Active ingredient
- gramicidin
- framycetin sulfate
- dexamethasone sodium metasulfobenzoate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
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 leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility 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 0800 035 2525 for help
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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.
What Sofradex Drops are used for
It is used in the eye(s) for:
It is used in the ear(s) for:
2. What you need to know before you use Sofradex Drops
Do not use Sofradex Drops and tell your doctor:
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
Other medicines and 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 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
Use in the eye
Use in the ear
How much to use
In the eye(s)
In the ear(s)
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;
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.
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 medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Sofradex Drops contains
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
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.
This leaflet was last revised in June 2021
© Sanofi, 1972 - 2021
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)800 035 2525