Prospecto: Information for the User

Tobramycin Teva 300 mg/5 ml Solution for Inhalation by Nebulizer

Read this prospectus carefully before starting to use the medication, as it contains important information for you.

• Keep this prospectus, 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 should not be given to others, even if they present the same symptoms of disease as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist even if they do not appear in this prospectus. See section 4.

1.Tobramycin Teva Solution for Inhalation by Nebulizer and its use

2.What you need to knowbeforestarting touse Tobramycin Teva Solution for Inhalation by Nebulizer

3.How to use Tobramycin Teva Solution for Inhalation by Nebulizer

4.Possible adverse effects

5Storage of Tobramycin Teva Solution for Inhalation by Nebulizer

6. Contents of the package and additional information

Tobramicina Teva solution for inhalation by nebulizer contains the active ingredient tobramycin. This is an antibiotic from the aminoglycoside family.

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

Tobramicina fights the infection caused by the Pseudomona bacteria in your lungs, and helps to improve your breathing.

When you inhale tobramycin, the antibiotic can directly reach your lungs to combat the bacteria causing the infection. To achieve the best results from this medication, follow the instructions in this leaflet.

What isPseudomonas aeruginosa?

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

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

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

Do not use Tobramicina Teva solution for inhalation by nebulizer

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

Warnings and precautions

Consult your doctor before starting to use Tobramicina Teva solution for inhalation by nebulizer if you have or have had any of the following conditions:

• Problems with hearing (including ringing in the ears and dizziness).
• Problems with the kidneys.
• 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 mainly related to myasthenia or Parkinson's disease.

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

Inhaling medications can cause chest tightness and wheezing, and this can occur with Tobi. Your doctor will monitor your first dose of Tobi 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 Tobi.

If you are using Tobi, Pseudomonas bacteria 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.

If the medication is administered by injection, tobramycin may cause hair loss, dizziness, and kidney damage, and may harm the fetus.

Children and adolescents

Tobramycin solution for inhalation by nebulizer can be administered to children and adolescents aged 6 years and older. Tobramycin cannot be administered to children under 6 years of age.

Advanced age

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

Use of Tobramicina Teva solution for inhalation by nebulizer with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

You should not take the following medications while using Tobramicina Teva solution for inhalation by nebulizer:

• Furosemide, or etacrynic acid, diuretics.
• Urea or mannitol intravenously.
• 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, tacrolimus, polymyxins: these medications may damage your kidneys.
• Platinum compounds (such as, carboplatin and cisplatin): these medications may damage your kidneys or ears.
• Anticholinesterases (such as, neostigmine and pyridostigmine), 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 solution for inhalation by nebulizer.

You should not mix or dilute Tobramicina solution for inhalation by nebulizer 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. Tobi last.

Also, check this order with your doctor.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

The safety of tobramycin inhalation during breastfeeding is unknown. If you are breastfeeding, consult your doctor before using any medication.

Driving and operating machinery

This medication is not expected to affect your ability to drive and operate machinery.

For inhalation use only.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.If in doubt, ask yourdoctor or pharmacist.

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

• The recommended dose is the same for all people aged 6 years and above.
• Usetwoampoules per day, for 28 days. Inhale the entire contents of one ampoule in the morning and another in the evening. Ideally, there should be a 12-hour interval between doses.
• Leave a minimum of 6 hoursbetween the two inhalations of tobramycin.
• After taking your medication for 28 days, you will then have a 28-day interval in which you should not inhale any dose of tobramycin, 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 the28-day treatment cycles, 28-day rest periods.

Repeat the cycle

If you use more tobramycinsolution for inhalation by nebulizerthan 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 swallow tobramycin solution for inhalation by nebulizer, inform your doctor as soon as possible.You can also consult your pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingestedor inhaled.

If you forgot to use Tobramycinsolution for inhalation by nebulizer

If you forgot to useTobramycinsolution for inhalation by nebulizerand 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.

If you interrupt the treatment withTobramycinsolution for inhalation by nebulizer

You should not stop usingTobramycinsolution for inhalation by nebulizeruntil you have completed the treatment or your doctor has told you to.

Instructions for the use of Tobramycinsolution for inhalation by nebulizer

This part of the prospectus explains how to use, care for, and handletobramycinsolution for inhalation by nebulizer. Read and follow these instructions carefully.

The equipment you need to inhale Tobramycin Teva solution for inhalation by nebulizer

Tobramycin Teva solution for inhalation by nebulizer must be used with a clean and dry reusable nebulizer PARI LC PLUS, along with a suitable compressor. Ask your doctor or physiotherapist for information on which compressor is best for you. Your doctor or physiotherapist may advise you on the proper use of your medication and the equipment you need. You may need different nebulizers for other inhaled medications for cystic fibrosis (CF).

Before starting treatment withTobramycin Teva solution for inhalation by nebulizer, you must ensure that you have the following equipment pieces:

• Ampoule of tobramycin
• Reusable nebulizerPARI LC PLUS
• Available compressor
• Tube to connect the nebulizer and compressor
• Clean paper or a cloth towel
• Nasal pinches (if necessary)

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

Usage instructions:

1. Wash your hands thoroughly with soap and water.

2. Each bag contains 4 ampoules. Cut or break the bag, remove an ampoule, and store the bag in the refrigerator.

3.Place the parts of your PARI LC PLUS nebulizer on a clean and dry paper or cloth towel. You should have the following elements:

a) Top part of the nebulizer

b) Nebulizer chamber

c) Inhalation valve

d) Mouthpiece with valve

e) Connector tube

4. Separate the top part of the nebulizer from the bottom part by turning the top part counterclockwise and then lifting it. Place the top part on the towel and deposit the bottom part of the nebulizer in a vertical position on the towel.

5. Connect one end of the tube to the air outlet of the compressor. Make sure the tube fits perfectly and connect the compressor to the power outlet.

6. Open the ampoule by holding the bottom part with one hand and turning the top part with the other hand. Be careful not to squeeze the ampoule until you are ready to empty it into the nebulizer chamber.

7. When ready, transfer the entire contents of the ampoule into the nebulizer chamber.

8. Replace the top part of the nebulizer. Turn the top part clockwise until it fits well to the bottom part of the nebulizer.

9. Place the mouthpiece at the outlet of the nebulizer. Press firmly the inspiratory valve on the top part of the nebulizer. The inspiratory valve should adjust easily (see the PARI LC PLUS nebulizer prospectus).

10. Connect the free end of the tube to the air intake on the bottom part of the nebulizer, making sure to keep the nebulizer in a vertical position. Press the tube firmly into the air intake.

Take your medication:

1. Turn on the compressor

1. Check that the mist coming out of the mouthpiece is uniform. If there is no mist, check all the tube connections and make sure the compressor is working correctly.

1. Stand or sit up to breathe normally.

1. Place the mouthpiece between your teeth and the top of your tongue. Breathe normally, although only through your mouth (you can use nasal pinches as a help). Try not to block the airflow with your tongue.
2. Continue until you have consumed the entire Tobramycin Teva solution for inhalation by nebulizer and there is no more mist.
3. Please remember to clean and disinfect the nebulizer after treatment. Never use a dirty or clogged nebulizer. Do not share your nebulizer with others.

It will take 15 minutes to consume the entire contents. You may hear a babbling sound when the nebulizer chamber is empty. If you interrupt or need to cough or rest during treatment, turn off the compressor to conserve your medication. When ready to resume treatment, turn on the compressor again.

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

Like all medicines, this medicine can 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 Tobi and inform your doctor immediately:

• Unusual difficulty breathing with wheezing or cough and chest 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 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 discomfort
• Muscle pain
• Hoarseness with sore throat and difficulty swallowing (laryngitis)

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

Other side effects:

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

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

If you have received Tobi at the same time or after repeated cycles of tobramycin or other aminoglycoside injected antibiotics, 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 may experience several symptoms specific to the disease. These may even occur while using tobramycin, but should not occur more frequently or worsen.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does 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, and in 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). Do not freeze.The bags (intact or opened) can be stored at room temperature (do not store above 25 °C) for a maximum of 28 days. Store in the original packaging to protect it from light.Never store an opened ampule. Once opened, the ampule must be used immediately and any remaining product must be discarded.

Do not use this medication if you observe visible signs of deterioration (turbidity in the solution). Tobramicina may be slightly yellowish and a color variation may be observed; this is not indicative of loss of activity if the solution has been stored as recommended.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Tobramycin Teva Inhalation Solution for Nebulizer Composition

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

Product Appearance and Packaging Content

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

It is presented in single-dose 5 ml ampoules.

Four ampoules are packaged and sealed in an aluminum bag..

Each package consists of 14 (56 ampoules), 28 (112 ampoules) or 42 (168 ampoules) aluminum bags, sufficient for one, two or three treatment cycles, respectively.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas (Madrid)

Spain

Responsible 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 Harlem

Netherlands

or

Merckle GmbH

Ludwig-Merckle-Str. 3

89143 Blaubeuren

Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with 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 Teva300 mg/5 ml soluzione per nebulizzatore

Portugal:Tobramicina Teva

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

Netherlands:Tobramycine 300 mg/5 ml PCH, vernevelossing

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

Last review date of this leaflet:February 2022

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