ARTELAC 3.2 MG/ML EYE DROPS SOLUTION

Active substance: METHYL HYDROXYPROPYL CELLULOSE

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PACKAGE LEAFLET: INFORMATION FOR THE
PACKAGE LEAFLET: INFORMATION FOR THE USER USER

ARTELAC®
HYPROMELLOSE

3.2 mg/ml
eye drops solution

The name of your medicine isis Artelac 3.2 mg/ml eye drops solution andis called Artelac in this this leaflet.
The name of your medicine Artelac 3.2 mg/ml eye drops solution and it it is called Artelac in leaflet.
Please read all of this leaflet carefully because it contains important information for you.
Please read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription, asas an over the counter item only a pharmacy. However, you you
This medicine is available without prescription, an over the counter item only in in a pharmacy. However,
still need to use Artelac carefully toto get the best results from it.
still need to use Artelac carefully get the best results from it.
– Keep leaflet. You may need to read it again.

– Keep thisthis leaflet. You may need to read it again.


– AskAsk your pharmacist if you need more information or advice.
your pharmacist if you need more information or advice.
– You must contact a doctor if symptoms worsen or do not not improve.

– You must contact a doctor if youryour symptoms worsen or doimprove.
– If any of side effects gets serious, or if you you notice any side not listed in this leaflet,
– If any of thethe side effects gets serious, or if notice any side effecteffect not listed in this leaflet,
please tell your doctor or pharmacist.
please tell your doctor or pharmacist.
In this leaflet:
this leaflet:
1. What Artelac is what it is it is for

1. What Artelac is andand what usedused for
2. Before use Artelac

2. Before youyou use Artelac
3. How to Artelac

3. How to use use Artelac
4. Possible effects

4. Possible sideside effects
5. How to store Artelac

5. How to store Artelac
6. Further information

6. Further information
1. WHAT ARTELAC IS AND WHAT IT IS USED FOR
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 contain hypromellose as the active ingredient, which is a form of cellulose.
Your drops are used as aa tear substitute and lubricant when applied to the eye.
Your drops are used as tear substitute and lubricant when applied to the eye.
The hypromellose in these drops increases the thickness of of the solution which has a moisturising effect and
The hypromellose in these drops increases the thickness the solution which has a moisturising effect and helps
the solution to stay in contact with the eye for a longer period of time.
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.
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
They are used to treat the symptoms of can eye", which is if it is not possible to surface of the eye because
natural tears are being produced. Dry eye"dry also be caused a dehydration of the close your eyelids partly or no
natural tears
completely. 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
2. BEFORE YOU USE ARTELAC
Do not use these drops
Do you have been told,
 ifnot use these dropsor know, that you are allergic (hypersensitive) to any of its ingredients
I section 6).
(see 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
Take special carecontact lenses – take out your lenses before using Artelac and then wait for at
 if you wear soft with these drops
I 15 minutes after using these drops before your lenses lenses back Artelac and then wait for at
least if you wear soft contact lenses – take out putting yourbefore usingin.
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.
Pregnancy and breast-feeding
I and drops can be used if you are pregnant or breast-feeding.
DrivingTheseusing machines
 All eye drops can cause a short term blurring of vision when first used so you should wait until your
Driving and using machines or using machines.
eyes are clear before driving
I All eye drops can cause a short term blurring of vision when first used so you should wait until your
3. HOWeyes USE clear before driving or using machines.
TO are ARTELAC
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 as your doctor or pharmacist has told you to. You should check with your
Always use your drops exactly not sure.
doctor or pharmacist if you are not sure.
The medicine is to be used only as drops applied into one or both eye(s).
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
Dosage
to give enough lubrication. one drop in the corner of the eye, nearest the nose, 3 to 5 times each day or as
The usual dose is to apply
required a give enough lubrication.
Dry eye is to condition that varies from person to person. Use the drops as often as you think necessary.
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.
If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

5. HOW TO STORE ARTELAC
 Keep out of the reach and sight 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.
 Keep the eye drops at normal room temperature (do not store above 25ºC).
 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 28 days 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.
6. FURTHER INFORMATION
What Artelac contains
The active ingredient is Hypromellose 3.2 mg/ml equivalent to 0.32% w/v.
The other ingredients are Sorbitol, Disodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate
Dihydrate, Disodium Edetate, Cetrimide and Water for Injections in Bulk. 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
Your eye drops are artificial tears and are supplied in 10 ml plastic eye drop bottles These eye drops are a clear
solution.
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.
Marketing Authorisation Holder and Manufacturer
The Manufacturer is:
The Marketing Authorisation Holder is:
Dr. Gerhard Mann Chem-pharm
Bausch & Lomb UK Ltd
Fabrik GmbH
106 London Road
13581 Berlin,
Kingston-Upon-Thames
Germany
Surrey, UK KT2 6TN
This leaflet was last approved in
03/2011


3288500.40728PB188/5/IRL/UK

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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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