Prospect: information for the user

Tobramycin SUN 300 mg/5 ml solution for inhalation by nebulizer

tobramycin

Read this prospect carefully before starting to use this medication,because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Tobramycin SUN and how it is used

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

3.How to use Tobramycin SUN

4.Adverse effects

5.Storage of Tobramycin SUN

6.Contents of the package and additional information

Tobramicina SUN contains an antibiotic medication called tobramycin. This belongs to a class of antibiotic medications known as aminoglycosides.

Tobramicina SUN is used in patients aged 6 years and above who suffer from cystic fibrosis, for the treatment of lung infections caused by a bacteria calledPseudomonas aeruginosa.

Tobramicina SUN combats the infection caused bythe bacteriaPseudomonasin your lungs and helps to improve your breathing.

When you inhale Tobramicina SUN, the antibiotic reaches your lungs directly to combat the bacteria causing the infection. For better results from this medication, follow the instructions in this prospectus.

What isPseudomonas aeruginosa?

It is a very common bacteria that infects almost all patients with cystic fibrosis at some point in their lives. Some patients do not contract this infection until a very advanced stage in their lives, while others contract it at a very young age.

This bacteria is one of the most damaging to people with cystic fibrosis. If the infection is not controlled properly, it can continue to damage your lungs, causing additional problems with your breathing.

Tobramicina SUN kills the bacteria that causes lung infections. This infection can be controlled successfully if the problem is addressed at an early stage.

No use Tobramicina SUN:

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

If any of these cases mentioned above apply to you, do not take this medication and consult your doctor.

Warnings and precautions

Consult your doctor before starting to use Tobramicina SUN if you suffer 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 cough, chest oppression
• blood in your sputum (substance you cough up)
• muscle weakness that lasts or worsens over time, for example symptoms related to myasthenia (muscle weakness) or Parkinson's disease.
• if you or your family members suffer from a mitochondrial disease (disorder caused by variants in the mitochondrial genome, the parts of your cells that help produce energy) or hearing loss due to antibiotic medication; some mitochondrial mutations may increase the risk of hearing loss when taking this medication.

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

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

If you are using Tobramicina SUN, Pseudomonas strains may become resistant to treatment over time. This means that over time, the medication may not work as well as it should. Consult with your doctor if you are concerned about this.

If tobramycin administration is via injection, this may cause occasional hearing loss, dizziness, and kidney damage, and may harm the fetus.

Children and adolescents

Tobramicina SUN can be administered to children and adolescents from 6 years of age. Tobramicina SUN should not be administered to children under 6 years of age.

Advanced age

If you are 65 years old or older, your doctor may perform additional tests to decide if Tobramicina SUN is a correct treatment for you.

Other medications and Tobramicina SUN

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

DO NOTtake the following medications while using Tobramicina SUN:

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

The following medications may increase the appearance of adverse effects if administered while you are receiving tobramycin injections:

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

If you are taking one or more of the medications described above, discuss it with your doctor before using Tobramicina SUN.

Do not mix or dilute Tobramicina SUN with any other medication in your nebulizer.

If you are taking multiple treatments for cystic fibrosis, do the following:

1. bronchodilator treatment, such as salbutamol
2. chest physical therapy
3. other inhaled medications
4. Tobramicina SUN last

Also, check this order with your doctor.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

The safety of inhaling this medication during pregnancy is unknown. When administered via injection, tobramycin and other aminoglycoside antibiotics may cause fetal damage, such as hearing loss.

Breastfeeding

If you are breastfeeding, consult your doctor before using any medication.

Driving and operating machinery

Tobramicina SUN should not affect your ability to drive and operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose istwoampoules per day (one in the morning and one at night) for 28 days.

• The recommended dose is the same for all people from 6 years old.
• Inhale the complete content of one ampoule through the mouth in the morning and another in the evening using the nebulizer.
• It is best to have the interval between the two doses as close to 12 hours as possible, but that interval must be at least 6 hours.
• After taking your medication for 28 days, there will be a 28-day break during which you must not inhale any dose of Tobramicina SUN. Then you will start another cycle after the break (as illustrated).
• It is essential to maintain the use of the product twice a day during your 28-day treatment period and follow the cycles of28 days of treatment, 28 days of rest

Repeat the cycle

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

Instructions for the use of Tobramicina SUN

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

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

The equipment you need to inhale Tobramicina SUN

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

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

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

Preparation of Tobramicina SUN for inhalation

• Wash your hands carefully with water and soap
• Each aluminum bag contains 4 ampoules.Cut or tear the bag.Remove one ampoule of Tobramicina SUN from the aluminum bag. Keep the remaining ampoules refrigerated in the original packaging
• Extend the parts of your nebulizer on a clean and dry paper towel or cloth
• Make sure you have the compressor and tube to connect the nebulizer to the compressor
• Follow the relevant instructions for the use of your nebulizer model carefully. Read the user manual provided by the manufacturer with the nebulizer. Check that your nebulizer and compressor are working properly according to the manufacturer's instructions before starting to use your medication.

Use of Tobramicina SUN with LC PLUS (PARI GmbH)

If you want more detailed instructions on the use and care of the nebulizer, consult the prospectus 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 ampoule of Tobramicina SUN by holding the lower tab with one hand and separating the upper part with the other hand, twisting it. Empty the entire content of the ampoule into the nebulizer cartridge

1. Replace the top part of the nebulizer, secure the mouthpiece, and place the inspiratory valve cap on the nebulizer. Then connect the compressor as indicated in the user 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 make sure the compressor is working properly

1. Sit or stand in a position where you can 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 suitable, you can use a nasal clip). Try not to block the airflow with your tongue

1. Continue until all Tobramicina SUN has been consumed 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 if you need to cough or rest during administration, turn off the compressor to avoid wasting the medication.

Turn on the compressor again when you are ready to resume treatment. Omit this dose if your next dose is due in less than 6 hours.

If you use moreTobramicina SUNthan you should

If you inhale too much Tobramicina SUN, your voice may become very hoarse. Make sure to inform your doctor as soon as possible. If you swallow Tobramicina SUN, inform your doctor as soon as possible.

If you forgot to use Tobramicina SUN

If you forgot to use Tobramicina SUN and at least 6 hours have passed before the next dose, take a dose as soon as possible. Otherwise, wait for the next dose. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Tobramicina SUN

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

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

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

Severe side effects

Stop using Tobramicina SUN and inform your doctor immediately if you experience any of the following side effects:

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

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

• hearing loss (buzzing in the ears is a sign of potential hearing loss), ringing in the ears

Your underlying lung disease may worsen while you are using Tobramicina SUN. This may be due to lack of efficacy. 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 congested nose, sneezing
• voice alteration (hoarseness)
• change in the color 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 alteration with sore throat and difficulty swallowing (laryngitis)

Other side effects

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

Unknown frequency (cannot be estimated from available data)

-increase in the amount of substance you cough up (sputum)

-chest pain

-reduced appetite

If you have received Tobramicina SUN at the same time or after repeated cycles of tobramycin or other aminoglycoside antibiotics, hearing loss has been reported as a side effect.

Injections of tobramycin or other aminoglycosides may cause allergic reactions, hearing problems, and kidney problems.

Patients with cystic fibrosis may experience several symptoms specific to the disease. These may even occur while taking Tobramicina SUN, but should not be more frequent or appear worse than before treatment.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possibleside effect that does not appear in this leaflet.You can also report them directly to theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Tobramicina SUN after the expiration date that appears on the packaging, in the bag, or printed on the ampule after CAD. The expiration 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 the transportation of the medication) 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 ampules if you have stored them at room temperature for more than 28 days.

Store the ampules in the original packaging to protect them from light. This medication is usually colorless and light yellow, but the color may vary and it may be dark yellow at times. This does not affect the activity of this medication, as long as the storage instructions are followed.

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

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

Medications should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help to protect the environment.

Tobramycin SUN Composition

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

Product Appearance and Packaging Contents

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

Tobramycin 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.

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible for Manufacturing

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Terapia SA

Str. Fabricii Nr. 124

400632, Cluj-Napoca

Romania

For more information about this medication, please contact the local representative of the marketing authorization holder:

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Phone: +34 93 342 78 90

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names

Germany:Tobramycin SUN 300mg Solution for a Nebulizer

Denmark:Tobramycin SUN 300mg/5ml inhalation fluid for nebulizer, solution

Spain:Tobramycin SUN 300mg/5ml solution for inhalation by nebulizer

France:Tobramycin SUN 300mg/5ml solution for inhalation by nebulizer

Italy:Tobramycin SUN 300mg/5ml solution for nebulizer

Netherlands:Tobramycin SUN 300mg/5ml nebulizer solution

Poland:Tobramycin SUN 300mg/5ml solution for nebulization

Romania:Tobramycin SUN 300mg/5ml solution for nebulizer

United Kingdom

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

Last review date of this leaflet: September 2021