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ARTELAC 0.32 % W/V EYE DROPS SINGLE DOSE UNIT

Active substance: HYPROMELLOSE

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Transcript
Assessed against UK PIL dated March
2011

By Carthika Kanagasabai at

mock up
3.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Artelac® 0.32% w/v Eye Drops Single Dose Unit
(hypromellose)

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.

The name of your medicine is Artelac 0.32% w/v Eye Drops Single Dose Unit but it will be referred to
as Artelac 0.32% throughout this 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 0.32% 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
1.
2.
3.
4.
5.
6.
1.

Directions for use

this leaflet:
What Artelac 0.32% is and what it is used for
Before you use Artelac 0.32%
How to use Artelac 0.32%
Possible side effects
How to store Artelac 0.32%
Further information







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.

WHAT ARTELAC 0.32% 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.

If you use more Artelac 0.32% 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.

BEFORE YOU USE ARTELAC 0.32%

4.

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


HOW TO USE ARTELAC 0.32%

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).

if you wear soft contact lenses – take out your lenses before using Artelac 0.32% and then wait for
at least 15 minutes after using these drops before putting your lenses back in.

POSSIBLE SIDE EFFECTS

Like all medicines, Artelac 0.32% 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.

Reporting of side effects:

Using other medicines

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.

Pregnancy and breast-feeding

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





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

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.

Page 1 of 2

5.












6.

HOW TO STORE ARTELAC 0.32%

Keep out of the sight and reach 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.
Do not store above 25ºC.
Keep container in the outer carton.
Protect from light.
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.
If your medicine appears to be discoloured or show any other signs of deterioration please return
to your pharmacist who will advise you further.
If your doctor tells you to stop using the medicine, please take them back to the pharmacist. Only
keep the medicine if your doctor tells you to.
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.

FURTHER INFORMATION

What Artelac 0.32% contains

The active ingredient is hypromellose 0.32% w/v. Each ml contains 3.2mg hypromellose.
The other ingredients are sorbitol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate
dihydrate and purified water.

What Artelac 0.32% looks like and contents of the pack
Artelac 0.32% is a clear, colourless solution.

Your medicine is supplied in plastic single-dose units in pack sizes of 30 and 60. Each single dose unit
has a volume of 0.6ml.
Your drops contain no preservative, therefore each unit is for single-use only.
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.

Manufacturer

Your medicine is manufactured by: Dr Gerhard Mann Chem-pharm Fabrik GmbH, 13581 Berlin,
Germany.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0422

P

Leaflet issue and revision date (Ref.): 03.03.15
Artelac® is a registered trademark of Dr. Gerhard Mann, Chem-pharm Fabrik GmbH.

Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Artelac® Preservative Free Single Dose Unit
3.2mg/ml eye drops, solution
(hypromellose)
The name of your medicine is Artelac Preservative Free Single Dose Unit 3.2 mg/ml eye drops,
solution, but it will be referred to as Artelac throughout this 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.

In
1.
2.
3.
4.
5.
6.
1.

this leaflet:
What Artelac is and what it is used for
Before you use Artelac
How to use Artelac
Possible side effects
How to store Artelac
Further information
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.

Using other medicines


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.

3.

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

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 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.

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.

Driving and using machines


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).

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.

Page 1 of 2

5.












6.

HOW TO STORE ARTELAC

Keep out of the sight and reach 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.
Do not store above 25ºC.
Keep container in the outer carton.
Protect from light.
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.
If your medicine appears to be discoloured or show any other signs of deterioration please return
to your pharmacist who will advise you further.
If your doctor tells you to stop using the medicine, please take them back to the pharmacist. Only
keep the medicine if your doctor tells you to.
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.

FURTHER INFORMATION

What Artelac contains

The active ingredient is hypromellose 3.2mg/ml.
The other ingredients are sorbitol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate
dihydrate and purified water.

What Artelac looks like and contents of the pack
Artelac is a clear, colourless solution.

Your medicine is supplied in plastic single-dose units in pack sizes of 30 and 60. Each single dose unit
has a volume of 0.6ml.
Your drops contain no preservative, therefore each unit is for single-use only.
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.

Manufacturer

Your medicine is manufactured by: Dr Gerhard Mann Chem-pharm Fabrik GmbH, 13581 Berlin,
Germany.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0422

P

Leaflet issue and revision date (Ref.): 03.03.15
Artelac® is a registered trademark of Dr. Gerhard Mann, Chem-pharm Fabrik GmbH.

Page 2 of 2

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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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