Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using TOBI PODHALER?
TOBI PODHALER contains the active ingredient tobramycin. TOBI PODHALER is used to
treat lung infections caused by a bacterium called Pseudomonas aeruginosa, in patients
who have cystic fibrosis.
2. What should I know before I use TOBI PODHALER?
Do not use if you have ever had an allergic reaction to tobramycin 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.
3. What if I am taking other medicines?
Some medicines may interfere with TOBI PODHALER and affect how it works.
4. How do I use TOBI PODHALER?
The usual dose for all patients aged 6 years and older is 4 capsules for inhalation
taken every 12 hours (each morning and evening).
Do not exceed the recommended dose.
5. What should I know while using TOBI PODHALER?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TOBI PODHALER.
Once removed from the blister strip, use the capsule immediately.
Use a new PODHALER device after 7 days. Discard the old one.
Tell your doctor if you become pregnant while using TOBI PODHALER.
Keep all of your doctor's appointments so that your progress can be checked.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using TOBI PODHALER.
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Things you should not do
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Do not swallow the capsules. The powder in the capsules are taken by inhalation only,
using a PODHALER device that is provided in the pack.
Do not use other capsules or powders in the PODHALER device.
Do not wash the PODHALER device.
Do not change or lower the dosage, without checking with your doctor.
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Driving or using machines
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TOBI PODHALER should not affect your ability to drive and use machines.
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Looking after your medicine
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Store this medicine in a cool, dry place, where the temperature stays below 30°C.
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6. Are there any side effects?
Active ingredient(s):
tobramycin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using TOBI PODHALER. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using TOBI PODHALER.
Where to find information in this leaflet:
1. Why am I using TOBI PODHALER?
TOBI PODHALER contains the active ingredient tobramycin in a powdered form. TOBI PODHALER is a class of medicines called aminoglycoside antibiotics.
Pseudomonas aeruginosa is a very common bacterium that infects the lung of nearly
everyone with cystic fibrosis, at some time during their lives. Some people do not
get this infection until later on in their lives, while others get it very young.
This infection is one of the most damaging bacteria for people with cystic fibrosis.
If it is not properly fought, it will continue to damage your lungs causing further
problems to your breathing.
TOBI PODHALER capsules are for oral inhalation only. The powder from the capsule is
inhaled (breathed into the lungs), using the TOBI PODHALER inhalation device provided
with the medicine. When you inhale the powder, tobramycin gets directly into your
lungs, to fight against the Pseudomonas aeruginosa bacteria causing the infection.
TOBI PODHALER is used to treat lung infections caused by a bacterium called pseudomonas
aeruginosa, in patients who have cystic fibrosis.
TOBI PODHALER is only available with a doctor’s prescription. It is not addictive.
This medicine can be used in children aged 6 years or over, adolescents, and adults.
2. What should I know before I use TOBI PODHALER?
Warnings
Do not use TOBI PODHALER if:
you are allergic to tobramycin, any type of aminoglycoside antibiotic, or any of the
ingredients listed at the end of this leaflet. See symptoms of an allergic reaction
under Section
6. Are there any side effects?.
Always check the ingredients to make sure you can use this medicine.
Do not give TOBI PODHALER to a child below the age of 6, unless directed to by the
child's doctor or pharmacist.
Check with your doctor if you:
have allergies to any other medicines or any other substances, such as foods, preservatives
or dyes. See symptoms of an allergic reaction under Section
6. Are there any side effects?.
aged 65 years or older, your doctor may perform additional tests to decide if TOBI
PODHALER is right for you. Your doctor will supervise your first dose of this medicine
and check your lung function before and after dosing.
are taking any other medicines
have hearing problems (including noises in the ears and dizziness)
have Kidney problems
have unusual difficulty in breathing with wheezing or coughing, chest tightness
blood in your sputum (the substance you cough up)
have muscle weakness that lasts or becomes worse in time, a symptom mostly related
to conditions such as myasthenia or Parkinson’s disease.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
TOBI PODHALER may affect your developing baby if you use it during pregnancy. Your
doctor or pharmacist will discuss the possible risks and benefits of using TOBI PODHALER
during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your baby may absorb this medicine from breast milk and therefore there is a possibility
of harm to the baby. Your doctor or pharmacist will discuss the risks and benefits
of using TOBI PODHALER during breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with TOBI PODHALER and affect how it works.
diuretics (fluid tablets), especially those that contain furosemide, etacrynic acid,
urea or intravenous mannitol
tobramycin or another aminoglycoside antibiotic by injection (eg. amikacin, gentamicin,
neomycin, streptomycin
Medicines that may
increase
the effect of TOBI PODHALER include:
Amphotericin B (an antifungal medicine)
Cefalotin or polymyxins (antibiotic medicines)
Ciclosporin or tacrolimus (medicines that help to control your body’s immune system)
Carboplatin, cisplatin, or other platinum compounds (usually used in the treatment
of various cancer types)
Anticholinesterase medicines, such as neostigmine and pyridostigmine
Botulinum toxin (a medicine used to relax muscles)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TOBI PODHALER.
4. How do I use TOBI PODHALER?
How much to use
The usual dose for all patients aged 6 years and older is 4 capsules for inhalation
taken every 12 hours (each morning and evening).
Do not exceed the recommended dose.
Follow the instructions provided when TOBI PODHALER was prescribed, including the
number of days it should be taken.
Always use TOBI PODHALER exactly as your doctor has told you.
Your doctor may ask you to use other medicines before using TOBI PODHALER.
You should check with your doctor if you are not sure.
Children 6 years and over should use this medicine with the help of an adult.
When initiating children on PODHALER treatment, caregivers should particularly provide
assistance to those aged 10 years or younger, and should continue to supervise them
until they are able to use the PODHALER inhaler properly without help. If you are
not sure how to use the medicine and PODHALER device, which are provided in the pack,
ask your doctor or pharmacist.
When to use TOBI PODHALER
TOBI PODHALER should be used twice a day (morning and evening) at about the same time
each day. You must leave as close as possible to 12 hours between doses.
Using your medicine at the same time each day will help you remember when to take
it. TOBI PODHALER is taken in a 28 day cycle.
After taking the medicine for 28 days, you will have a 28-day break, during which
you do not inhale any TOBI PODHALER. You then start another course.
Please check the order of medications with your doctor.
If you are taking several different inhaled treatments and performing therapies for
cystic fibrosis, you should use TOBI PODHALER last.
How to use TOBI PODHALER
USE A NEW PODHALER INHALATION DEVICE EVERY WEEK
Wash and fully dry hands.
Just before use, remove the PODHALER device from its case by holding the base and
twisting off the top of the case in a counter-clockwise direction. Set the top of
the case aside. Briefly inspect the inhaler to make sure it is not damaged or dirty,
and then stand it in the base of the case.
Holding the body of the inhaler, unscrew and remove the mouth piece from the inhaler
body. Set the mouth piece aside on a clean, dry surface.
Separate the morning and evening doses from the capsule card. Peel back the foil from
the capsule card to reveal one capsule and remove it from the card.
Immediately insert the capsule into the inhaler chamber. Replace the mouth piece and
screw it on firmly until it stops. Do not over tighten.
The medication is now ready for inhalation.
Fully exhale away from the inhaler.
Position the inhaler with the mouth piece facing towards you. Place mouth over the
mouth piece creating a tight seal. Inhale the powder deeply with a single continuous
inhalation.
Remove inhaler from mouth, and hold breath for a count of approximately 5 seconds
then exhale normally away from the inhaler.
After a few normal breaths, perform a second inhalation from the same capsule, repeating
steps 7, 8 and 9.
Unscrew mouth piece and remove the capsule from the chamber. Inspect the used capsule.
It should appear punctured and empty .
If the capsule is punctured but still contains some powder, place it back into the
chamber with the punctured side of the capsule inserted first, replace the mouth piece
and take another two inhalations from the capsule (repeat step 5, then steps 7 to
11). Reinspect capsule.
If the capsule appears to be unpunctured, place it back into the chamber, replace
the mouth piece, press the button firmly as far as it goes and take another two inhalations
from the capsule (repeat steps 5 to 11). If the capsule is still full and appears
to be unpunctured, replace the inhaler with the reserve inhaler and try again (repeat
steps 2, 3, and 5 to 11). Discard the empty capsule.
Repeat, starting at step 4, for the remaining 3 capsules of the dose.
Replace the mouth piece and screw it on firmly until it stops. When the full dose
(4 capsules) has been inhaled, wipe the mouthpiece with a clean, dry cloth.
Place inhaler back in storage case and close tightly. The inhaler should never be
washed with water.
Continue to take TOBI PODHALER, in the cycling pattern, for as long as your doctor
tells you.
It is important that you keep using the product twice each day during your 28 days
on treatment and that you keep to the 28-day on and 28-day off cycle. Continue to
take TOBI, in the cycling pattern, for as long as your doctor tells you.
If you forget to use TOBI PODHALER
TOBI PODHALER should be used twice a day (morning and evening) at about the same time
each day. You must leave as close as possible to 12 hours between doses. If you miss
your dose at the usual time, take your dose as soon as you remember if there are at
least 6 hours to your next dose. Then go back to using your medicine as you would
normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
Use your medicine at the same time each day. This will help you remember to take your
medicine dose.
If you have trouble remembering when to use your medicine, ask your doctor or pharmacist
for some hints.
If you use too much TOBI PODHALER
If you think that you have used too much TOBI PODHALER, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre (Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you use too much of this medicine, you may feel:
dizziness
ringing in the ears
loss of hearing
difficulty or decreased breathing
weakness
5. What should I know while using TOBI PODHALER?
Things you should do
Once removed from the blister strip, use the capsule immediately.
Avoid using the product in a very humid environment, for example in tropical regions
or in bathrooms.
Use a new PODHALER device after 7 days. Discard the old one.
Keep all of your doctor's appointments so that your progress can be checked. Over
time, strains of Pseudomonas can become resistant to the treatment of an antibiotic.
This may mean that TOBI PODHALER may not work as well as it should over time.
Call your doctor straight away if you:
become pregnant.
are about to be started on any new medicine.
experience a persistent cough and it is worrying you. Inhaling medicines can also
cause cough and this may happen when using this medicine. Inhaling medicines can cause
chest tightness and wheezing. This may happen immediately after inhaling this medicine.
are taking tobramycin or another aminoglycoside antibiotic by injection, it may sometimes
cause hearing loss, dizziness, and kidney damage, and may harm an unborn child.
Remind any doctor, dentist or pharmacist you visit that you are using TOBI PODHALER.
Things you should not do
Do not swallow the capsules. The powder in the capsules are taken by inhalation only,
using a Podhaler device that is provided in the pack. If you have swallowed the capsules
in error, tell your doctor as soon as possible. When swallowed, the capsules will
not harm you, but this medicine will not work against your lung infection, as it is
meant to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not use other capsules or powders in the Podhaler device.
Do not wash the Podhaler device.
Do not change or lower the dosage, without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TOBI PODHALER
affects you.
TOBI PODHALER should not affect your ability to drive and use machines.
Looking after your medicine
Clean the Podhaler after each use by wiping it with a clean dry cloth or tissue.
It is important to keep your Podhaler clean and dry. It may not work as well if it
gets dirty or wet.
Keep your medicine in the original container until it is time to use it.
Keep the Podhaler in its tightly closed case when not in use.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine
Discard your medicine when your doctor stops your treatment with TOBI PODHALER or
you find that it has passed the expiry date.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Allergic reactions
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What TOBI PODHALER contains
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Active ingredient
(main ingredient)
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Tobramycin
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Other ingredients
(inactive ingredients)
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Distearoylphosphatidylcholine
Calcium chloride dihydrate
Sulfuric acid (for pH adjustment)
The capsule shell contains:
Hypromellose (E464)
Potassium chloride (E508)
Carrageenan (E407)
Carnauba wax (E903)
Indigo carmine aluminium lake
Isopropyl alcohol
Propylene glycol
Purified water
Shellac
Titanium dioxide
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Potential allergens
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Soya bean products
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Each hard capsule contains tobramycin 28 mg inhalation powder.
Do not take this medicine if you are allergic to any of these ingredients.
What TOBI PODHALER looks like
TOBI PODHALER is Clear, colourless capsules, containing a white to almost white powder.
The capsules have "MYL TPH" in blue radial imprinted on one part of the capsule, and
the Mylan logo in blue radial imprinted on the other part of the capsule.
Each sealed foil pack contains a capsule card. The card contains a daily dose of 8
capsules (combined morning and evening doses).
A carton contains 224 capsules and 5 plastic podhaler devices (AUST R 182302).
The capsules must be administered specifically with a Podhaler® device provided in the same pack.
Who distributes TOBI PODHALER
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
TOBI® and Podhaler® are a Viatris company trade mark.
This leaflet was prepared in August 2024.
TOBI PODHALER_cmi\Aug24/00