NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
TOBRAMYCIN MYLAN
tobramycin
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about Tobramycin Mylan.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Tobramycin Mylan against the benefits expected for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What Tobramycin Mylan is used for
Tobramycin is an antibiotic that belongs to a group of medicines called aminoglycoside antibiotics.
Tobramycin works by preventing bacteria from growing and thereby killing them. Tobramycin is used to treat serious bacterial infections, including:
meningitis (infection of the brain)
septicaemia (infection of the blood)
respiratory tract infections
gastrointestinal tract infections
skin and skin structure infections, including infected burns
bone infections
urinary tract infections.
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 available only with a doctor’s prescription.
Before you are given Tobramycin Mylan
When you must not be given it
You must not be given Tobramycin Mylan if you have an allergy to:
any medicine containing tobramycin
any of the ingredients listed at the end of this leaflet
any other similar medicines such as amikacin, gentamycin and neomycin
Some of the symptoms of an allergic reaction may include
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
You must not be given tobramycin if you have a history of hypersensitivity or serious toxic reactions (such as hearing loss or kidney problems) to tobramycin or any other aminoglycosides.
If you are not sure whether you should be given this medicine, talk to your doctor.
Before you are given it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you are pregnant or plan to become pregnant.
Like most aminoglycoside antibiotics, tobramycin is not recommended for use during pregnancy. If there is a need for you to be given tobramycin, your doctor will discuss with you the benefits and risks of using it during your pregnancy.
Tell your doctor if you are breast-feeding or plan to breast-feed.
Tobramycin passes into breast milk and is not recommended for use during breast-feeding. If there is a need for you to be given tobramycin, you doctor will discuss the possible risks and benefits of using it during breast-feeding.
Tell your doctor if you have or have had any of the following medical conditions:
kidney problems
muscular disorders (eg myasthenia gravis, Parkinson’s disease)
hearing problems.
If you have not told your doctor about any of the above, tell him/her before you are given Tobramycin Mylan.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Tobramycin Mylan may interfere with each other. These include:
fluid tablets (diuretics) e.g. furosemide (frusemide), etacrynic acid, bumetanide or other potent diuretics.
neurotoxic or nephrotoxic antibiotics such as aminoglycosides, cephaloridine, polymixin B, colistin, cisplatin and vancomycin.
other antibiotics to treat infections
amphotericin B (amphotericin), a medicine used to treat fungal infections.
opioid analgesics (e.g. codeine, morphine, pethidine, fentanyl)
some general anaesthetic agents
muscle relaxants (e.g. succinylcholine)
These medicines may be affected by Tobramycin Mylan or may affect how well it works. You may need different amounts of your medicines, or you may need to be given different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How Tobramycin Mylan is given
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
How much is given
Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight and kidney function.
How it is given
Tobramycin is given as an injection into a muscle or as a slow injection into a vein (intravenously).
Tobramycin should only be given by a doctor or nurse.
If you take too much (overdose)
As Tobramycin Mylan is usually given to you in hospital under the supervision of your doctor, it is very unlikely that you will receive an overdose. However, if you experience side effects tell your doctor or nurse immediately, or if you are not already in hospital, go to the Accident & Emergency Department at your nearest hospital.
Symptoms of a tobramycin overdose may include the side effects listed below in the ‘Side Effects’ section, but are usually of a more severe nature.
In case of overdose, immediately contact the Poisons Information Centre for advice (telephone 13 11 26).
You may need urgent medical attention.
While you are being given Tobramycin Mylan
Things you must do
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Tobramycin Mylan.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Things to be careful of
Be careful driving or operating machinery until you know how Tobramycin Mylan affects you.
This medicine may cause (dizziness, light-headedness, tiredness, drowsiness, etc.) in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Tobramycin Mylan.
This medicine helps most people with certain infections, but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects. If you are over 65 years of age you may have an increased chance of getting side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
tiredness or weakness
fever
nausea or vomiting
sore mouth and gums
pain at the injection site.
rash or itchiness
The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
signs of an allergic reaction, such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing or difficulty breathing.
hearing problems
ringing in the ears
muscle weakness
decreased urination
diarrhoea, even after stopping antibiotics for several weeks.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Other side effects not listed above may also occur in some people.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Do not be alarmed by the following list of side effects.
You may not experience any of them.
After using Tobramycin Mylan
Storage
Tobramycin Mylan will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C.
Product description
What it looks like
Tobramycin Mylan is a clear, colourless liquid filled in a glass vial.
Ingredients
Tobramycin Mylan contains tobramycin as the active ingredient.
It also contains the following inactive ingredients:
disodium edetate
sodium bisulfite
sulfuric acid
sodium hydroxide
This medicine contains sulfites and residual apramycin and kanamycin B.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Supplier
Tobramycin Mylan is supplied in Australia by:
Alphapharm Pty Limited
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au
Australian registration numbers:
Tobramycin Mylan 80 mg/2 mL: AUST R 234429
This leaflet was prepared on
16 July 2020.
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