Consumer medicine information

Soframycin

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.

What is in this leaflet

This leaflet answers some common questions about Soframycin.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Soframycin against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Soframycin is used for

Soframycin is used to treat bacterial infection of the eye or ear. Soframycin is an antibiotic of the aminoglycoside class. It works by killing bacteria.

Your doctor may have prescribed Soframycin for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor's prescription.

Before you use it

When you must not use it

Do not use Soframycin if you have an allergy to Soframycin or any of the ingredients listed at the end of this leaflet.

Do not use Soframycin in your ear if you have a hole in your eardrum (tympanic membrane).

Do not use Soframycin if you are pregnant or intend to become pregnant. Like most aminoglycosides, Soframycin is not recommended for use during pregnancy

Do not use Soframycin after the expiry date (EXP) printed on the pack. If you use this medicine after the expiry date has passed, it may not work as well.

Do not use Soframycin if the packaging is torn or shows signs of tampering or if it doesn't look quite right.

If you are not sure whether you should start using Soframycin, contact your doctor or pharmacist.

Before you start to use it

Tell your doctor if you have allergies to:

  • antibiotics, especially framycetin
  • any other medicines, especially antibiotics such as neomycin, paromomycin and kanamycin
  • any other substances, such as foods, preservatives or dyes

Tell your doctor if you are pregnant or intend to become pregnant. Like most medicines of this kind, Soframycin is not recommended to be used during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of using it if you are pregnant.

Soframycin may affect your developing baby if you use it during pregnancy.

Tell your Doctor or Pharmacist if you are breast feeding or intend to breast feed your baby. It is not known whether Soframycin may affect your developing baby if you use while breast feeding your baby.

Tell your doctor if you have any wounds or damaged skin in your ear canal if your Doctor prescribed Soframycin to treat an ear infection. Antibiotics belonging to the aminoglycoside class may cause permanent loss of hearing or deafness in some cases when it has been applied to open wounds or damaged skin in the ear.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

How to use it

How much to use

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

Usually, Soframycin should be used as follows:

Remove the cap from the bottle immediately before use and place it back on the bottle immediately after use.

  • 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.

How to use it

Soframycin Drops for the ear may be used following the steps below:

  1. Wash your hands well with soap and water.
  2. Shake the bottle.
  3. Remove the lid.
  4. To use the drops, tilt your head so that the affected ear is uppermost.
  5. Position the rubber dropper, which is attached to the bottle, directly above the ear hole.
  6. With the bottle tipped upside down, gently squeeze the rubber dropper until 2 or 3 drops fall into the ear.
  7. Keep your head tilted for about a minute to allow the drops to penetrate deep into the ear.
  8. Replace the lid, sealing it tightly.
  9. Wash your hands again with soap and water to remove any residue

Soframycin Drops for the eye may be used following the steps below:

You may find it easier to put drops in your eye while you are sitting or lying down.

  1. Wash your hands well with soap and water.
  2. Shake the bottle.
  3. Remove the lid.
  4. Hold the bottle upside down in one hand between your thumb and middle finger.
  5. Using your other hand, gently pull down your lower eyelid to form a pouch.
  6. Tilt your head back and look up.
  7. Put the tip of the bottle close to your eye. Do not let it touch your eye.
  8. Release one drop into your eye by gently squeezing/tapping or pressing the base of the bottle with your index finger.
  9. Close your eye. Do not blink or rub your eye.
  10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about 2 minutes. This will help stop the medicine draining through the tear duct to the nose or throat, from where it can be absorbed into other parts of your body. Ask your doctor or pharmacist for more specific instructions on this technique.
  11. Repeat steps 4-10 to instil the second drop or follow the directions given to you by your doctor and pharmacist.
  12. Replace the lid, sealing it tightly.
  13. Wash your hands again with soap and water to remove any residue.

If you are not sure how to use eye drops, ask your doctor or pharmacist.

How long to use it

Continue using Soframycin until your doctor or pharmacist tells you to stop.

Do not stop using it unless your doctor or pharmacist tells you to even if you feel better.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to.

Otherwise, use it as soon as you remember, and then go back to using your medicine as you would normally.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

While you are using it

Things you must do

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist 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 must not do

Do not give Soframycin to anyone else, even if they have the same condition as you.

Do not use Soframycin to treat any other complaints unless your doctor or pharmacist tells you to.

Do not stop using Soframycin, or lower the dosage, without checking with your doctor or pharmacist.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Soframycin.

Although most people will not experience a side effect, Soframycin has been known to cause allergic reactions.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Itching or redness of the eyes or ears

After using it

Storage

Keep your medicine in a cool, dry place where the temperature stays below 25°C. Do not refrigerate.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

Soframycin should be discarded 4 weeks after first opening.

If your doctor or pharmacist tells you to stop using Soframycin or the medicine has passed the expiry date, ask your pharmacist what to do with any that is left over.

Return any unused medicine to your pharmacist.

Product description

What it looks like

Soframycin Eye/Ear Drops is a sterile colourless solution in an amber glass dropper bottle. Each bottle contains 8 mL of solution.

Ingredients

Soframycin does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Soframycin Eye/Ear Drops contains:

Active ingredient:

  • framycetin sulfate (5 mg/mL)

Inactive ingredients:

  • citric acid monohydrate
  • sodium citrate dihydrate
  • sodium chloride
  • benzalkonium chloride (preservative)
  • water for injections

Supplier

Soframycin is supplied in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall No: 1800 818 806

Soframycin is supplied in New Zealand by:

sanofi-aventis new zealand limited
Level 8, 56 Cawley Street
Ellerslie, Auckland
Freecall No:0800 283 684

This leaflet was prepared in April 2020

soframcycin-ccdsv3-cmiv3-29apr20

Australian Registration Number: AUST R 47541

® = Registered Trademark

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Soframycin Eye

Active ingredient

Framycetin sulfate

Schedule

S4

 

1 Name of Medicine

Soframycin (framycetin sulfate) 5 mg/mL ear/eye drops.

6.7 Physicochemical Properties

C23H46N6O13,xH2SO4. 615 (base).

Chemical structure.


CAS number.

The CAS number is 4146-30-9.

2 Qualitative and Quantitative Composition

Framycetin sulfate 5 mg/mL (0.55% w/v).

Excipients with known effect.

Benzalkonium chloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Soframycin is a clear bright colourless aqueous solution.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antibiotics, ATC code: S01AA07.

Mechanism of action.

Framycetin sulfate is a bactericidal antibiotic. It is active against a wide variety of both Gram-positive and Gram-negative bacteria commonly found in superficial eye infections: staphylococci (including strains resistant to other antibiotics), Pseudomonas aeruginosa, coliforms and pneumococci. It is exceptionally well tolerated by the tissues of the eye. Preparations containing it are non-irritant.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

No data available.

Distribution.

No data available.

Metabolism.

No data available.

Excretion.

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

In the eye: Conjunctivitis, blepharitis, styes, corneal abrasions and burns. Prophylactically following removal of foreign bodies. Also indicated for corneal ulcers.
In the ear: Otitis externa.

4.3 Contraindications

Known hypersensitivity to framycetin sulfate or to any of the excipients listed, see Section 6.1.
Soframycin is contraindicated in case of eardrum perforation.

4.4 Special Warnings and Precautions for Use

In patients known to be allergic to Streptomyces-derived antibiotics (neomycin, paromomycin, kanamycin), cross-sensitisation to framycetin sulfate may occur, but not invariably so.
Aminoglycoside antibiotics may cause irreversible, partial or total deafness when applied topically to open wounds or damaged skin. This effect is aggravated by renal or hepatic impairment and by prolonged duration of treatment. The treatment should not be continued after resolution of symptoms.
Contact with soft contact lenses should be avoided. Contact lenses should be removed prior to application and patients should wait at least 15 minutes before reinsertion. The excipient Benzalkonium chloride is known to discolour soft contact lenses.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category D)
Gentamicin and other aminoglycosides cross the placenta. There is evidence of selective uptake of gentamicin by the foetal kidney resulting in cellular damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in-utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the foetus. It should also be noted that therapeutic blood levels in the mother do not equate with safety for the foetus.
There are no available data on Soframycin use in pregnant women. No conclusions can be drawn regarding whether or not Soframycin is safe for use during pregnancy. Soframycin should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the foetus.
There are no available data on the presence of Soframycin in human milk, milk production, or the effects on the breastfed infant. No conclusions can be drawn regarding whether or not Soframycin is safe for use during breastfeeding. Soframycin should be used during breastfeeding only if the potential benefits to the mother outweigh the potential risks, including those to the breastfed child.

4.8 Adverse Effects (Undesirable Effects)

Local allergic reactions of the hypersensitivity type have rarely been reported.
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems (Australia) or https://nzphvc.otago.ac.nz/reporting/ (New Zealand).

4.2 Dose and Method of Administration

In the eye: 2 drops every one or two hours initially, diminishing to 2 or 3 drops three times daily.
In the ear: 2 or 3 drops may be instilled into the external auditory meatus thrice daily; or a wick may be saturated with drops.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of this registration.

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).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Citric acid - anhydrous, sodium citrate, sodium chloride, water-purified, benzalkonium chloride (as a preservative).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Eye/Ear Drops: 8 mL bottle.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes