Prospecto: information for the user

TOBI Podhaler 28mg powder for inhalation (hard capsule)

tobramycin

Read this prospect carefully before starting to take this medicine, because 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 medicine 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 section4.

1.What isTOBI Podhalerand what it is used for

2.What you need to know before starting to useTOBI Podhaler

3.How to useTOBI Podhaler

4.Possible adverse effects

5.Storage ofTOBI Podhaler

6.Contents of the package and additional information

Usage instructions with the Podhaler device (back)

What isTOBI Podhaler

TOBI Podhalercontains a medicine called tobramycin that is an antibiotic. This antibiotic belongs to a class called aminoglycosides.

What is TOBI Podhaler used for

TOBI Podhaleris used in patients aged6years and older who have cystic fibrosis to treat lung infections caused by a bacteria calledPseudomonas aeruginosa.

To get the best results with this medicine, use it as indicated in this leaflet.

How TOBI Podhaler works

TOBI Podhaler is an inhalation powder contained within capsules. When you inhale TOBI Podhaler, the antibiotic can reach your lungs directly to combat the bacteria causing the infection and improve your breathing.

What isPseudomonas aeruginosa

It is a very common bacteria that infects the lungs of almost all people with cystic fibrosis at some point in their lives. Some people do not contract this infection until later stages of their lives, while others contract it very young. It is one of the most harmful bacteria for those with cystic fibrosis. If the infection is not adequately combated, it will continue to damage your lungs, and cause you more respiratory problems.

No use TOBI Podhalerif you are allergic

• to tobramycin, any aminoglycoside antibiotic, or any of the other ingredients in this medication (listed in section 6)

If this applies to you, inform your doctor before takingTOBI Podhaler.

If you think you may be allergic, ask your doctor for advice.

Warnings and precautions

Inform your doctor if you have or have had any of the following conditions:

• hearing problems (including ringing in the ears and dizziness); or your mother has had hearing problems after taking an aminoglycoside
• specific genetic variants (a change in the gene) related to inherited hearing anomalies from your mother

• kidney problems

• excessive difficulty breathing with wheezing or coughing, feeling of chest tightness
• blood in sputum (the substance expelled when coughing)

• muscle weakness that persists or worsens over time, a symptom mainly related to conditions such as myasthenia or Parkinson's disease

If any of these conditions apply to you, inform your doctor before takingTOBI Podhaler.

If you are 65 years or older, your doctor may perform additional tests to decide ifTOBI Podhalercan be used.

Inhaling medications can cause chest tightness and wheezing, and this may occur immediately after inhalingTOBI Podhaler. Your doctor will supervise the first dose ofTOBI Podhalerand monitor your lung function before and after administration. Your doctor may ask you to use other appropriate medications before takingTOBI Podhaler.

Inhaling medications can also cause coughing, and this may occur withTOBI Podhaler. Inform your doctor if the cough persists and is bothersome.

Over time, strains ofPseudomonasmay become resistant to treatment with an antibiotic. This means that, over time, TOBI Podhalermay no longer work as it should. Inform your doctor if this concerns you.

If you are taking tobramycin or any other aminoglycoside antibiotic by injection, these may sometimes cause hearing loss, dizziness, and kidney damage.

Children

TOBI Podhaler should not be administered to children under 6 years.

Other medications and TOBI Podhaler

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those purchased without a prescription.

You should not use the following medications while takingTOBI Podhaler:

• furosemide or ethacrynic acid, diuretics
• other medications with diuretic properties such as urea or intravenous mannitol

• other medications that may damage your kidneys or ears

The following medications may increase the likelihood of adverse effects if administered while receiving injections of tobramycin or another aminoglycoside antibiotic:

• amphotericin B, cephalothin, polymyxins (used to treat microbial infections), cyclosporine, tacrolimus (used to reduce immune system activity). These medications may damage your kidneys.
• platinum compounds such as carboplatin and cisplatin (used to treat certain types of cancer). These medications may damage your kidneys or ears.
• anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), 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 takingTOBI Podhaler.

Pregnancy and breastfeeding

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

The safety of inhaling this medication during pregnancy is 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 taking this medication.

Driving and operating machinery

TOBI Podhaler has no or negligible influence on the ability to drive and operate machinery.

Follow exactly the administration instructions for TOBI Podhaler as indicated by your doctor. In case of doubt, consult your doctor again.

Caregivers should provide assistance to children starting treatment with TOBI Podhaler, especially to children 10 years of age or younger, and should continue supervising them until they are able to use the Podhaler device properly without assistance.

How much TOBI Podhaler to use

Inhale the contents of 4 capsules twice a day (4 capsules in the morning and 4 capsules at night) using the Podhaler device.

The dose is the same for anyone 6 years of age or older. Do not exceed the recommended dose.

When to use TOBI Podhaler

Administering the capsules at the same time each day will help you remember when to administer them. Inhale the contents of 4 capsules twice a day as follows:

• You must inhale the contents of 4 capsules in the morning using the Podhaler device.
• You must inhale the contents of 4 capsules at night using the Podhaler device.
• You must leave an interval as close as possible to 12 hours between doses, but this must be at least 6 hours.

If you are using different inhalation treatments and are following other therapies for cystic fibrosis, you must use TOBI Podhaler after completing all the above. Check with your doctor the order of medications.

How to use TOBI Podhaler

• For inhalation use only.
• Do not swallow the capsules.
• Use the capsules only with the inhaler provided in the package. The capsules must be stored in the capsule tray until you need to use them.
• When starting a new weekly capsule pack, use the new inhaler provided in the package. Each inhaler must be used only for 7 days.
• Read the instructions at the end of this leaflet for more information on how to use the inhaler.

For how long to use TOBI Podhaler

After using TOBI Podhaler for 28 days, you must take a 28-day break, during which you will not inhale TOBI Podhaler. Then, start another cycle.

It is essential to use the product systematically twice a day during the 28 days of treatment and to respect the cycle of 28 days of treatment and 28 days without it.

Repeat the cycle

Continue using TOBI Podhaler as your doctor instructs.

If you have any doubts about how long you should use TOBI Podhaler, consult your doctor or pharmacist.

If you use more TOBI Podhaler than you should

If you inhale too much TOBI Podhaler, inform your doctor as soon as possible. If you swallow TOBI Podhaler, do not worry but inform your doctor as soon as possible.

If you forgot to use TOBI Podhaler

If you forgot to use TOBI Podhaler and at least 6 hours have passed before the next dose, inhale the 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 have any other questions about the use of this medication, ask your doctor or pharmacist.

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

People with cystic fibrosis suffer from many symptoms of the disease. These may still occur while using TOBI Podhaler, but they should not occur more frequently or worsen.

If your underlying lung disease worsens while using TOBI Podhaler,inform your doctor immediately.

Some side effects may be serious

• Excessive difficulty breathing with whistling or coughing and chest tightness (frequent).

If you experience any of them,interrupt the use ofTOBI Podhaler and inform your doctor immediately.

• Bloody sputum when coughing (very frequent)
• Decreased hearing (tinnitus may be a warning sign of hearing loss), ringing or buzzing in the ears (frequent).

If you experience any of them,inform your doctor immediately.

Other side effects may include:

Very frequent(may affect more than 1 in 10people)

• Sensation of choking
• Coughing, productive cough, voice alteration (hoarseness)
• Throat pain
• Fever

Frequent(may affect up to 1 in 10people)

• Whistling, crackles (crepitus)
• Chest discomfort, chest pain of muscular or bony origin
• Stuffy nose
• Nasal bleeding
• Vomiting, nausea
• Diarrhea
• Skin rash
• Alteration of taste
• Loss of voice.

Unknown frequency(cannot be estimated from available data)

• General feeling of discomfort
• Change in color of the substance expectorated (sputum)

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly to the Spanish System of Pharmacovigilance of Medicines for Human Use: https://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 box or capsule label.

• Store in the original packaging to protect it from moisture.

Once the capsule is removed from the blister pack, it must be used immediately.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition ofTOBI Podhaler

• The active ingredient is tobramycin. A capsule contains 28mg of tobramycin.
• The other components are DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), calcium chloride, sulfuric acid (for pH adjustment).

Appearance of the product and contents of the pack

TOBI Podhaler powder for inhalation (hard capsule) consists of a white to off-white powderfilled in transparent and colourless hard capsules with« MYL TPH»printed in blue on one part of the capsule and the Mylan logo printed in blue on the other part of the same.

TOBI Podhaleris supplied in monthly packs containing 4weekly boxes and a spare Podhaler device in its storage case.

Each weekly box contains 7blister packs (capsule plates) of 8capsules each, and a Podhaler device in its storage case.

The following pack sizes are available:

56powder for inhalation (hard capsule) and 1inhaler (weekly pack)

224(4x56) powder for inhalation (hard capsule) and 5inhalers (monthly pack)

448(8x56) powder for inhalation (hard capsule) and 10inhalers (2x monthly pack wrapped in a sheet)

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart

Dublin 15

DUBLIN

Manufacturer

McDermott Laboratories Ltd T/A Mylan Dublin Respiratory

Unit 25, Baldoyle Industrial Estate

Grange Road, Baldoyle

Dublin 13, D13 N5X2

Ireland

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe

Benzstrasse 1

61352 Bad Homburg v. d. Hoehe

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet: 03/2023

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu

INSTRUCTIONS FOR USE OF THE PODHALER DEVICE