Patient leaflet - Sofradex ear/eye drops
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
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)
What you need to know before you use Sofradex Drops
Do not use Sofradex Drops:
If you are allergic (hypersensitive) to framycetin sulphate, dexamethasone sodium
metasulphobenzoate, gramicidin or any of the other ingredients of this medicine (listed in section 6).
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 • Your eye or ear inflammation is due to an infection caused by a fungus or a virus. • You have untreated eye or ear infections caused by microorganisms that may be masked or enhanced by the steroids.
if you are using these drops in your eye and:
- your eye inflammation is due to an infection called tuberculosis (TB).
- you have pus in your eye(s)
- you have eye pain or eyelid swelling or a red eye, the cause of which has not been diagnosed. Inappropriate use is potentially blinding.
- 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 and:
- you have pus in your ear(s).
- you have a damaged (perforated) eardrum.
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.
Warnings and precautions
Talk to your doctor or pharmacist before using Sofradex Drops if:
- You experience blurred vision or other visual disturbances.
- You have ototoxicity or family history of ototoxicity (harmful effects to ear) with signs and symptoms including ringing in ears, imbalance (associated with dizziness, nausea, and blurry vision), decreased hearing, hearing loss.
- You know (or think) you have a mitochondrial disease (mutations in the parts of your cells which help make energy). These diseases may increase your risk of hearing loss with this product.
Prolonged use may lead to allergy and the emergence of non-susceptible (resistant) bacteria. Repeated and prolonged use (more than 7 days) requires monitoring of intraocular pressure due to the risk of glaucoma, cataract formation or unsuspected infections. Prolonged use in children and infants may lead to the risk of partial or total deafness.
Other medicines and Sofradex Drops
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
- 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 or pharmacist before using this medicine if:
- You are pregnant, might become pregnant, or think you may be pregnant.
- You are breast-feeding or planning to breast-feed.
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.
How to use Sofradex Drops
Always use this medicine exactly as your doctor or pharmacist has told you. 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
Patient Information Leaflet (framycetin sulphate, dexamethasone (as dexamethasone sodium metasulphobenzoate), gramicidin)
Sofradex Ear/Eye Drops
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Ref: 1915/150923/1/F 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.
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 medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine 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, increased sweating, burning, stinging, itching or swelling or eczema of the eye or ear area.
- Your eyes have problems focussing or develop a blind spot. You may have increased pressure in the eye (glaucoma).
- 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.
- You experience blurred vision.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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.
If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
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.
Contents of the pack and other information
What Sofradex Drops contain
- Each bottle contains framycetin sulphate 0.5% w/v, dexamethasone (as sodium metasulphobenzoate) 0.05% w/v and gramicidin 0.005% 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 look like and contents of the pack
Sofradex Drops are sterile clear colourless ear/eye drops. The drops come in a 8ml dropper bottle.
Manufacturer and Licence Holder
Zentiva k.s., U Kabelovny 130, 102 37 Prague, Czech Republic and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE
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
PL 15184/1915
Leaflet revision date: 15/09/23
Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet in a format suitable for you 6
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Ref: 1915/150923/1/B POM