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ARTELAC 3.2 MG/ML EYE DROPS SOLUTION

Active substance(s): HYPROMELLOSE

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Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

Nazwa produktu
Product Name

ULOTKA PIL

Artelac 3.2mg/ml
Eye drops solution

PACKAGE LEAFLET: INFORMATION FOR THE USER
Kolor nadruku Colours

Artelac® 3.2 mg/ml Eye Drops, Solution
Hypromellose

Black

Opracowane przez
Designed by
Nr korekty
Proof No

7

Data
Date

21-09-2015

Nr wykrojnika
Spec No

93038

Kod Wytwórcy
Manufacturer code

40728PB188/7-IE/UK

Kod farmaceutyczny
Pharmacode

873
120 x 270 mm

Kod wersji
Valeant version code

P1UKIE01

Inny kod
Other code

Rozmiar czcionki
Font size

minimum 8 pt

Wymiar ulotki
PIL size

Krój czcionki
Font used

Helvetica Neue LT W1G
55 Roman
56 Italic
75 Bold
76 Bold Italic

Gramatura papieru
Paper weight

The name of your medicine is Artelac 3.2 mg/ml Eye Drops, Solution and it is called
Artelac in this 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.

- g/m2

Komentarze Comments (Reason for the change)

873

- PMR_ICN-15-0626-A
- Factory (Packing site): DMP Berlin

Akceptacja Techniczna Technical Approval

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.

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

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

873

Always use your solution 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

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873

United Kingdom/Ireland
(UK/IE)

873

Kraj
Country (ISO)

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.

ULOTKA PIL

Artelac 3.2mg/ml
Eye drops solution

Kolor nadruku Colours

Kraj
Country (ISO)

United Kingdom/Ireland
(UK/IE)

Nr wykrojnika
Spec No

93038

Kod Wytwórcy
Manufacturer code

40728PB188/7-IE/UK

Kod farmaceutyczny
Pharmacode

873
120 x 270 mm

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

Black

Opracowane przez
Designed by
Nr korekty
Proof No

7

Data
Date

21-09-2015

Kod wersji
Valeant version code

P1UKIE01

Inny kod
Other code

Rozmiar czcionki
Font size

minimum 8 pt

Wymiar ulotki
PIL size

Krój czcionki
Font used

Helvetica Neue LT W1G
55 Roman
56 Italic
75 Bold
76 Bold Italic

Gramatura papieru
Paper weight

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.

- g/m2

4. POSSIBLE SIDE EFFECTS

Komentarze Comments (Reason for the change)

873

- PMR_ICN-15-0626-A
- Factory (Packing site): DMP Berlin

873

Nazwa produktu
Product Name

Akceptacja Techniczna Technical Approval

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.
If any of the side effects get 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 or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via:
United Kingdom:
Yellow Card Scheme - Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971; Fax: +353 1 6762517
Website: http://www.hpra.ie; E-mail: medsafety@hpra.ie

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

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 reach and sight of children.
• Do not use this medicine after its expiry date which is stated on the label.
- 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 your drops above 25°C.
• 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 bottle which should be thrown away 28 days after first opening.
• Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
What Artelac contains
• The active ingredient is: hypromellose 3.2 mg/ml (0.32 % w/v).
• The other ingredients are: cetrimide, disodium phosphate dodecahydrate,
sodium dihydrogen phosphate dihydrate, disodium edetate, sorbitol and water
for injections. The preservative in your eye drops is cetrimide, which means that
Artelac can be used if your eyes are sensitive to other preservatives such as
benzalkonium chloride.
What Artelac looks like and contents of the pack
These eye drops are a clear sterile solution and are supplied in plastic eye drop
bottles. Each bottle has a volume of 10 ml.

873

Marketing Authorisation Holder
Bausch & Lomb UK Ltd., 106 London Road, Kingston-Upon-Thames, Surrey, KT2
6TN, UK
Manufacturer
Dr Gerhard Mann Chem-pharm Fabrik GmbH, 13581 Berlin, Germany
PA555/007/001
PL 03468/0032
This leaflet was approved September 2015
®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
© Bausch & Lomb Incorporated.
P1UKIE01

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6. CONTENTS OF THE PACK AND OTHER INFORMATION

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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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