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ARTELAC 3.2MG/ML EYE DROPS SOLUTION

Active substance(s): 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.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse.
What is in this leaflet:
1. What Artelac is and what it is used for
2. What you need to know before you use Artelac
3. How to use Artelac
4. Possible side effects
5. How to store Artelac
6. Contents of the pack and other information
1. What Artelac is and what it is used for
Artelac contains the active ingredient hypromellose which acts as a
lubricant to treat symptoms of dry eye. It is a soothing solution that
is used as an artificial tear when the eyes are lacking in tears.
Your eyes will normally produce just enough natural tears to allow
them to move easily and comfortably. If your eyes do not produce
enough tears they can become dry, red and painful.
Your drops keep the surface of the eye lubricated (moist) when
production of tears is less than normal, and has a refreshing,
cooling action. 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 your eye for a longer period of
time.
Artelac can be used by children, adults and the elderly.
2. What you need to know before you use Artelac
Do NOT use Artelac
• If you are allergic to hypromellose or any of the ingredients of
this medicine (listed in Section 6).
Warnings and precautions
• Talk to your doctor or pharmacist before using Artelac.
• 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.
• If your eyes continue to feel dry and sore, stop using your drops
and tell your doctor.
Other medicines and Artelac
• Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Pregnancy, breast-feeding and fertility
• If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
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. Check with your doctor or pharmacist if you are not
sure.
This medicine is only to be used as drops applied into one or both
eye(s).
The recommended dose is
The usual dose is to apply 1 drop in the corner of the eye, nearest
the nose, 3 to 5 times each day or as required to give enough
lubrication. Ensure the dropper tip does not touch any surface
including the eye surface.
Dry eye is a condition that varies from person to person. Use the
drops as often as you think necessary.
Directions for use
• Wash your hands before using your drops
• 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 (see
picture)
• Take care not to touch the dropper
with your eye or fingers
• 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, put the cap
back on the bottle tightly
If you use more Artelac than you should
lf you accidentally use a larger dose than recommended, this may
cause some blurring of vision, which will soon pass.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
If you forget to take Artelac
Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Artelac can cause side effects, although not
everybody gets them.
In very rare cases, some patients with severe damage to the clear
layer at the front of the eye (the cornea) have developed cloudy
patches on the cornea due to calcium build-up during treatment.
You may briefly have blurred vision or a slight stinging feeling after
using your drops. Frequency cannot be estimated from the
available data.
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. 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.
• 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 used 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. Contents of the pack and other 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) 07.01.2016.
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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