Prospecto: information for the user

Bramitob 300mg/4ml solution for inhalation by nebulizer

Tobramycin

Read this prospect carefully before starting to use this medicine because it contains important information for you.

BRAMITOB contains tobramycin, an antibiotic from the aminoglycoside family, useful for combating infections caused byPseudomonas aeruginosa.

BRAMITOB is used to treat chronic respiratory infections in patients with cystic fibrosis caused by a type of bacteria calledPseudomonas. This medication destroys bacteria and helps improverespiration.Pseudomonasis a common bacteria that infects almost all patients with cystic fibrosis at some point in their lives. Some people do not contract this infection until advanced age, while others contract it at a very young age. If not properly treated, the infection will continue to damage the lungs and cause additional problems. BRAMITOB is administered via inhalation, allowing tobramycin to reach the lungs directly to combat the bacteria causing the infection.

BRAMITOB is indicated only for patients over 6 years old.

To achieve the best possible result, you must use this medication as instructed.

Do not use Bramitob:

• If you are allergic to tobramycin or any of the other components of this medication (listed in section 6) or to any other aminoglycoside antibiotic.
• If you are taking any of the medications listed in the section “Other medications and Bramitob”.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Bramitob.

Bramitob contains tobramycin, which belongs to a group of medications that, on occasion, may cause loss of hearing, dizziness, and kidney damage.(see section 4 "Possible side effects"). Inform your doctor if you experience any of the following:

• If you feel chest tightness after using Bramitob.Your doctor will supervise the administration of the first dose of Bramitob and check your lung function before and after administration. If you do not yet use a bronchodilator (for example, salbutamol), your doctor may recommend that you use it before the administration of Bramitob.
• If you have ever experienced any type of neuromuscular disorders such as parkinsonism or other alterations characterized by muscle weakness, including myasthenia gravis.
• If you have ever had kidney problems. Before using Bramitob, your doctor may check if your renal function is adequate by performing a test on urine or blood samples. Your doctor may monitor this function regularly throughout treatment.
• If you have ever experienced ringing in the ears, any other hearing problems, or dizziness. Your doctor may check your hearing before administering Bramitob or at any time during treatment.
• If you detect blood in your sputum. Inhalation of medications may cause coughing, and your doctor may recommend that you stop treatment with Bramitob until almost no blood remains in your sputum, or until it has completely disappeared.
• If you are concerned that Bramitob is not as effective as it should be. Bacteria sometimes develop resistance to antibiotic treatment.

Other medications and Bramitob

Before starting treatment, inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• Do not use Bramitob if you are taking diuretics (medications that increase urine volume) containing furosemide or etacrynic acid without consulting your doctor.
• Do not use Bramitob if you are taking intravenous and oral urea or manitol (medications used to treat serious diseases in hospitalized patients).
• Some medications may cause kidney or ear damage that may be exacerbated by treatment with Bramitob.

You may receive injections of tobramycin or other aminoglycosides while receiving treatment with inhaled Bramitob. Administration of these injections should be avoided while taking any of the medications listed below, as they may increase the low levels of aminoglycosides caused by inhaled Bramitob:

• amphotericin B, cephalothin, polymyxins (medications for treating bacterial and fungal infections)
• ciclosporin, tacrolimus (medications for controlling immune response in transplant patients)
• platinum compounds used for cancer treatment (for example, carboplatin and cisplatin)
• medications with anticholinesterase activity used to relax muscles (for example, neostigmine and pyridostigmine), botulinum toxin

If this is your case, inform your doctor.

Pregnancy and breastfeeding

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

It is not known if inhaling this medication during pregnancy causes side effects. When administered by injection, tobramycin and other aminoglycoside antibiotics may cause fetal damage, such as hearing loss and kidney problems.

If you are breastfeeding, consult your doctor before using this medication.

Driving and operating machinery

Bramitob has a minimal influence on the ability to drive and operate machinery.

In rare cases, Bramitob may cause dizziness. Consequently, Bramitob may affect your ability to drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The usage instructions for Bramitob are included after the Dosage section.

Do notmix or dilute Bramitob with other medications in the nebulizer.

If you are receiving different treatments for cystic fibrosis, use them in the following order:

• bronchodilator (for example, salbutamol), next
• respiratory physiotherapy, next
• other inhaled medications, last
• Bramitob

Consult the indicated order with your doctor.

Bramitob must be used with a reusable PARI LC PLUS or PARI LC SPRINT nebulizer (only for personal use), clean and dry, along with an appropriate compressor. Ask your doctor or physiotherapist for information on which compressor is best for your case.

The single-dose Bramitob container must be opened just before use. Any solution that is not used must be discarded immediately.

Dosage

• The dose (one 4 ml container) is the same for all people aged 6 years and above.
• Usetwocontainers per day for 28 days. Inhale the contents of one container in the morning and the other at night. You must leave a 12-hour interval between each dose.
• Subsequently, rest for 28 days without taking the medication before starting a new 28-day treatment cycle.
• It is essential that you use the medication twice a day during the 28-day treatment period, and that you respect the28-day treatment cycles followed by 28 days without treatmentwithBramitob. Continue usingBramitobin this manner until your doctor tells you to stop.

If you use more Bramitob than you should

If you inhale too much Bramitob, your voice may become hoarse. 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, phone91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Bramitob

• If more than 6 hours have elapsed until the next dose (container), use Bramitob now.
• If less than 6 hours have elapsed until the next dose (container), skip this dose (container).

Continue with the next dose in a normal manner.

Usage instructions

Bramitobmust be used exclusively in a nebulizer; do not use it in any other way.

1. Wash your hands thoroughly with water and soap before opening the single-dose container according to the following instructions.
2. Double the single-dose container forward and backward (figure A).
3. Separate a new container carefully from the strip, first from the top and then from the middle (figure B), leaving the rest in the aluminum wrapping.
4. Open the single-dose container by turning the top in the direction indicated by the arrow (figure C).
5. Gently press the container to transfer its contents to the nebulizer chamber (figure D).

1. Connect the compressor.
2. Check that the mist coming out of the mouthpiece is uniform.
3. Stand or sit up to breathe normally.
4. Place the mouthpiece between your teeth and the top ofyour tongue. Breathenormally, although only through your mouth (you can use nose clips as a help). Try not to block the airflow with your tongue.
5. Continue until you have consumed the entire Bramitob, which occurs after approximately 15 minutes.
6. If someone interrupts you, or you need to cough or rest during the administration of the medication, turn off the compressor to save medication. Reconnect the compressor when you are ready to start treatment.

If you still have doubts about how to use this medication, consult your doctor or pharmacist.

Maintenance of the nebulizer and compressor:

Follow the manufacturer's instructions for the maintenance and use of the nebulizer and compressor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you are unsure about any of the side effects listed below, ask your doctor to explain them to you.

The mostfrequentside effects of Bramitob that may affect up to 1 in 10 people are: cough and hoarseness.

The lessfrequentside effects of Bramitob that may affect up to 1 in 100 people are: mouth ulcers (due to candida infection), dizziness, hearing loss, increased saliva production, tongue inflammation, rash, sore throat, and alteration of liver function test (elevated liver enzymes), wheezing, nausea, dry mucosa, presence of blood in sputum, oropharyngitis (throat inflammation), chest pain, hearing loss, headache, breathing difficulty, weakness, increased sputum production (substance excreted when coughing), stomach pain, and fungal infections.

The rareside effects that may affect up to 1 in 1,000 people are: loss of appetite, ringing in the ears, chest tightness or difficulty breathing, loss of voice, nasal bleeding, nasal secretion, mouth ulcers, vomiting, taste alterations, asthma, dizziness, muscle weakness, fever, and laryngitis (voice alteration with sore throat and difficulty swallowing).

The very rareside effects that may affect up to 1 in 10,000 people are: lymph node swelling, drowsiness, hearing problems, ear pain, rapid and deep breathing (hyperventilation), sinusitis (inflammation of nasal sinuses), diarrhea, allergic reactions including urticaria and pruritus, oxygen deficiency in the blood and tissues (hypoxia), back pain, pain, abdominal discomfort, and general feeling of unease.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Use Website:www.notificaram.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.

• For single use only. Do not use this medication after the expiration date that appears on the label and on the outer packaging next to CAD. The expiration date is the last day of the month indicated. Bramitob can also be used even if the color of the solution has changed.

Expiration in use: Bramitob bags (intact or opened) can be stored for up to 3months at a temperature not exceeding 25°C.

• Store the containers in the refrigerator (between 2°C and 8°C). If a refrigerator is not available and for transportation, store the containers for up to 3months at a temperature below 25°C.

• Store the containers in the original packaging to protect them from light.

• After opening the single-dose container, use it immediately.

• After the first administration, dispose of the used single-dose container immediately.

• Medicines should not be thrown away through drains or in the trash. Deposit the containers and medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Bramitob

The active principle is tobramycin. Each 4ml of the single-dose container contains 300mg of tobramycin.

The other components (excipients) are: sodium chloride, sulfuric acid and sodium hydroxide (to adjust the pH), water for injectable preparations.

Appearance of the product and contents of the container

Bramitob is presented as a clear yellowish solution.

Bramitob solution for nebulization is presented in single-dose containers of 4ml. Each sealed bag contains 4 containers, in sizes of 4, 16, 28 or 56 units.

Only some container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Chiesi España, S.A.U., Plaça d’Europa, 41-43, 10th floor – 08908 L’Hospitalet de Llobregat - Barcelona (Spain)

Responsible manufacturer:

Chiesi Farmaceutici S.p.A., 96 Via San Leonardo, 43122 Parma (Italy).

or

Genetic S.p.A., Contrada Canfora, 84084 Fisciano (Italy).

This medicine has been authorized in the following member states of the European Economic Area with the following names:

Austria: Bramitob

Czech Republic: Bramitob

Denmark: Bramitob

Finland: Bramitob

Germany: Bramitob

Greece: Bramitob

Hungary: Bramitob

Ireland: Bramitob

Italy: Tobrineb

Netherlands: Bramitob

Norway: Bramitob

Poland: Bramitob

Portugal: Bramitob

Slovak Republic: Bramitob

Spain: Bramitob

Sweden: Bramitob

United Kingdom (Northern Ireland): Bramitob

Last review date of this leaflet:January 2022.

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

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:

https://www.aemps.gob.es/cima/especialidad.do?metodo=verPresentaciones&codigo=68621