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SOFRADEX EAR-EYE DROPS SOLUTION

Active substance(s): DEXAMETHASONE SODIUM METASULPHOBENZOATE / FRAMYCETIN SULPHATE / GRAMICIDIN / DEXAMETHASONE SODIUM METASULPHOBENZOATE / FRAMYCETIN SULPHATE / GRAMICIDIN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Sofradex®
Ear/Eye Drops, Solution
framycetin sulphate 0.5% w/v
dexamethasone (as dexamethasone
sodium metasulphobenzoate) 0.05% w/v
gramicidin 0.005% w/v
Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully before
you start using this medicine because
it contains important information for
you.
 Keep this leaflet. You may need to read
it again
 If you have any further questions, ask
your doctor or pharmacist
 This medicine has been prescribed for
only you. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours
 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.

What is in this leaflet

What Sofradex Drops are used for

1. What Sofradex Drops are and what they
are used for
2. What you need to know before you use
Sofradex Drops
3. How to use Sofradex Drops
4. Possible side effects
5. How to store Sofradex Drops
6. Contents of the pack and other
information

It is used in the eye(s) for:

1. What Sofradex Drops are
and what they are used for
Sofradex Ear/Eye Drops, Solution (called
Sofradex Drops in this leaflet) contains
three medicines called Framycetin
sulphate, Gramicidin and Dexamethasone
sodium metasulphobenzoate.
 Framycetin sulphate and Gramicidin
belong to a group of medicines called
antibiotics. These work by killing the
bacteria that is causing the infection.
 Dexamethasone sodium
metasulphobenzoate. This belongs to
a group of medicines called steroids. It
works by lowering inflammation

 Inflammation in the eye when
prevention of bacterial infection is
also needed. Signs include sore, red or
swollen eyes
It is used in the ear(s) for:
 Inflammation of the ear canal (otitis
externa)

If you are using these drops in your
eye
 Your eye inflammation is due to an
infection caused by a fungus or a virus
 Your eye inflammation is due to an
infection called tuberculosis (TB)
 You have pus in your eye(s)
 You have glaucoma
 You have an ulcer in your eye(s) caused
by the herpes simplex virus (herpetic
keratitis)
If you are using these drops in your ear

2. What you need to know before you
use Sofradex Drops
Do not use this medicine and tell
your doctor if:
 You are allergic (hypersensitive) to
framycetin sulphate, dexamethasone
sodium metasulphobenzoate,
gramicidin or any of the other
ingredients of Sofradex Drops (listed in
Section 6 below).
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat, tongue
and worsening of redness, itching or
swelling of the eye or eyelid

 You have a damaged (perforated) ear
drum
Do not use this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
using Sofradex Drops.
Other medicines and Sofradex Drops
• Please tell your doctor if you are
taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
• Some medicines may increase the
effects of Sofradex Drops and your
doctor may wish to monitor you

carefully if you are taking these
medicines (including some medicines
for HIV: ritonavir,cobicistat).
Pregnancy and breast-feeding
Talk to your doctor before using this
medicine if you are pregnant, might
become pregnant, or think you may be
pregnant.
If you are breast-feeding or planning
to breast-feed, talk to your doctor or
pharmacist before taking or using any
medicine.
Driving and using machines
You may have blurred eyesight straight
after using Sofradex Drops. If this happens,
do not drive or use any tools or machines
until you can see clearly.
3. How to use Sofradex Drops
Always use Sofradex Drops exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.
How to use this medicine
 This medicine can be used in the eye
and the ear
 Do not use this medicine for more than

7 days without talking to your doctor
Use in the eye
 Wash your hands
 Remove the cap on the bottle
 Tilt your head back
 Squeeze one or two drops inside the
lower lid without touching your eye with
the bottle
 Close your eye
 Wipe away any excess drops with a clean
tissue
 Always put the cap back on the bottle as
soon as you have used it
Use in the ear
 Wash your hands
 Remove the cap on the bottle
 Tilt your head on one side
 Squeeze two or three drops into your
ear
 Lie your head with your affected ear
facing upwards for a few minutes
 Wipe away any excess drops with a clean
tissue
 Always put the cap back on the bottle as
soon as you have used it

How much to use
In the eye(s)
 One or two drops in the affected eye six
times a day or more if advised by your
doctor
 Keep using Sofradex Drops as instructed
by your doctor

If you have any further questions on
the use of this product, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Sofradex Drops can
cause side effects, although not everybody
gets them

In the ear(s)
 Two or three drops in the ear three or
four times a day
 Keep using Sofradex Drops as instructed
by your doctor
If you forget to use Sofradex Drops
If you forget a dose, put some in as soon
as you remember. However, if it is nearly
time for the next dose, skip the missed
dose. Do not use a double dose to make
up for a forgotten dose.
If you stop using Sofradex Drops
Keep using these drops until your doctor
tells you to stop. Otherwise, you could get
an infection or the inflammation could get
worse.

Stop using Sofradex Drops and see a
doctor as soon as possible if;
 You get any kind of skin problem, such
as a rash or itching around your eyes or
irritation burning, stinging, itching or
swelling
 Your eyes have problems focussing or
develop a blind spot. You may have
increased pressure in the eye
 You have difficulty seeing at night or
notice that your eyesight is cloudy and
fuzzy, or you see halos around lights.
These could be signs of cataracts. This
may occur after using the medicine for a
long time
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.

United Kingdom
You can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Malta
You can also report side effects directly via
ADR Reporting www.medicinesauthority.
gov.mt/adrportal
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. How to store Sofradex Drops
Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Sofradex Drops after the expiry
date which is stated on the label and
carton. The expiry date refers to the last
day of that month.

pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.

Marketing Authorisation Holder
6. Contents of the pack and other
information
What Sofradex Drops contains
 The eye drops contain the active
substances: framycetin sulphate
(0.5%w/v), dexamethasone sodium
metasulphobenzoate (equivalent to
0.050% w/v of dexamethasone) and
gramicidin (0.005%w/v)
 The other ingredients are citric acid
monohydrate, sodium citrate, lithium
chloride, phenylethyl alcohol, industrial
methylated spirit, polysorbate 80 and
water for injection. Sodium hydroxide
and hydrochloric acid are used for pH
adjustment.

Store below 25°C. Do not refrigerate.

What Sofradex Drops looks like and
contents of the pack

Sofradex Drops are sterile when you buy
them, so you must not keep them for
more than 28 days after opening the
bottle.

Sofradex® Drops are clear colourless ear/
eye drops. The drops are also available in
5ml, 8ml and 10ml dropper bottles. Not all
pack sizes may be marketed.

Medicines should not be disposed of via
wastewater or household waste. Ask your

Marketing Authorisation Holder and
Manufacturer

Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 08453727101
email:uk-medicalinformation@sanofi.com
Manufacturer
Zentiva k.s.,
U Kabelovny 130
102 37 Prague 10,
Czech Republic
This leaflet does not contain all the
information about your medicine. If you
have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised
in May 2017
© Sanofi, 1972 - 2017

ZV/578 15

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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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