TOBI PODHALER 28 mg POWDER FOR INHALATION (HARD CAPSULE)

Introduction

Package Leaflet: Information for the User

TOBI Podhaler 28mg powder for inhalation (hard capsule)

tobramycin

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is TOBI Podhaler and what is it used for
2. What you need to know before you use TOBI Podhaler
3. How to use TOBI Podhaler
4. Possible side effects
5. Storage of TOBI Podhaler
6. Contents of the pack and further information

Instructions for use with the Podhaler device (on the back)

1. What is TOBI Podhaler and what is it used for

What isTOBI Podhaler

TOBI Podhaler contains a medicine called tobramycin which is an antibiotic. This antibiotic belongs to a class called aminoglycosides.

What is TOBI Podhaler used for

TOBI Podhaler is used in patients aged 6 years and older who have cystic fibrosis to treat lung infections caused by a bacterium called Pseudomonas aeruginosa.

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

How TOBI Podhaler works

TOBI Podhaler is a powder for inhalation that is contained within capsules. When you inhale TOBI Podhaler, the antibiotic can go directly to your lungs to fight the bacteria that cause the infection and improve your breathing.

What isPseudomonas aeruginosa

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

2. What you need to know before you use TOBI Podhaler

Do not useTOBI Podhaler

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

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

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

Warnings and precautions

Tell your doctor if you have or have ever 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
• certain genetic variants (a change in the gene) related to inherited hearing loss from your mother

• kidney problems

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

• 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 apply to you, tell your doctor before taking TOBI Podhaler.

If you are 65 years or older, your doctor may perform additional tests to decide if TOBI Podhaler can work for you.

Inhaling medicines can cause chest tightness and wheezing and this can happen immediately after inhaling TOBI Podhaler. Your doctor will supervise the first dose of TOBI Podhaler and monitor your lung function before and after administration. You may be asked to use other appropriate medicines before taking TOBI Podhaler.

Inhaling medicines can also cause coughing and this can happen with TOBI Podhaler. Tell your doctor if the cough persists and is bothersome.

Over time, Pseudomonasstrains can become resistant to treatment with an antibiotic. This means that over time, TOBI Podhaler may stop working as it should. Tell your doctor if this concerns you.

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

Children

TOBI Podhaler should not be given to children under 6 years of age.

Other medicines and TOBI Podhaler

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Do not use the following medicines while taking TOBI Podhaler:

• Furosemide or ethacrynic acid, diuretics
• Other medicines with diuretic properties such as intravenous urea or mannitol

• Other medicines that can harm your kidneys or ears.

The following medicines may increase the risk of harmful effects if given while you are receiving injectionsof tobramycin or another aminoglycoside antibiotic:

• Amphotericin B, cephalothin, polymyxins (used to treat microbial infections), cyclosporine, tacrolimus (used to reduce the activity of the immune system). These medicines can harm your kidneys.
• Platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer). These medicines can harm your kidneys or ears.
• Anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin. These medicines can cause or worsen muscle weakness.

If you are taking one or more of the above medicines, discuss this with your doctor before taking TOBI Podhaler.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

It is not known if inhaling this medicine during pregnancy causes adverse effects.

When given by injection, tobramycin and other aminoglycoside antibiotics can cause harm to a fetus, such as deafness.

If you are breastfeeding, ask your doctor before taking this medicine.

Driving and using machines

TOBI Podhaler has no or negligible influence on the ability to drive and use machines.

3. How to use TOBI Podhaler

Follow the instructions for administration of TOBI Podhaler given by your doctor. If you are unsure, ask your doctor again.

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

How much TOBI Podhaler to use

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

The dose is the same for anyone aged 6 years and older. Do not exceed the recommended dose.

When to use TOBI Podhaler

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

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

If you are using several different inhaled treatments and are following other therapies for cystic fibrosis, you should use TOBI Podhaler after you have done all the others. Check with your doctor the order of the medicines.

How to use TOBI Podhaler

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

For how long to use TOBI Podhaler

After you have used TOBI Podhaler for 28 days, you should take a break from treatment for 28 days, during which you will not inhale TOBI Podhaler. Then you will start another cycle.

It is important that you systematically use the product twice a day for 28 days with treatment and that you respect the cycle of 28 days with treatment and 28 days without treatment.

Repeat the cycle

Continue using TOBI Podhaler as directed by your doctor.

If you are unsure how long to use TOBI Podhaler, consult your doctor or pharmacist.

If you use more TOBI Podhaler than you should

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

If you forget to use TOBI Podhaler

If you forget to use TOBI Podhaler and it is at least 6 hours before your next dose, inhale the dose as soon as you can. Otherwise, wait for your next dose. Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

People with cystic fibrosis have many symptoms of the disease. These may still occur while you are using TOBI Podhaler, but they should not happen more often or get worse.

If your underlying lung disease worsens while you are using TOBI Podhaler, tell your doctor immediately.

Some side effects can be serious

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

If you experience any of these, stop using TOBI Podhaler and tell your doctor immediately.

• Coughing up blood (very frequent)
• Hearing loss (ringing in the ears is a possible warning sign of hearing loss), noises (such as hissing) in the ears (frequent).
• Low urine output, vomiting, confusion, and swelling of legs, ankles, or feet, as these can be signs of sudden kidney function decrease (unknown)

If you experience any of these, tell your doctor immediately.

Other side effects may include:

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

• Shortness of breath
• Cough, productive cough, voice alteration (hoarseness)
• Sore throat
• Fever

Frequent (may affect up to 1 in 10 people)

• Wheezing, crackling
• Chest discomfort, chest pain of muscular or bone origin
• Stuffy nose
• Nosebleed
• Vomiting, nausea
• Diarrhea
• Skin rash
• Alteration of taste
• Loss of voice.

Frequency not known (cannot be estimated from the available data)

• Feeling unwell
• Change in the color of the sputum (phlegm)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of TOBI Podhaler

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton or blister pack.

• Store in the original package to protect from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and additional information

Composition ofTOBI Podhaler

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

Appearance of the product and pack contents

TOBI Podhaler powder for inhalation (hard capsule) consists of a powder for inhalation of white to off-white color filled in hard, transparent, and colorless 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 Podhaler is supplied in monthly packs containing 4 weekly boxes and a reserve Podhaler device in its protective case.

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

The following pack sizes are available:

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

224 (4 x 56) powder for inhalation (hard capsule) and 5 inhalers (multiple monthly pack)

448 (8 x 56) powder for inhalation (hard capsule) and 10 inhalers (2 x multiple monthly pack wrapped in a foil)

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

You can request more information about this medicinal product from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: April 2025

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency web site: https://www.ema.europa.eu

INSTRUCTIONS FOR USE OF THE PODHALER DEVICE

Read carefully the following instructions to learn how to use and care for your Podhaler device.

Inside your weekly pack of TOBI Podhaler

Each weekly pack of TOBI Podhaler contains:

• 1 inhaler (the Podhaler device) and its protective case.
• 7 capsule plates (one plate for each day of the week).
• Each capsule plate contains 8 capsules (corresponding to a daily dose: you should inhale the contents of 4 capsules in the morning and the contents of 4 capsules in the evening).

How to inhale your medication with the Podhaler device

• Use only the Podhaler device contained in this pack.Do not use the TOBI Podhaler capsules with any other device, and do not use the Podhaler device to take any other medication.
• When you start a new weekly pack of capsules, use the new Podhaler device included in the pack. Each Podhaler device is used only for 7 days. Ask your pharmacist how to dispose of unused medications and inhalers.
• Do not swallow the capsules.The powder from the capsules is for inhalation only.
• Always keep the capsules in the capsule plate until you need to use them. Do not remove them from the capsule plate beforehand.
• When not in use, keep the Podhaler device in its protective case.

REMEMBER:

• For inhalation use only.
• Do not swallow the TOBI Podhaler capsules.
• Use only the inhaler contained in this pack.
• Always keep the TOBI Podhaler capsules in the capsule plate. Remove a capsule only just before you are about to use it. Do not store the capsules in the inhaler.
• Always keep the TOBI Podhaler capsules and the device in a dry place.
• Never place the TOBI Podhaler capsules directly into the mouthpiece of the device.
• Always keep the device with the mouthpiece facing down while puncturing the capsule.
• Never press the puncture button more than once at the same time.
• Never blow into the mouthpiece of the device.
• Never wash the Podhaler device with water. Keep it dry and store it in its case.

Additional information

Occasionally, tiny fragments of the capsule may pass through the filter and enter your mouth.

• If this happens, you may notice these fragments on your tongue.
• If these fragments are swallowed or inhaled, they are not harmful to your health.

• The possibility of the capsule breaking into fragments may increase if the capsule is accidentally punctured more than once or if the device is not kept with the mouthpiece facing down during step 7.