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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Tobramycin Teva Inhalation Solution for Nebulizer is and what it is used for

Tobramycin Teva Inhalation Solution for Nebulizer contains the active substance tobramycin. This is an antibiotic belonging to the aminoglycoside family.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important to follow your doctor's instructions regarding dosage, administration interval, and duration of treatment. Do not store or reuse this medication. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via the sink or in household waste.

Tobramycin Teva solution for inhalation by nebulizer 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 fights the infection caused by the Pseudomonas bacteria in your lungs and helps improve your breathing.

When you inhale tobramycin, the antibiotic can reach your lungs directly to fight 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 do not acquire this infection until later in life, while others are affected at a very young age.

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

Tobramycin kills the bacteria causing lung infections. This infection can be successfully controlled if addressed at an early stage.

2. What you need to know before using Tobramycin Teva inhalation solution for nebulizer

Do not use Tobramycin Teva inhalation solution for nebulizer

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

Warnings and precautions

Consult your doctor before starting to use Tobramycin Teva inhalation solution for nebulizer if you have or have ever had 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 (substance you cough up)
• Muscle weakness that lasts or worsens over time, symptoms mostly related to myasthenia or Parkinson's disease.

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

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

While using Tobi, strains of Pseudomonas may over time become resistant to treatment. 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 administered by injection, tobramycin may occasionally cause hair loss, dizziness, kidney damage, and may harm the fetus.

Children and adolescents

Tobramycin inhalation solution for nebulizer can be administered to children and adolescents aged 6 years and older. Tobramycin must 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 determine whether Tobramycin inhalation solution for nebulizer is an appropriate treatment for you.

Using Tobramycin Teva inhalation solution for nebulizer with other medicines

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

You must not take the following medicines while using Tobramycin Teva inhalation solution for nebulizer:

• Furosemide or ethacrynic acid (diuretics).
• Intravenous urea or mannitol.
• Other medicines that may damage your nervous system, kidneys, or hearing.

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

• Amphotericin B, cephalothin, cyclosporine, tacrolimus, polymyxins: these medicines may damage your kidneys.
• Platinum compounds (such as carboplatin and cisplatin): these medicines may damage your kidneys or hearing.
• Anticholinesterases (such as neostigmine and pyridostigmine), 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 inhalation solution for nebulizer.

Do not mix or dilute Tobramycin inhalation solution for nebulizer 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. Tobi last.

Confirm this order with your doctor as well.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

If you are pregnant or planning to become pregnant, discuss with your doctor 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 harm the fetus, such as causing deafness.

Breastfeeding

It is unknown whether inhaled tobramycin can be detected in breast milk at the recommended dose. If you are breastfeeding, consult your doctor before using any medicine.

Driving and using machines

This medicine is not expected to affect your ability to drive or operate machinery.

3. How to use Tobramycin Teva inhalation solution for nebulizer

For inhalation use only.

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

• The recommended dose is the same for all individuals aged 6 years and older.
• Use two vials each day for 28 days. Inhale the entire contents of one vial in the morning and another in the evening. Ideally, there should be a 12-hour interval between doses.
• You must leave a minimum of 6 hours between the two tobramycin inhalations.
• After taking your medicine for 28 days, you must then have a 28-day interval during which you should not inhale any dose of tobramycin, before starting another cycle.
• It is important to maintain using the product twice daily throughout your 28-day treatment period and to continue the 28-day on, 28-day off cycles.

ON Tobramycin inhalation solution for nebulizer	OFF Tobramycin inhalation solution for nebulizer
Take tobramycin inhalation solution for nebulizer twice daily. Every day for 28 days.	Do not take tobramycin inhalation solution for nebulizer for the next 28 days.

Repeat the cycle

If you inhale more Tobramycin inhalation solution for nebuliser than you should

If you inhale too much tobramycin, your voice may become very hoarse. Make sure to inform your doctor as soon as possible. If you accidentally swallow tobramycin inhalation solution for nebuliser, inform your doctor immediately. You may also contact your pharmacist right away or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested or inhaled.

If you forget to use Tobramycin inhalation solution for nebuliser

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

If you stop using Tobramycin inhalation solution for nebuliser

You must not stop using Tobramycin inhalation solution for nebuliser until you have completed the full course of treatment or your doctor has instructed you to stop.

Instructions for using Tobramycin inhalation solution for nebuliser

This section of the leaflet explains how to use, care for, and handle tobramycin inhalation solution for nebuliser. Please read and follow these instructions carefully.

Equipment needed to inhale Tobramycin Teva inhalation solution for nebuliser

Tobramycin Teva inhalation solution for nebuliser must be used with a clean and dry reusable PARI LC PLUS nebuliser, together with a suitable compressor. Ask your doctor or physiotherapist for advice on which compressor is best suited for your case. Your doctor or physiotherapist can advise you on the proper use of your medication and the equipment you require. You may need different nebulisers for other inhaled medications used to treat cystic fibrosis (CF).

Before starting treatment with Tobramycin Teva inhalation solution for nebuliser, ensure you have the following equipment:

• Tobramycin ampoule
• Reusable PARI LC PLUS nebuliser
• Suitable compressor
• Tubing to connect the nebuliser and compressor
• Clean paper or cloth towel
• Nose clips (if needed)

Before using your medication, check that your nebuliser and compressor are working correctly according to the manufacturer's instructions.

Instructions for use:

1. Wash your hands thoroughly with soap and water.

1. Each pouch contains 4 ampoules. Cut or tear open the pouch, remove one ampoule, and store the remaining pouch in the refrigerator.

1. Place the components of your PARI LC PLUS nebuliser on a clean, dry paper or cloth towel. You should have the following parts:
   • Nebuliser top piece
   • Nebuliser chamber
   • Inhalation valve
   • Mouthpiece with valve

e) Connecting tube

1. Separate the top of the nebuliser from the bottom by turning the top piece counterclockwise, then lift it off. Place the top piece on the towel and position the bottom chamber upright on the towel.

2. Connect one end of the tubing to the air outlet of the compressor. Ensure the tubing fits securely, then plug the compressor into an electrical outlet.

1. Open the ampoule by holding the bottom with one hand and twisting the top with the other. Be careful not to squeeze the ampoule until you are ready to empty it into the nebuliser chamber.

1. When ready, transfer the entire contents of the ampoule into the nebuliser chamber.

1. Replace the top of the nebuliser. Turn the top clockwise until it is securely attached to the bottom chamber.

2. Attach the mouthpiece to the outlet of the nebuliser. Press the inspiratory valve firmly into the top of the nebuliser. The inspiratory valve should fit easily (refer to the PARI LC PLUS nebuliser instructions for use).

3. Connect the free end of the tubing to the air inlet at the bottom of the nebuliser, ensuring the nebuliser remains in an upright position. Press the tubing firmly into the air inlet.

Take your medication:

1. Turn on the compressor.

1. Check that a uniform mist is coming from the mouthpiece. If no mist is produced, check all tubing connections and ensure the compressor is functioning properly.

1. Stand or sit in an upright position to allow normal breathing.

1. Place the mouthpiece between your teeth and the top of your tongue. Breathe normally, through your mouth only (you may use nose clips to assist). Try not to block the airflow with your tongue.
2. Continue until all of the Tobramycin Teva inhalation solution for nebuliser has been used and no more mist is produced.
3. Please remember to clean and disinfect the nebuliser after treatment. Never use a dirty or blocked nebuliser. Do not share your nebuliser with other people.

It will take approximately 15 minutes to inhale the full dose. You may hear a sputtering sound when the nebuliser chamber is empty. If treatment is interrupted or you need to cough or rest, turn off the compressor to conserve your medication. When ready to resume, turn the compressor back on.

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

4. Possible adverse effects

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

Some adverse effects may be serious:

If you experience any of the following adverse effects, stop using Tobi 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 (frequent)
• Low urine volume, vomiting, confusion, and swelling in the legs, ankles, or feet, as these may be signs of a sudden decrease in kidney function (frequency not known)

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 have received Tobi at the same time as, or after, repeated courses 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 specific to their disease. These symptoms may also occur while you are receiving tobramycin, but they should not occur more frequently or worsen.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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 Teva Inhalation Solution for Nebulizer

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

Do not use this medicine after the expiry date stated on the packaging, the pouch, and the ampoule after EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. The pouches (intact or opened) may be stored at room temperature (do not store above 25°C) for up to 28 days. Keep in the original packaging to protect from light. An opened ampoule must never be stored. Once opened, the ampoule should be used immediately and any remaining solution must be discarded.

Do not use this medicine if you notice visible signs of deterioration (such as cloudiness in the solution). Tobramycin may be slightly yellowish and a variation in colour may be observed; this is not indicative of loss of potency if the solution has been stored as recommended.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tobramycin Teva nebulizer solution for inhalation

• The active substance is tobramycin. Each 5 ml ampoule contains 300 mg of tobramycin.
• The other components are: sodium chloride, water for injections, sulfuric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

Appearance of the medicine and contents of the pack

Tobramycin nebulizer solution for inhalation is a clear or slightly yellowish solution.

It is supplied in single-dose 5 ml ampoules.

Four ampoules are packaged and sealed in an aluminum pouch.

Each pack contains 14 (56 ampoules), 28 (112 ampoules), or 42 (168 ampoules) aluminum pouches, sufficient for one, two, or three treatment cycles, respectively.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas (Madrid)

Spain

Manufacturer

Norton Healthcare Limited

T/A Ivax Pharmaceuticals UK,

Aston Lane North, Whitehouse Vale Industrial Estate, Preston Brook,

Runcorn, Cheshire, WA7 3FA,

United Kingdom

or

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

or

Merckle GmbH

Ludwig-Merckle-Str. 3

89143 Blaubeuren

Germany

This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Tobramycin TEVA

Germany: Tobramycin Teva® 300 mg/5 ml Steri-Neb® Lösung für einen Vernebler

Ireland: Tobramycin Teva 300 mg/5 ml Nebuliser Solution

Italy: Tobramicina Teva 300 mg/5 ml soluzione per nebulizzatore

Portugal: Tobramicina Teva

Spain: Tobramicina Teva 300 mg/5 ml solución para inhalación por nebulizador

The Netherlands: Tobramycine 300 mg/5 ml PCH, vernevelossing

United Kingdom (Northern Ireland): Tymbrineb 300 mg/5 ml Nebuliser Solution

Date of the most recent review of this leaflet: August 2025

“Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”