Tobi Podhaler 28 mg powder for inhalation (hard capsule)
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
TOBI Podhaler 28 mg powder for inhalation (hard capsule)
tobramycin
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What TOBI Podhaler is and what it is used for
- What you need to know before using TOBI Podhaler
- How to use TOBI Podhaler
- Possible adverse effects
- How to store TOBI Podhaler
- Contents of the pack and other information
Instructions for use with the Podhaler device (on the reverse)
1. What TOBI Podhaler is and what it is used for
What is TOBI Podhaler
TOBI Podhaler contains a medicine called tobramycin, which is an antibiotic. This antibiotic belongs to a class known as aminoglycosides.
What TOBI Podhaler is 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 exactly as instructed in this leaflet.
How TOBI Podhaler works
TOBI Podhaler is a powder for inhalation contained within capsules. When you inhale TOBI Podhaler, the antibiotic reaches your lungs directly to fight the bacteria causing the infection and improve your breathing.
What is Pseudomonas aeruginosa
Pseudomonas aeruginosa is a very common bacterium that infects the lungs of almost all people with cystic fibrosis at some point in their lives. Some individuals do not acquire this infection until later in life, while others become infected at a very young age. It is one of the most harmful bacteria for people with cystic fibrosis. If the infection is not adequately treated, it will continue to damage your lungs and cause increasing breathing problems.
2. What you need to know before using TOBI Podhaler
Do not use TOBI Podhaler
- if you are allergic to tobramycin, to any type of aminoglycoside antibiotic, or to any of the other ingredients of this medicine (listed in section 6).
If this applies to you, inform your doctor before taking TOBI Podhaler.
If you think you may be allergic, consult your doctor for advice.
Warnings and precautions
Inform your doctor if you have or have ever had any of the following conditions:
- hearing problems (including ringing in the ears and dizziness); or if your mother had hearing problems after taking aminoglycosides
- certain genetic variants (a change in the gene) associated with maternally inherited hearing disorders
- kidney problems
- excessive difficulty breathing with wheezing or coughing, or a feeling of tightness in the chest
- blood in the sputum (the substance you cough up)
- persistent or worsening muscle weakness, a symptom mainly related to conditions such as myasthenia gravis or Parkinson's disease
If any of these apply to you, inform your doctor before taking TOBI Podhaler.
If you are 65 years of age or older, your doctor may carry out additional tests to determine whether TOBI Podhaler is suitable for you.
Inhaling medication may cause chest tightness and wheezing, which may occur immediately after inhaling TOBI Podhaler. Your doctor will supervise your first dose of TOBI Podhaler and monitor your lung function before and after administration. Your doctor may ask you to use other appropriate medications before taking TOBI Podhaler.
Inhaling medication may also cause coughing, which may occur with TOBI Podhaler. Inform your doctor if coughing persists and is bothersome.
Over time, Pseudomonas strains may become resistant to antibiotic treatment. This means that TOBI Podhaler may eventually stop working as effectively. Inform your doctor if you are concerned about this.
If you are receiving injectable tobramycin or any other aminoglycoside antibiotic, these may occasionally cause hearing loss, dizziness, and kidney damage.
Children
TOBI Podhaler must not be given to children under 6 years of age.
Other medicines and TOBI Podhaler
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
You must not use the following medicines while taking TOBI Podhaler:
- Furosemide or etacrynic acid, diuretics
- Other medicines with diuretic properties such as intravenous urea or mannitol
- Other medicines that may damage your kidneys or hearing
The following medicines may increase the risk of harmful 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 medicines may damage the kidneys.
- Platinum compounds such as carboplatin and cisplatin (used to treat certain types of cancer). These medicines may damage your kidneys or hearing.
- Anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin. These medicines may cause the onset or worsening of muscle weakness.
If you are taking one or more of the medicines listed above, discuss this with your doctor before taking TOBI Podhaler.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
It is unknown whether inhaling this medicine during pregnancy causes adverse effects.
When administered by injection, tobramycin and other aminoglycoside antibiotics may cause fetal harm, such as deafness.
If you are breastfeeding, consult 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 exactly the instructions for using TOBI Podhaler given by your doctor. If in doubt, consult your doctor again.
Caregivers should assist children starting treatment with TOBI Podhaler, especially children aged 10 years or younger, and continue supervising them until they are able to use the Podhaler device properly without help.
How much TOBI Podhaler should you use
Inhale the contents of 4 capsules twice daily (4 capsules in the morning and 4 capsules in the evening), using the Podhaler device.
The dose is the same for all individuals 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 to use them. Inhale the contents of 4 capsules twice daily as follows:
- Inhale the contents of 4 capsules in the morning using the Podhaler device.
- Inhale the contents of 4 capsules in the evening using the Podhaler device.
- Leave an interval as close as possible to 12 hours between doses, but no less than 6 hours.
If you are using several different inhaled treatments and following other therapies for cystic fibrosis, you should use TOBI Podhaler after completing all the others. Check with your doctor about the correct order of administration of your 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 should remain in the blister pack until you are ready to use them.
- When starting a new weekly blister pack of capsules, use the new inhaler provided in the package. Each inhaler should be used for only 7 days.
- Read the instructions at the end of this leaflet for more information on how to use the inhaler.
How long to use TOBI Podhaler
After using TOBI Podhaler for 28 days, you should take a 28-day break during which you do not inhale TOBI Podhaler. Then you will start another cycle.
It is important that you consistently use the product twice daily during the 28-day treatment period and strictly follow the cycle of 28 days on treatment and 28 days off treatment.
WITH TOBI Podhaler | WITHOUT TOBI Podhaler |
Use TOBI Podhaler twice daily, every day for 28 days | Do not use TOBI Podhaler for the next 28 days |
Repeat the cycle
Continue using TOBI Podhaler as directed by your doctor.
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 more TOBI Podhaler than prescribed, 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 forget to use TOBI Podhaler
If you forget to use TOBI Podhaler and there are at least 6 hours until your next dose, inhale the missed dose as soon as possible. Otherwise, wait for your next scheduled dose. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
People with cystic fibrosis suffer from many symptoms of the disease. These may still occur while you are using TOBI Podhaler, but they should not become more frequent or worsen.
If your underlying lung disease worsens while you are using TOBI Podhaler, contact your doctor immediately.
Some adverse effects may be serious
- Severe breathing difficulties with wheezing or coughing and chest tightness (frequent).
If you experience any of these, stop using TOBI Podhaler and contact your doctor immediately.
- Coughing up blood (very common)
- Hearing loss (ringing in the ears may be an early warning sign of hearing loss), noises (such as buzzing) in the ears (frequent)
- Low urine volume, vomiting, confusion, and swelling of the legs, ankles or feet, as these may be signs of sudden decline in kidney function (frequency not known)
If you experience any of these, contact your doctor immediately.
Other adverse effects may include:
Very common (may affect more than 1 in 10 people)
- Feeling of suffocation
- Cough, productive cough, voice alteration (hoarseness)
- Sore throat
- Fever
Common (may affect up to 1 in 10 people)
- Wheezing, crackles (crepitation)
- Chest discomfort, chest pain of muscular or bony origin
- Nasal congestion
- Nosebleeds
- Vomiting, nausea
- Diarrhea
- Skin rash
- Altered sense of taste
- Loss of voice
Frequency not known (cannot be estimated from available data)
- General feeling of malaise
- Change in the colour of the substance you cough up (sputum)
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of TOBI Podhaler
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton or capsule plate.
- Store in the original packaging to protect it from moisture.
Once the capsule is removed from the capsule plate (blister), it should be used immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of TOBI Podhaler
- The active substance is tobramycin. One capsule contains 28 mg of tobramycin.
- The other components are DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), calcium chloride, and sulfuric acid (for pH adjustment).
Nature of the product and pack contents
TOBI Podhaler for inhalation powder (hard capsule) consists of a white to off-white powder for inhalation, filled into transparent, 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 capsule.
TOBI Podhaler is supplied in monthly packs containing 4 weekly boxes and 1 spare Podhaler device in its storage case.
Each weekly box contains 7 blisters (capsule plates) with 8 capsules each, and 1 Podhaler device in its storage case.
The following pack sizes are available:
56 inhalation powder (hard capsule) and 1 inhaler (weekly pack)
224 (4 × 56) inhalation powder (hard capsule) and 5 inhalers (multiple monthly pack)
448 (8 × 56) inhalation powder (hard capsule) and 10 inhalers (2 × multiple monthly packs wrapped in a film)
Only some pack sizes may be marketed.
Marketing Authorization Holder
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland
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 Authorization Holder:
Belgium/Belgium/Belgium Viatris Healthcare Tel/Tel: +32 2 658 61 00 | Lithuania Mylan Healthcare UAB Tel: +370 5 205 1288 |
| Luxembourg/Luxembourg Viatris Healthcare Tel/Tel: +32 2 658 61 00 |
Czech Republic Viatris CZ s.r.o. Tel: +420 222 004 400 | Hungary Mylan EPD Kft. Tel: +36 1 465 2100 |
Denmark Viatris ApS Tlf: +45 28 11 69 32 | Malta V.J. Salomone Pharma Ltd Tel: +356 21 22 01 74 |
Germany Viatris Healthcare GmbH Tel: +49 800 0700 800 | Netherlands Mylan Healthcare B.V. Tel: +31 20 426 3300 |
Estonia BGP Products Switzerland GmbH Estonia branch Tel: +372 6363 052 | Norway Viatris AS Tlf: +47 66 75 33 00 |
Greece BGP PRODUCTS S.A. Tel: +30 210 9891 777 | Austria Mylan Österreich GmbH Tel: +43 1 86 390 |
Spain Viatris Pharmaceuticals, S.L. Tel: +34 900 102 712 | Poland Mylan Healthcare Sp. z o.o. Tel.: +48 22 546 6400 |
France Viatris Médical Tél: +33 1 40 80 15 55 | Portugal Viatris Healthcare, Lda. +351 214 127 200 |
Croatia Viatris Hrvatska d.o.o. Tel: +385 1 235 059 90 | Romania BGP PRODUCTS SRL Tel.: +40 372 579 000 |
Ireland Mylan Ireland Limited Tel: +353 1 8711600 | Slovenia Viatris Healthcare d.o.o. Tel: +386 1 23-63-180 |
Iceland Icepharma hf. Tel: +354 540 8000 | Slovakia Viatris Slovakia s.r.o Tel: +421 2 32 199 100 |
Italy Mylan Italia S.r.l. Tel: +39 0261246921 | Finland Viatris Oy Puh/Tel: +358 20 720 9555 |
Cyprus Varnavas Hadjipanayis Ltd Tel: +357 2220 7700 | Sweden Viatris AB Tel: +46 8 630 19 00 |
Latvia Mylan Healthcare SIA Tel: +371 676 055 80 |
Date of the most recent review of this leaflet: April 2025
Other sources of information
Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu
INSTRUCTIONS FOR USE OF THE PODHALER DEVICE
Read the following instructions carefully 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 storage case.
- 7 blister packs of capsules (one blister pack for each day of the week).
- Each blister pack contains 8 capsules (corresponding to a daily dose: you must inhale the contents of 4 capsules in the morning and the contents of 4 capsules in the evening).
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Capsule blister pack | Inhaler | Storage case |
How to inhale your medicine using the Podhaler device
- Use only the Podhaler device provided in this package. Do not use TOBI Podhaler capsules with any other device, and do not use the Podhaler device for any other medicine.
- When starting a new weekly pack of capsules, use the new Podhaler device included in the pack. Each Podhaler device is for use for only 7 days. Ask your pharmacist how to dispose of unused medicines and inhalers.
- Do not swallow the capsules. The powder in the capsules is for inhalation.
- Always keep the capsules in the blister pack until you are ready to use them. Do not remove them from the blister pack in advance.
- When not in use, store the Podhaler device in its tightly closed case.
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Set the cap aside. Quickly inspect the inhaler to ensure it is not damaged or dirty. Place the inhaler upright into the base of the case. |
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Place the mouthpiece on a clean, dry surface. |
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Remove the capsule from the blister pack. |
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Replace the mouthpiece. Screw the mouthpiece back on firmly until it stops turning. Do not overtighten (2). |
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Pierce the capsule by pressing the blue button down firmly with your thumb, then release the button. You are now ready to inhale the capsule in 2 separate inhalations (Steps 8 and 9). |
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Before placing the mouthpiece in your mouth, breathe out fully away from the inhaler. Place your lips around the mouthpiece to form a tight seal. Inhale the powder deeply in one single breath. Remove the inhaler from your mouth and hold your breath for about 5 seconds. Then breathe out normally, away from the inhaler. |
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| If the capsule is pierced but still contains some powder:
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| If the capsule is not pierced:
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REMEMBER:
- For inhalation use only.
- Do not swallow the TOBI Podhaler capsules.
- Use only the inhaler provided in this package.
- Always keep the TOBI Podhaler capsules in the blister pack. Remove a capsule only immediately before use. 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 hold the device with the mouthpiece pointing downward while piercing the capsule.
- Never press the piercing 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 protective case.
Additional Information
Occasionally, very tiny fragments of the capsule may pass through the filter and enter your mouth.
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If this occurs, you may notice these fragments on your tongue.
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If these fragments are swallowed or inhaled, they are not harmful to your health.
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The likelihood of the capsule breaking into fragments may increase if the capsule is accidentally pierced more than once or if the device is not kept with the mouthpiece pointing downward during step 7.