• 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 only. 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.

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:

• 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 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.

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.

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).

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.

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.

• 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

• 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

• 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

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 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.

Keep using these drops until your doctor tells you to stop. Otherwise, you could get an infection, or the inflammation could get worse.

• 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.

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.

• 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.

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.

Marketing Authorisation Holder

Manufacturer

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.