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TOBRAMYCIN 300 MG/ 5 ML NEBULISER SOLUTION

Active substance(s): TOBRAMYCIN

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Package leaflet: Information for the patient

Tobramycin 300 mg/ 5 ml nebuliser solution
tobramycin
Read all of this leaflet carefully before you start using 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. See section 4.
What is in this leaflet
1. What Tobramycin is and what it is used for
2. What you need to know before you use Tobramycin
3. How to use Tobramycin
4. Possible side effects
5. How to store Tobramycin
6. Contents of the pack and other information

1. What Tobramycin is and what it is used for
Tobramycin contains an antibiotic medicine called tobramycin. It belongs to a class
of antibiotic medicines called aminoglycosides.

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, polymyxins (used to treat microbial
infections), tacrolimus (used to reduce the activity of immune system). These
medicines may harm your kidneys
- platinum compounds such as carboplatin and cisplatin (used to treat some forms
of cancer). These medicines may harm your kidneys or hearing
- anticholinesterases such as neostigmine and pyridostigmine (used to treat
muscle weakness), 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 this with your doctor
before you use Tobramycin.

Pregnancy and breast-feeding
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before using this medicine.
It is not known whether inhaling this medicine when you are pregnant causes side
effects. When given as an injection, tobramycin and other aminoglycoside
antibiotics can cause harm to an unborn child, such as deafness.

Tobramycin fights the infection caused by Pseudomonas bacteria in your lungs and
helps to improve your breathing.

Driving and using machines
Tobramycin should not affect your ability to drive and use machines.

When you inhale Tobramycin, the antibiotic can get directly into your lungs to fight
against the bacteria causing the infection. For the best results of this medicine, use
it as this leaflet instructs you.

3. How to use Tobramycin

Tobramycin kills the bacteria that cause infections in the lungs. The infection can be
controlled successfully if the problem is tackled early.

2. What you need to know before you use Tobramycin
Do NOT use Tobramycin
- if you are allergic to tobramycin, to any type of aminoglycoside antibiotic or to
any of the other ingredients of this medicine (listed in section 6).
If any of above applies to you, do not use 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 Tobramycin 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 worsens with time, for example symptoms related
to conditions such as myasthenia (muscle weakness) or Parkinson's disease.
If any of these apply to you, tell your doctor before you use Tobramycin.
Inhaling medicines can cause chest tightness and wheezing and this can happen
with Tobramycin. Your doctor will supervise your first dose of Tobramycin 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 using
Tobramycin.
If you are using Tobramycin, 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 are receiving tobramycin by injection, it can sometimes cause hearing loss,
dizziness and kidney damage, and can harm an unborn child.
Children and adolescents
Tobramycin can be used by children and adolescents aged 6 years and older.
Tobramycin should not be given to children less than 6 years old.
Older people
If you are aged 65 years and older, your doctor may perform additional tests to
decide if Tobramycin is right for you.
Other medicines and Tobramycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

3. Open the Tobramycin 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 chamber.

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 Tobramycin.
Please check this order with your doctor as well.

Breast-feeding
If you are breast-feeding your child, you should talk to your doctor before using this
medicine.

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.

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.

You should not mix or dilute Tobramycin with any other medicines in your
nebuliser handset.

Tobramycin is used in patients aged 6 years and older who have cystic fibrosis to
treat chest infections caused by a bacteria called Pseudomonas aeruginosa.

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 while very young.

Use of Tobramycin 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 by twisting the top anticlockwise
and then lifting it. Place the top on the towel and stand the nebuliser chamber
upright on the towel.

4. Replace the nebuliser top, put the mouthpiece and the inspiratory valve cap in
place on the nebuliser, and connect the compressor as indicated in your PARI LC
PLUS nebuliser leaflet.
5. Turn on the compressor. Check that there is 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.

Always use this medicine exactly as your doctor has told you. Check with your
doctor if you are not sure.
The recommended dose is two ampoules each day (one in the morning and one in
the evening) for 28 days.
- the recommended dose is the same for all persons aged 6 years and older
- inhale by mouth the full contents of one ampoule in the morning and one
ampoule in the evening using the nebuliser handset
- it is best to have an interval as close as possible to 12 hours between the doses,
but this interval must be at least 6 hours
- after you have used your medicine for 28 days, you then have a 28-day break,
during which you do not inhale any Tobramycin. You then start another course
after the break (as illustrated)
- it is important that you keep using the medicine twice each day during your
28 days on treatment and that you keep to the 28-day on, 28-day off cycle

On Tobramycin
Use Tobramycin twice a day,
every day for 28 days

Off Tobramycin
Do not use any Tobramycin
for the next 28 days

Repeat cycle
Continue using Tobramycin on this cyclical basis for as long as your doctor tells you.
If you have questions about how long to use Tobramycin, talk to your doctor or
pharmacist.
Instructions for use of Tobramycin
This part of the leaflet explains how to use, care and handle Tobramycin. Please
read carefully and follow these instructions.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
The equipment you need for inhaling Tobramycin
Tobramycin should be used with a clean and dry reusable nebuliser.
The LC PLUS nebuliser (manufactured by PARI GmbH) is suitable for use with
Tobramycin.
Your doctor or physiotherapist can advise you on the proper use of Tobramycin and
the equipment you need. You may need different nebulisers for your other inhaled
medicines for cystic fibrosis.
Preparing to inhale Tobramycin
- wash your hands thoroughly with soap and water
- each foil pouch contains 4 ampoules. Cut or tear open the pouch. Remove one
ampoule of Tobramycin from the aluminium pouch. Keep the rest of the
medicine refrigerated in the original carton
- lay out all the pieces of your nebuliser on a clean, dry paper or cloth towel
- make sure you have a suitable compressor and tubing to connect the nebuliser
to the compressor
- be careful to follow the appropriate instructions for use for your type of
nebuliser, you must read the leaflet provided 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.

You should NOT take the following medicines while you are using Tobramycin
- furosemide or ethacrynic acid, diuretics ('water tablets')
- other medicines which may affect kidney function such as urea or intravenous
mannitol
- other medicines which may harm your nervous system, kidneys or hearing.

8. Continue until all of the Tobramycin 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.
If you use more Tobramycin than you should
If you inhale too much Tobramycin you may get a very hoarse voice. Make sure you
tell your doctor as soon as possible. If Tobramycin is swallowed, tell your doctor as
soon as possible.
If you forget to use Tobramycin
If you forget to use Tobramycin and there are at least 6 hours to your next dose, use
your dose as soon as you can. Otherwise, wait for your next dose. Do not take a
double dose to make up for a forgotten dose.
If you stop using Tobramycin
Do not stop using Tobramycin unless your doctor tells you to do so, as your lung
infection may not be controlled sufficiently and may become worse.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Serious side effects
Stop using Tobramycin and tell your doctor immediately about any of the
following serious side effects:
- unusual difficulty in breathing with wheezing or coughing and chest tightness
- allergic reactions including hives and itching
Tell your doctor immediately about any of the following serious side effects:
- 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 using Tobramycin. This
may be due to a lack of effect. Tell your doctor straight away if this happens.
Other side effects
Tell your doctor as soon as possible about any of the following side effects:
Very common (may affect more than 1 in 10 users)
- runny or stuffy nose, sneezing
- voice alteration (hoarseness)
- discoloration of the substance you cough up (sputum)
- worsening of lung function test results

Folding
350--2 --87.5 mm
430--8 zigzag--48 mm

350 mm

Name of Product:

AWS TYPE

Country

Language

Location

PIL

EUUK - UNITED KINGDOM

ENGLISH

Halol -2 - UTL

Tobramycin 300 mg/ 5 ml nebuliser solution
Code

044BP2793A

Void artwork Code No:

CD-PDD-

Actual Size

350 x 430 mm

Reason:

REMARKS:

EUUK- UNITED KINGDOM
Size: 350x430 mm

No. of Colors : 1
Specification / Type of paper
Color codes:
Super Fine 41 GSM ITC Paper

Folding
350--2 --87.5 mm
430--8 zigzag--48 mm

BLACK

Artwork Prepared by :
Sun Pharmaceutical Industries Limited
Packaging Development Department [PDD]
SPIL - Vadodara

Prepared by

Checked by

Approved by

Approval History Attached

Approved by RA

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Patient info. Leaflet

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Common (may affect up to 1 in 10 users)
- generally feeling unwell
- muscle pain
- voice alteration with sore throat and difficulty swallowing (laryngitis)
Other side effects
- itching
- itchy rash
- rash
- loss of the voice
- disturbed sense of taste
- sore throat
Not known (frequence cannot be estimated from the available data)
- increased quantity of the substance you cough up (sputum)
- chest pain
- reduced appetite.
If you use Tobramycin 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 using Tobramycin, 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, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Tobramycin
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 label or the
pouch or carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2oC -8oC). If you don't have a refrigerator available (such as
when you are transporting your medicine) you can store the carton with the
medicines (pouches opened or unopened) below 25oC for up to 28 days. Do not
use Tobramycin ampoules which have been stored at room temperature for more
than 28 days.
Store your ampoules in the original package in order to protect from light. This
medicine is normally colourless to light yellow 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.
Do not use this medicine if you notice that it has gone cloudy, or if there are bits in
the solution.
Never store an opened ampoule. Once opened an ampoule should be used
immediately and any remaining product should be discarded.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other information
What Tobramycin contains
- The active substance is tobramycin. Each ampoule of 5 ml contains 300 mg
tobramycin, corresponding to 60 mg/ml.
- The other ingredients are: sodium chloride, water for injection, nitrogen (E941),
sulfuric acid (E513) (for pH adjustment) and/or sodium hydroxide (E524) (for pH
adjustment).
What Tobramycin looks like and contents of the pack
Tobramycin nebuliser solution is a clear, colourless to light yellow solution free from
visible particulate matter.
Tobramycin is provided in a ready-to-use ampoule. Ampoules are packed in foil
pouches, one foil pouch contains 4 ampoules which corresponds to 2 days of
treatment.
Tobramycin 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 marketed.
Marketing Authorisation Holder and manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Folding
350--2 --87.5 mm
430--8 zigzag--48 mm

044BP2793A

This leaflet was last revised in 01/2017

Suppliers LOGO / ID here

This medicinal product is authorised in the Member States of the EEA under
the following names
Germany:
Tobramycin SUN 300 mg Lösung für einen Vernebler
Denmark:
Tobramycin SUN 300 mg/ 5 ml inhalationsvæske til
nebulisator, opløsning
Spain:
Tobramicina SUN 300 mg/ 5 ml solución para inhalación por
nebulizador
France:
Tobramycine SUN 300 mg/ 5 ml solution pour inhalation par
nébuliseur
Hungary:
Tobramicin SUN 300 mg/ 5 ml oldat porlasztásra
Italy:
Tobramicina SUN 300 mg/ 5 ml soluzione per nebulizzatore
Netherlands:
Tobramycine SUN 300 mg/ 5 ml verneveloplossing
Poland:
Tobramycyna SUN 300 mg/ 5 ml roztwór do nebulizacji
Romania:
Tobramicină SUN 300 mg/ 5 ml soluţie pentru nebulizator
United Kingdom:
Tobramycin 300 mg/ 5 ml nebuliser solution

350 mm
EUUK- UNITED KINGDOM
Size: 350x430 mm

100

95

75

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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.

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