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ARTELAC EYE DROPS SINGLE DOSE UNIT PRESERVATIVE FREE 0.32% W/V

Active substance(s): HYPROMELLOSE

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S1649 LEAFLET Artelac 20150727

PACKAGE LEAFLET: INFORMATION FOR USER
®

ARTELAC EYE DROPS SINGLE DOSE UNIT
PRESERVATIVE FREE 0.32 % W/V
(hypromellose)
Your medicine is known as Artelac Eye Drops Single Dose Unit
Preservative Free 0.32 % w/v but will be referred to as Artelac
throughout the following 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.

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.
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

6. Further information



release the lower eyelid, and blink a few times to make sure the
eye is covered by the liquid

1. WHAT ARTELAC IS AND WHAT IT IS USED FOR




repeat the procedure for your other eye
when you have finished, throw away the single-dose unit

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

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).

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.

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.
Using other medicines


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.

You should wait 5 minutes before using any other eye
medication.

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.

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

5. HOW TO STORE ARTELAC

6. FURTHER INFORMAT ION



KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

What Artelac contains



Do not store above 25°C.



Solution contains hypromellose 0.32% w/v.



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





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

Artelac also contains sorbitol, disodium phosphate
dodecahydrate, sodium dihydrogen phosphate dihydrate and
water for injections



Do not use after the expiry date printed on the pack.

What Artelac looks like and contents of the pack



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

Artelac is a clear, sterile eye drops solution in a single dose unit.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmist
who will tell you what to do.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



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.

Manufacturer

Artelac is available in pack sizes of 30 and 60 single dose units.
Product Licence holder

These products are manufactured by Dr. Gerhard Mann Chempharm, Fabrik GmbH, 13581 Berlin, Germany.
P

PL 19488/1649

Leaflet revision date: 27 July 2015
Artelac is a registered trade mark of Dr. Gerhard Mann Chempharm. Fabrik GmbH.
S1649 LEAFLET Artelac 20150727

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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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