28 mg inhalation powder, hard capsules
tobramycin
What TOBI Podhaler is and what it is used for
What TOBI Podhaler is
TOBI Podhaler contains the drug tobramycin, which is an antibiotic. This antibiotic belongs to a class called aminoglycosides.
What TOBI Podhaler is used for
TOBI Podhaler is used to treat lung infections caused by the bacterium Pseudomonas aeruginosa in patients aged 6 and over with cystic fibrosis.
Follow the instructions in this leaflet to get the best possible treatment results.
How TOBI Podhaler works
TOBI Podhaler is capsules that are filled with inhalation powder. When you inhale TOBI Podhaler, the medicine goes directly into the lungs to fight the bacteria causing the infection and improve your breathing.
What is Pseumdomonas aeruginosa
It is a very common bacterium that at some point in life infects the lungs of almost everyone who has cystic fibrosis. Some people don’t get this infection until later in life, while others get it very early. This bacteria is one of the most harmful to people with cystic fibrosis. If an infection is not treated properly, it will continue to damage your lungs and cause you further breathing problems.
What you need to know before you take TOBI Podhaler
Do not take TOBI Podhaler
- if you are allergic to tobramycin, any type of aminoglycoside antibiotic, or any of the other ingredients of this medicine (listed in section 6).
If this applies to you, do not take TOBI Podhaler and tell your doctor.
Consult a doctor if you think you may be allergic.
Warnings and precautions
Tell your doctor if you have ever had any of the following problems:
- hearing problems (including ringing in the ears and dizziness)
- kidney problems
- unusual difficulty breathing with wheezing, coughing, or tightness in the chest
- bloody expectoration
- muscle weakness that persists or worsens over time, a symptom mainly linked to diseases such as myasthenia gravis or Parkinson’s disease.
If this applies to you, tell your doctor before taking TOBI Podhaler.
If you are 65 years of age or older, your doctor may do some additional tests to determine if TOBI Podhaler is suitable for you.
Inhalation of medicines may cause chest tightness and wheeze, and these symptoms may occur immediately after inhalation of the TOBI Podhaler. Your doctor will be with you when you inhale the first dose of TOBI Podhaler and will check your lung function before and after dosing. The doctor may prescribe other suitable medicines for you to take before TOBI Podhaler.
Inhalation of medicines can also cause coughing and this also applies to TOBI Podhaler. Contact your doctor if the cough persists and is bothersome to you.
Strains of Pseudomonas can become resistant to treatment with antibiotics over time. This means that after a while TOBI Podhaler may not have as good an effect as it should. Contact your doctor if this concerns you.
When tobramycin or other aminoglycoside antibiotics are given by injection, hearing loss, dizziness, and kidney damage can sometimes occur.
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, have recently taken, or might take any other medicines.
You should not take the following medicines while taking TOBI Podhaler:
- furosemide or ethacrynic acid, diuretics
- other drugs with diuretic properties, eg urea or mannitol is given intravenously
- other medicines, which can damage the kidneys or hearing.
The following medicines may increase the risk of harmful effects if they are given to you while you are also receiving injections of tobramycin or other aminoglycoside antibiotics:
- amphotericin B, cephalothin, polymyxins (used to treat microbial infections ), cyclosporine, and tacrolimus (used to suppress the immune system). These medicines can damage the kidneys.
- platinum compounds such as carboplatin and cisplatin (used to treat certain forms of cancer). These medicines can damage the kidneys or hearing.
- anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness) or botulinum toxin. These drugs can cause or worsen muscle weakness.
If you are taking one or more of the above medicines, you should contact 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 whether inhalation of this medicine can cause side effects during pregnancy.
If tobramycin and other aminoglycoside antibiotics are injected, they can cause birth defects, such as deafness.
If you are breastfeeding, talk to your doctor before taking this medicine.
Driving ability and use of machinery
TOBI Podhaler has a little or negligible effect on the ability to drive and use machines.
How to take TOBI Podhaler
Always take TOBI Podhaler as directed by your doctor. Consult a doctor if you are unsure.
Caregivers must help children who start treatment with TOBI Podhaler, especially those who are 10 years of age or younger. This support should continue until they can use the Podhaler inhaler correctly without help.
How much TOBI Podhaler you should take
Inhale the contents of 4 capsules twice a day (4 capsules in the morning and 4 capsules in the evening) using the Podhaler inhaler.
Dose one is the same for everyone from the age of 6. Do not take more than the recommended dose.
When should you take TOBI Podhaler?
If you take the capsules at the same time every day, it will be easier to remember when to take them. Inhale the contents of 4 capsules twice a day as follows:
- Inhale 4 capsules in the morning with the Podhaler inhaler.
- Inhale 4 capsules in the evening with the Podhaler inhaler.
- It is best if 12 hours pass between doses, but at least 6 hours must pass.
If you use several different medicines for inhalation or other treatment against cystic fibrosis, you should take TOBI Podhaler when you have finished all other treatment measures. Ask your doctor about the order of your medications.
How to take TOBI Podhaler
- For inhalation only.
- Do not swallow the capsules.
- Only use the capsules with the inhaler included in the package. The capsules must remain in the blister card until you need to use them.
- When you start a new pack, use the new inhaler included in that pack. Each inhaler should only be used for 7 days.
- Read the instructions at the end of this leaflet for more information on how to use the inhaler.
How long to take TOBI Podhaler
When you have taken TOBI Podhaler for 28 days, you should make a 28-day break in the treatment when you should not use TOBI Podhaler. Then you start with the next treatment cycle.
It is important that you continue to use the medicine twice a day during the 28 days of treatment and that you follow the cycle of 28 days of treatment followed by 28 days off.
| WITH TOBI Podhaler | WITHOUT TOBI Podhaler |
| Take TOBI Podhaler twice daily for 28 days | Do not take TOBI Podhaler for the next 28 days |
Repeat the cycle |
Continue to take TOBI Podhaler as directed by your doctor.
Consult a doctor or pharmacist if you wonder how long you should continue treatment with TOBI Podhaler.
If you have taken too much TOBI Podhaler
If you inhale too much TOBI Podhaler, tell your doctor immediately. There is no danger if you swallow TOBI Podhaler but tell your doctor as soon as possible.
If you forget to take TOBI Podhaler
If you have forgotten to take TOBI Podhaler and it is at least 6 hours until the next dose, you should take a dose as soon as possible. Otherwise, you should wait until the next dose. Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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. You may still experience such symptoms while taking TOBI Podhaler, but they should not occur more often or be worse than before.
If the underlying lung disease appears to worsen while taking TOBI Podhaler, contact your doctor immediately.
Some side effects can be serious.
- unusual difficulty breathing with wheezing or coughing and chest tightness (common).
If you experience any of these symptoms: stop taking TOBI Podhaler and contact your doctor immediately.
- coughing up blood (very common)
- impaired hearing (ringing in the ears can be a warning sign of hearing loss), and disturbing noises in the ears such as tinnitus (common).
If you experience any of these symptoms, tell your doctor immediately.
Other side effects can be:
Very common (may affect more than 1 in 10 people)
- respiratory distress
- cough, coughing up phlegm, voice change (hoarseness)
- sore throat
- fever.
Common (may affect up to 1 in 10 people)
- wheezing, rattling breathing
- chest discomfort, chest pain originating in muscles or bones
- nasal congestion
- nosebleed
- vomiting, nausea
- diarrhea
- rash
- altered sense of taste
- vote loss.
Frequency not known (cannot be calculated from available data)
- general malaise
- discolored sputum.
How TOBI Podhaler should be stored
- Store out of sight and reach of children.
- Use before the expiry date stated on the carton or blister card.
- Store in the original packaging. Moisture sensitive.
Once the capsule has been removed from the blister card, it should be used immediately.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tobramycin. One capsule contains 28 mg of tobramycin.
- Other ingredients are DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine), calcium chloride and sulfuric acid (for pH adjustment).
Appearance and package sizes of the medicine
TOBI Podhaler inhalation powder, hard capsules consist of a white or almost white powder for inhalation in clear, colorless hard capsules with “MYL TPH” printed in blue on one side of the capsule and the Mylan logo printed in blue on the other side.
TOBI Podhaler is supplied as monthly packs containing 4 weekly cartons and a spare Podhaler inhaler with a protective cap.
Each weekly carton contains 7 blister cards with 8 capsules in each and a Podhaler inhaler with a protective cap.
The package sizes are as follows:
56 inhalation powders, hard capsules, and 1 inhaler (weekly pack)
224 (4 x 56) inhalation powders, hard capsules, and 5 inhalers (1-month pack)
448 (8 x 56) inhalation powders, hard capsules, and 10 inhalers (2-month packaging in foil)
Not all pack sizes may be available in your country.
Marketing Authorisation Holder
Mylan IRE Healthcare Limited
Unit 35/36 Grange Parade,
Baldoyle Industrial Estate, Dublin 13
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 CEO Hoehe
Benzstrasse 1
61352 Bad Homburg CEO Hoehe
GermanyManufacturer
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 CEO Hoehe
Benzstrasse 1
61352 Bad Homburg CEO Hoehe
Germany13 May 2022