Tobramycin 300 mg/ 5 ml nebuliser solution

• 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.

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

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.

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.

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

• 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.

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 you or your family members have a mitochondrial mutation disease (condition caused by variants in the genome of mitochondria, the parts of your cells which help make energy) or loss of hearing due to antibiotic medicines; certain mitochondrial mutations may increase your risk of hearing loss with this product.

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.

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.

If you are aged 65 years and older, your doctor may perform additional tests to decide if Tobramycin is right for you.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

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.

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

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.

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.

Breast-feeding

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

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

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.

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.

• 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.

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

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

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

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

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 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 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.

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.

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.

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

Common (may affect up to 1 in 10 users)

• generally feeling unwell
• muscle pain
• voice alteration with sore throat and difficulty swallowing (laryngitis)

• 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.

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.

• 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).

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.