ARTELAC 0.32% W/V EYE DROPS SINGLE DOSE UNIT

Active substance: HYPROMELLOSE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ARTELAC
HYPROMELLOSE

®

0.32% w/v eye drops
SINGLE DOSE UNIT
PRESERVATIVE FREE

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The name of your medicine is Artelac 0.32% w/v eye drops Single Dose Unit Preservative Free and it is called
Artelac SDU Preservative Free in this leaflet.
Please read all of this leaflet carefully because it contains important information for you.

In this leaflet:
1. What Artelac SDU Preservative Free is and what it is used for
2. Before you use Artelac SDU Preservative Free
3. How to use Artelac SDU Preservative Free
4. Possible side effects
5. How to store Artelac SDU Preservative Free
6. Further information
1. WHAT ARTELAC SDU PRESERVATIVE FREE 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 SDU PRESERVATIVE FREE
Do not use these drops
n f you have been told, or know, that you are allergic (hypersensitive) to any of its ingredients
i
(see section 6).
Take special care with these drops
n f you wear soft contact lenses – take out your lenses before using Artelac SDU Preservative Free
i
and then wait for at least 15 minutes after using these drops before putting your lenses back in.
Using other medicines
n  ou should wait 5 minutes before using any other eye medication.
Y
Pregnancy and breast-feeding
n  hese drops can be used if you are pregnant or breast-feeding.
T
Driving and using machines
n  ll eye drops can cause a short term blurring of vision when first used so you should wait until your
A
eyes are clear before driving or using machines.
3. HOW TO USE ARTELAC SDU PRESERVATIVE FREE
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

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This medicine is available without prescription, as an over the counter item only in a pharmacy. However, you
still need to use Artelac SDU Preservative Free 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.

–  any of the side effects gets serious, or if you notice any side effect not listed in this leaflet,
If
please tell your doctor or pharmacist.

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
– holding the unit by the label end, remove a single-dose unit
from the pack
– twist the cap off the single-dose unit
– 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, throw away the single-dose unit
Always read the label before using this medicine.


If you use more Artelac SDU Preservative Free 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 SDU Preservative Free 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.

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5. HOW TO STORE ARTELAC SDU PRESERVATIVE FREE

n Keep out of the reach and sight of children.

n 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.

n Keep the eye drops at normal room temperature (do not store above 25ºC).

n Protect from light.

n 
Your eye drops are sterile until first opened. It is important to keep the drops as clean
as possible during use.

n Your drops come in single-dose, single-use units, which should be thrown away immediately after use.

n 
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.

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6. FURTHER INFORMATION
What Artelac SDU Preservative Free contains
The active ingredient is Hypromellose 0.32% w/v.
The other ingredients are Sorbitol, Disodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate
Dihydrate and Purified Water.
What Artelac SDU Preservative Free looks like and contents of the pack
Your eye drops are artificial tears and are supplied in plastic single-dose units in pack sizes of 30, 60 and 120.
Each single dose unit has a volume of 0.5 ml. Your drops contain no preservative, therefore each unit is for
single-use only. These eye drops are a clear solution.
Your drops do not contain a preservative and can be used by patients who are hypersensitive to preservatives or
who wear contact lenses.
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 Marketing Authorisation Holder is: The manufacturer is:
Bausch & Lomb UK Ltd., Dr Gerhard Mann Chem-pharm
106 London Road,

Fabrik GmbH
Kingston-Upon-Thames, Surrey, 13581 Berlin
PL 03468/0033 Germany
This leaflet was last approved in

03/2011


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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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