Soframycin®

Framycetin Sulfate (fra-me-see-tin sul-fate)

Consumer Medicine Information (CMI)

What is in this leaflet • any other medicines, especially

antibiotics such as neomycin,
This leaflet answers some common paromomycin and kanamycin
questions about Soframycin.
Before you use it • any other substances, such as
It does not contain all the available foods, preservatives or dyes
When you must not use it
information. It does not take the Tell your Doctor or Pharmacist if
place of talking to your doctor or Do not use Soframycin if you have you are pregnant or intend to
pharmacist. an allergy to Soframycin or any of become pregnant.
the ingredients listed at the end of
All medicines have risks and Like most medicines of this kind,
this leaflet.
benefits. Your doctor or pharmacist Soframycin is not recommended to
has weighed the risks of you using Do not use Soframycin in your ear be used during pregnancy. Your
Soframycin against the benefits they if you have a hole in your eardrum doctor or pharmacist will discuss the
expect it will have for you. (tympanic membrane). risks and benefits of using it if you
If you have any concerns about Do not use Soframycin if you are are pregnant.
using this medicine, ask your pregnant or intend to become Soframycin may affect your
doctor or pharmacist. pregnant. developing baby if you use it during
Keep this leaflet with the medicine. Like most aminoglycosides, pregnancy.
Soframycin is not recommended for
You may need to read it again. Taking other medicines
use during pregnancy.
Contact lenses should be removed Tell your Doctor or Pharmacist if
prior to use and you should wait at you are taking any other
What Soframycin is least 15 minutes before reinsertion of medicines, including any that you
used for lenses. buy without a prescription from
your pharmacy, supermarket or
Do not use Soframycin after the
Soframycin is used to treat bacterial health food shop.
expiry date (EXP) printed on the
infection of the eye or ear. pack.
Soframycin is an antibiotic of the
If you use this medicine after the
aminoglycoside class. It works by expiry date has passed, it may not
killing bacteria. How to use it
work as well.
Your doctor may have prescribed Do not use Soframycin if the
Soframycin for another reason. How much to use
packaging is torn or shows signs of
Ask your doctor if you have any tampering or if it doesn't look Follow all directions given to you
questions about why Soframycin quite right. by your doctor and pharmacist
has been prescribed for you. carefully.
If you are not sure whether you
This medicine is only available with should start using Soframycin, These directions may differ from the
a doctor's prescription. contact your doctor or pharmacist. information contained in this leaflet.
Usually, Soframycin should be
Before you start to use it used as follows:
Tell your doctor or pharmacist if For the eye
you have allergies to: 2 drops every one or two hours
• antibiotics especially framycetin initially, diminishing to 2 or 3 drops
three times daily.

SOFRAMYCIN® 1
For the ear tear duct to the nose or throat, tell your doctor or pharmacist
2 or 3 drops may be instilled into the from where it can be absorbed immediately.
ear three times daily. into other parts of your body. Ask
your doctor or pharmacist for Things you must not do
How to use it more specific instructions on this
Do not give Soframycin to anyone
technique.
Soframycin Drops for the ear may else, even if they have the same
11. Repeat steps 4-10 to instil the condition as you.
be used following the steps below:
second drop or follow the
Remove the cap from the bottle Do not use Soframycin to treat any
directions given to you by your
immediately before use and place it other complaints unless your
doctor and pharmacist.
back on the bottle immediately after doctor or pharmacist tells you to.
12. Replace the lid, sealing it tightly.
use. To use the drops, tilt your head Do not stop using Soframycin, or
so that the affected ear is uppermost. 13. Wash your hands again with soap lower the dosage, without checking
Position the rubber dropper, which is and water to remove any residue. with your doctor or pharmacist.
attached to the bottle, directly above If you are not sure how to use eye
the ear hole. With the bottle tipped drops, ask your doctor or
upside down, gently squeeze the pharmacist.
rubber dropper until 2 or 3 drops fall Side effects
into the ear. Keep your head tilted for How long to use it
about a minute to allow the drops to Tell your doctor or pharmacist as
penetrate deep into the ear. Continue using Soframycin until
soon as possible if you do not feel
your doctor or pharmacist tells you
Soframycin Drops for the eye may well while you are using
to stop.
be used following the steps below: Soframycin.
Do not stop using it unless your
You may find it easier to put drops in Although most people will not
doctor or pharmacist tells you to
your eye while you are sitting or experience a side effect, Soframycin
even if you feel better.
lying down. has been known to cause allergic
reactions.
1. Wash your hands well with soap If you forget to use it
and water. Tell your doctor or pharmacist if
If it is almost time for your next you notice any of the following and
2. Shake the bottle. dose, skip the dose you missed and they worry you:
3. Remove the lid. use your next dose when you are
• Itching or redness of the eyes or
meant to.
4. Hold the bottle upside down in ears
one hand between your thumb Otherwise, use it as soon as you
and middle finger. remember, and then go back to
using your medicine as you would
5. Using your other hand, gently
normally.
pull down your lower eyelid to After using it
form a pouch. If you are not sure what to do, ask
your doctor or pharmacist. Storage
6. Tilt your head back and look up.
If you have trouble remembering
7. Put the tip of the bottle close to Keep your medicine in a cool, dry
to use your medicine, ask your
your eye. Do not let it touch your place where the temperature stays
pharmacist for some hints.
eye. below 25°C. Do not refrigerate.
8. Release one drop into your eye by Keep it where children cannot
gently squeezing/tapping or reach it.
pressing the base of the bottle While you are using it A locked cupboard at least one-and-
with your index finger.
a-half metres above the ground is a
9. Close your eye. Do not blink or Things you must do good place to store medicines.
rub your eye.
If you are about to be started on Disposal
10. While your eye is closed, place
any new medicine, tell your doctor,
your index finger against the Soframycin should be discarded 4
dentist or pharmacist that you are
inside corner of your eye and weeks after first opening.
using Soframycin.
press against your nose for about
If you become pregnant while If your doctor or pharmacist tells
2 minutes. This will help stop the
using Soframycin, stop using it and you to stop using Soframycin or
medicine draining through the
the medicine has passed its expiry

SOFRAMYCIN® 2
date, ask your pharmacist what to
do with any that is left over. Australian Registration Number:
Return any unused medicine to AUST R 47541
your pharmacist.

® Registered Trademark

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 - anhydrous
• sodium citrate
• sodium chloride
• benzalkonium chloride
(preservative)
• water - purified

Supplier
Soframycin is supplied in Australia
by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113

Soframycin is supplied in New

Zealand by:
sanofi-aventis new zealand limited
Level 8
56 Cawley Street
Ellerslie, Auckland

This leaflet was prepared in January

2020.
soframycin-ccdsv3-cmiv2-10jan20

SOFRAMYCIN® 3