Sofradex Ear-Eye Drops Solution
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Sofradex® Ear/Eye Drops, solution
(framycetin sulphate 0.5% w/v, dexamethasone
0.05% w/v, gramicidin 0.005% w/v)
Read all of this leaflet carefully before you start using this medicine.
• 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 you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• 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
The name of your medicine is Sofradex® Ear/Eye Drops, solution but will be referred to as Sofradex throughout the leaflet.
In this leaflet:
1. What Sofradex is and what it is used for
2. Before you use Sofradex
3. How to use Sofradex
4. Possible side effects
5. How to store Sofradex
6. Further information
What Sofradex is
Sofradex 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
What Sofradex is 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
It is used in the ear(s) for:
• Inflammation of the ear canal (otitis externa)
2. Before you use Sofradex
Do not use this medicine and tell your doctor if:
x You are allergic (hypersensitive) to framycetin sulphate, dexamethasone sodium metasulphobenzoate, gramicidin or any of the other ingredients of Sofradex (listed in Section 6 'further information').
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
If you are using these drops in your eye
x Your eye inflammation is due to an infection caused by a fungus or a virus
x Your eye inflammation is due to an infection called tuberculosis (TB) x You have pus in your eye(s) x You have glaucoma
x 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
x 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.
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. If this happens, do not drive or use any tools or machines until you can see clearly.
3. How to use Sofradex
Always use Sofradex 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 as instructed by your doctor
In the ear(s)
• Two or three drops in the ear three or four times a day
• Keep using Sofradex as instructed by your doctor
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
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Sofradex® Ear/Eye Drops, solution;
PL 18799/2844
Leaflet date: 19.05.2016 POM
If you forget to use Sofradex
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
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.
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not refrigerate.
• Sofradex are sterile when you buy them.
• Discard contents 28 days after first opening.
• Do not use Sofradex after the expiry date which is stated on the carton and bottle label after 'Exp'. The expiry date refers to the last day of that month.
• 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.
4. Possible side effects
6. Further Information
Like all medicines, Sofradex can cause side effects, although not everybody gets them
Stop using Sofradex 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
What Sofradex contains
Each bottle contains 0.5% w/v of framycetin sulphate, dexamethasone sodium meta-sulphobenzoate (equivalent to 0.050% w/v of dexamethasone) and 0.005% w/v of gramicidin.
The other ingredients are citric acid, sodium citrate, lithium chloride, phenylethyl alcohol, industrial methylated spirit, polysorbate 80, water for injection. sodium hydroxide and hydrochloric acid (pH adjustment).
What Sofradex looks like and contents of the pack
Sofradex is sterile, clear and colourless ear/eye drop. It is available in a 10ml dropper bottle.
Manufactured by: Patheon UK Limited, Covingham, Swindon, Wiltshire, SN3 5BZ, UK.
