TOBRAMICIN SUN 300 MG/5 ML SOLUTION FOR NEBULIZER INHALATION

2. What you need to know before you use Tobramycin SUN

Do not use Tobramycin SUN:

• if you are allergic to tobramycin, to any aminoglycoside antibiotic, or to any of the other ingredients of this medicine (listed in section 6).

If any of the above cases apply to you, do not take this medicine and consult your doctor.

Warnings and precautions

Consult your doctor before starting to use Tobramycin SUN if you suffer from or have ever suffered from 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 your sputum (the matter you cough up)
• muscle weakness that lasts or worsens over time, such as symptoms related to myasthenia (muscle weakness) or Parkinson's disease.
• if you or your family members suffer from a mitochondrial mutation disease (a disorder caused by variants in the mitochondrial genome, the parts of your cells that help produce energy) or hearing loss due to taking antibiotic medicines; some mitochondrial mutations may increase the risk of hearing loss when taking this medicine.

If any of these cases apply to you, inform your doctor before using Tobramycin SUN.

Inhaling medicines can cause chest tightness and wheezing, and this can occur with Tobramycin SUN. Your doctor will supervise your first dose of Tobramycin SUN and check your lung function before and after the dose. If you are not doing so, your doctor may have you use a bronchodilator (e.g., salbutamol) before using Tobramycin SUN.

If you are using Tobramycin SUN, Pseudomonasstrains may become resistant to treatment over time. This means that over time, the medicine may not work as well as it should. Consult your doctor if you are concerned about this.

If tobramycin is administered by injection, it can occasionally cause hearing loss, dizziness, and kidney damage, and may harm the fetus.

Children and adolescents

Tobramycin SUN can be administered to children and adolescents from 6 years of age. Tobramycin SUN should 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 tests to decide if Tobramycin SUN is a suitable treatment for you.

Other medicines and Tobramycin SUN

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

DO NOTtake the following medicines while using Tobramycin SUN:

• furosemide or ethacrynic acid, diuretics (medicines against fluid retention)
• other medicines that may affect kidney function, such as intravenous urea or mannitol
• other medicines that can damage your nervous system, kidneys, or ears.

The following medicines may increase the risk of harmful effects if administered while you are receiving injectionsof tobramycin:

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

If you are taking one or more of the above medicines, discuss this with your doctor before using Tobramycin SUN.

Do not mix or dilute Tobramycin SUN with any other medicine in your nebulizer.

If you are taking several different treatments for cystic fibrosis, you should take them in the following order:

1. bronchodilator treatment, such as salbutamol
2. chest physiotherapy
3. other medicines for inhalation
4. Tobramycin SUN last

Also, check this order with your doctor.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

It is not known if inhaling this medicine during pregnancy causes adverse effects. When administered by injection, tobramycin and other aminoglycoside antibiotics can cause harm to the fetus, such as deafness.

Breastfeeding

If you are breastfeeding, ask your doctor for advice before using any medicine.

Driving and using machines

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

3. How to use Tobramycin SUN

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose is twoampoules per day (one in the morning and one in the evening) for 28 days.

• the recommended dose is the same for all individuals from 6 years of age.
• inhale by mouth the complete contents of one ampoule in the morning and one in the evening using the nebulizer
• it is best if the interval between doses is as close as possible to 12 hours, but this interval must be at least 6 hours
• after taking your medicine for 28 days, there will be a pause of 28 days during which you should not inhale any dose of Tobramycin SUN. Then, you will start another cycle after the pause (as illustrated)
• it is important that you maintain the use of the product twice a day during your 28-day treatment period and follow the cycles of 28 days of treatment, 28 days of rest

Repeat the cycle

Continue using Tobramycin SUN with this cyclical pattern for the time indicated by your doctor. If you have any doubts about the duration of treatment with Tobramycin SUN, consult your doctor or pharmacist.

Instructions for use of Tobramycin SUN

This part of the leaflet explains how to use, care for, and handle Tobramycin SUN. Read and follow these instructions carefully.

If you have any additional questions about the use of this medicine, consult your doctor or pharmacist.

The equipment you need to inhale Tobramycin SUN

Tobramycin SUN must be used with a reusable, clean, and dry nebulizer.

The LC PLUS nebulizer (manufactured by PARI GmbH) is suitable for use with Tobramycin SUN.

Your doctor or physiotherapist may advise you on the correct use of Tobramycin SUN and the equipment you need. You may need different nebulizers for your other inhaled medicines for cystic fibrosis.

Preparing Tobramycin SUN for inhalation

• Wash your hands carefully with water and soap
• Each aluminum bag contains 4 ampoules. Cut or tear the bag. Remove one Tobramycin SUN ampoule from the aluminum bag. Keep the remaining ampoules refrigerated in the original packaging
• Lay out the parts of your nebulizer on a clean and dry paper or cloth towel
• Make sure you have the compressor and tube to connect the nebulizer to the compressor
• Follow the instructions for use of your nebulizer model carefully, you must read the instruction manual that the manufacturer provides with the nebulizer. Check that your nebulizer and compressor are working properly according to the manufacturer's instructions before starting to use your medicine.

Using Tobramycin SUN with LC PLUS (PARI GmbH)

If you want to obtain more detailed instructions on the use and care of the nebulizer, consult the leaflet that comes with the PARI LC PLUS.

1. Remove the top part of the nebulizer by turning it counterclockwise and lifting it. Place the top part on the towel and put the nebulizer cartridge upright on the towel.

1. Connect one end of the tube to the air outlet of the compressor. Make sure the tube fits perfectly. Connect one end of the tube to the air outlet of the compressor

1. Open the Tobramycin SUN ampoule by holding the lower tab with one hand and separating the upper tip with the other hand, twisting it. Empty the entire contents of the ampoule into the nebulizer cartridge

1. Put the top part of the nebulizer back, fix the mouthpiece, and place the inspiratory valve cap on the nebulizer. Then connect the compressor as indicated in the instruction manual of your PARI LC PLUS nebulizer

1. Turn on the compressor. Check that there is a constant mist coming out of the mouthpiece. If there is no mist, check all the tube connections and that the compressor is working properly

1. Sit or stand in a way that allows you to breathe normally

1. Place the mouthpiece between your teeth and on the tip of your tongue. Breathe normally, but only through your mouth (if your doctor considers it appropriate, you can use a nose clip). Try not to block the airflow with your tongue

1. Continue until all of the Tobramycin SUN has been used and no more mist is produced. The complete inhalation should take around 15 minutes. You may hear a gurgling sound when the nebulizer container is empty.

1. Remember to clean and disinfect your nebulizer after treatment according to the manufacturer's instructions. Never use a dirty or clogged nebulizer. Do not share your nebulizer with others.

If you are interrupted or need to cough or rest during administration, turn off the compressor to avoid wasting the medicine.

Turn the compressor back on when you are ready to restart the treatment. Omit this dose if your next dose is due in 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. Make sure to inform your doctor as soon as possible. If you swallow Tobramycin SUN, inform your doctor as soon as possible.

If you forget to use Tobramycin SUN

If you forget to use Tobramycin SUN and it is at least 6 hours until your next dose, take a dose as soon as possible. Otherwise, wait for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Tobramycin SUN

Do not stop using Tobramycin SUN unless your doctor tells you to, as the lung infection may not be properly controlled and may worsen.

If you have any additional questions about the use of this medicine, consult 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 SUN and tell your doctor immediatelyif you experience any of the following side effects:

• unusual difficulty breathing with wheezing or coughing and chest tightness
• allergic reactions, including hives and itching

Tell your doctor immediatelyif you experience any of the following side effects:

• hearing loss (ringing in the ears is a sign of potential hearing loss), noises (such as whistling) in the ears

Your underlying lung disease may worsen while you are using Tobramycin SUN. This may be due to lack of efficacy. Tell your doctor immediately if this happens.

Other side effects

Tell 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)

• nasal discharge or congestion, sneezing
• voice alteration (hoarseness)
• discoloration of the sputum
• worsening of lung function test results

Common (may affect up to 1 in 10 people)

• general feeling of discomfort
• muscle pain
• voice alteration with sore throat and difficulty swallowing (laryngitis)

Other side effects

• itching
• itchy skin rash
• skin rash
• loss of voice
• altered sense of taste
• sore throat

Frequency not known (cannot be estimated from the available data)

• increased amount of sputum
• chest pain
• reduced appetite

If you have received Tobramycin SUN at the same time or after repeated cycles of tobramycin or other aminoglycoside antibiotics 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.

Patients with cystic fibrosis have various symptoms of the disease. These may even occur while taking Tobramycin SUN, but they should not be more frequent or seem worse than before treatment.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tobramicina SUN

Keep this medicine out of the sight and reach of children.

Do not use Tobramicina SUN after the expiry date which is stated on the packaging, on the bag, or printed on the ampoule after CAD. The expiry date is the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C). If you do not have a refrigerator (for example, during transportation of the medicine), you can keep the aluminum bags (opened or closed) at room temperature (not above 25°C) for a maximum of 28 days. Do not use the Tobramicina SUN ampoules if you have stored them at room temperature for more than 28 days.

Keep the ampoules in the original packaging to protect them from light. This medicine is usually colorless to light yellow, but the color may vary and sometimes may be dark yellow. This does not affect the activity of this medicine, as long as the storage instructions are followed.

Do not use this medicine if you notice that it becomes cloudy or if there are particles in the solution.

Never store an opened ampoule. Once an ampoule is opened, it must be used immediately and any remaining product must be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tobramicina SUN

• The active ingredient is tobramycin. Each 5 ml ampoule contains 300 mg of tobramycin, which corresponds to 60 mg/ml.
• The other ingredients are sodium chloride, water for injectable preparations, sulfuric acid (E513) (for pH adjustment) and/or sodium hydroxide (E524) (for pH adjustment).

Appearance of the Product and Package Contents

Tobramicina SUN solution for inhalation by nebulizer is a clear, colorless to light yellow solution without visible particles.

Tobramicina SUN is presented in a ready-to-use ampoule. The ampoules are packaged in aluminum bags, one aluminum bag contains 4 ampoules corresponding to 2 days of treatment.

Tobramicina SUN is available in packages of 56, 112, or 168 ampoules, which are sufficient for one, two, or three treatment cycles, respectively.

Only some package sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Terapia SA

Str. Fabricii Nr. 124

400632, Cluj-Napoca

Romania

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

This medicine is authorized in the Member States of 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

Netherlands: Tobramycine SUN 300 mg/5 ml verneveloplossing

Poland: Tobramycyna SUN 300 mg/5 ml roztwór do nebulizacji

Romania: Tobramicina SUN 300 mg/5 ml solutie pentru nebulizator

United Kingdom

(Northern Ireland): Tobramycin 300 mg/5 ml nebuliser solution

Date of the last revision of this leaflet: September 2021