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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Tobramycin

Read the entire leaflet carefully before you start using 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Contents of the leaflet

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

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

What Tobramycin Accord is used for

Tobramycin Accord contains a medicine called tobramycin, which is an aminoglycoside antibiotic.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Tobramycin Accord is used in patients aged 6 years and older who have cystic fibrosis, for the treatment of lung infections caused by a bacterium called Pseudomonas aeruginosa.

Tobramycin Accord fights the infection caused by Pseudomonas bacteria in your lungs and helps improve your breathing.

When you inhale Tobramycin Accord, the antibiotic can reach your lungs directly to act against the bacteria causing the infection. For the best outcome with this medicine, follow the instructions in this leaflet.

What is Pseudomonas aeruginosa

Pseudomonas aeruginosa is a very common bacterium that infects almost all patients with cystic fibrosis at some point in their lives. Some patients become infected at a later stage of life, while others are infected at a very young age.

It is one of the most harmful bacteria for people with cystic fibrosis. If the infection is not adequately controlled, it may continue to damage the lungs, causing further breathing problems.

Tobramycin Accord kills the bacteria causing lung infections. This infection can be successfully controlled if treated early.

2. What you need to know before using Tobramycin Accord

Do not use Tobramycin Accord

• 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 apply to you, do not take this medicine and consult your doctor. If you think you may be allergic, seek advice from your doctor.

Warnings and precautions

Talk to your doctor before starting to use Tobramycin Accord if you have or have ever had any of the following conditions:

• Hearing problems (including tinnitus 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 persists or worsens over time, symptoms mainly related to myasthenia or Parkinson's disease.

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

Inhaling medications may cause chest tightness and wheezing, and this may occur with Tobramycin Accord. Your doctor will monitor your first dose of Tobramycin Accord and check your lung function before and after dosing. If you are not already doing so, your doctor may ask you to use a bronchodilator (e.g. salbutamol) before using Tobramycin Accord.

If you are using Tobramycin Accord, Pseudomonas strains may over time become resistant to treatment. This means that over time, the medicine may not work as well as expected. Consult your doctor if you are concerned about this.

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

Children and adolescents

Tobramycin Accord may be administered to children and adolescents aged 6 years and older. Tobramycin Accord must not be given to children under 6 years of age.

Elderly patients

If you are 65 years of age or older, your doctor may carry out additional monitoring to determine whether Tobramycin Accord is suitable for you.

Other medicines and Tobramycin Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

You must not use the following medicines while using Tobramycin 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 harmful 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 medicines may damage the kidneys.
• Platinum compounds such as carboplatin and cisplatin (used to treat certain types 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 the onset or worsening of muscle weakness.

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

Do not mix or dilute Tobramycin 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. Tobramycin Accord last.

Please also confirm this order with your doctor.

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant, consult your doctor about whether this medicine could cause harm to you or the fetus.

It is unknown whether inhaling this medicine during pregnancy causes adverse effects.

When administered by injection, tobramycin and other aminoglycoside antibiotics may cause fetal harm, such as deafness.

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

Driving and using machines

Tobramycin Accord is not expected to affect your ability to drive or operate machinery.

3. How to use Tobramycin Accord

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

How much of this medicine you should use and how often you should use it

• The recommended dose is the same for all individuals aged 6 years and older.
• Use two ampoules each day for 28 days. Inhale the full 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 a minimum interval of 6 hours between the two inhalations of Tobramycin Accord.
• After using your medicine for 28 days, you will then have a 28-day interval during which you must not inhale any dose of Tobramycin Accord, before starting another cycle.
• It is important to maintain using the product twice daily throughout your 28-day treatment period and to maintain the cycles of 28 days on treatment, 28 days off treatment.

Repeat the cycle

If you use more Tobramycin Accord than you should

If you inhale too much Tobramycin Accord, your voice may become very hoarse. Make sure to inform your doctor as soon as possible. If you swallow Tobramycin 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 at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Tobramycin Accord

If you forget to use Tobramycin Accord and there are at least 6 hours before your next dose, take a new dose as soon as possible. Otherwise, wait until your next scheduled dose. Do not take a double dose to make up for missed doses.

Instructions for using Tobramycin Accord

This section of the leaflet explains how to use, care for, and handle Tobramycin Accord.

Please read and follow these instructions carefully.

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

Equipment needed to inhale Tobramycin Accord

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

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

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

Preparing Tobramycin Accord for inhalation

• Wash your hands thoroughly with soap and water.
• Each aluminum pouch of Tobramycin Accord contains 7 ampoules. Cut or tear open the pouch. Remove one ampoule of Tobramycin Accord from the pouch. Return the remaining ampoules to the aluminum pouch and store them in the refrigerator.
• Lay out the parts of your nebulizer on a clean, dry paper or cloth towel.
• Ensure you have the correct compressor and tubing to connect the nebulizer and compressor.
• Carefully follow the instructions for your specific nebulizer model. Read the instruction 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 medicine.

Using Tobramycin Accord with LC PLUS (PARI GmbH)

For more detailed instructions on the use and care of the nebulizer, refer to the instruction manual provided with the PARI LC PLUS.

1. Remove the top part of the nebulizer by turning it counterclockwise and lifting it off. Place this top part on the towel and stand the nebulizer chamber upright on the towel.
2. Connect one end of the tubing to the air outlet of the compressor. Ensure the tubing fits securely. Plug the compressor into an electrical outlet.
3. Open the Tobramycin Accord ampoule by holding the lower tab with one hand and twisting and pulling off the top tip with the other hand. Empty the entire contents of the ampoule into the nebulizer chamber.

1. Replace the top of the nebulizer, attach the mouthpiece, and place the inspiratory valve cap onto 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 a constant mist is coming from the mouthpiece. If there is no mist, check all tubing connections and ensure the compressor is functioning properly.
3. Sit or stand in a position that allows you to breathe normally.
4. Place the mouthpiece between your teeth and over 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 Tobramycin Accord has been used and no more mist is produced. The complete inhalation should take approximately 15 minutes. You may hear a gurgling sound when the nebulizer chamber is empty.

2. Remember to clean and disinfect your nebulizer after treatment according to the manufacturer's instruction manual. Never use a dirty or blocked nebulizer. Do not share your nebulizer with other people.

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. Skip this dose if your next dose is due in less than 6 hours.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious

If you experience any of the following adverse effects, stop using Tobramycin Accord and contact 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 adverse effects, contact your doctor immediately:

• Hearing loss (ringing in the ears is a potential warning 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 effectiveness. Inform your doctor immediately if this occurs.

Some adverse effects are very common

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

• Runny or stuffy nose, sneezing
• Voice changes (hoarseness)
• Discoloration of the substance you cough up (sputum)
• Worsening of pulmonary function test results

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

Some adverse effects are common

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

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

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

Other adverse effects:

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

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

If you have received Tobramycin Accord at the same time as, or following repeated cycles of, injected 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 have various symptoms related to their disease. These symptoms may even occur while using Tobramycin Accord, but should not become more frequent or appear worse than before treatment.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tobramycin Accord

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging, on the pouch, or printed on the ampoule. The expiry date refers to the last day of that month.
• Do not use this medicine if it appears cloudy or if particles are visible in the solution.
• Store in a refrigerator (between 2°C and 8°C). If a refrigerator is not available (for example, during transport of the medicine), the aluminium pouches (opened or unopened) may be kept at room temperature (not exceeding 25°C) for a maximum of 28 days.
• Do not use Tobramycin Accord ampoules that have been stored at room temperature for more than 28 days.
• Tobramycin Accord is usually light yellow in colour, which may vary and sometimes appear dark yellow. This does not affect the activity of Tobramycin Accord, provided storage instructions are followed.

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

6. Contents of the container and other information

Composition of Tobramycin Accord

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

Appearance of the product and contents of the container

Tobramycin Accord is a clear, slightly yellow solution supplied in ready-to-use vials.

The vials are packed in aluminum bags; one aluminum bag contains 7 vials.

Tobramycin Accord is available in packs of 56 vials, which is sufficient for one treatment cycle.

Marketing Authorization Holder:

Accord Healthcare S.L.U.

World Trade Center,

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona, Spain

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 up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es