ARTELAC 3.2MG/ML EYE DROPS SOLUTION

Active substance: HYPROMELLOSE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Artelac® 3.2mg/ml Eye Drops, Solution
(hypromellose)
This product is available using the above name but will be referred
to as Artelac throughout the following leaflet.
Please read all of this entire 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.
HYPROMELLOSE
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.
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.
• If the expiry date has passed, take the medicine back to your
pharmacist.
• Do not store above 25ºC.
• 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 use within 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.
• If the solution becomes discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist.
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, Sodium 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.
Manufacturer
Artelac is manufacturer by Dr Gerhard Mann Chem-pharm Fabrik
GmbH, Brunsbutteler Damm 165, 13581 Berlin. Procured from within
the EU by the Product license Holder Pharma-XL Limited, Unit 5-7
Colonial Way, Watford, Herts WD24 4PR and repackaged by OPD
Laboratories Ltd, Colonial Way, Watford, Herts WD24 4PR.
POM
PL No: 29510/0059

Artelac 3.2mg/ml Eye Drops, Solution

Leaflet revision and issue date (Ref) 29.11.2013.
Artelac is a registered Trade Mark of Dr Gerhard Mann Chempharm Fabrik GmbH., Germany.
To request a copy of this leaflet in Braille, large print or audio
please call 01923 332 796.

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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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