Skip to Content

TOBI 300MG/5ML NEBULISER SOLUTION

Active substance(s): TOBRAMYCIN

View full screen / Print PDF » Download PDF ⇩
Transcript
Dummy Code

This is one of the most damaging bacteria for people with cystic
fibrosis. If the infection is not properly controlled, it will continue
to damage your lungs causing further problems to your breathing.
Tobi kills the bacteria that cause infections in the lungs. The
infection can be controlled successfully if the problem is tackled
early.

Package leaflet: Information for the user

TOBI® 300 mg/5 ml
Nebuliser Solution
Tobramycin
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
What is in this leaflet :
1. What Tobi is and what it is used for
2. What you need to know before you use Tobi
3. How to use Tobi
4. Possible side effects
5. How to store Tobi
6. Contents of the pack and other information
1. What Tobi is and what it is used for
What is Tobi for?
Tobi contains a medicine called tobramycin. This is an
aminoglycoside antibiotic.
Tobi is used in patients aged six years and older who have cystic
fibrosis to treat chest infections caused by a bacteria called
Pseudomonas aeruginosa
Tobi fights the infection caused by Pseudomonas bacteria in your
lungs, and helps to improve your breathing.
When you inhale Tobi, the antibiotic can get directly into your
lungs to fight against the bacteria causing the infection. For the
best results of this medicine, take it as this leaflet instructs you.
What is Pseudomonas aeruginosa?
This is a very common bacteria that infects 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.

2. What you need to know before you use Tobi
Do not use Tobi:
• if you are allergic to tobramycin, any type of aminoglycoside
antibiotic, or any of the other ingredients of this medicine
(listed in Section 6).
If any of the above apply to you, do not take this medicine and
talk to your doctor.
If you think you may be allergic, ask your doctor for advice.
Warnings and precautions
Talk to your doctor before using Tobi if you have or if you have
ever had any of the following conditions:
• Hearing problems (including ringing in your ears and dizziness)
• Kidney problems
• Unusual difficulty in breathing with wheezing or coughing,
chest tightness
• Blood in your sputum (the substance you cough up)
• Muscle weakness that lasts or becomes worse in time, symptom
mostly related to condition such as myasthenia or Parkinson’s
disease
If any of these apply to you, tell your doctor before you take Tobi.
Inhaling medicines can cause chest tightness and wheezing and
this can happen with Tobi. Your doctor will supervise your first
dose of Tobi and check your lung function before and after
dosing. If you are not already doing so, your doctor may ask you to
use a bronchodilator, (e.g. salbutamol), before taking Tobi.
If you are taking Tobi, strains of Pseudomonas can become
resistant to the treatment over time. This can mean the medicine
may not work as well as it should over time. Talk to your doctor if
you are concerned about this.
If you have it by an injection, tobramycin can sometimes cause
hearing loss, dizziness and kidney damage, and can harm an
unborn child.
Children and adolescents
Tobi can be taken by children and adolescents aged 6 years and
older. Tobi should not be given to children less than 6 years old.

1373072_R92_p2_LFT.indd 1

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
Both
WO:
1373072
Comp. Description: Leaflet_TOBI SOLUTION_SOLI_300MG/5ML_R92
Comp. Number New: 1373072 R92
Comp. Number Old: N/A
Format/Dimension: 594 x 177 mm
Tech. Drawing No.: N/A

Production Site:
CTM:
Printing Colours:

Catalent UK
Stone, Christina
PANTONE 287 C

Technical Colours: Cutting
Dimensions

Minimum Font Size: 8.5pt
Font Type: Frutiger LT Pro
23/02/2016

Other medicines and Tobi
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
You should not take the following medicines while you are
taking Tobi:
• Furosemide or ethacrynic acid, diuretics (“water tablets”)
• Urea or intravenous mannitol
• Other medicines which may harm your nervous system, kidneys
or hearing.
The following medicines can increase the chances of harmful
effects occurring if they are given to you while you are receiving
injections of tobramycin:
• Amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins:
these medicines may harm your kidneys.
• Platinum compounds (such as carboplatin and cisplatin): these
medicines may harm your kidneys or hearing.
• Anticholinesterases, (such as neostigmine and pyridostigmine),
or botulinum toxin: these medicines may cause muscle weakness
to appear or become worse.
If you are taking one or more of the above medicines, discuss with
your doctor before you take Tobi.
You should not mix or dilute Tobi with any other medicine in your
nebuliser.

If you are breast feeding your child, you should talk to your doctor
before using your medicine.
Driving and using machines
Tobi should not affect your ability to drive and use machines.
3. How to use Tobi
Always use this medicine exactly as your doctor has told you. Check
with your doctor if you are not sure.
How much of this medicine you should take and how often you
should take it
• The recommended dose is the same for all persons aged 6 years
and older.
• Use two ampoules each day, for 28 days. Inhale the full contents
of one ampoule in the morning, and one in the evening. Ideally,
there should be a 12 hour gap between the doses.
• You must leave at least 6 hours between two Tobi inhalations.
• After taking your medicine for 28 days, you then have a 28 day
break, where you don’t inhale any Tobi, before starting another
course
• 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, 28-day off cycle.

If you are taking several different treatments for cystic fibrosis, you
should take them in the following order:
1. bronchodilator therapy, such as salbutamol
2. chest physiotherapy
3. other inhaled medicines
4. then Tobi.
Please check this order with your doctor as well.
Pregnancy and breast-feeding
If you want to become pregnant or are pregnant, you should talk
to your doctor about the possibility of this medicine causing any
harm to you or the unborn child.
It is not known whether inhaling this medicine when you are
pregnant causes side effects.
When they are given by an injection, tobramycin and other
aminoglycoside antibiotics can cause harm to an unborn child, such
as deafness.

If you take more Tobi than you should
If you inhale too much Tobi you may get a very hoarse voice. Make
sure you tell your doctor as soon as possible. If Tobi is swallowed,
tell your doctor as soon as possible.
If you forget to take Tobi
If you forget to take Tobi and there are at least 6 hours to your
next dose, take your dose as soon as you can. Otherwise, wait for
your next dose. Do not double the dose to make up for the
missed dose.

Instructions for use of Tobi
This part of the leaflet explains how to use, care and handle Tobi.
Please read carefully and follow these instructions.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

3. Open the Tobi ampoule by holding the
bottom tab with one hand and twisting
off the top with your other hand.
Squeeze all the contents of the
ampoule into the nebuliser bottom.

The equipment you need for inhaling Tobi
Tobi should be used with a clean and dry reusable nebuliser.
The LC PLUS nebuliser (manufactured by PARI GmbH) is suitable
for use with Tobi.
Your doctor or physiotherapist can advise you on the proper use of
Tobi and the equipment you need. You may need different
nebulisers for your other inhaled medicines for cystic fibrosis.
Preparing to inhale Tobi
• Wash your hands thoroughly with soap and water.
• Each Tobi foil pouch contains a tray with 14 ampoules. Cut or
tear open the pouch. Remove one Tobi ampoule from the tray
by gently pulling apart from any attached ampoules at the
bottom tabs. Put the tray back in the foil pouch and keep it in
the refrigerator.
• Lay out all the pieces of your nebuliser on a clean, dry paper or
cloth towel.
• Make sure you have the suitable compressor, and tubing to
connect the nebuliser and compressor.
• Be careful to follow the appropriate instructions for use for
your type of nebuliser, you must read the leaflet provided with
the nebuliser by the manufacturer. Check that your nebuliser
and compressor are working properly according to the
manufacturer’s instructions before you start to take your
medicine.
Use of Tobi with LC PLUS (PARI GmbH)
For more detailed instructions on the use and care of the
nebuliser, please read the leaflet provided with the PARI LC PLUS.
1. Remove the nebuliser top from the nebuliser bottom by
twisting the top anticlockwise and then lifting it. Place the top
on the towel and stand the nebuliser bottom upright on the
towel.
2. Connect one end of the tubing to the compressor air outlet.
Make sure that the tubing fits snugly. Plug the compressor into
the electrical outlet.

4. Replace the nebuliser top, put the mouthpiece and the
inspiratory valve cap in place on the nebuliser, then connect the
compressor as indicated in your PARI LC PLUS nebuliser leaflet.
5. Turn on the compressor. Check that there is a steady mist
coming from the mouthpiece. If there is no mist, check all
tubing connections and that the compressor is working
properly.
6. Sit or stand in an upright position so that
you can breathe normally.
7. Place the mouthpiece between your
teeth and on top of your tongue.
Breathe normally, but only through your
mouth (you may use a nose clip if your
doctor agrees). Try not to block the
airflow with your tongue.
8. Continue until all of the Tobi is gone and
there is no longer any mist being
produced. It should take about 15 minutes to take all the
treatment. You may hear a spluttering sound when the
nebuliser cup is empty.
9. Please remember to clean and disinfect your nebuliser after
treatment according to the manufacturer’s instructions. You
should never use a dirty or clogged nebuliser. You should not
share your nebuliser with other people.
If you are interrupted, or need to cough or rest during your
treatment, turn off the compressor to save your medicine.
Turn the compressor on again when you are ready to restart your
treatment. Leave out this dose if your next dose is due in less
than 6 hours.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
1373072 R92
not everybody gets them.

23/02/2016 08:26

The Maltings

Proof Number: 2
Braille:

Older people
If you are aged 65 years and older, your doctor may perfom
additional tests to decide if Tobi is right for you.

Benjamin Taylor

! PL E ASE TU R N OVE R P R I NT I N G O N !
609745_0

Some side effects can be serious
If you experience any of the following, stop taking Tobi and tell
your doctor straight away:
• Unusual difficulty in breathing with wheezing or coughing and
chest tightness
• Allergic reactions including hives and itching
If you experience any of the following, tell your doctor
straight away:
• Loss of hearing (ringing in the ears is a potential warning sign
of hearing loss), noises (such as hissing) in the ears
Your underlying lung disease may worsen while you are taking
Tobi. This may be due to a lack of efficacy. Tell your doctor straight
away if this happens.
Some side effects are very common
These side effects may affect more than 1 in 10 people.
• Runny or stuffy nose, sneezing
• Voice alteration (hoarseness)
• Discoloration of the substance you cough up (sputum)
• Worsening of lung function test results
If any of these affects you severely, tell your doctor.
Some side effects are common
These side effects may affect up to 1 in 10 people.
• Generally feeling unwell
• Muscle pain
• Voice alteration with sore throat and difficulty swallowing
(laryngitis)
If any of these affects you severely, tell your doctor.
Other side effects:
• Itching
• Itchy rash
• Rash
• Loss of the voice
• Disturbed sense of taste
• Sore throat
If any of these affects you severely, tell your doctor.
If you have had Tobi at the same time as or following repeated
courses of tobramycin or another aminoglycoside antibiotic by
injection, hearing loss has been reported as a side effect.
Injections of tobramycin or other aminoglycosides can cause
allergic reactions, hearing problems and kidney problems.
People with cystic fibrosis have many symptoms of the disease.
These may still happen while taking Tobi, but should not be any
more frequent or seem worse than before.

Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly (see details below). By
reporting side effects, you can help provide more information on
the safety of this medicine.
United Kingdom
Ireland

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail:
medsafety@hpra.ie

5. How to store Tobi
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated
on the box or pouch, or stamped on the ampoule.
• Do not use this medicine if you notice that it has gone cloudy,
or if there are bits in the solution.
• Store at 2-8°C (in a refrigerator). If you don’t have a refrigerator
available (such as when you are transporting your medicine)
you can store the foil pouches (opened or unopened) at room
temperature (not above 25°C) for up to 28 days.
• Do not use Tobi ampoules which have been stored at room
temperature for more than 28 days.
• Store your ampoules in the original packaging as this medicine
is sensitive to very strong light. This medicine is normally a
slightly yellow colour but this can vary and sometimes it can be
a darker yellow. This does not change the way this medicine
works provided that the storage instructions have been
followed.
Never store an opened ampoule. Once opened an ampoule should
be used immediately, and any remaining product should be
discarded.

What Tobi looks like and contents of the pack
Tobi is a clear, slightly yellow solution that comes in a ready-to-use
ampoule.
Ampoules are packed in foil pouches, one foil pouch
contains 14 ampoules which corresponds to 7 days of treatment.
Tobi is available in packs of 56, 112 or 168 ampoules, which is
enough to last one, two or three cycles of treatment, respectively.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Novartis Pharmaceuticals UK Limited
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
UK
The manufacturer is:
Novartis Pharma GmbH
Roonstrasse 25
90429
Nürnberg
Germany
For further information please call
01 260 1255 (Ireland only)
01276 698370 (UK only)
This leaflet was last revised in February 2016

6. Contents of the pack and other information
What Tobi contains
• The active ingredient is tobramycin. One ampoule
contains 300mg of tobramycin as a single dose.
• The other ingredients are sodium chloride, water for injections,
sodium hydroxide and sulphuric acid (for adjusting the level of
acidity).

1373072_R92_p2_LFT.indd 2

23/02/2016 08:26

The Maltings

Approval Box and Ready for Print Box only to be used
in case ArtBase is not used.

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
Both
WO:
1373072
Comp. Description: Leaflet_TOBI SOLUTION_SOLI_300MG/5ML_R92
Comp. Number New: 1373072 R92
Comp. Number Old: N/A
Format/Dimension: 594 x 177 mm
Tech. Drawing No.: N/A

Production Site:
CTM:
Printing Colours:

Checking against manuscript according to
SOP-0022667. To be signed by AwOps.

Catalent UK
Stone, Christina
PANTONE 287 C

Technical Colours: Cutting
Dimensions

Technical approval. To be signed by Manufacturing Site.

Minimum Font Size: 8.5pt
Font Type: Frutiger LT Pro
Proof Number: 2
Braille:

23/02/2016

1373072 R92

Benjamin Taylor

! PL E ASE TU R N OVE R P R I NT I N G O N !
609745_0

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide