Prospect: information for the patient

Tobramycin Altan300 mg/5 ml Solution for inhalation by nebulizer

Tobramycin

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, 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 you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Tobramycin Altan and how it is used

2.What you need to know before starting to use Tobramycin Altan

3.How to use Tobramycin Altan

4.Possible adverse effects

5.Storage of Tobramycin Altan

6.Contents of the package and additional information

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

What is Tobramicina Altan used forTobramicina Altan

Tobramicina Altan is used in patients aged 6 years and older with cystic fibrosis for the treatment of lung infections caused by a bacteria calledPseudomonas aeruginosa.

Tobramicina Altan combats the infection caused by the Pseudomonas bacteria in your lungs and helps improve your breathing.

How Tobramicina Altan works

When you inhale Tobramicina Altan, 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 prospectus.

What isPseudomonas aeruginosa?

It is a very common bacteria 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 controlled properly, it can continue to damage your lungs, causing additional problems with your breathing.

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

Do not useTobramycin

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

If any of these cases mentioned above apply to you, do not take this medicine and consult your doctor.

Consult your doctor if you think you may be allergic.

Warnings and precautions:

Consult your doctor before starting to useTobramycinif you suffer or have ever suffered from 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 cough, 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 Tobramycin

If you or your maternal family members have a disease caused by a mitochondrial mutation (a genetic disease) or hearing loss due to antibiotics, it is recommended that you inform your doctor or pharmacist before taking this medicine. Certain mitochondrial mutations may increase your risk of hearing loss with this product. Your doctor may recommend genetic tests before administering tobramycin.

The inhalation of medicines can cause chest tightness and wheezing and this may occur with Tobramycin. Your doctor will monitor your first dose of Tobramycin and check your lung function before and after the dose. If you are not doing this, your doctor may make you use a bronchodilator (e.g. salbutamol) before using Tobramycin.

If you are using Tobramycin, Pseudomonas bacteria 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.

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

Children and adolescents

Tobramycincan be administered to children and adolescents from 6 years of age. Tobramycin cannot be administered to children under 6 years of age.

Older adults

If you are 65 years old or older, your doctor may perform additional tests to decide if Tobramycin is a correct treatment for you.

Use of Tobramycin with other medicines

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

You should not take the following medicines while usingTobramycin:

• Furosemide or ethacrynic acid, diuretics
• Urea or mannitol intravenously
• Other medicines that may damage your nervous system, kidneys, or ears.

The following medicines may increase the appearance of harmful effects if administered while you are receivinginjectionsof 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 ears.
• Anticholinesterases (such as neostigmine and pyridostigmine), or botulinum toxin: these medicines may cause the appearance or worsening of muscle weakness.

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

You should not mix or dilute Tobramycin with any other medicine 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 medicines
4. Tobramycin. 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 of this medicine causing harm to you or the fetus.

The effects of inhaling this medicine when pregnant are unknown.

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

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

Driving and operating machinery

Tobramycin should not affect your ability to drive and operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

What amount of this medication should you use and how often you should use it

• The recommended dose is the same for all people aged 6 years and above.
• Usetwoampoules every day, for 28 days. Inhale the complete content of one ampoule in the morning and another in the evening. Ideally, there should be a 12-hour interval between doses.
• You should leave a period ofat least 6 hoursbetween the two inhalations of Tobramicina.
• After taking your medication for 28 days, you will then have a 28-day interval in which you should not inhale any dose of Tobramicina, 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 that you maintain the28-day treatment cycles, 28-day rest periods.

Repeat the cycle

If you use more Tobramicina than you should

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

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

If you forgot to use Tobramicina

If you forgot to use Tobramicina 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 using Tobramicina

This part of the prospectus explains how to use, care for, and handle Tobramicina. Read and follow these instructions carefully.

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

The equipment you need to inhale Tobramicina

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

The PARI LCPLUS(manufactured by PARI GmbH) nebulizer is suitable for use with Tobramicina.

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

Preparing Tobramicina for inhalation

• Wash your hands carefully with soap and water.

• Each aluminum foil package of Tobramicina contains a tray with 14 ampoules. Cut or tear the package. Remove one ampoule of Tobramicina from the tray by gently pulling the lower tab to separate it from the rest of the ampoules. Put the tray back in the aluminum foil package 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 using your nebulizer model, you must read the user manual that the manufacturer attaches with the nebulizer. Check that your nebulizer and compressor are working properly according to the manufacturer's instructions before starting to use your medication.

Using Tobramicina with LCPLUS(PARI GmbH)

For more detailed instructions on using and caring for the nebulizer, read the user manual that comes with the PARI LCPLUS.

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.

1. 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.

1. Open the ampoule of Tobramicina by holding the lower tab with one hand and separating the top end with the other hand, twisting it. 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 inhalation valve cap on the nebulizer. Then connect the compressor as indicated in the user manual for your PARI LCPLUS nebulizer.

1. 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.

1. Sit or stand in a position where you can breathe normally

1. 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 Altan has been consumed and no more mist is produced. 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. Do not 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 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 Tobramicina andinform 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 you are using Tobramicina. This may be due to lack of effectiveness. Inform your doctor immediately if this occurs.

Some side effects are very common

These side effects can 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 can 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 Tobramicina at the same time or after repeated cycles of tobramycin or other aminoglycoside antibiotics, hearing loss has been reported as a side effect.

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

Patients with cystic fibrosis may experience several symptoms characteristic of the disease. These may even occur while taking Tobramicina but should not be more frequent or appear worse than before treatment.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possibleside 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, or printed on the ampule.
• Do not use this medication if it becomes cloudy or if there are particles in the solution.
• Store in refrigerator(between2°Cand8°C). If you do not have a refrigerator (for example during medication transport) you can keep the aluminum bags (open or closed) at room temperature (not above25°C) for a maximum of 28 days.
• Do not use Tobramycin ampules if they have been stored at room temperature for more than 28 days.
• Store the ampule in the original packaging to protect it from light. This medication usually has a light yellow color, which may vary and sometimes may be dark yellow. This does not affect the activity of this medication, as long as the storage instructions are followed.

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

Composition of Tobramicina Altan

• The active ingredient is tobramycin. Oneampoule contains 300 mg of tobramycin as a single dose.
• The other components are sodium chloride, water for injection, sodium hydroxide, and sulfuric acid (to adjust the acidity level).

Appearance of the product and contents of the packagingTobramicina Altan is a transparent, slightly yellow solution that is presented in a ready-to-use ampoule.

The ampoules are packaged in aluminum bags, one aluminum bag contains 7 ampoules that correspond to 7 days of treatment.

Tobramicina Altan is available in packaging of 56 ampoules, which are sufficient for a treatment cycle.

It may be that not all packaging sizes are marketed.

Holder of the marketing authorization:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1st Floor, Office F.

Edificio Prisma,

Las Rozas, 28230 Madrid

Responsible for manufacturing:

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo, s/n

01118 Bernedo (Álava)

Spain

Altan Pharmaceuticals, S.A.

Avda. de la Constitución, 198-199

Polígono Industrial Monte Boyal, Casarrubios del Monte, 45950 Toledo

Spain

This medicine is authorized in the following member states of the EU with the following names:

France: Tobramycine Zentiva 300 mg/5 ml Solution for inhalation by nebulizer

Germany: Tobramycin Zentiva 300 mg/ 5 ml Solution for a nebulizer

Italy: Tobramicina Altan 300 mg/5 ml solution for nebulizer

Portugal: Tobramicina Altan. 300 mg/ 5 ml Solution for Inhalation by Nebulization

Spain: Tobramicina Altan. 300 mg/ 5 ml Solution for inhalation by nebulizer

United Kingdom: Tobramycin 300 mg/ 5 ml Nebuliser solution

Last review date of this leaflet: October 2023

Other sources of information

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