TOBRAMICIN ACCORD 300 mg / 5 ml SOLUTION FOR NEBULIZER INHALATION

2. What you need to know before you use Tobramicina Accord

Do not use Tobramicina Accord

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

If any of the above applies to you, do not take this medicine 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 have or have ever had any of the following conditions:

• Hearing problems (including ringing in the ears and dizziness).
• Kidney problems.
• Unusual breathing difficulties with wheezing or coughing, chest tightness.
• Blood in your sputum (the substance you cough up).
• 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.

Inhaling medicines can cause chest tightness and wheezing, and this can occur with Tobramicina Accord. Your doctor will supervise your first dose of Tobramicina Accord 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 Tobramicina Accord.

If you are using Tobramicina Accord, 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 issue.

If you use it by injection, tobramycin can occasionally cause 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.

Elderly people

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 medicines and Tobramicina Accord

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Do not use the following medicines while using Tobramicina Accord:

• Furosemide or ethacrynic acid, diuretics.
• Other medicines that may affect kidney function, such as intravenous urea or mannitol.
• Other medicines that may damage your nervous system, kidneys, or ears.

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

• Amphotericin B, cephalothin, cyclosporin, polymyxins (used to treat microbial infections), tacrolimus (used to reduce immune system activity): These medicines may damage the kidneys.
• Platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer): These medicines may damage the kidneys or ears.
• Anticholinesterases (such as neostigmine and pyridostigmine (used to treat muscle weakness) or botulinum toxin: These medicines may cause or worsen muscle weakness.

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

Do not mix or dilute Tobramicina Accord 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 inhaled medicines.
4. Tobramicina Accord last.

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 that this medicine may harm you or the fetus.

It is not known whether 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.

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

Driving and using machines

Tobramicina Accord should not affect your ability to drive and use machines.

3. How to use Tobramicina Accord

Follow the instructions for administering this medicine exactly as indicated by your doctor. Consult your doctor if you have any doubts.

How much of this medicine to use and how often to use it

• The recommended dose is the same for all people aged 6 years and older.
• Use twoampoules each day, for 28 days. Inhale the complete contents of one ampoule in the morning and another in the evening. Ideally, there should be an interval of 12 hours between doses.
• You must leave a minimum period of 6 hoursbetween the two inhalations of Tobramicina Accord.
• After using your medicine 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 the cycles of 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Tobramicina Accord

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

Instructions for using Tobramicina Accord

This part of the leaflet explains how to use, care for, and handle Tobramicina Accord.

Read and follow these instructions carefully.

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

The equipment you need to inhale Tobramicina Accord

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

The 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 medicines for cystic fibrosis.

Preparing Tobramicina Accord for inhalation

• Wash your hands carefully 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.
• Lay out 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 for using your nebulizer model carefully, and read the instruction manual provided by the manufacturer. Check that your nebulizer and compressor are working properly according to the manufacturer's instructions before starting to use your medicine.

Using Tobramicina Accord with LC PLUS (PARI GmbH)

For more detailed instructions on using and caring for the nebulizer, read the instruction manual provided with the PARI LC PLUS.

1. Remove the top part of the nebulizer by twisting it counterclockwise and lifting it. Place the top part on the towel and stand the nebulizer cup 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 Tobramicina Accord 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 cup.

1. Put the top part of the nebulizer back, fix the mouthpiece, and place the valve cap on the nebulizer. Then connect the compressor as indicated in the instruction manual of 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 that the compressor is working properly.
3. Sit or stand in a way that allows you to 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 used and no more mist is produced. The complete inhalation should take around 15 minutes. You may hear a gurgling sound when the nebulizer cup 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

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

• Unusual difficulty breathing with wheezing or coughing and chest tightness.
• Allergic reactions including hives and itching.

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

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

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

Some side effects are very common

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

• Runny or stuffy nose, sneezing.
• Voice alteration (hoarseness).
• Discoloration of the sputum.
• Worsening of lung function test results.

If any of these affect you severely, tell your doctor.

Some side effects are common

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

• Feeling unwell.
• Muscle pain.
• Voice alteration with sore throat and difficulty swallowing (laryngitis).

If any of these affect you severely, tell your doctor.

Other side effects:

• Itching.
• Itchy skin rash.
• Skin rash.
• Loss of voice.
• Altered sense of taste.
• Sore throat.

If any of these affect you severely, tell your doctor.

If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

If you have received Tobramicina Accord at the same time as or after repeated cycles of tobramycin or other aminoglycoside antibiotics injected, 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 characteristic of the disease. These may occur even while using Tobramicina Accord but should not be more frequent or seem worse than before treatment.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them 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 Accord

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the packaging, on the bag, or printed on the ampoule. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice that it becomes cloudy or if there are particles in the solution.
• Store in the refrigerator(between 2°C and 8°C). If you do not have a refrigerator (e.g., 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 Accord ampoules if you have stored them at room temperature for more than 28 days.
• Tobramicina Accord usually has a light yellow color, which may vary and sometimes can be dark yellow. This does not affect the activity of Tobramicina Accord, as long as the storage instructions are followed.

You should never store an opened ampoule. Once an ampoule is opened, it must be used immediately and any remaining solution must be discarded.

6. Packaging contents and additional information

Composition ofTobramicina Accord

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

Appearance of the product and packaging contents

Tobramicina Accord is a clear, slightly yellow solution presented in a ready-to-use ampoule.

The ampoules are packaged in aluminum bags, one aluminum bag contains 7 ampoules.

Tobramicina Accord is available in packs of 56 ampoules, which is sufficient for a treatment cycle.

Marketing authorization holder:

Accord Healthcare S.L.U.

World Trade Center,

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Manufacturer:

Accord Healthcare Polska

Sp. z.o.o. Magazyn Importera

ul. Lutomierska 50, Pabianice

95-200 Poland

This leaflet was approved in August 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es