What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 04425/0210.

Sofradex Ear/Eye Drops

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sofradex®

Ear/Eye Drops, Solution

framycetin sulphate 0.5% w/v dexamethasone (as dexamethasone sodium metasulphobenzoate) 0.05% w/v gramicidin 0.005% w/v

Is this leaflet hard to see or read? Phone 0845 372 7101 for help

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • 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.

What is in this leaflet

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

1. 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)

2. What you need to know before you use Sofradex Drops

Do not use Sofradex Drops and tell your doctor :

  • 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
  • if you are using these drops in your eye and:
    • 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 and:
    • 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.

Warnings and precautions

  • Talk to your doctor or pharmacist if you experience blurred vision or other visual disturbances.

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 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 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 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

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.

4. 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 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
  • 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.

United Kingdom

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.

Malta

You can also report side effects directly via ADR Reporting www.medicinesauthority. gov.mt/adrportal

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 out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Store below 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.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Sofradex Drops contains

  • 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.

What Sofradex Drops looks like and contents of the pack

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 and Manufacturer

Marketing Authorisation Holder

Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 08453727101
email:uk-medicalinformation@sanofi.com

Manufacturer

Zentiva k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

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.

This leaflet was last revised in May 2018

© Sanofi, 1972 - 2018