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TYMBRINEB 300 MG/5 ML NEBULISER SOLUTION

Active substance(s): TOBRAMYCIN / TOBRAMYCIN

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PE3455

Tymbrineb 300 mg/5 ml
Nebuliser Solution
tobramycin

Package leaflet:
Information for the patient

Other medicines and Tymbrineb
Nebuliser Solution

Preparing your medicine for inhalation

1.
Tell your doctor or pharmacist if you are
taking, have recently taken any other
medicines, including medicines
obtained without a prescription.
2.

Wash your
hands
thoroughly with
soap and water.
Each foil pouch
contains 4
You should not use Tymbrineb
ampoules. Cut
Nebuliser Solution if you are taking any
or tear open the
of the following:
pouch, remove
• Diuretics (water tablets) containing
an ampoule and
furosemide;
put the foil
• Urea or mannitol, which are used in
pouch in the
hospital to treat serious conditions;
refrigerator.
• Drugs that may harm your kidneys or 3. Lay out the
hearing could be made worse by
pieces of your
Tymbrineb Nebuliser Solution.
PARI LC PLUS
nebuliser on a
You may be receiving injections of
clean, dry paper
Tymbrineb or other aminoglycosides as
or cloth towel.
well as using inhaled tobramycin. Such
You should
injections, which may increase the very
have the
low levels of aminoglycosides caused
following
by inhaled tobramycin, are not
pieces:
recommended when the following
a. Nebuliser top
medicines are also being taken:
b. Nebuliser
• Amphotericin B, cefalotin,
bottom
ciclosporin, tacrolimus, polymixins
c. Inspiratory
• Platinum compounds (e.g.,
valve cap
carboplatin and cisplatin)
d. Mouthpiece
• Anticholinesterases (e.g.,
with valve
neostigmine and pyridostigmine),
e. Tubing.
botulinum toxin.

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, pharmacist or nurse.
- 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 you
doctor, pharmacist or nurse. This
includes any possible side effects not Pregnancy, breast-feeding and fertility
listed in this leaflet. See section 4.
If you are pregnant or breast-feeding,
What is in this leaflet
think you may be pregnant or are
1. What Tymbrineb Nebuliser Solution planning to have a baby, ask your
doctor or pharmacist for advice before
is and what it is used for
taking this medicine.
2. What you need to know before you

1

2 pair of ampoules

3/4
a
d

c

b
e

4. 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.

5. Connect one end of the tubing to the
compressor air
3.
outlet. Make
The possible side effects of inhaling
sure that the
Tymbrineb in pregnant women are not
4.
tubing fits
known.
However,
higher
blood
levels
of
5.
snugly and plug
Tymbrineb and similar medicines,
the compressor
which
can
occur
when
they
are
given
6.
into the
by injection, can harm an unborn baby
5
electrical outlet.
(e.g., by causing deafness).
Tymbrineb Nebuliser
6. Open the
1 What
Solution is and what it is used Breast feeding
ampoule by
for
holding the
It is unknown whether inhaled
bottom tab with
Tymbrineb can be detected in
Tymbrineb Nebuliser Solution contains
one hand and
breast-milk at the recommended dose.
the active substance tobramycin. This is
6
twisting off the
an aminoglycoside antibiotic.
Fertility
top with your
other hand. Be careful not to
Tymbrineb Nebuliser Solution is used in Possible effects on fertility are unlikely,
squeeze the ampoule until you are
patients aged six years and older.
but cannot be excluded.
ready to empty it into the nebuliser
Tymbrineb Nebuliser Solution is used
Driving and using machines
bottom.
for treating chest infection in Cystic
This medicine is not expected to affect 7. When you are ready, squeeze all of
Fibrosis (CF) caused by a common
the contents of the
bacterium, Pseudomonas aeruginosa.It your ability to drive and use machines.
ampoule into the
kills the bacterium and helps improve
to use Tymbrineb
3 How
nebuliser bottom.
your breathing. As Tymbrineb is
Nebuliser Solution
inhaled, rather than taken as a pill,
8. Replace the
more of the antibiotic gets into your
For inhalation use.
nebuliser top. Turn
lungs.
the top clockwise
Always use this medicine exactly as
it is securely
your doctor or pharmacist has told you.
What
you
need
to
know
before
2 you use Tymbrineb Nebuliser Check with your doctor or pharmacist if until
fastened to the
nebuliser bottom.
you are not sure.
Solution
use Tymbrineb Nebuliser Solution
How to use Tymbrineb Nebuliser
Solution
Possible side effects
How to store Tymbrineb Nebuliser
Solution
Contents of the pack and other
information

Do not use Tymbrineb Nebuliser
Solution
• if you are allergic to Tymbrineb or
any of the other ingredients of this
medicine (listed in section 6) or to
any other aminoglycoside antibiotic.
Warnings and precautions
Talk to your doctor or pharmacist
before using Tymbrineb Nebuliser
Solution if any of the following apply to
you:
- if you have hearing problems, if you
have experienced ringing in your
ears, or if you have experienced
dizziness, your doctor may test your
hearing and balance before starting
Tymbrineb or at any time during
Tymbrineb treatment;
- if you are coughing up blood, your
doctor may ask you to stop using
Tymbrineb until there is little or no
blood in your sputum;
- if you have had kidney problems,
your doctor may check that your
kidneys are working properly;
- if you have suffered from muscle
weakness – symptoms mostly related
to disorders such as myasthenia or
Parkinson’s disease;
- if you are resistant to antibiotics, you
should speak to your doctor.

Pregnancy

The recommended dose is two
ampoules per day for 28 days. The
usual dose is the same for all persons
aged 6 years and older. Inhale the
contents of one ampoule in the
morning and one in the evening. There
should be a 12-hour gap between the
doses.

9. Attach the
mouthpiece to the
7
nebuliser outlet.
Firmly push the
inspiratory valve cap in place on the
nebuliser top. The inspiratory valve
cap must fit snugly (check with your
PARI LC PLUS nebuliser leaflet).

You then have 28 days without taking
your medicine before starting another
28-day treatment course again.

10. Connect the free end of the tubing
to the air intake on the bottom of the
nebuliser, making sure you keep the
nebuliser upright. Press the tubing
on the air intake firmly.

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.

Taking your medicine

1 Turn on the compressor.
1
Tymbrineb Nebuliser Solution should
2 Make sure there
be used with a clean, dry PARI LC PLUS
is a steady mist
reusable nebuliser and a suitable
coming from
compressor. Ask your doctor or
the
physiotherpist for advice on which
mouthpiece. If
compressor to use. Your doctor or
there is no mist,
physiotherapist can advise you on the
check that all
proper use of your medicine and the
the tubing
2
equipment you need. You may need
connections
different nebulisers for other inhaled
and that the
medicines such as dornase alfa, which
compressor is
can be used to improve sputum
working
clearance in CF.
correctly.
Before you start to use Tymbrineb
3 Sit or stand in
Nebuliser Solution, make sure you have
an upright
the following pieces of equipment:
3/4
position so that
Take special care with Tymbrineb
• Tymbrineb ampoule
you can breathe
Nebuliser Solution
• PARI LC PLUS reusable nebuliser
normally.
Inhaled medicines including Tymbrineb • Suitable compressor
• Tubing to connect the nebuliser and 4 Place the
can cause chest tightness. Your doctor
compressor
mouthpiece
will supervise your first dose of
• Clean paper or cloth towels
between your
Tymbrineb Nebuliser Solution and
• Nose clips (if required)
teeth and on
check your lung function before and
top of your
after dosing. Your doctor may ask you
You should check that your nebuliser
tongue. Breathe
to use a bronchodilator (e.g.
and compressor are working properly
through your mouth (you may find
salbutamol), if you are not already
according to the manufacturer’s
that nose clips help). Try not to block
doing so, before taking Tymbrineb
instructions before you start to use your
the airflow with your tongue.
Nebuliser Solution.
medicine.
5 Continue until all of the Tymbrineb
Children
Nebuliser Solution is gone and there
Do not give this medicine to children
is no longer any mist being
less than 6 years old because there is
produced.
not enough data in this population.

6 Please remember to clean and
disinfect your nebuliser after
treatment. You should never use a
dirty or clogged nebuliser. You
should not share your nebuliser with
other people.
It should take about 15 minutes to take
all of the medicine. You may hear a
spluttering sound when the nebuliser
cup is empty. If you are interrupted or
need to cough or rest during the
treatment, turn off the compressor to
save your medicine. When you are
ready to restart your treamtent, turn the
compressor on again.







Swelling of the lymph glands
Sleepiness
Hyperventilating
Sinusitis
General feeling of being unwell

People with cystic fibrosis experience
many symptoms of the disease. These
may still occur while taking Tymbrineb
Nebuliser Solution but should not be
any more frequent or seem worse than
before. Patients have commonly
reported symptoms such as sputum
discolouration, chest infection, muscle
pain, nasal polyps and ear infections.

Reporting of side effects
If you are taking several different
treatments for CF, you should take them If you get any side effects, talk to your
doctor or pharmacist. This includes any
in the following order:
possible side effects not listed in this
leaflet. You can also report side effects
• bronchodilator (e.g., salbutamol)
directly via the Yellow Card Scheme at:
• chest physiotherapy
www.mhra.gov.uk/yellowcard.
• other inhaled medicines
By reporting side effects you can help
• and then Tymbrineb Nebuliser
provide more information on the safety
Solution.
of this medicine.
If you are not sure, check the order with
your doctor.
How to store Tymbrineb
If you use more Tymbrineb Nebuliser
Solution than you should
If you inhale too much Tymbrineb you
may get a very hoarse voice. Make sure
you tell your doctor as soon as
possible.
If you accidentally swallow Tymbrineb
Nebuliser Solution, don’t worry, but tell
your doctor as soon as possible.
If you forget to use Tymbrineb
Nebuliser Solution
Do not take a double dose to make up
for a forgotten dose.
You must not take two doses within six
hours. Take the dose immediately if
there are at least six hours to your next
dose or miss out this dose if your next
dose is due in less than six hours.
If you stop using Tymbrineb Nebuliser
Solution
You should not stop using Tymbrineb
Nebuliser Solution until you have
completed the course of treatment or
told to do so by your doctor.

5

Nebuliser Solution

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 outer
packaging, pouch and ampoule after
EXP. The expiry date refers to the last
day of that month.
Store in a refrigerator (2 – 8°C). Do not
freeze. You can store the foil pouches
(opened or unopened) at room
temperature (do not store above 25°C)
for up to 28 days. Store in the original
package in order to protect from light.
Never store an opened ampoule. Once
opened the ampoule should be used
immediately.
Do not use this medicine if you notice
any visible signs of deterioration
(cloudiness or bits in the solution).
Tymbrineb solution may be slightly
yellow and some variability in colour
may be observed; this does not indicate
loss of activity providing the solution
has been stored as recommended.

Do not throw away any medicines via
If you have any further questions on the wastewater or household waste. Ask
use of this medicine, ask your doctor or your pharmacist how to throw away
pharmacist.
medicines you no longer use. These
measures will help protect the
4 Possible side effects
environment.
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
Some side effects can be serious
• Chest tightness with difficulty
breathing (rare)
• Allergic and hypersensitivity
reactions including hives and itching
(very rare)
If any of these serious side effects
happen to you, stop taking Tymbrineb
Nebuliser Solution and tell your doctor
immediately.
The following side effects have been
reported at the approximate
frequencies shown:
Uncommon (may affect up to 1 in 100
people):
• Voice alteration (hoarseness)
• Increased cough
• Shortness of breath
• Sore throat
Rare (may affect up to 1 in 1,000
people):
• Chest pain
• General pain
• Laryngitis (voice alteration with sore
throat and difficulty swallowing)
• Ringing in the ears
• Mouth ulceration
• Rash
• Weakness
• Fever
• Headache
• Feeling sick (nausea)
• Being sick (vomiting)
• Loss of appetite
• Dizziness
• Increased sputum quantity
• Coughing up blood
• Loss of voice
• Nose bleeds
• Runny nose
• Taste disturbances
• Asthma
• Back pain
• Patients who have received
Tymbrineb Nebuliser Solution at the
same time as, or following repeated
doses of injected tobramycin or
related drugs, may develop hearing
loss.
Very rare (may affect up to 1 in 10,000
people):
• Abdominal pain
• Ear pain
• Diarrhoea
• Fungal infections (e.g., thrush)

6

Contents of the pack and other
information

What Tymbrineb Nebuliser Solution
contains
• The active substance is tobramycin.
Each 5 ml single dose ampoule
contains 300 mg of tobramycin..
• The other ingredients are: sodium
chloride, Water for injections, sulfuric
acid (for pH-adjustment) and sodium
hydroxide (for pH-adjustment).
What Tymbrineb Nebuliser Solution
looks like and contents of the pack
Tymbrineb Nebuliser Solution is a clear
to slightly yellow solution.
Tymbrineb Nebuliser Solution is
supplied in 5 ml, single dose ampoules.
4 ampoules are packed and sealed in a
foil pouch.
Each carton comprises 14 (56
ampoules), 28 (112 ampoules) or 42
(168 ampoules) foil pouches, 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
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne,
BN22 9AG, UK
Manufacturer:
Ivax Pharmaceuticals UK,
Preston Brook,
Runcorn,
Cheshire,
WA7 3FA,
United Kingdom
This leaflet was last revised in 01/2017
PL 00289/1437

26117-K

Expand Transcript

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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