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GELTEARS

Active substance(s): CARBOMER 980

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

Nazwa produktu
Product Name

Package leaflet: Information for the user

ULOTKA PIL

GelTears
Carbomer 0,2% w/w
eye gel

Kolor nadruku Colours

0.2% w/w Carbomer eye gel

Black
Kraj
Country (ISO)

UK/Ireland (UK/IE)

Opracowane przez
Designed by
Nr korekty
Proof No

6

Data
Date

13-11-2015

Nr wykrojnika
Spec No

5283

Kod Wytwórcy
Manufacturer code

49202PB574/4-IE/UK

Kod farmaceutyczny
Pharmacode

887
120 x 360 mm

Kod wersji
Valeant version code

P1UKIE01

Inny kod
Other code

Rozmiar czcionki
Font size

minimum 9 pt

Wymiar ulotki
PIL size

Krój czcionki
Font used

Frutiger Neue LT W1G
Condensed
Frutiger Neue LT W1G
Bold Condensed

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
- QRD update and harmonisation of leaflet
- PMR_ICN-15-0739-A

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

up to manufacturer

Read all of this leaflet carefully before you start using 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 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.
What is in this leaflet
1. What GelTears is and what it is used for
2. What you need to know before you use GelTears
3. How to use GelTears
4. Possible side effects
5. How to store GelTears
6. Contents of the pack and other information
1. What GelTears is and what it is used for?
GelTears is a clear colourless liquid gel and contains a lubricant that is used as a
substitute for natural 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 and irritated. It can also be used in patients
who suffer from sore eyes because their tear film is unstable. GelTears will help
keep your eyes comfortable.
2. What you need to know before you use GelTears
Do not use GelTears if you are allergic to any of the ingredients of this medicine
(listed in section 6).
Other medicines and GelTears
If GelTears is used at the same time with other eye drops/eye ointments, there should
be an application time interval of approximately 15 minutes between use of such
other medications and GelTears should always be the last medication to be applied.
Tell your doctor or pharmacist if you are taking, have recently or might take any
other medicines.
Warnings and Precautions
Your vision may become blurred if too much gel is added at one time, or if you use
your medicine more often than is required. This effect can last for up to an hour. If
you are affected you may be able to speed up recovery of normal vision by blinking
vigorously for a few seconds. If this does not work, try gently rubbing the eyelid.
This should help the gel to collect in the conjunctival sac beneath the eye where it
will no longer interfere with your vision.
Children and adolescents aged to 18 years:
The safety and efficacy of GelTears in children and adolescents at the posology
recommended in adults has been established by clinical experience, but no clinical
trial data are available.
Pregnancy, breast-feeding and fertility
Do not use GelTears if you are pregnant, may be pregnant, or are breastfeeding.
Ask your doctor or pharmacist for advice.
Contact lenses
Take special care with GelTears if you wear contact lenses. Contact lenses should
be removed during treatment with GelTears. And then wait for 15 minutes after
application before putting them back in.
Benzalkonium chloride is used as a preservative in GelTears, and is known to be
absorbed by soft contact lenses. Over time benzalkonium chloride can collect in soft
contact lenses, and therefore may cause irritation, or discolour the lenses. Therefore
use of Geltears while using soft contact lenses is not recommended. GelTears can,
however, be used with daily disposable lenses because a new pair is used each day.
Driving and using machines
As with all eye preparations, you may have blurred vision for a little while after
putting the gel in. Wait until your vision is clear before driving or using machines.
3. How to use GelTears
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You should take care not to touch the end of the dropper nozzle onto your eyes,
fingers or any other surface. Remember to replace the cap after use. The
recommended dose is to place one drop of gel in the corner of the eye, nearest the
nose, 3 to 4 times each day and approximately 30 minutes before going to bed.
Children and adolescents aged to 18 years
The safety and efficacy of GelTears in children and adolescents at the posology
recommended in adults has been established by clinical experience, but no clinical
trial data are available.
The amount of gel used should be enough to cover the eye properly.
Follow these instructions carefully.
1. Wash hands thoroughly.
2. Twist off the cap.
3. Look upwards and gently pull down the lower eyelid.
4. Hold the GelTears tube just above your eye and gently squeeze
until some gel falls into the gap between your eyeball and
lower eyelid.
5. Release the lower eyelid, and move your eye while open to ensure the gel covers
the eye completely.
6. Repeat the process in the other eye if necessary.
If you use more GelTears than you should it is very unlikely that you will suffer
an overdose, but if you suddenly feel unwell after using the gel, tell your doctor or
eye specialist.
If you forget to use your medicine, use it as soon as you remember and then
continue as before.

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

Nazwa produktu
Product Name

ULOTKA PIL

GelTears
Carbomer 0,2% w/w
eye gel

Kolor nadruku Colours

Black
Kraj
Country (ISO)

UK/Ireland (UK/IE)

Opracowane przez
Designed by
Nr korekty
Proof No

6

Data
Date

13-11-2015

Nr wykrojnika
Spec No

5283

Kod Wytwórcy
Manufacturer code

49202PB574/4-IE/UK

Kod farmaceutyczny
Pharmacode

887
120 x 360 mm

Kod wersji
Valeant version code

P1UKIE01

Inny kod
Other code

Rozmiar czcionki
Font size

minimum 9 pt

Wymiar ulotki
PIL size

Krój czcionki
Font used

Frutiger Neue LT W1G
Condensed
Frutiger Neue LT W1G
Bold Condensed

Gramatura papieru
Paper weight

Komentarze Comments (Reason for the change)
- QRD update and harmonisation of leaflet
- PMR_ICN-15-0739-A

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval

up to manufacturer

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them. Your eyes may sting a little when the drops are put in. These effects
will wear off within a few minutes. Visual disturbance, blurred vision and irritation
with prolonged use may occur. A few reports of allergy have been received
following use of GelTears eye gel. This is due to one of the ingredients in the
formulation. If you develop pain, swelling or redness in or around the eyes, you
should stop using your medicine and consult your doctor or pharmacist.
• If you experience any other undesirable effects whilst using this medicine,
please talk to 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:
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: www.hpra.ie; E-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store GelTears
Keep this medicine out of the sight and reach of children.
• Do not use the eye gel after the expiry date which is stated on the tube and the
carton after the letters “EXP”. The expiry date refers to the last day of that month.
• Store GelTears eye gel below 25ºC (normal room temperature).
• GelTears is sterile until first opened. It is important to keep the tube as clean as
possible during use.
• The tube has a flat cap, which allows it to stand in an upright position.
• Dispose of any remaining contents 28 days after first opening the tube. It may be
helpful to make a written record on the tube of the date on which you opened it.
• Remember this medicine is for you. Do not give it to someone else.
• Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What GelTears contains
• The active substance is Carbomer. Each tube contains 2.0mg of carbomer in
each 1g of gel.
• The other ingredients are benzalkonium chloride, sorbitol, sodium hydroxide
and purified water.
What GelTears looks like and contents of the pack
GelTears is a clear colourless gel. Each tube contains 10 g of eye gel.
Marketing Authorisation Holder
Bausch & Lomb UK Ltd
106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, England, United Kingdom
Tel: (01748) 828864, E-mail: bl@professionalinformation.co.uk
Manufacturer
Dr. Gerhard Mann, Chem.-pharm. Fabrik GmbH
Brunsbuetteler Damm 165-173
13581 Berlin, Germany
Tel: +49 – 30 – 33093-0, Fax: +49 – 30 – 33093-350
A copy of this Patient Information Leaflet is available in large print and audio
format at www.xpil.medicines.org.uk
For any information about this medicine, please contact the Marketing
Authorisation Holder (please see above).
FURTHER INFORMATION
GelTears is used for the symptomatic treatment of ‘dry eye’, which is a dehydration
of the surface of the eye resulting from disturbances in tear secretion or tear
quality. The dry eye condition can also be caused when it is not possible to close
your eyelids either partly or completely.
This condition is so common that one in five patients who go to see an
ophthalmologist suffers from a dry eye condition. There are many causes, such as
reduced tear production in old age, air-conditioned rooms, computer work,
hormonal changes during menopause, etc. Environmental and climatic effects can
also play a role in the development of dry eye conditions.
What do we understand by the term “dry eye”?
During the course of the day we blink 14,000 times on an average. With each
blinking motion of the eye, a very thin tear film is distributed over the surface of
the eyeball, which keeps it smooth, clean and moist, and protects the eye from
pollutants. When the volume or the composition of the tear film is disturbed,
desiccation phenomena (drying out) of the cornea and conjunctiva occur and the
patient experiences symptoms such as burning, dry eye sensation, gritty feeling,
feeling of pressure, and sensitivity to light.
Geltears is a soothing gel solution which moistens the eye and provides tear-like
lubrication to the eyes and eyelids. The carbomer in GelTears increases the
thickness of the gel which assists the gel in remaining in contact with the eye for a
longer period of time.
Your ophthalmologist prescribed a tear substitute for the alleviation of your
complaints. In addition to using the preparation consistently as directed, you
should follow the recommendations below:
• Let fresh air into your apartment or house several times a day
• Take care that you drink sufficiently
• Go out into the fresh air frequently
• Do not direct air vents towards your eyes
• Take breaks when working in front of a computer screen.
It is, however, also important that you consult your ophthalmologist regularly for
follow-up examinations, because dry eye conditions may lead to a serious disease
if they are treated incorrectly or inadequately.
This was last revised in: October 2015
®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
P1UKIE01
© Bausch & Lomb Incorporated.
49202PB574/4-IE/UK

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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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