Sofradex Ear-Eye Drops Solution
500000/PL1a
Sofradex Ear/Eye Drops, Solution
(framycetin sulphate/ dexamethasone sodium meta-sulphobenzoate/ gramicidin)
Patient Information Leaflet
The name of your medicine is Sofradex Ear/Eye Drops, Solution but will be referred to as Sofradex Drops throughout the rest of this leaflet.
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 onto others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Sofradex drops are and what they are used for
2. Before you use Sofradex Drops
3. How to use Sofradex Drops
4. Possible side effects
5. How to store Sofradex Drops
6. Further information
1. WHAT SOFRADEX DROPS ARE AND WHAT THEY ARE| USED
What Sofradex Drops are
Sofradex Drops contain three medicines called Framycetin sulphate, Gramicidin and Dexamethasone sodium meta-sulphobenzoate.
• 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 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
It is used in the ear(s) for:
• Inflammation of the ear canal (otitis externa)
2. 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). Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your lips, face, throat and worsening of redness, itching or swelling of the eye or eyelid
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
• 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.
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 or 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 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.
Continued overleaf
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.
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
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.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd, both of St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Patheon UK Limited, Covingham, Swindon, Wiltshire SN3 5BZ, United Kingdom.
Sofradex Ear/Eye Drops, Solution pQM
PL No: 18067/0491 -
This leaflet was last revised on 21st July 2016.
Sofradex® is the registered trademark of Aventis Pharma S.A.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.
5. HOW TO STORE SOFRADEX DROPS
• Keep out of the sight and reach of children.
• 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 28 days 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 you notice any sign of discolouration or deterioration of your medicine, please tell your pharmacist immediately.
6. FURTHER INFORMATION
What Sofradex Drops contain
• Each bottle contains 0.5% w/v of framycetin sulphate, dexamethasone sodium meta-sulphobenzoate (equivalent to 0.05% w/v of dexamethasone) and 0.005% w/v of gramicidin.
• The other ingredients are anhydrous citric acid, sodium citrate, lithium chloride, phenylethyl alcohol, industrial methylated spirit, polysorbate 80, purified water. Hydrochloric acid and sodium hydroxide (both for pH adjustment).
What Sofradex Drops looks like and contents of the pack
Sofradex Drops are clear, colourless ear/eye drops. The drops are available in 10 ml dropper bottles.
500000/PL1a