Consumer medicine information

Soframycin 0.5% Eye drops

Framycetin sulfate

BRAND INFORMATION

Brand name

Soframycin Eye

Active ingredient

Framycetin sulfate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Soframycin 0.5% Eye drops.

1. Why am I using Soframycin?


Soframycin contains the active ingredient framycetin sulfate. Soframycin is used to treat bacterial infection of the eye or ear.
For more information, see Section 1. Why am I using Soframycin? in the full CMI.

2. What should I know before I use Soframycin?


Do not use if you have ever had an allergic reaction to Soframycin or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Soframycin? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Soframycin and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Soframycin?

  • For the eye: 2 drops every one or two hours initially, diminishing to 2 or 3 drops three times daily.
  • For the ear: 2 or 3 drops may be instilled into the ear three times daily.

Instructions can be found in Section 4. How do I use Soframycin? in the full CMI.

5. What should I know while using Soframycin?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Soframycin.
  • Wait at least 15 minutes before reinserting contact lenses after you have used Soframycin in the eyes. One of the ingredients in Soframycin is known to discolour soft contact lenses.
  • If you become pregnant while using Soframycin, stop using it and tell your doctor or pharmacist immediately.
Things you should not do
  • Do not stop using Soframycin, or lower the dosage, without checking with your doctor or pharmacist.
  • Do not use Soframycin to treat any other complaints unless your doctor or pharmacist tells you to.
Looking after your medicine
  • Keep Soframycin in a cool dry place where the temperature stays below 25°C. Do not refrigerate.

For more information, see Section 5. What should I know while using Soframycin? in the full CMI.

6. Are there any side effects?


Side effects include itching or redness of the eyes or ears.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Soframycin Eye

Active ingredient

Framycetin sulfate

Schedule

S4

 

1 Name of Medicine

Framycetin sulfate.

2 Qualitative and Quantitative Composition

Framycetin sulfate 5 mg/mL (0.55% w/v).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Soframycin is a clear bright colourless aqueous solution.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre, telephone number 13 11 26 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFRASUL.gif C23H46N6O13,xH2SO4. 615 (base).
CAS number. 4146-30-9.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SOFRAMST.gif