Tobramycin Sun

Package leaflet: Information for the patient

Tobramycin SUN 300 mg/5 ml solution for nebuliser

tobramycin
Generic medicine
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Tobramycin SUN is and what it is used for

Tobramycin SUN contains a medicine called tobramycin, which belongs to a group of antibiotic medicines known as aminoglycosides.
Tobramycin SUN is used in patients aged 6 years and older with cystic fibrosis to treat lung infections caused by a bacterium called Pseudomonas aeruginosa.
Tobramycin SUN fights the infection in the lungs caused by Pseudomonas bacteria and helps improve breathing.
When you inhale Tobramycin SUN, the antibiotic goes directly into the lungs to fight the bacteria causing the infection. To get the best results from this medicine, take it exactly as indicated in this leaflet.

What is Pseudomonas aeruginosa?
It is a very common bacterium that infects almost all patients with cystic fibrosis at some point in their lives. Some patients become infected with this bacterium at an older age, while others contract it at a very young age.
This bacterium is one of the most harmful for patients with cystic fibrosis. If the infection is not properly controlled, it continues to damage the lungs, leading to further complications.
Tobramycin SUN kills the bacteria causing this lung infection. This infection can be effectively controlled, especially if the problem is addressed early.

2. What you need to know before using Tobramycin SUN

DO NOT use Tobramycin SUN

• 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 the above conditions apply to you, do not use this medicine and inform your doctor.
If you think you may be allergic, consult your doctor for advice.
Warnings and precautions
Talk to your doctor before using Tobramycin SUN if you have or have ever had any of the following conditions:

• hearing problems (including ringing in the ears and dizziness)
• kidney problems
• unusual difficulty breathing with wheezing or coughing, chest tightness
• blood in the sputum (the substance you cough up)
• persistent or worsening muscle weakness, for example symptoms that could be related to conditions such as myasthenia (muscle weakness) or Parkinson's disease
• if you or your family members have a mitochondrial mutation disorder (a condition caused by variants in the mitochondrial genome, the parts of cells that help produce energy) or hearing loss due to antibiotic use; certain mitochondrial mutations may increase the risk of hearing loss with this product. If any of the above conditions apply to you, inform your doctor before using Tobramycin SUN.

Inhaling medicines may cause chest tightness and wheezing, and this may occur with the use of Tobramycin SUN. Your doctor will monitor your first dose of Tobramycin SUN and will check your lung function before and after administration. If you are not already doing so, your doctor may prescribe a bronchodilator (e.g., salbutamol) to be used before taking Tobramycin SUN.
While taking Tobramycin SUN, Pseudomonas strains may over time become resistant to treatment. This could mean that the medicine may no longer work as effectively over time. Talk to your doctor if you are concerned that this may be happening.
Tobramycin may occasionally cause hearing loss, dizziness, and kidney damage, and may harm the fetus if administered by injection.
Children and adolescents
Tobramycin SUN may be used in children and adolescents aged 6 years and older.
Tobramycin SUN must not be administered to children under 6 years of age.
Elderly
If you are 65 years of age or older, your doctor may perform additional checks to determine whether Tobramycin SUN is an appropriate treatment for you.
Other medicines and Tobramycin SUN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must NOT take the following medicines while taking Tobramycin SUN:

• furosemide or etacrynic acid, diuretics (medicines to increase urine production)
• other medicines that may affect kidney function, such as intravenous urea or mannitol
• other medicines that may damage the nervous system, kidneys, or hearing.

The following medicines may increase the risk of harmful effects if administered while receiving injections containing tobramycin:

• amphotericin B, cephalothin, cyclosporine, polymyxins (used to treat microbial infections), tacrolimus (used to reduce immune system activity). These medicines may damage your kidneys
• platinum compounds such as carboplatin or cisplatin (used to treat certain types of cancer). These medicines may damage your kidneys or hearing
• anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin. These medicines may cause muscle weakness that may appear or worsen.

If you are taking one or more of the medicines listed above, discuss this with your doctor before taking Tobramycin SUN.
Do not mix or dilute Tobramycin SUN with any other medicine in your nebulizer.
If you are using several different treatments for cystic fibrosis, they should be taken in the following order:

1. bronchodilator therapy, such as salbutamol
2. chest physiotherapy
3. other inhaled medicines
4. Tobramycin SUN
   Confirm this order with your doctor.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
It is not known whether inhaling this medicine during pregnancy may cause adverse effects. When administered by injection, tobramycin and other aminoglycoside antibiotics may cause harm to the fetus, such as deafness.
Breastfeeding
If you are breastfeeding your baby with breast milk, you must speak with your doctor before using this medicine.
Driving and using machines
Tobramycin SUN does not affect the ability to drive or operate machinery.

3. How to use Tobramycin SUN

Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor.
The recommended dose is two vials per day (one in the morning and one in the evening) for 28 days.

• the recommended dose is the same for all patients aged 6 years and older
• inhale the entire contents of one vial in the morning and one vial in the evening via the mouth using a nebulizer
• ideally, there should be an interval as close as possible to 12 hours between the two doses, but in any case at least 6 hours
• after taking the medicine for 28 days, you must stop for 28 days, during which you should not inhale Tobramycin SUN. After this break, you must start another treatment cycle (as illustrated)
• it is important to continue taking the medicine twice daily for the full 28-day treatment period and to follow the cycle of 28 days on treatment and 28 days off treatment.

Yes Tobramycin SUN No Tobramycin SUN
Take Tobramycin SUN twice daily Do not take Tobramycin SUN
every day for 28 days for the next 28 days
Repeat the cycle
Continue using Tobramycin SUN on this cyclic basis for the duration prescribed by your doctor. If you
have questions about how long to continue treatment with Tobramycin SUN, consult your doctor or pharmacist.
Instructions for using Tobramycin SUN
This section of the leaflet explains how to use, care for, and handle Tobramycin SUN. Please read
carefully and follow the instructions below.
If you have further questions about how to use this medicine, ask your doctor or pharmacist.
Accessories for inhalation of Tobramycin SUN
Tobramycin SUN must be used with a clean and dry reusable nebulizer.
For use with Tobramycin SUN, the LC PLUS nebulizer (manufactured by PARI GmbH) is available.
Your doctor or physiotherapist can instruct you on the preparation of Tobramycin SUN and the necessary
accessories. Different nebulizers may be required for other inhaled medicines used in cystic fibrosis.
Preparation for inhalation of Tobramycin SUN

• wash your hands thoroughly with soap and water.
• each aluminum pouch contains 4 vials. Cut or tear open the pouch. Remove one vial of Tobramycin SUN from the aluminum pouch. Store the remaining medicine in the refrigerator in the original packaging.
• place the parts of the nebulizer on a clean, dry paper or cloth towel
• ensure you have the compressor and the correct tubing to connect the compressor to the nebulizer
• carefully follow the appropriate instructions for use of the nebulizer; read the instruction leaflet provided with the nebulizer by the manufacturer. Check that the nebulizer and compressor are working correctly according to the manufacturer's instructions before starting treatment.

Using Tobramycin SUN with LC PLUS (PARI GmbH)
For more detailed instructions on the use and maintenance of the nebulizer, please read the instruction leaflet provided with the PARI LC PLUS.

1. remove the top part of the nebulizer from the bottom by rotating the top part counterclockwise, then lifting it off. Place the top part on the towel and position the bottom part upright on the towel
2. connect one end of the tubing to the air outlet of the compressor. Ensure the tubing is securely attached. Plug the compressor into the electrical outlet
3. open the Tobramycin SUN vial by holding the lower tab with one hand and twisting the top part with the other. Squeeze all the contents of the vial into the bottom part of the nebulizer

4. reattach the top part of the nebulizer, place the mouthpiece and inspiratory valve cap onto the nebulizer, and connect the compressor as indicated in the instruction leaflet provided with the PARI LC PLUS nebulizer
5. turn on the compressor. Check that a constant mist is coming from the mouthpiece. If not, check all tubing connections and ensure the compressor is functioning properly
6. sit or stand upright so you can breathe normally
7. place the mouthpiece between your teeth and above the tongue. Breathe normally, but only through your mouth (you may need to use nasal clips if your doctor advises). Try not to block the airflow with your tongue

8. continue until all the Tobramycin SUN has been inhaled and no more mist is produced. This should take approximately 15 minutes. You may hear a sputtering sound when the nebulizer cup is empty
9. remember to clean and disinfect the nebulizer after treatment according to the manufacturer's instructions. Never use a dirty or clogged nebulizer. Never share your nebulizer with others.

If your treatment is interrupted, you need to cough, or you need a rest during treatment,
turn off the compressor to preserve the medicine.
Turn the compressor back on when you are ready to continue treatment. Discard any remaining
solution if the next dose is due within less than 6 hours.
If you use more Tobramycin SUN than you should
If you inhale too much Tobramycin SUN, your voice may become very hoarse. Consult your doctor as
soon as possible. If you accidentally swallow Tobramycin SUN, consult your doctor as soon as possible.
If you forget to use Tobramycin SUN
If you forget to take Tobramycin SUN and there are at least 6 hours before the next dose, take it as
soon as possible. Otherwise, wait for your next scheduled dose. Do not take a double dose to make up
for a missed dose.
If you stop using Tobramycin SUN
Do not stop using Tobramycin SUN unless your doctor tells you to, as your lung infection may not be
adequately controlled and could worsen.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
If you experience any of the following side effects, stop taking Tobramycin SUN and inform your doctor immediately:

• unusual shortness of breath with wheezing or cough and chest tightness
• allergic reactions including hives and itching

If you experience any of the following serious side effects, inform your doctor immediately:

• hearing loss (ringing in the ears may be an early sign of hearing loss), noises (such as ringing) in the ears

Your underlying lung disease may worsen while you are taking Tobramycin SUN. This may be due to lack of effectiveness. Inform your doctor immediately if this occurs.

Other side effects
Inform your doctor as soon as possible if you experience any of the following side effects:

Very common (may affect more than 1 in 10 people)

• runny or stuffy nose, sneezing
• voice changes (hoarseness)
• change in the colour of the substance you cough up (sputum)
• worsening of lung function test results

Common (may affect up to 1 in 10 people)

• general feeling of being unwell
• muscle pain
• voice changes with sore throat and difficulty swallowing (laryngitis)

Other side effects

• itching
• itchy skin rash
• skin rash
• loss of voice
• change in taste sensation
• sore throat

Not known (frequency cannot be estimated from the available data)

• increased amount of substance coughed up (sputum)
• chest pain
• decreased appetite

If you are taking Tobramycin SUN at the same time as or following repeated courses of tobramycin or another aminoglycoside antibiotic by injection, be aware that 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 various symptoms related to this disease. These may still occur during treatment with Tobramycin SUN, but should not become more frequent or worse than before.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tobramycin SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, pouch, or carton after 'Exp'. The expiry date refers to the last day of that month.
Store in a refrigerator (2 - 8 °C). If a refrigerator is not available (for example, when transporting the medicine), the product may be stored in the pouch (opened or unopened) at room temperature not exceeding 25 °C for up to 28 days. Do not use vials of Tobramycin SUN that have been stored at room temperature for more than 28 days.
Keep the vials in the original packaging to protect the medicine from light. This medicine is normally colourless or slightly yellow, but this may vary and sometimes it may appear a darker yellow. This does not affect the medicinal action of the product provided that storage conditions have been respected.
Do not use this medicine if you notice that it has become cloudy or if you see particles in the solution.
Never store an opened vial. Once the vial has been opened, it must be used immediately and any remaining product must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Tobramycin SUN contains

• The active substance is tobramycin. Each 5 ml vial contains 300 mg of tobramycin, corresponding to 60 mg/ml.
• The other components are: sodium chloride, water for injections, nitrogen (E941), sulfuric acid (E513) (for pH adjustment) and/or sodium hydroxide (E524) (for pH adjustment).

Description of the appearance of Tobramycin SUN and package contents
Tobramycin SUN solution for nebuliser is a clear, particle-free solution, colourless to slightly yellow.
Tobramycin SUN is supplied as ready-to-use vials. The vials are packed in aluminium pouches, each pouch containing 4 vials, corresponding to 2 days of treatment.
Tobramycin SUN is available in packs of 56, 112 or 168 vials, sufficient for one, two or three treatment cycles, respectively.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Legal Representative in Italy:
Sun Pharma Italia Srl
Viale Giulio Richard, 1
20143 Milano
Italy

Manufacturer
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) 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
Italy: Tobramicina SUN 300 mg/5 ml soluzione per nebulizzatore
The Netherlands: Tobramycine SUN 300 mg/5 ml verneveloplossing
Poland: Tobramycyna SUN 300 mg/5 ml roztwór do nebulizacji
Romania: Tobramicinã SUN 300 mg soluţie pentru nebulizator
United Kingdom (Northern Ireland): Tobramycin 300 mg/5 ml nebuliser solution