Leaflet: information for the user

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

Tobramycin

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What isTobramycin Accordand what it is used for

2. What you need to know before starting to useTobramycin Accord

3. How to useTobramycin Accord

4. Possible side effects

5. Storage ofTobramycin Accord

6. Contents of the pack and additional information

What Tobramicina Accord is used for

Tobramicina Accord contains a medication called tobramycin, which is an aminoglycoside antibiotic.

Tobramicina Accord 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 Accord fights the infection caused by the bacteriaPseudomonasin your lungs, and helps to improve your breathing.

When you inhale Tobramicina Accord, the antibiotic can directly reach your lungs to combat the bacteria causing the infection. For better results from this medication, follow the instructions in this leaflet.

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 contract it at an advanced stage of their life, while others contract it at a very young age.

It is one of the most harmful bacteria for people with cystic fibrosis. If the infection is not properly controlled, it can continue to harm the lungs, causing additional breathing problems.

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

No useTobramicina Accord

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

If any of the above cases apply to you, do not take this medication and consult your doctor. If you think you may be allergic, ask your doctor for advice.

Warnings and precautions

Consult your doctor before starting to use Tobramicina Accord if you suffer or have ever suffered from any of the following conditions:

• Auditory problems (including tinnitus and dizziness).
• Renal problems
• Unusual respiratory difficulty with wheezing or cough, chest oppression
• Blood in your sputum (the substance you expel when coughing)
• Muscle weakness that lasts or worsens over time, symptoms mainly related to myasthenia or Parkinson's disease.

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

The inhalation of medications can cause chest oppression and wheezing, and this can occur with Tobramicina Accord. Your doctor will supervise your first dose of Tobramicina Accord and monitor 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 Accord.

If you are using Tobramicina Accord, 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 your doctor if you are concerned about this issue.

If you use it by injection, tobramycin may cause occasional hearing loss, dizziness, and kidney damage and may harm the fetus.

Children and adolescents

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

Older adults

If you are 65 years of age or older, your doctor may perform additional checks to decide if Tobramicina Accord is suitable for you.

Other medications and Tobramicina Accord

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

You should not use the following medications while using Tobramicina Accord:

• Furosemide or etacrynic acid, diuretics
• Other medications that may affect renal function, such as urea or intravenous mannitol.
• Other medications that may damage your nervous system, kidneys, or ears

The following medications may increase the risk 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 the activity of the immune system): These medications may damage the kidneys.
• Platinum compounds such as carboplatin and cisplatin (used to treat certain types of cancer): These medications may damage the kidneys or ears.
• Anticholinesterases (such as neostigmine and pyridostigmine (used to treat muscle weakness) or botulinum toxin: These medications may cause the onset 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 Accord.

You should not mix or dilute Tobramicina Accord 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 physiotherapy
3. other medications to inhale
4. Tobramicina Accord at the end.

Also, check this order with your doctor.

Pregnancy and breastfeeding

If you are pregnant or want to become pregnant, consult your doctor about the possibility of this medication causing harm to you or the fetus.

The effects of inhaling this medication during pregnancy are unknown.

When administered by injection, tobramycin and other aminoglycoside antibiotics may cause fetal damage, such as hearing loss.

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

Driving and operating machinery

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor if you have any doubts.

How much of this medication should you use and how often

• The recommended dose is the same for all people aged 6 years and above.
• Usetwoampoules every day for 28 days. Inhale the complete contents of one ampoule in the morning and another in the evening. Ideally, there should be a 12-hour interval between doses.
• You must leave aminimum period of 6 hoursbetween the two inhalations of Tobramicina Accord.
• After using your medication for 28 days, you will then have a 28-day interval during which you should not inhale any dose of Tobramicina Accord before starting another cycle.
• It is essential that you maintain the use of the product twice a day during your 28-day treatment period and maintain thecyclesof 28 days of treatment, 28 days of rest.

Repeat the cycle

If you use more Tobramicina Accord than you should

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

In case of overdose or accidental ingestion, inform your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Tobramicina Accord

If you forgot to use Tobramicina Accord and there are at least 6 hours left before the next dose, take a new dose as soon as possible. Otherwise, wait for the next dose. Do not take a double dose to compensate for the missed doses.

Instructions for the use of Tobramicina Accord

This part of the prospectus explainshow to use, care for, and handleTobramicina Accord.

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 Accord

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

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

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

Preparation of Tobramicina Accord for inhalation

• Wash your hands thoroughly with water and soap.
• Each aluminum bag of Tobramicina Accord contains 7 ampoules. Cut or tear the bag. Remove one ampoule of Tobramicina Accord from the bag. Put the remaining ampoules back in the aluminum bag and store it in the refrigerator.
• Extend the parts of your nebulizer on a clean and dry paper or cloth towel.
• Make sure you have the correct compressor and tube to connect the nebulizer and compressor.
• Follow the instructions carefully for the use of your nebulizer model. 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 Accord with LC PLUS (PARI GmbH)

For more detailed instructions on the use and care of the nebulizer, read the user manual provided 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.
2. Connect one end of the tube to the air outlet of the compressor. Make sure the tube fits perfectly. Connect the compressor to the power outlet.
3. Open the ampoule of Tobramicina Accord by holding the lower tab with one hand and twisting the upper part with the other hand. Empty the entire contents of the ampoule into the nebulizer cartridge.

1. Put the top part of the nebulizer back on, secure the mouthpiece, and place the inspiratory valve cap on the nebulizer. Then connect the compressor as indicated in the user manual for your PARI LC PLUS nebulizer.
2. 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.
3. Sit or stand in a position where you can breathe normally.
4. Place the mouthpiece between your teeth and on the tip of your tongue. Breathe normally, but only through your mouth (you may find it helpful to use a nose clip). Try not to block the airflow with your tongue.

1. Continue until all the Tobramicina Accord has been consumed and there is no more mist. 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 the compressor back on when you are ready to resume treatment. Omit this dose if your next dose is due in less than 6 hours.

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

Some side effects can be serious

If you experience any of the following side effects, stop using Tobramicina Accord andinform your doctor immediately:

• Unusual difficulty breathing with wheezing or cough andchest tightness
• Allergic reactions including hives and itching

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

• Loss of hearing (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 Tobi. This may be due to lack of effectiveness. Inform your doctor immediately if this occurs.

Some side effects are very common

These side effects may affect more than 1 in 10 people.

• Runny or congested nose, sneezing
• Hoarseness
• Discoloration of the substance you cough up (sputum)
• Worsening of lung function test results

If any of them affect you severely,inform your doctor.

Some side effects are common

These side effects may affect up to 1 in 10 people.

• General feeling of being unwell
• Muscle pain
• Hoarseness with sore throat and difficulty swallowing (laryngitis)

If any of them affect you severely,inform your doctor.

Other side effects:

• Itching
• Skin rash with itching
• Skin rash
• Loss of voice
• Altered sense of taste
• Sore throat

If any of them affect you severely,inform your doctor.

If you consider that any of the side effects you experience are serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

Tobramycin or other aminoglycoside injections may cause allergic reactions, hearing problems, and kidney problems.

Patients with cystic fibrosis present several symptoms specific to the disease. These may even appear while using Tobramicina Accord but should not be more frequent or seem worse than before treatment.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it ispossibleside effects that do not appear in this prospectus.You can also report them directly through the Spanish 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 this medication after the expiration date that appears on the packaging, in the bag, or printed on the ampule. The expiration date refers to the last day of that month.
• Do not use this medication if you observe that it becomes cloudy or if there are particles in the solution.
• Storein the refrigerator(between2°Cand8°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 above25°C) for a maximum of 28 days.
• Do not use the Tobramicina Accord ampules if they have been stored at room temperature for more than 28 days.
• Tobramicina Accord usually presents a light yellow color, which may vary and sometimes may be dark yellow. This does not affect the activity of Tobramicina Accord, as long as the storage instructions are followed.

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

Composition ofTobramycin Accord

• The active ingredient is tobramycin. A vial contains 300 mg of tobramycin, as a single dose
• The other components are sodium chloride, water for injectable preparations, sodium hydroxide, nitrogen, and sulfuric acid (for pH adjustment)

Appearance of the product and contents of the packaging

Tobramycin Accord is a transparent, slightly yellow solution that is presented in a ready-to-use vial

The vials are packaged in aluminum bags, one aluminum bag contains 7 vials

Tobramycin Accord is available in packaging of 56 vials, which is sufficient for a treatment cycle

Holder of the marketing authorization:

Accord Healthcare S.L.U.

World Trade Center,

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Responsible for manufacturing:

Accord Healthcare Polska

Sp. z.o.o. Importer's Warehouse

ul. Lutomierska 50, Pabianice

95-200 Poland

This leaflet was approved in August 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es