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GOLDEN EYE 0.1% W/V EYE DROPS SOLUTION

Active substance(s): PROPAMIDINE ISETHIONATE

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0.1% w/v eye drops solution
Propamidine Isetionate

Patient Information Leaflet

Read all of the leaflet carefully because it contains important information for you.
This medicine is available without a prescription. However, you still need to use Golden
Eye 0.1 % w/v Eye Drops Solution 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 after two days.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Golden Eye 0.1% w/v Eye Drops Solution is and what it is used for
2. Before you use Golden Eye 0.1% w/v Eye Drops Solution
3. How to use Golden Eye 0.1% w/v Eye Drops Solution
4. Possible side effects
5. Storing Golden Eye 0.1% w/v Eye Drops Solution
6. Further information
1. WHAT GOLDEN EYE 0.1 % w/v EYE DROPS SOLUTION IS AND WHAT IT IS USED FOR
Propamidine isetionate, the active ingredient, belongs to a group of medicines called
antiseptics. Antiseptics are used to treat infections caused by bacteria.
Golden Eye 0.1% w/v Eye Drops Solution is used to treat minor eye or eyelid infections, such as
conjunctivitis and blepharitis (inflammation of the eyelids).
2. BEFORE YOU USE GOLDEN EYE 0.1 % w/v EYE DROPS SOLUTION
Do not use Golden Eye 0.1% w/v Eye Drops Solution and talk to your doctor or pharmacist if:
• You are allergic to propamidine isetionate or anything else contained in the eye drops (see
section 6 for a full list of ingredients).
• You are pregnant or trying to become pregnant.
• You are breast-feeding.
• You wear contact lenses.
Do not use Golden Eye 0.1% w/v Eye Drops Solution and talk to your doctor or pharmacist
straight away if any of the following apply to you:
• Your eye is painful (rather than just feeling sore or gritty) or you have pain or swelling around
the eye or face.
• Your sight is affected by loss of vision, reduced or blurred vision or you see halos around
lights.
• It is too painful to open your eyes properly.
• You have "dry eye syndrome"
• Your pupil (the black circle in the centre of your eye) looks different. It may be torn, not round,
very big or does not change size in the light.
• Your eye looks cloudy.
• You have injured your eye.
• You are already using other eye drops or eye ointment.
• You think there may be something in your eye or you have splashed something in your eye.
• You have had eye surgery or laser treatment in the last 6 months.
If you wear contact lenses and have been advised to use Golden Eye 0.1% w/v Eye Drops
Solution by a doctor, pharmacist or contact lens practitioner:
• Do not wear contact lenses while using the drops.
• If you wear hard contact lenses or disposable contact lenses, you can start wearing them
again after you have finished using the drops.
• If you wear soft contact lenses you should wait 24 hours after finishing using the drops
before starting to use them again. Benzalkonium chloride is known to discolour soft contact
lenses.
Taking other medicines: Tell your doctor or pharmacist if you are taking any other medicines,
including those bought without a prescription, especially other eye drops or eye ointment.
Pregnancy and breast-feeding: Do not take this medicine if you are pregnant, trying to become
pregnant or breast-feeding. If you become pregnant while using the drops, stop using them and see
your doctor.
Important information about some of the ingredients of this medicine: Golden Eye 0.1% w/v
Eye Drops Solution contains benzalkonium chloride which may cause eye irritation.
Driving and using machinery. Golden Eye 0.1% w/v Eye Drops Solution can sometimes cause
blurred vision for a short while after administration. You must not drive or operate machinery until
you can see clearly again.
TP/GEDPL/UK/15v5

CUSTOMER Cambridge Healthcare
DESCRIPTION GoldenEye Drops 0.1% Leaflets

COLOURS USED
Black

CODE REF. TP GEDPL UK 15v5
PRINTER REF. D55850
Clearly mark on amendments
and return to: proofs@technoprint.net

SIZE 252.5mm x 121mm

Proposed changes to print layout of Golden Eye Drops PIL

APPROVED AND PROCEED
AMEND AND RE-SUBMIT

FOLDED SIZE 22mm x 121mm inc. 3mm lip

NUMBER OF PAGES 2

LANGUAGE
Overall size 12 cm by
25.4 English
cm, double sided

AMEND AND PROCEED

Signature:_________________________
Date:______________________________

Please check all information is correct and
there are no spelling errors. Should errors
or omissions be noticed after printing or
publication, Technoprint regret that they
cannot be held responsible.

PROOF BY Chloe Joyner

PROOF NO. 3
DATE 16/10/15
DATA MATRIX/BAR CODE -

Patient Information Leaflet continued

3.
HOWInformation
TO USE GOLDEN
EYE 0.1 % w/v EYE DROPS SOLUTION
Patient
Leaflet continued
Always follow your pharmacist's instructions.
3.
HOW your
TO USE
GOLDEN
0.1 %using
w/vthe
EYEdrops.
DROPS SOLUTION
• Wash
hands
before EYE
and after
Always
follow
your pharmacist's
instructions.

Take off
the bottle
cap.
• Tilt head gently backwards.
Wash your
hands the
before
using dropper,
the drops.
• Without
touching
eyeand
withafter
the bottle
apply one or two drops to each affected eye.
offup
thetobottle
cap.
• Take
Do this
4 times
each day. This means that you should use it about every 3 to 4 hours through

head gently backwards.
theTiltday.
• Without touching the eye with the bottle dropper, apply one or two drops to each affected eye.

Do this
up to 4does
timesnot
each
day. This
that stop
you should
usedrops
it about
3 toyour
4 hours
through
If your
condition
improve
aftermeans
two days,
using the
andevery
consult
doctor
or
the day.
pharmacist.
If your
condition
does
two days,
drops your
and consult
your doctor
you miss
a dose,
usenot
theimprove
drops asafter
directed
abovestop
andusing
then the
continue
normal course
of or
pharmacist.
treatment.
If the contents of this tube are swallowed, contact your doctor straight away or go to your nearest
If you miss
a dose,
use the drops
directed
above
and
then
continue
your normal
of
hospital
casualty
department.
Takeasthe
container
with
you
so that
the medicine
can course
be identified.
treatment.
If the contents of this tube are swallowed, contact your doctor straight away or go to your nearest
4. POSSIBLE SIDE EFFECTS
hospital casualty department. Take the container with you so that the medicine can be identified.
Most people use Golden Eye 0.1% w/v Eye Drops Solution without any problems, but like all
medicines, it can have side effects. Side effects that may occur include:
4.
POSSIBLE
SIDE
EFFECTS
Reactions
on or
around
the eye which are mild: stinging or burning; irritation or itching; inflammation
Most
people
use
Golden
Eyehappens
0.1% w/vtoEye
Solution
problems,
but likeIfall
of the skin; skin rash. If this
you,Drops
you must
see without
a doctorany
as soon
as possible.
your
medicines,
it can have
side effects.
Side effects
may
occur
vision
is disturbed
or symptoms
become
worse, that
or you
have
anyinclude:
other unusual symptoms or
Reactionswith
on oryour
around
the eyediscontinue
which are use
mild:and
stinging
or your
burning;
irritation
or itching; inflammation
concerns
medicine,
consult
doctor
or pharmacist.
of the skin; skin rash. If this happens to you, you must see a doctor as soon as possible. If your
is disturbed
or
symptoms
become
or you
have any
unusualthem,
symptoms
or doctor
Reporting
of
side
effects
Ifvision
you have
any
other
problems and
think worse,
that your
medicine
mayother
be causing
tell your
youreffects,
medicine,
use pharmacist
and consultor
your
doctor
pharmacist.
Ifconcerns
get with
any side
talkdiscontinue
to your doctor,
nurse.
Thisorincludes
any possible side
oryou
pharmacist.
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
If you
have any other problems and
think
that your
may
causing
them,
tellinformation
your doctor
at:
www.mhra.gov.uk/yellowcard.
BySOLUTION
reporting
side medicine
effects you
canbehelp
provide
more
5. STORING
GOLDEN EYE DROPS
or pharmacist.
on
the safety of this medicine.
• Keep all medicines out of the sight and reach of children.
• Do not store above 25°C.
5.
STORING
GOLDEN
EYE DROPS
SOLUTION
• Discard
within
four weeks
of first opening.
Keep
medicines
outexpiry
of thedate
sightshown
and reach
of bottle
children.
• Do
notalluse
it after the
on the
and carton after EXP. The expiry date refers
• to
Dothe
notlast
store
dayabove
of the25°C.
month
• Always
Discard replace
within four
weeks
of first
opening.
the top
firmly
on the
bottle after using.
• Do
not use
after the
shown
on the bottle and carton after EXP. The expiry date refers
Return
any itunused
eyeexpiry
dropsdate
to your
pharmacist.
to the last day of the month
• Always replace the top firmly on the bottle after using.
6. FURTHER INFORMATION
• Return any unused eye drops to your pharmacist.
What Golden Eye 0.1% w/v Eye Drops Solution contains
The active ingredient is Propamidine isetionate 0.1% w/v.
6.
INFORMATION
TheFURTHER
other ingedients
are sodium chloride, benzalkonium chloride solution, purified water, sodium
What Golden
0.1% w/vacid
Eyefor
Drops
Solution contains
hydroxide
and Eye
hydrochloric
pH adjustment.
The active ingredient is Propamidine isetionate 0.1% w/v.
The other
ingedients
are w/v
sodium
benzalkonium
chloride
water, sodium
What
Golden
Eye 0.1%
Eyechloride,
Drops Solution
looks like
and solution,
contentspurified
of the pack
hydroxide
hydrochloric
acid for
pH adjustment.
Golden
Eyeand
0.1%
w/v Eye Drops
Solution
is a clear solution available in a 10ml bottle.
What Golden
Eye 0.1% w/v
Eye Drops
Solution
looks
and contents
of the pack
Marketing
Authorisation
Holder:
Typharm
Limited,
14Dlike
Wendover
Road, Rackheath
Industrial
Golden
Eye 0.1%NR13
w/v Eye
Drops
Solution
is a clear solution available in a 10ml bottle.
Estate, Norwich,
6LH,
United
Kingdom.

Marketing
Authorisation
Holder:
Cambridge
Healthcare
Supplies Ltd,
Chestnut
Drive,Industrial
Typharm
Limited,
14D
Wendover
Road,
Rackheath
Manufacturers:
Patheon UK
Limited,
Kingfisher
Drive,
Covingham,
Swindon,
Wiltshire
SN3 5BZ, UK.
Estate,
Norwich,
NR13
6LH,
United
Kingdom.
Wymondham,
Norfolk
NR18
9SB,
United
J L Bragg
Limited,
33-34
Boss
Hall
Road,Kingdom.
Ipswich, IP1 5BN, United Kingdom
Manufacturer:
L BraggUK
Limited,
33-34
Boss Hall
Road,
Ipswich, IP1
5BN, United
Kingdom
Manufacturers:
Limited,
Kingfisher
Drive,
Covingham,
Swindon,
Wiltshire
SN3 5BZ, UK.
Date leaflet textJPatheon
prepared:
August
2011.
J L Bragg Limited, 33-34 Boss Hall Road, Ipswich, IP1 5BN, United Kingdom
This leaflet was last revised in: October 2015.
Date leaflet text prepared: August 2011.

TP/GEDPL/UK/11v2
TP/GEDPL/UK/15v5
TP/GEDPL/UK/11v2

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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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