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TYMBRINEB 300 MG/5 ML NEBULISER SOLUTION

Active substance(s): TOBRAMYCIN

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ZINC Ref:

EAS1278a LEA TOBRAMYCIN (TYMBRINEB) 300MG/5ML NEB SOL TUK
PE3306

Dim’s Changed?:
YES
Length:
500 mm
Width:
252 mm
Folded to:
63 x 63 mm
Foil Width:
N/A

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Version:

Colours Used:

Tymbrineb 300 mg/5 ml
Nebuliser Solution
tobramycin
Package leaflet:
Information for the patient

6

12 December 2017

CYAN

BLACK
PANTONE® GREEN C
Template

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

63mm

Tymbrineb Nebuliser Solution should be used with a clean, dry PARI LC
PLUS reusable nebuliser and a suitable compressor. Ask your doctor or
Read all of this leaflet carefully before physiotherpist for advice on which compressor to use. Your doctor or
you start using this medicine
physiotherapist can advise you on the proper use of your medicine and the
because it contains important
equipment you need. You may need different nebulisers for other inhaled
information for you.
medicines such as dornase alfa, which can be used to improve sputum
- Keep this leaflet. You may need to
clearance in CF.
read it again.
Before you start to use Tymbrineb Nebuliser Solution, make sure you have
- If you have any further questions,
the following pieces of equipment:
63mm
ask your doctor, pharmacist or
nurse.
• Tymbrineb ampoule
- This medicine has been prescribed for you only. Do not pass it on to
• PARI LC PLUS reusable nebuliser
others. It may harm them, even if their signs of illness are the same as
• Suitable compressor
yours.
• Tubing to connect the nebuliser and compressor
- If you get any side effects, talk to your doctor, pharmacist or nurse. This
• Clean paper or cloth towels
includes any possible side effects not listed in this leaflet. See section 4.
• Nose clips (if required)
What is in this leaflet

1. What Tymbrineb Nebuliser Solution is and what it is used for
2. What you need to know before you use Tymbrineb Nebuliser Solution
3. How to use Tymbrineb Nebuliser Solution
4. Possible side effects
5. How to store Tymbrineb Nebuliser Solution
6. Contents of the pack and other information

You should check that your nebuliser and compressor are working properly
according to the manufacturer’s instructions before you start to use your
medicine.
Preparing your medicine for inhalation

1 What Tymbrineb Nebuliser Solution is and what it is used for
Tymbrineb Nebuliser Solution contains the active substance tobramycin.
This is an aminoglycoside antibiotic.
Tymbrineb Nebuliser Solution is used in patients aged six years and older.
Tymbrineb Nebuliser Solution is used for treating chest infection in Cystic
Fibrosis (CF) caused by a common bacterium, Pseudomonas aeruginosa.
It kills the bacterium and helps improve your breathing. As tobramycin is
inhaled, rather than taken as a pill, more of the antibiotic gets into your
lungs.

1. Wash your hands thoroughly with soap and water.
2. Each foil pouch contains 4 ampoules. Cut or tear open the pouch,
remove an ampoule and put the foil pouch in the refrigerator.
2 pair of ampoules

2 What you need to know before you use Tymbrineb Nebuliser
Solution

Do not use Tymbrineb Nebuliser Solution
• if you are allergic to tobramycin or any of the other ingredients of this
medicine (listed in section 6) or to any other aminoglycoside antibiotic.
Warnings and precautions

3. Lay out the pieces of your PARI LC PLUS nebuliser on a clean, dry paper
or cloth towel. You should have the following pieces:
a. Nebuliser top
b. Nebuliser bottom
c.
Inspiratory valve cap
d. Mouthpiece with valve
e. Tubing

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 tobramycin or at any time during
tobramycin treatment;
- if you are coughing up blood, your doctor may ask you to stop using
tobramycin 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.
4.
Take special care with Tymbrineb Nebuliser Solution
Inhaled medicines including tobramycin can cause chest tightness. Your
doctor will supervise your first dose of Tymbrineb Nebuliser Solution and
check your lung function before and after dosing. Your doctor may ask you 5.
to use a bronchodilator (e.g. salbutamol), if you are not already doing so,
before taking Tymbrineb Nebuliser Solution.

3/4

a
d

c
b
e

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.
Connect one end of the tubing to the compressor air outlet. Make sure
that the tubing fits snugly and plug the compressor into the electrical
outlet.

Children
Do not give this medicine to children less than 6 years old because there is
not enough data in this population.
Other medicines and Tymbrineb Nebuliser Solution
Tell your doctor or pharmacist if you are taking, have recently taken any
other medicines, including medicines obtained without a prescription.
You should not use Tymbrineb Nebuliser Solution if you are taking any of
the following:
• Diuretics (water tablets) containing furosemide;
• Urea or mannitol, which are used in hospital to treat serious conditions;
• Drugs that may harm your kidneys or hearing could be made worse by
Tymbrineb Nebuliser Solution.

5

6. Open the ampoule by holding the bottom tab with one hand and
twisting off the top with your other hand. Be careful not to squeeze the
ampoule until you are ready to empty it into the nebuliser bottom.

You may be receiving injections of tobramycin or other aminoglycosides as
well as using inhaled tobramycin. Such injections, which may increase the
very low levels of aminoglycosides caused by inhaled tobramycin, are not
6
recommended when the following medicines are also being taken:
• Amphotericin B, cefalotin, ciclosporin, tacrolimus, polymixins
7. When you are ready, squeeze all of the contents of the ampoule into the
• Platinum compounds (e.g., carboplatin and cisplatin)
nebuliser bottom.
• Anticholinesterases (e.g. neostigmine and pyridostigmine), botulinum
toxin.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
7
The possible side effects of inhaling tobramycin in pregnant women are not
known. However, higher blood levels of tobramycin and similar medicines,
8. Replace the nebuliser top. Turn the top clockwise until it is securely
which can occur when they are given by injection, can harm an unborn
fastened to the nebuliser bottom.
baby (e.g., by causing deafness).

9. Attach the mouthpiece to the nebuliser outlet. Firmly push the
inspiratory valve cap in place on the nebuliser top. The inspiratory valve
It is unknown whether inhaled tobramycin can be detected in breast-milk at
cap must fit snugly (check with your PARI LC PLUS nebuliser leaflet).
the recommended dose.
10. Connect the free end of the tubing to the air intake on the bottom of the
Fertility
nebuliser, making sure you keep the nebuliser upright. Press the tubing
on the air intake firmly.
Possible effects on fertility are unlikely, but cannot be excluded.
Breast feeding

Driving and using machines
This medicine is not expected to affect your ability to drive and use
machines.

3 How to use Tymbrineb Nebuliser Solution
For inhalation use.
Always use this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
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.

ZINC Ref:

EAS1278a LEA TOBRAMYCIN (TYMBRINEB) 300MG/5ML NEB SOL TUK Dim’s Changed?:
YES
Length:
500 mm
Width:
252 mm
Folded to:
63 x 63 mm
Foil Width:
N/A

Colours Used:

Taking your medicine
1

1 Turn on the compressor.

Version:
CYAN

6

12 December 2017
BLACK
PANTONE® GREEN C
Template






Sleepiness
Hyperventilating
Sinusitis
General feeling of being unwell

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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.

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2 Make sure there is a steady mist coming from the mouthpiece. If there is
no mist, check that all the tubing connections and that the compressor is Reporting of side effects
working correctly.
2
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 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.
3 Sit or stand in an upright position so that you can breathe normally.
3/4

5 How to store Tymbrineb 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.

4 Place the mouthpiece between your teeth and on top of your tongue.
Breathe through your mouth (you may find that nose clips help). Try not Do not use this medicine if you notice any visible signs of deterioration
to block the airflow with your tongue.
(cloudiness or bits in the solution). Tobramycin solution may be slightly
yellow and some variability in colour may be observed; this does not
5 Continue until all of the Tymbrineb Nebuliser Solution is gone and there indicate loss of activity providing the solution has been stored as
is no longer any mist being produced.
recommended.

6 Please remember to clean and disinfect your nebuliser after treatment. Do not throw away any medicines via wastewater or household waste. Ask
You should never use a dirty or clogged nebuliser. You should not share your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
your nebuliser with other people.
It should take about 15 minutes to take all of the medicine. You may hear a
6 Contents of the pack and other information
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
What Tymbrineb Nebuliser Solution contains
save your medicine. When you are ready to restart your treatment, turn the • The active substance is tobramycin. Each 5 ml single dose ampoule
compressor on again.
contains 300 mg of tobramycin.
• The other ingredients are: sodium chloride, Water for injections, sulfuric
If you are taking several different treatments for CF, you should take them
acid (for pH-adjustment) and sodium hydroxide (for pH-adjustment).
in the following order:
What Tymbrineb Nebuliser Solution looks like and contents of the pack
• bronchodilator (e.g., salbutamol)
Tymbrineb Nebuliser Solution is a clear to slightly yellow solution.
• chest physiotherapy
Tymbrineb Nebuliser Solution is supplied in 5 ml, single dose ampoules.
• other inhaled medicines
• and then Tobramycin Nebuliser Solution.
4 ampoules are packed and sealed in a foil pouch.
Each carton comprises 14 (56 ampoules), 28 (112 ampoules) or 42 (168
If you are not sure, check the order with your doctor.
ampoules) foil pouches, which is enough to last one, two or three cycles of
treatment, respectively.
If you use more Tymbrineb Nebuliser Solution 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 you accidentally swallow Tymbrineb Nebuliser Solution, don’t worry, but
tell your doctor as soon as possible.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne, BN22 9AG, UK

If you forget to use Tymbrineb Nebuliser Solution

Manufacturer:
Ivax Pharmaceuticals UK,
Preston Brook,
You must not take two doses within six hours. Take the dose immediately
Runcorn,
if there are at least six hours to your next dose or miss out this dose if your Cheshire,
next dose is due in less than six hours.
WA7 3FA,
United Kingdom
If you stop using Tymbrineb Nebuliser Solution
This leaflet was last revised in 12/2017
You should not stop using Tymbrineb Nebuliser Solution until you have
completed the course of treatment or told to do so by your doctor.
PL 00289/1437
Do not take a double dose to make up for a forgotten dose.

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.
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)
• Swelling of the lymph glands

EAS1278a

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