TOBI 28 mg Proszek Do Inhalacji, Kapsułka Twarda

Treść ulotki

1. TOBI Podhaler 28 mg powder for inhalation, hard capsules
   1. What is TOBI Podhaler and what is it 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. Content of the pack and other information

TOBI Podhaler 28 mg powder for inhalation, hard capsules

tobramycin

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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

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

What is TOBI 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 starting from 6 years of age with cystic fibrosis to treat long
term an infection caused by a bacterium called Pseudomonas aeruginosa.
To obtain the best results from this medicine, please use it as indicated in this leaflet.

How does TOBI Podhaler work
TOBI Podhaler is an inhalation powder contained in capsules. When you inhale TOBI Podhaler,
the antibiotic can enter directly into the lungs to fight against the bacteria that cause
the infection and improve breathing.

What isPseudomonas aeruginosa
This is a very common bacterium that infects almost all patients with cystic fibrosis at some
point in their lives. Some patients do not contract this infection until later in life,
while others contract it when still very young. This is one of the most harmful bacteria for
patients with cystic fibrosis. If the infection is not kept under control, it will continue to
damage the lungs, causing further breathing problems.

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

Do not take TOBI Podhaler

• if you are allergicto tobramycin, or 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 before 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 ringing in the ears and dizziness) or if your mother had hearing problems after taking an aminoglycoside
• certain genetic variations (changes in the gene) related to inherited hearing disorders from your mother
• kidney problems
• unusual difficulty breathing with wheezing, coughing, or chest tightness
• blood in your sputum (the substance you cough up)
• muscle weakness that persists or gets worse over time, a symptom related to conditions such as myasthenia or Parkinson's disease. If any of the above conditions apply to you, see your doctor before taking TOBI Podhaler.

If you are 65 years of age or older, your doctor may perform additional checks to decide if
TOBI Podhaler is a suitable treatment.
Inhalation medicines can cause chest tightness and wheezing that can
occur immediately after inhaling TOBI Podhaler. Your doctor will monitor the administration
of the first dose of TOBI Podhaler and check lung function before and after taking the
dose. Your doctor may ask you to use other appropriate medicines before taking TOBI
Podhaler.
Inhaling medicines can cause coughing, and this can happen with TOBI Podhaler. Talk to your
doctor if the cough persists or is a problem.
Over time, strains of Pseudomonasmay become resistant to treatment. This
means that TOBI Podhaler may no longer work as needed over time. Talk
to your doctor if you think this is happening.
If you are taking tobramycin or other aminoglycoside antibiotics by injection, this 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.
You should not take the following medicines while taking TOBI Podhaler:

• Furosemide or ethacrinic acid, diuretics
• Other medicines with diuretic properties such as urea or mannitol intravenously
• Other medicines that can damage the kidneys or hearing.

The following medicines may increase the likelihood of harmful effects that may occur if
they are given while receiving injectionsof tobramycin or other aminoglycoside
antibiotics:

• Amphotericin B, cefalotin, polymyxin (used to treat bacterial infections), cyclosporine, tacrolimus (used to reduce the activity of the immune system). These medicines can damage the kidneys.
• Platinum compounds such as carboplatin and cisplatin (used to treat some types 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 medicines can cause the appearance or worsening of

muscle weakness.
If you are taking one or more of the medicines listed above, talk to your doctor before taking
TOBI Podhaler.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
It is not known whether inhaling this medicine causes unwanted effects during pregnancy.
When given by injection, tobramycin and other aminoglycoside antibiotics
can cause harm to the fetus, such as deafness.
If you are breastfeeding, you should talk to your doctor before using this medicine.

Driving and using machines
TOBI Podhaler does not or negligibly alters the ability to drive vehicles and use
machinery.

3. How to take TOBI Podhaler

Take TOBI Podhaler following your doctor’s instructions exactly. If you have any doubts, consult your
doctor.
Healthcare professionals should assist children at the beginning of treatment with TOBI Podhaler,
particularly those aged 10 years or younger, and should continue supervision until they are able to use the Podhaler device correctly without help.

How much TOBI Podhaler to take
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 everyone aged 6 years and over. Do not exceed the recommended dose.

When to take 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 specified below:

• 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 allow at least 12 hours between doses, but this interval must be at least 6 hours.

If you are undergoing other treatments via inhalation and are following other therapies for cystic fibrosis,
you should take TOBI Podhaler last. Check with your doctor the order of the medications.

How to take TOBI Podhaler

• For inhalation use only.
• Do not swallow the capsules.
• Use the capsules only with the inhaler provided in this package. The capsules must remain in their blister pack until the time of use.
• When you start a new weekly pack of capsules, use the new inhaler that is provided in the package. Each inhaler should be used for only 7 days.
• Please read the instructions at the end of this leaflet for more information on how to use the inhaler.

For how long to take TOBI Podhaler
After taking TOBI Podhaler for 28 days, there must be 28 days of therapy interruption, during which you
should not inhale TOBI Podhaler. Then you start another cycle.
It is important that you continue to use the product twice a day during the 28 days of treatment and
that you respect the 28-day treatment and 28-day interruption cycle.

YES TOBI PodhalerNO TOBI Podhaler
Take TOBI Podhaler
twice a day, every
day for 28 days
Do not take TOBI
Podhaler for the next
28 days

Repeat the cycle
Continue taking TOBI Podhaler as prescribed by your doctor.
If you have any doubts about the duration of treatment with TOBI Podhaler, ask your doctor or pharmacist.

If you take more TOBI Podhaler than you should
If you inhale too much TOBI Podhaler, consult your doctor as soon as possible. If TOBI Podhaler is swallowed,
do not worry, but consult 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 until the next dose,
take the dose as soon as possible. Otherwise, wait for the next dose. Do not take a
double dose to make up for a missed dose.
If you have any doubts about using 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 can still appear
during the intake of TOBI Podhaler, but they should not be more frequent or seem more severe
than before.
If the pre-existing lung disease appears to worsen during the intake of TOBI Podhaler,

inform your doctor immediately.

Some side effects can be serious

• Unusual difficulty breathing with wheezing or cough and chest tightness (common). If any of these side effects occur, stop taking TOBI Podhaler andinform your doctor immediately.
• Blood in sputum (very common)
• Decreased hearing (tinnitus is a potential warning sign of hearing loss), noises (such as whistling) in the ears (common).
• Low urine volume, vomiting, confusion and swelling in the legs, ankles or feet, as these may be signs of a sudden decrease in kidney function (not known) If any of these side effects occur, inform your doctor immediately.

Other side effects may include:
Very common (may affect more than 1 in 10 people)

• Shortness of breath
• Cough, cough with phlegm, altered voice (hoarseness)
• Sore throat
• Fever

Common (may affect up to 1 in 10 people)

• Breathlessness, crackles (crepitations)
• Chest discomfort, musculoskeletal chest pain
• Blocked nose
• Nosebleed
• Vomiting, nausea
• Diarrhoea
• Skin rash
• Altered taste
• Loss of voice.

Not known (frequency cannot be estimated based on available data)

• Feeling unwell
• Change in colour of sputum (the substance you cough up)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this 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. How to store 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 pack or on the capsule container.
• Store in the original packaging to protect the medicine from moisture.

Once removed from the container (blister) a capsule must be used immediately.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What TOBI Podhaler contains

• The active substance 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).

Description of the appearance of TOBI Podhaler and content of the pack
TOBI Podhaler powder for inhalation, hard capsules consists of an inhalation powder from white
to almost white contained in clear, light-colored hard capsules imprinted with “MYL TPH” with blue
ink on one side of the capsule and the Mylan logo imprinted in blue on the other side.
TOBI Podhaler is supplied in monthly packs containing 4 weekly boxes and a spare Podhaler device
in its case.
Each weekly box contains 7 blisters (capsule containers) of 8 capsules each, and a
Podhaler device in its case.
The following packs are available:
56 hard capsules, powder for inhalation and 1 inhaler (weekly pack)
224 (4 x 56) hard capsules, powder for inhalation and 5 inhalers (monthly multi-pack)
448 (8 x 56) hard capsules, powder for inhalation and 10 inhalers (2 monthly multi-packs wrapped
in a film)
Not all pack sizes may be marketed.

Marketing Authorisation 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 on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Viatris
Tél/Tel: +32 2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 2 658 61 00

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: +36 1 465 2100

Danmark
Viatris ApS
Tlf.: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: +356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan Healthcare B.V.
Tel: +31 20 426 3300

Eesti
Viatris OÜ
Tel: + 372 6363 052

Norge
Viatris AS
Tlf: +47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 210 0100002

Österreich
Viatris Austria GmbH
Tel: + 43 1 86 390

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712

Polska
Viatris Healthcare Sp. z o.o.
Tel.: +48 22 546 6400

France
Viatris Santé
Tél: +33 1 40 80 15 55

Portugal
Viatris Healthcare, Lda.
Tel: ++351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP PRODUCTS SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: +386 1 23 63 180

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: +39 02 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: +46 8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

Altre fonti d’informazioni
More 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
Please read the following instructions carefully to learn how to use and care for the
Podhaler device.

Content of the weekly pack of TOBI Podhaler
Each weekly pack of TOBI Podhaler contains:

• 1 inhaler (the Podhaler device) and its case.
• 7 blisters (one blister for each day of the week).
• Each blister contains 8 capsules (corresponding to a daily dose: content of 4 capsules to be inhaled in the morning and content of 4 capsules to be inhaled in the evening).

How to inhale the medicine with the Podhaler device

• Use only the Podhaler device contained in this pack.Do not use TOBI Podhaler capsules with any other device, and do not use the Podhaler device to take other medicines.
• When you start a new weekly pack of capsules, use the new Podhaler device that is supplied in the pack. Each Podhaler device should only be used for 7 days. Ask your pharmacist how to dispose of medicines and inhalers that are no longer needed.
• Do not swallow the capsules.The powder in the capsules is only for inhalation.
• Always keep the capsules in the blister until the time of use. Do not remove the capsules from the blister in advance.
• Store the Podhaler device in its case when not in use.

	d e	l F a r
Blister (capsule container)	Inhaler	Case

e n z i a

1. Wash and dry your hands thoroughly.

	2. • Immediately before use, remove the inhaler from its case by holding it by the base and rotating the o top part of the case counterclockwise. Put the top part of the case aside. c Check the inhaler to make sure it is not damaged or dirty. a Hold the inhaler upright on the base of the case.
	m 3. • Hold the body of the inhaler and unscrew the mouthpiece in a r counterclockwise direction. Put the mouthpiece aside on a clean, dry surface. F l
I	e 4. Tear along the perforations of the blister lengthwise and then d widthwise as shown in figures (1) and (2) a n a i l a t
e n z i a	5. • Peel off the foil covering the blister to release a single capsule. Remove the capsule from the blister.

	6. • Immediately insert the capsule into the chamber of the inhaler (1). o Put the mouthpiece back on. Screw the mouthpiece on tightly until it stops. Do c not overtighten (2). a m
	r 7. • Hold the inhaler with the mouthpiece pointing downwards Puncture the capsule by firmly pressing the blue button with your thumb to the end of its stroke, then release the button. Now it is ready to inhale the capsule in 2 distinct breaths F (Steps 8 and 9). l e
	d 8. Inhale the capsule – 1st breath: Before putting the mouthpiece in your mouth, exhale completely, away from the inhaler. a Position your mouth over the mouthpiece – to obtain an optimal seal. n Inhale the powder deeply with a single breath. Remove the inhaler from your mouth, and hold your breath for a about 5 seconds. i
z i a I	l a 9. Inhale the capsule – 2nd breath: Take a few normal breaths away from the inhaler. t When you are ready, proceed with the 2nd breath by repeating the instructions in step 8, using the same capsule.
A g e n	10. Unscrew the mouthpiece (1) and remove the capsule from the chamber (2).

	11. Examine the used capsule. It should appear punctured and empty. If it is empty, discard the capsule. o c a
	m If the capsule is punctured but still contains some powder: Put the capsule back into the chamber of the inhaler (step 6). Put the punctured part of the capsule first. r Put the mouthpiece back on and repeat steps 8, 9 and 10. a
	If the capsule does not appear to be punctured: l Put the capsule back into the chamber of the inhaler and (step 6) Put the mouthpiece back on and repeat steps 7, 8 and 9. d After this, if the capsule is still full and does not appear to be punctured, replace the inhaler with the spare inhaler and repeat steps 2, 3, 6, 7, 8, 9 and 10. a
	n 12. Take the other 3 capsules in the same way. Then for each remaining capsule, repeat steps 5, 6, 7, 8, 9, 10 and 11. Discard the empty capsules. i l a
n z i a I	t 13. • Put the mouthpiece back on and screw it on tightly until it stops. When the entire dose (4 capsules) has been inhaled, clean the mouthpiece with a dry, clean cloth. Do not wash the inhaler with water.

14. • Put the inhaler back into the case Screw the top part of the case on clockwise until it is closed tightly. o c a m

REMEMBER:

• For inhalation use only.
• Do not swallow TOBI Podhaler capsules.
• Use only the inhaler contained in this pack.
• Always keep TOBI Podhaler capsules in their blister. Remove one capsule only immediately before use. Do not store the capsules in the inhaler.
• Always keep TOBI Podhaler capsules and the device in a dry place.
• Never put a TOBI Podhaler capsule directly into the mouthpiece of the device.
• Always hold the inhaler with the mouthpiece pointing downwards when 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. Avoid getting it wet and store it in its case.

Further information
Sometimes, small pieces of the capsule can get past the flange and into your mouth.

• If this happens, you should be able to feel these pieces on your tongue.
• It is not harmful if these pieces are swallowed or inhaled.
• The likelihood of the capsule breaking into pieces increases if the capsule is accidentally punctured more than once or if the inhaler is not held with the mouthpiece pointing downwards during step 7.

APPENDIX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE
TERMS OF MARKETING AUTHORISATIONS
Scientific conclusions
Taking into account the assessment of the Pharmacovigilance and Risk Assessment Committee
( Pharmacovigilance and Risk Assessment Committee, PRAC) of the Periodic Safety Update Reports ( Periodic Safety Update Report, PSUR) for tobramycin (powder for
inhalation, capsules), the PRAC’s scientific conclusions are as follows:
In light of the available data on nephrotoxicity from the literature, including in some
cases a close temporal relationship and a positive response to treatment discontinuation
(positive de-challenge), the PRAC considers that there is at least a reasonable possibility of a
causal relationship between tobramycin (powder for inhalation, capsules) and acute renal failure
(ARF). The PRAC concluded that the product information for medicines containing tobramycin
(powder for inhalation, capsules) should be amended accordingly.
Having examined the PRAC recommendation, the Committee for Human Medicinal Products
( Committee for Human Medicinal Products, CHMP) agrees with the overall conclusions and
with the justification of the recommendation.

Justification for the variation of the terms of marketing authorisations
Based on the scientific conclusions on tobramycin (powder for inhalation, capsules) the CHMP
considers that the benefit/risk ratio of the medicines containing tobramycin (powder for
inhalation, capsules) remains unchanged subject to the proposed changes to the product information.
The CHMP recommends the variation of the terms of marketing authorisations.