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SOFRADEX EAR-EYE DROPS SOLUTION

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sofradex ® Ear/Eye Drops, Solution
(framycetin sulphate, dexamethasone sodium metasulphobenzoate, gramicidin)
Driving and using machines

Read all of this leaflet carefully before you start using this
medicine






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.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.

3.HOW TO USE SOFRADEX® DROPS

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.

Always use Sofradex® Drops exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

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.

How to use this medicine




In this leaflet:
What Sofradex® Drops are and what they are used for.
Before you use Sofradex® Drops
How to use Sofradex® Drops
Possible side effects
How to store Sofradex® Drops
Further information

1.
2.
3.
4.
5.
6.

Do not use this medicine for more than 7 days without talking to your
doctor

Use in the eye

1. WHAT SOFRADEX ® DROPS ARE AND WHAT THEY ARE USED
FOR
What Sofradex® Drops are
®

This medicine can be used in the eye and the ear

®

Sofradex Ear/Eye Drops (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






Wash your hands





Close your eye

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
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

®

What Sofradex Drops are used for
It is used in the eye(s) for:
 Inflammation in the eye when prevention of bacterial infection is also
needed. Signs include sore, red or swollen eyes







Wash your hands




Wipe away any excess drops with a clean tissue
Always put the cap back on the bottle as soon as you have used it

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

How much to use

It is used in the ear(s) for:

In the eye(s)

 Inflammation of the ear canal (otitis externa)
2. BEFORE YOU USE SOFRADEX® DROPS

X Do not use this medicine and tell your doctor if:



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

In the ear(s)

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




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

redness, itching or swelling of the eye or eyelid

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 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 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.
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

If you are using these drops in your ear
 You have a damaged (perforated) ear drum

Stop using Sofradex® Drops and see a doctor as soon as possible
if;

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.
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.

1



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

Talk to your doctor or pharmacist if you get any of the side effects or if
you notice any side effects not listed in this leaflet.
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 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.
Do not store above 25°C. Do not refrigerate.
Sofradex® Drops are sterile when you buy them, so you must not keep
them for more than four weeks after opening the bottle.
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.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Sofradex® Drops contains



Each bottle contains the active substances: framycetin sulphate
5.0mg/ml (0.5%w/v) gramicidin 0.05mg/ml (0.005% w/v)
dexamethasone (as sodium metasulphobenzoate) 0.5mg/ml
(0.050% w/v)



The other ingredients are anhydrous citric acid, sodium citrate,
lithium chloride, phenylethyl alcohol, industrial methylated spirit,
polysorbate 80, purified water, sodium hydroxide and hydrochloric
acid.

What Sofradex® Drops looks like and contents of the pack
Sofradex® Drops are in an amber glass bottle fitted with a rubber teat
dropper under a blue, plastic cap containing a practically clear,
colourless to slightly green-yellow aqueous solution. The drops come
in a 10ml dropper bottle.
Manufacturer and Licence Holder
Sofradex® is manufactured by Patheon UK Limited., Covingham,
Swindon, Wiltshire, SN3 5BZ, United Kingdom and is Procured from
within the EU and repackaged by Product Licence holder:
Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3
0RB.
PL 16378/0571

POM

Revision date: 29.04.2016
Leaflet Reference: SOFEYE

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.

Sofradex® is a registered trademark of Aventis Pharma S.A

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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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