Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tobi

Document Subject

Generated Narrative: MedicinalProductDefinition mpe0dd692dcb560bc04bfa1cbfaca9ecff

identifier: http://ema.europa.eu/identifier/EU/1/10/652/001-003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: TOBI Podhaler 28 mg inhalation powder, hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-e0dd692dcb560bc04bfa1cbfaca9ecff

identifier: http://ema.europa.eu/identifier/EU/1/10/652/001-003

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - tobi

Attesters

Instructions for use with the Podhaler device (overleaf)

What is in this leaflet

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

What TOBI Podhaler is TOBI Podhaler contains a medicine called tobramycin which is an antibiotic. This antibiotic belongs to a class called 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 bacteria called Pseudomonas aeruginosa.

For the best results from this medicine, please use it as this leaflet instructs you.

How TOBI Podhaler works TOBI Podhaler is a powder for inhalation that is filled into capsules. When you inhale TOBI Podhaler, the antibiotic can enter directly into your lungs to fight against the bacteria causing the infection and to improve your breathing.

What is Pseudomonas aeruginosa It is a very common bacterium that infects the lungs of nearly everyone with cystic fibrosis at some time during their lives. Some people do not get this infection until later on in their lives, while others get it very young. It is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly fought, it will continue to damage your lungs, causing further problems to your breathing.

Do not take 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, tell your doctor without taking TOBI Podhaler. If you think you may be allergic, ask your doctor for advice. Warnings and precautions Tell your doctor if you have ever had any of the following conditions:
• hearing problems (including noises in the ears and dizziness), or your mother has had hearing problems after taking an aminoglycoside
• certain gene variants (a change in the gene) related to hearing abnormalities inherited from your mother
• kidney problems
• unusual difficulty in breathing with wheezing or coughing, chest tightness
• blood in your sputum (the substance you cough up)
• muscle weakness that lasts or becomes worse over time, a symptom mostly 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 aged 65 years or older, your doctor may perform additional tests to decide if TOBI Podhaler is right for you.

Inhaling medicines can cause chest tightness and wheezing and this can happen immediately after inhalation of TOBI Podhaler. Your doctor will supervise your first dose of TOBI Podhaler and check your lung function before and after dosing. Your doctor may ask you to use other appropriate medicines before taking TOBI Podhaler.

Inhaling medicines can also cause cough and this can happen with TOBI Podhaler. Talk to your doctor if the cough is persistent and is a burden for you.

Strains of Pseudomonas can become resistant to treatment with an antibiotic over time. This means that TOBI Podhaler may not work as well as it should over time. Talk to your doctor if you are concerned about this.

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

Children TOBI Podhaler should not be given to children less than 6 years old.

Other medicines and TOBI Podhaler Tell your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

You should not take the following medicines while you are taking TOBI Podhaler:

• Furosemide or ethacrynic acid, diuretics
• Other medicines with diuretic properties such as urea or intravenous mannitol
• Other medicines which may harm your kidneys or hearing.

The following medicines can increase the chances of harmful effects occurring if they are given to you while you are also receiving injections of tobramycin or other aminoglycoside antibiotic:

• Amphotericin B, cefalotin, polymyxins (used to treat microbial infections), ciclosporin, tacrolimus (used to reduce the activity of immune system). These medicines may harm the kidneys.
• Platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer). These medicines may harm the kidneys or hearing.
• Anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin. These medicines may cause muscle weakness to appear or become worse..

If you are taking one or more of the above medicines, discuss with your doctor before you take TOBI Podhaler. Pregnancy and breast-feeding If you are pregnant or breast-feeding, 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 inhaling this medicine when you are pregnant causes side effects.

When they are given by an injection, tobramycin and other aminoglycoside antibiotics can cause harm to an unborn child, such as deafness.

If you are breast feeding, you should talk to 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.

Always take TOBI Podhaler exactly as your doctor has told you. You should check with your doctor if you are not sure.

Caregivers should provide assistance to children starting TOBI Podhaler treatment, particularly those aged 10 years 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 take Inhale the content 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 everyone aged 6 years and older. Do not exceed the recommended dose.

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

• 4 capsules in the morning to be inhaled using the Podhaler device.
• 4 capsules in the evening to be inhaled using the Podhaler device.
• It is best to leave close to 12 hours between doses, but this must be at least 6 hours

If you are taking several different inhaled treatments and following other therapies for cystic fibrosis, you should take TOBI Podhaler after all of these are done. Please check the order of medications with your doctor.

How to take TOBI Podhaler

• For inhalation use only.
• Do not swallow the capsules
• Only use the capsules with the inhaler provided in this pack. The capsules should remain in the capsule card until you need to use them.
• When you start a new weekly pack of capsules, use the new inhaler that is supplied in the pack. Each inhaler is only used for 7 days.
• Please read the instructions at the end of this leaflet for more information about how to use the inhaler.

How long to take TOBI Podhaler After you have taken TOBI Podhaler for 28 days, you then have a 28-day break, during which you do not inhale any TOBI Podhaler. You then start another course. It is important that you keep using the product twice each day during your 28 days on treatment and that you keep to the 28-day on, 28-day off cycle. ON TOBI Podhaler OFF TOBI Podhaler Take TOBI Podhaler twice a day, every day for 28 days Do not take any TOBI Podhaler for the next 28 days

Repeat cycle

Continue taking TOBI Podhaler as your doctor tells you. If you have questions about how long to take TOBI Podhaler for, talk to your doctor or your pharmacist.

If you take more TOBI Podhaler than you should If you inhale too much TOBI Podhaler, tell your doctor as soon as possible. If TOBI Podhaler is swallowed, don t worry but tell your doctor as soon as possible.

If you forget to take TOBI Podhaler If you forget to take TOBI Podhaler and there are at least 6 hours to your next dose, take your dose as soon as you can. Otherwise, wait for your next dose. Do not take a double dose to make up for a forgotten dose.

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

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 happen while taking TOBI Podhaler, but should not be any more frequent or seem worse than before.

If your underlying lung disease seems worse while taking TOBI Podhaler, tell your doctor straight away.

Some side effects can be serious

• Unusual difficulty in breathing with wheezing or coughing and chest tightness (common). If you experience any of these, stop taking TOBI Podhaler and tell your doctor straight away.

• Coughing up blood (very common)

• Decreasing hearing (ringing in the ears is a potential warning sign of hearing loss), noises (such as hissing) in the ears (common). If you experience any of these, tell your doctor straight away.

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

Common (may affect up to 1 in 10 people)

• Wheezing, rales (crackles)
• Chest discomfort, chest pain from muscles or skeletal origins
• Blocked nose
• Nosebleed
• Vomiting, nausea
• Diarrhoea
• Rash
• Disturbed sense of taste.
• Loss of voice

Not known (frequency cannot be estimated from the available data)

• Generally feeling unwell
• Discoloration of the substance you cough up (sputum)

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

• 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 box or capsule card.
• Store in the original packaging in order to protect from moisture.

Once removed from the capsule card (blister), a capsule should be used immediately.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

What TOBI Podhaler contains

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

What TOBI Podhaler looks like and contents of the pack TOBI Podhaler inhalation powder, hard capsules consist of a white to almost white powder for inhalation filled into clear colourless hard capsules with MYL TPH imprinted in blue ink on one part of the capsule and the Mylan logo imprinted in blue on the other part of the capsule.

TOBI Podhaler is supplied in monthly packs containing 4 weekly cartons and a reserve Podhaler device in its storage case.

Each weekly carton contains 7 blisters (capsule cards) of 8 capsules each, and a Podhaler device in its storage case.

The following pack sizes are available: 56 inhalation powder, hard capsules and 1 inhaler (weekly pack) 224 (4 x 56) inhalation powder, hard capsules and 5 inhalers (monthly multipack) 448 (8 x 56) inhalation powder, hard capsules and 10 inhalers (2 x monthly multipack wrapped in foil)

Not all pack sizes may be available in your country.

Marketing Authorisation Holder Viatris Healthcare Limited Damastown Industrial Park Mulhuddart Dublin 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Viatris
T l/Tel: +32 2 658 61 Lietuva Mylan Healthcare UAB Tel: +370 5 205 1

.: +359 2 44 55 Luxembourg/Luxemburg Viatris
T l/Tel: +32 2 658 61 esk republika Viatris CZ s.r.o. Tel: +420 222 004 Magyarorsz g Viatris Healthcare Kft. Tel.: +36 1 465 2Danmark Viatris ApS Tlf: +45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: +356 21 22 01 Deutschland Viatris Healthcare GmbH Tel: +49 800 0700 Nederland Mylan Healthcare B.V. Tel: +31 20 426 3Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 Norge Viatris AS Tlf: +47 66 75 33
Viatris Hellas Ltd : +30 210 0100 sterreich Mylan sterreich GmbH Tel: + 43 1 86 Espa a Viatris Pharmaceuticals, S.L.U. Tel: +34 900 102 Polska Mylan Healthcare Sp. z o.o. Tel.: +48 22 546 6France Viatris Sant
T l: +33 1 40 80 15 Portugal Viatris Healthcare, Lda. Tel: +351 214 127 Hrvatska Viatris Hrvatska d.o.o. Tel: +385 1 23 50 Rom nia BGP PRODUCTS SRL Tel: +40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Viatris d.o.o. Tel: +386 1 236 31 sland Icepharma hf. S mi: + 354 540 8Slovensk republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 Italia Viatris Italia S.r.l. Tel: +39 02 612 46Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9
Varnavas Hadjipanayis Ltd : +357 2220 7Sverige Viatris AB
Tel: +46 8 630 19 Latvija Mylan Healthcare SIA Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: