Ulunar Breezhaler

Package leaflet: Information for the user

Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules

indacaterol/glycopyrronium
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

Contents of this leaflet

1. What Ulunar Breezhaler is and what it is used for
2. What you need to know before using Ulunar Breezhaler
3. How to use Ulunar Breezhaler
4. Possible side effects
5. How to store Ulunar Breezhaler
6. Contents of the pack and other information
   Instructions for use of the Ulunar Breezhaler inhaler

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

What Ulunar Breezhaler is
This medicine contains two active substances called indacaterol and glycopyrronium, which belong to
a group of medicines called bronchodilators.
What Ulunar Breezhaler is used for
This medicine is used to make breathing easier for adult patients who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD).
In COPD, the muscles around the airways tighten. This makes breathing difficult. This medicine prevents the tightening of these muscles in the lungs, making it easier for air to move in and out of the lungs.
If you use this medicine once daily, it will help reduce the effects of COPD on your daily activities.

2. What you need to know before using Ulunar Breezhaler

Do not use Ulunar Breezhaler

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ulunar Breezhaler if any of the following apply to you:

• you suffer from asthma – this medicine must not be used for the treatment of asthma;
• you have heart problems;
• you have seizures or convulsions;
• you have thyroid gland problems (thyrotoxicosis);
• you have diabetes;
• you are using medicines for your lung disease that contain active substances similar to those in Ulunar Breezhaler (belonging to the same class) (see section “Other medicines and Ulunar Breezhaler”);
• you have kidney problems;
• you have severe liver problems;
• you have a condition affecting the eyes called closed-angle glaucoma;
• you have difficulty urinating. If any of these apply to you (or you think they might), talk to your doctor, pharmacist, or nurse before using this medicine.

During treatment with Ulunar Breezhaler

• Stop using the medicine and seek immediate medical help if any of the following occur:
• eye pain or discomfort, temporary blurred vision, halos around lights, or colored images, associated with red eyes – these may be signs of an acute attack of closed-angle glaucoma;
• difficulty breathing or swallowing, swelling of the tongue, lips, or face, rash, itching, or hives (signs of an allergic reaction);
• chest tightness, cough, wheezing, or shortness of breath immediately after using this medicine – these may be signs of a condition called paradoxical bronchospasm.
• Contact your doctor immediately if your COPD symptoms, such as shortness of breath, wheezing, or cough, do not improve or worsen.

Ulunar Breezhaler is used as a maintenance therapy for COPD. Do not use this medicine to treat a sudden attack of shortness of breath or wheezing.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age. This is because the medicine has not been studied in this age group.
Other medicines and Ulunar Breezhaler
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• any medicine that may be similar to Ulunar Breezhaler (contains similar active substances).
• medicines called beta-blockers, which may be used for high blood pressure or other heart problems (such as propranolol), or for an eye condition called glaucoma (such as timolol).
• medicines that lower potassium levels in the blood. These include:
• corticosteroids (e.g., prednisolone),
• diuretics used for high blood pressure, such as hydrochlorothiazide,
• medicines for respiratory problems (such as theophylline).

Pregnancy and breastfeeding
There are no data on the use of this medicine during pregnancy, and it is not known whether the active substances in this medicine pass into breast milk. Indacaterol, one of the active substances in Ulunar Breezhaler, may inhibit labour due to its effect on the uterus.
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. You must not take Ulunar Breezhaler unless advised by your doctor.
Driving and using machines
It is unlikely that this medicine affects the ability to drive or operate machinery.
However, this medicine may cause dizziness (see section 4). If you experience dizziness when taking this medicine, do not drive or operate machinery.
Ulunar Breezhaler contains lactose
This medicine contains lactose (23.5 mg per capsule). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Ulunar Breezhaler

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Ulunar Breezhaler to use
The usual dose is the inhalation of the contents of one capsule daily.
Inhaling once a day is sufficient, as the effect of this medicine lasts for 24 hours.
Do not use more medicine than your doctor has recommended.
Elderly (aged 75 years and over)
If you are aged 75 years or older, you can use this medicine at the same dose as other adults.
When to inhale Ulunar Breezhaler
Use this medicine every day at the same time. This will also help you remember to take it.
You may inhale Ulunar Breezhaler at any time before or after eating or drinking.
How to inhale Ulunar Breezhaler

• Ulunar Breezhaler is for inhalation use only.
• This pack contains an inhaler and capsules (in blisters) containing the medicine as an inhalation powder. Use the capsules only with the inhaler provided in this pack (the Ulunar Breezhaler inhaler). The capsules must remain in the blister until you are ready to use them.
• Remove the foil from the blister to open it – do not push the capsules through the protective foil.
• When starting a new pack, use the new Ulunar Breezhaler inhaler provided in the new pack.
• Dispose of the inhaler from each pack after using all the capsules in the pack.
• Do not swallow the capsules.
• Read the instructions at the end of this leaflet for further information on how to use the inhaler.

If you use more Ulunar Breezhaler than you should
If you have inhaled too much medicine or if someone else has accidentally used your capsules, inform
your doctor immediately or go to the nearest emergency department. Show the Ulunar
Breezhaler packaging. Medical treatment may be necessary. You may notice your heart beating faster
than usual, have a headache, feel drowsy, feel nauseous or need to vomit, or you may experience visual disturbances, feel constipated or have difficulty urinating.
If you forget to use Ulunar Breezhaler
If you have forgotten to inhale a dose at your usual time, inhale a dose as soon as possible on the same
day. Then take your next dose as usual the following day. Do not inhale more than one
dose on the same day.
How long to continue treatment with Ulunar Breezhaler

• Continue using Ulunar Breezhaler for as long as your doctor tells you to.
• COPD is a long-term condition and you must take Ulunar Breezhaler every day, not only when you have difficulty breathing or other COPD symptoms. If you have any doubts about how long to take this medicine, ask your doctor or pharmacist.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious:
Common (may affect up to 1 in 10 people)

• difficulty breathing or swallowing, swelling of the tongue, lips or face, hives, skin rash – may be signs of an allergic reaction.
• feeling tired or very thirsty, increased appetite without weight gain, and urinating more than usual – may be signs of high blood sugar levels (hyperglycemia).

Uncommon (may affect up to 1 in 100 people)

• tight chest pain with increased sweating – may be a serious heart problem (ischemic heart disease).
• difficulty breathing with shortness of breath or cough.
• swelling, especially of the tongue, lips, face or throat (possible signs of angioedema).
• eye pain or discomfort, temporary blurred vision, visual halos or colored images associated with red eyes – may be signs of glaucoma.
• irregular heartbeat.

If you experience any of these serious side effects, seek immediate medical help.
Other side effects may include:
Very common (may affect more than 1 in 10 people)

• stuffy nose, sneezing, cough, headache with or without fever – may be signs of an upper respiratory tract infection.

Common

• combination of sore throat and runny nose – may be signs of nasopharyngitis.
• painful and frequent urination – may be signs of a urinary tract infection called cystitis.
• feeling of pressure or pain in the cheeks and forehead – may be signs of sinus congestion.
• stuffy or runny nose.
• dizziness.
• headache.
• cough.
• sore throat.
• upset stomach, indigestion.
• dental caries.
• difficulty and pain when urinating – may be signs of bladder obstruction or urinary retention.
• fever.
• chest pain.

Uncommon

• difficulty sleeping.
• fast heartbeat.
• palpitations – signs of an abnormal heartbeat.
• altered voice (hoarseness).
• nosebleeds.
• diarrhea or stomach pain.
• dry mouth.
• itching or skin rash.
• pain in muscles, ligaments, tendons, joints and bones.
• muscle spasm.
• muscle pain, aches or soreness.
• pain in arms or legs.
• swelling of hands, ankles and feet.
• fatigue.

Rare (may affect up to 1 in 1000 people)

• tingling or numbness.

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via 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 Ulunar Breezhaler

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Scad"/"EXP". The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the capsules in the original blister to protect them from moisture and only remove them from the blister just before use.
The inhaler supplied in each pack must be discarded after all the capsules in the pack have been used.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ulunar Breezhaler Contains

• The active substances are indacaterol (as maleate) and glycopyrronium bromide. Each capsule contains 143 micrograms of indacaterol maleate, equivalent to 110 micrograms of indacaterol, and 63 micrograms of glycopyrronium bromide, equivalent to 50 micrograms of glycopyrronium. The delivered dose (the dose released from the mouthpiece of the inhaler) is equivalent to 85 micrograms of indacaterol (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms of glycopyrronium (equivalent to 54 micrograms of glycopyrronium bromide).
• The other components of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2, under “Ulunar Breezhaler contains lactose”).
• The capsule shell ingredients are hypromellose, calcium chloride, tartrazine (E102), and black printing ink (on the capsule cap) and blue printing ink (on the capsule body).
  o The ingredients of the black printing ink (on the capsule cap) are shellac (E904), propylene glycol, ammonium hydroxide, potassium hydroxide, and black iron oxide (E172).
  o The ingredients of the blue printing ink (on the capsule body) are shellac (E904), indigotine (E132), and titanium dioxide (E171).

Description of the Appearance of Ulunar Breezhaler and Package Contents
Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder capsules are transparent and yellow, containing a white to almost white powder. The product code

“IGP110.50” is printed in blue under two blue bands on the body of the capsule, and the company logo ( ) is printed in black on the cap of the capsule.
This package contains, in addition to the capsules in a blister, a device called an inhaler. Each blister contains 6 or 10 hard capsules.
The following pack sizes are available:
Single pack containing 6x1, 10x1, 12x1, 30x1, or 90x1 hard capsules and 1 inhaler.
Multiple pack containing 96 (4 packs of 24 x 1) hard capsules and 4 inhalers.
Multiple pack containing 150 (15 packs of 10 x 1) hard capsules and 15 inhalers.
Multiple pack containing 150 (25 packs of 6 x 1) hard capsules and 25 inhalers.
Not all pack sizes may be marketed in your country.

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

Manufacturer
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicine, please contact the local representative of the marketing authorization holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Laboratorios Farmacéuticos ROVI, S.A. Novartis Poland Sp. z o.o.
Tel: +34 91 375 62 30 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

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

Please read the instructions for use completely before using Ulunar Breezhaler.

Insert Puncture and release Inhale Check that the
deeply capsule is empty
1 Check

Step 1a: Step 2a: Step 3a: Check that the capsule
Remove the cap Puncture the capsule Exhale is empty
once only completely Open the inhaler to
Hold the inhaler in Do not blow into the check whether powder
an upright position. mouthpiece. remains in the capsule.
Puncture the capsule
by firmly pressing
both side buttons
simultaneously.
When the capsule is If powder remains in
punctured, you should the capsule:
hear a click. close the inhaler;
Puncture the capsule repeat steps 3a to 3c.
once only.

With powder Empty
Step 1b: Step 3b:

Open the inhaler Inhale deeply
the medicine
Hold the inhaler as
shown in the figure.
Place the mouthpiece
into your mouth and
seal your lips firmly
around it.
Step 2b: Release the side Do not press the side
buttons buttons.
Inhale as quickly and
deeply as possible.
You will hear a humming
sound during inhalation.
You may taste the
medicine during
inhalation.

Step 1c: Remove the empty capsule

Remove the capsule Discard the empty capsule
Separate one blister into household waste.
from the rest of the Close the inhaler and
blister. replace the cap.
Peel off the protective
foil from the blister and
remove the capsule.
Do not push the capsule
through the foil.
Do not swallow the capsule.
Step 3c:
Hold your breath
Hold your breath for
up to 5 seconds.

Important Information

• Ulunar Breezhaler capsules must always be stored in the blister and only removed immediately before use. Never insert the capsule directly into the mouthpiece. Do not push the capsule through the foil to remove it from the blister.
• Do not swallow the capsule.
• Do not use Ulunar Breezhaler capsules with any other inhaler.
• Do not use the Ulunar Breezhaler inhaler to take capsules of any other medicine.
• Never place the capsule in your mouth or into the inhaler 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 Ulunar Breezhaler package contains: Frequently Asked Questions How to clean the inhaler

• One Ulunar Breezhaler inhaler Wipe the outside and
• One or more blisters, each containing 6 or Why didn’t the inhaler the inside of the mouthpiece 10 Ulunar Breezhaler capsules for use with make a sound when I with a clean, dry, lint-free the inhaler inhaled? cloth to remove any
  The capsule may become powder residue.
  lodged in the chamber. If Keep the inhaler dry.
  this occurs, gently tap the Never wash the inhaler
  base of the inhaler to with water.
  dislodge the capsule.

of the inhaler. Inhale
the medicine again by
repeating steps 3a to
3c.
Disposal
What should I do if Disposal of the inhaler after use
there is still powder in After using all the capsules,
the capsule? the inhaler must be
You have not taken a discarded. Ask your
sufficient dose of the pharmacist how to dispose
medicine. Close the of medicines and inhalers
inhaler and repeat steps you no longer use.
3a to 3c.
I coughed after
inhalation – what does it
mean?
This may happen.
As long as the capsule is
empty, you have taken a
sufficient dose of the
medicine.
I felt small pieces of the
capsule on my tongue –
what does it mean?
This may happen. It is
not harmful. The likelihood
of the capsule breaking
into small pieces increases
if the capsule is pierced
more than once.