ONBREZ 150 MCG Inhalation powder, hard capsule

Зміст інструкції

1. Onbrez Breezhaler 150 micrograms powder for inhalation, hard capsules, 300 micrograms powder for inhalation, hard capsules
   1. What is Onbrez Breezhaler and what it is used for
   2. What you need to know before taking Onbrez Breezhaler
   3. How to take Onbrez Breezhaler
   4. Possible side effects
   5. How to store Onbrez Breezhaler
   6. Content of the pack and other information

Onbrez Breezhaler 150 micrograms powder for inhalation, hard capsules, 300 micrograms powder for inhalation, hard capsules

indacaterol

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

1. What is Onbrez Breezhaler and what it is used for

What is Onbrez Breezhaler
Onbrez Breezhaler contains the active substance indacaterol, which belongs to a group of medicines
called bronchodilators. When inhaled, it relaxes the muscles in the walls of the small airways in the
lungs. This helps to open the airways, making it easier to breathe.

What is Onbrez Breezhaler used for
Onbrez Breezhaler is used to make breathing easier for adult patients who have difficulty
breathing due to a chronic lung disease called chronic obstructive pulmonary disease
(COPD). In COPD, the muscles around the airways narrow. This makes it difficult
to breathe. This medicine relaxes the muscles in the lungs, making it easier for air to enter and leave
the lungs.

2. What you need to know before taking Onbrez Breezhaler

Do not take Onbrez Breezhaler

• if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Onbrez Breezhaler

• if you suffer from asthma (in this case you should not use Onbrez Breezhaler);
• if you have heart problems;
• if you suffer from epilepsy;
• if you have problems with your thyroid (hyperthyroidism);
• if you have diabetes (high blood sugar levels).

During treatment with Onbrez Breezhaler,

• stop taking the medicine and inform your doctor immediatelyif shortly after taking the medicine you feel chest tightness, have a cough, wheezing or shortness of breath. This could be a sign of a condition called bronchospasm.
• inform your doctor immediately if your COPD symptoms(wheezing, shortness of breath, cough) do not improve or worsen.

Children and adolescents
Onbrez Breezhaler must notbe given to children or adolescents under 18 years of age.

Other medicines and Onbrez Breezhaler
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are taking:

• medicines for breathing problems that are similar to Onbrez Breezhaler (e.g. medicines such as salmeterol and formoterol). Adverse effects are more likely to occur.
• medicines called beta-blockers, used for high blood pressure or other heart problems (such as propranolol) or for an eye disease called glaucoma (such as timolol).
• medicines that lower the level of potassium in the blood. These include: o steroids (e.g. prednisolone); o diuretics used for high blood pressure, such as hydrochlorothiazide; o medicines for breathing problems such as theophylline.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
You should not take Onbrez Breezhaler unless your doctor has told you to.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that Onbrez Breezhaler will affect your ability to drive or use machines.

Onbrez Breezhaler contains lactose
This medicine contains lactose (milk sugar). If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Onbrez Breezhaler

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

How much Onbrez Breezhaler to take

• The usual dose is to inhale the contents of one capsule per day. Your doctor will tell you whether to take a 150 micrograms capsule or a 300 micrograms capsule, based on your condition and how you respond to treatment. Do not take more medicine than has been advised by your doctor.
• Use the inhaler every day at the same time; the effects last 24 hours. This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night. It will also help you remember to use it.

How to use Onbrez Breezhaler

• In this package you will find an inhaler and capsules (in blisters) that contain the medicine as a powder for inhalation. The Onbrez Breezhaler inhaler allows you to inhale the medicine contained in a capsule.
• Use the capsules only with the inhaler provided in this package (the Onbrez Breezhaler inhaler). The capsules must remain in the blister until you use them.
• When you start a new package, use the new Onbrez Breezhaler inhaler contained in the new package.
• Dispose of each inhaler after you have used all the capsules.
• Do not swallow the capsules.

to use the inhaler.
If you take more Onbrez Breezhaler than you should
If you have inhaled too much Onbrez Breezhaler or if others have used your capsules, inform your doctor immediately
or go to the nearest emergency room. Show the Onbrez Breezhaler package. Medical care may
be needed. You may feel that your heart is beating faster than usual, you may
have a headache, feel sleepy, nauseous or vomit.

If you forget to take Onbrez Breezhaler
If you forget to inhale a dose, take the next dose the following day, at the usual time. Do not
take a double dose to make up for a forgotten dose.

How long to continue treatment with Onbrez Breezhaler

• Continue treatment with Onbrez Breezhaler until your doctor tells you to stop.
• COPD is a long-term illness and you must take Onbrez Breezhaler every dayand not only when you have difficulty breathing or other COPD symptoms. If you have any doubts about the duration of treatment with Onbrez Breezhaler, ask your doctor or pharmacist for advice.

If you have any further questions on 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.
Some side effects can be serious. Tell your doctor immediately

• if you have a feeling of tightness in the chest (common);
• if you have high blood sugar levels (diabetes). If you feel tired, very thirsty or hungry (without gaining weight) and do not urinate as usual (common);
• if you have an irregular heartbeat (uncommon);
• if you have symptoms of an allergic reaction, such as skin rashes, itching, hives, difficulty breathing or swallowing, dizziness (uncommon);
• if you have difficulty breathing, with shortness of breath or cough (uncommon).

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

• cold symptoms. You may have all or many of the following symptoms: sore throat, runny nose, stuffy nose, sneezing, cough, headache.

Common side effects (may affect up to 1 in 10 people)

• feeling of pressure or pain in the cheeks and forehead (sinus inflammation)
• runny nose
• cough
• sore throat
• headache
• dizziness
• palpitations
• muscle spasm
• swelling of the hands, ankles and feet (edema)
• itching/rash
• chest pain
• muscle, bone or joint pain.

Uncommon side effects (may affect up to 1 in 100 people)

• strong heartbeat
• tingling or numbness
• muscle pain.

Some people sometimes cough immediately after inhaling the medicine. Coughing is a common symptom
in COPD. If you cough shortly after inhaling the medicine, do not worry. Check the inhaler to see if the capsule is empty and you have taken the whole dose. If the
capsule is empty, do not worry. If the capsule is not empty you should inhale again, as described
in the instructions.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Appendix V. By reporting side effects you can help
to provide more information on the safety of this medicine.

5. How to store Onbrez Breezhaler

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and blister after
“Scad.” and “EXP”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original packaging to protect the medicine from moisture and only remove it at the
time of use.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater 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 the pack containsOnbrez Breezhaler

• Each Onbrez Breezhaler 150 micrograms capsule contains 150 micrograms of indacaterol, as indacaterol maleate. The other ingredients include lactose and the capsules are made of gelatin.
• Each Onbrez Breezhaler 300 micrograms capsule contains 300 micrograms of indacaterol, as indacaterol maleate. The other ingredients include lactose and the capsules are made of gelatin.

Description of the appearance of Onbrez Breezhaler and contents of the pack
This pack contains an inhaler and capsules, contained in a blister. The capsules are
transparent (colourless) and contain a white powder.

• The Onbrez Breezhaler 150 micrograms capsules have the product code “ IDL 150” printed in blackabove a blackband and the company logo ( ) printed in blackbelow the blackband.
• The Onbrez Breezhaler 300 micrograms capsules have the product code “ IDL 300” printed in blueabove a blueband and the company logo ( ) printed in bluebelow the blueband.

The following packs are available:
Pack containing 10 capsules and 1 inhaler.
Pack containing 30 capsules and 1 inhaler.
Multipack consisting of 2 packs (each containing 30 capsules and 1 inhaler).
Multipack consisting of 3 packs (each containing 30 capsules and 1 inhaler).
Multipack consisting of 30 packs (each containing 10 capsules and 1 inhaler).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: +421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu

INSTRUCTIONS FOR USING THE ONBREZ BREEZHALER INHALER
Read the instructions for usecompletely before using Onbrez Breezhaler.

InsertPierce and releaseInhale
deeply
Check that the
capsule is empty
123
Verify
ca

Step 1a:

Remove the cap
Step 2a:

Pierce the capsule once
only
Hold the inhaler in
a vertical position.
Pierce the capsule
by firmly pressing
both side buttons
simultaneously.
Step 3a:

Exhale
completely
Do not blow into
the mouthpiece.

Check that the capsule
is empty
Open the inhaler to
see if any powder
remains in the capsule.

When the capsule is
pierced, you should hear a
noise.
Pierce the capsule once
only.
If powder remains in the
capsule:

• close the inhaler;
• repeat steps 3a to 3c

Step 1b:

Open the inhaler
Step 3b:

Inhale the medicine
deeply
Hold the inhaler as
shown in the figure.
Bring the mouthpiece to
your mouth and close
your lips firmly
around the mouthpiece.
Do not press the side
buttons.
Step 1c:

Remove the capsule
Remove a capsule from
the blister.
Do not swallow the capsule.

Remove the empty capsule
Dispose of the empty capsule
in household waste.
Close the inhaler and
replace the cap.
Step 3c:

Hold your breath
Hold your breath for
up to 5 seconds.

Important information

• Onbrez Breezhaler capsules must always be stored in the blister and only removed immediately before use.
• Do not swallow the capsule.
• Do not use Onbrez Breezhaler capsules with any other inhaler.
• Do not use the inhaler

Onbrez Breezhaler to
take capsules of
any other
medicine.

• Never put the Step 1e: Close the inhalercapsule directly into the mouthpiece.
• Do not press the side buttons more than once.
• Do not blow into the mouthpiece.
• Do not press the side buttons while inhaling through the mouthpiece.
• Do not handle the capsules with wet hands.
• Never wash the inhaler with water

The Onbrez Breezhaler pack contains:

• One Onbrez Breezhaler inhaler
• One or more blisters, each containing 6 or Frequently asked questionsWhy didn’t the inhaler
  make a noise when I
  inhaled?The capsule may be stuck in the chamber. If this happens, gently shake the base of the inhaler to dislodge the capsule. Inhale the medicine again, repeating steps 3a to 3c. What should I do if
  powder remains in the
  capsule?You have not taken a sufficient dose of medicine. Close the inhaler and repeat steps 3a to 3c. I coughed after
  inhalation - what does
  this mean?This can happen. As long as the capsule is empty, you have taken a sufficient dose of medicine. I felt small pieces of
  capsule on my tongue -
  what does this mean?This can happen. It is not harmful. The chances of the capsule breaking into small pieces increase if the capsule is pierced more than once. How to clean the inhalerWipe the outside and inside of the mouthpiece with a clean, dry, lint-free cloth to remove any powder residue. Keep the inhaler dry. Never wash the inhaler with water. 10 Onbrez Breezhaler capsules for use with the inhaler

Disposal
of the inhaler after use
After you have used all
the capsules, the inhaler must
be disposed of. Ask your
pharmacist how to dispose of
medicines and inhalers
that you no longer use.