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HYPROMELLOSE 0.32% W/V EYE DROPS SINGLE DOSE UNIT

Active substance(s): HYPROMELLOSE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Artelac® 0.32%w/v eye drops single dose unit
(hypromellose)
The name of your medicine is Artelac 0.32%w/v eye drops single dose unit but will be referred to as Artelac throughout
this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or your doctor or pharmacist has 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 after number of days.
What is in this leaflet:
1. What Artelac is and what it is used for
2. What you need to know before you take Artelac
3. How to take 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 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.
You must talk to a doctor if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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 taking 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.
Other medicines and Artelac
 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
 You should wait 5 minutes before using any other eye medication.
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 TAKE 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.
The medicine is to be used only as drops applied into one or both eye(s).
The recommended dose is
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with
your doctor or pharmacist if you are not sure.
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.
If you forget to take Artelac
Do not take a double dose to make up for the a forgotten dose

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.
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.
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.
(frequency cannot be estimated from the available data)
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 the eye drops after the expiry date which is stated on the carton and bottle label after „Exp‟. The expiry
date refers to the last day of that month.
Do not store above 25°C. Store in the original container in order to protect from light.
Artelac are sterile until first opened. It is important to keep the drops as clean as possible during use.
Artelac come in single dose, single use units, which should be thrown away immediately after use.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Artelac contains
The active ingredient in Artelac is hypromellose.
Each single dose unit contains 0.32%w/v hypromellose.
The other ingredients are sorbitol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and
water for injections.
What Artelac looks like and contents of the pack
Artelac are a sterile clear solution and are supplied in plastic single dose units has a volume of 0.5ml, these drops
contain no preservative and therefore each unit is for single dose only. Each pack contains 60 single dose units.
Artelac do not contain preservative and can be used if your eyes are sensitive to preservatives or if you wear contact
lenses.
Manufactured by: Laboratoire CHAUVIN, Z.I. Ripotier Haut, 07200 AUBENAS – France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Artelac® 0.32%w/v eye drops single dose unit;

PL 18799/2486

Leaflet date: 08.09.2016
Artelac is a registered trademark of Bausch and Lomb.

P

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hypromellose 0.32%w/v eye drops single dose unit
The name of your medicine is Hypromellose 0.32%w/v eye drops single dose unit but will be referred to as
Hypromellose throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or your doctor or pharmacist has 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 after number of days.
What is in this leaflet:
1. What Hypromellose is and what it is used for
2. What you need to know before you take Hypromellose
3. How to take Hypromellose
4. Possible side effects
5. How to store Hypromellose
6. Contents of the pack and other information
1. WHAT HYPROMELLOSE IS AND WHAT IT IS USED FOR
Hypromellose contains 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.
You must talk to a doctor if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYPROMELLOSE
Do not use Hypromellose
 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 taking Hypromellose
 if you wear soft contact lenses – take out your lenses before using Hypromellose and then wait for at least
15 minutes after using these drops before putting your lenses back in.
Other medicines and Hypromellose
 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
 You should wait 5 minutes before using any other eye medication.
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 TAKE HYPROMELLOSE
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.
The medicine is to be used only as drops applied into one or both eye(s).
The recommended dose is
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with
your doctor or pharmacist if you are not sure.
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 Hypromellose 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.
If you forget to take Hypromellose
Do not take a double dose to make up for the a forgotten dose

4. POSSIBLE SIDE EFFECTS
Like all medicines, Hypromellose 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.
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.
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.
(frequency cannot be estimated from the available data)
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 HYPROMELLOSE
Keep out of the sight and reach of children
Do not use the eye drops after the expiry date which is stated on the carton and bottle label after „Exp‟. The expiry
date refers to the last day of that month.
Do not store above 25°C. Store in the original container in order to protect from light.
Hypromellose are sterile until first opened. It is important to keep the drops as clean as possible during use.
Hypromellose come in single dose, single use units, which should be thrown away immediately after use.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Hypromellose contains
The active ingredient in Hypromellose is hypromellose.
Each single dose unit contains 0.32%w/v hypromellose.
The other ingredients are sorbitol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and
water for injections.
What Hypromellose looks like and contents of the pack
Hypromellose are a sterile clear solution and are supplied in plastic single dose units has a volume of 0.5ml, these
drops contain no preservative and therefore each unit is for single dose only. Each pack contains 60 single dose units.
Hypromellose do not contain preservative and can be used if your eyes are sensitive to preservatives or if you wear
contact lenses.
Manufactured by: Laboratoire CHAUVIN, Z.I. Ripotier Haut, 07200 AUBENAS – France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
P
Hypromellose 0.32%w/v eye drops single dose unit; PL 18799/2486
Leaflet date: 08.09.2016

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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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