaflet was last approved on 4 June 2014.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

50****/PL1*

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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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