Ultibro Breezhaler

Patient Information Leaflet: Information for the User

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

indacaterol/glycopyrronium
Please read all of this leaflet carefully before you start using 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, 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 Ultibro Breezhaler is and what it is used for
2. What you need to know before using Ultibro Breezhaler
3. How to use Ultibro Breezhaler
4. Possible side effects
5. How to store Ultibro Breezhaler
6. Contents of the pack and other information
   Instructions for use of the Ultibro Breezhaler inhaler

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

What Ultibro Breezhaler is
This medicine contains two active substances called indacaterol and glycopyrronium, which belong to
a group of medicines known as bronchodilators.
What Ultibro Breezhaler is used for
This medicine is used to help adults with breathing difficulties caused by a lung disease called chronic obstructive pulmonary disease (COPD) breathe more easily.
In COPD, the muscles around the airways tighten, making breathing difficult. This medicine prevents the tightening of these muscles in the lungs, making it easier for air to flow into and out of the lungs.
If you use this medicine once daily, it will help reduce the effects of COPD in your daily activities.

2. What you need to know before using Ultibro Breezhaler

Do not use Ultibro 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 Ultibro 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 problems with your thyroid gland (thyrotoxicosis);
• you have diabetes;
• you are using medicines for your lung disease that contain active substances similar (belonging to the same class) to those in Ultibro Breezhaler (see section “Other medicines and Ultibro Breezhaler”);
• you have kidney problems;
• you have severe liver problems;
• you have a condition of the eye called closed-angle glaucoma;
• you have difficulty urinating. If any of these apply to you (or you think they might apply), talk to your doctor, pharmacist or nurse before using this medicine.

During treatment with Ultibro Breezhaler

• Stop using the medicine and seek immediate medical help if any of the following occur:
• eye pain or discomfort, temporary blurred vision, halos or colored images around lights, 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, shortness of breath or wheezing immediately after using this medicine – these may be signs of a condition called paradoxical bronchospasm.
• Inform your doctor immediately if your COPD symptoms, such as breathlessness, shortness of breath or cough, do not improve or worsen.

Ultibro Breezhaler is used as a maintenance therapy for COPD. Do not use this medicine to treat a sudden attack of breathlessness or shortness of breath.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age. This is because this medicine has not been studied in this age group.
Other medicines and Ultibro 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:

• any medicine that may be similar to Ultibro 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 disease called glaucoma (such as timolol).
• medicines that lower potassium levels in the blood. These include:
• steroids (e.g. prednisolone),
• diuretics used for high blood pressure, such as hydrochlorothiazide,
• medicines for breathing 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 of this medicine pass into breast milk. Indacaterol, one of the active substances in Ultibro Breezhaler, may inhibit labour due to its effect on the uterus.
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. You must not take Ultibro Breezhaler unless advised by your doctor.
Driving and using machines
It is unlikely that this medicine will affect your 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.
Ultibro 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 him/her before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Ultibro Breezhaler

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Ultibro Breezhaler to use
The usual dose is inhaling 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 Ultibro Breezhaler
Use this medicine every day at the same time. This will help you remember to take it.
You may inhale Ultibro Breezhaler at any time before or after eating or drinking.
How to inhale Ultibro Breezhaler

• Ultibro Breezhaler is for inhalation use only.
• This pack contains a single inhaler and capsules (in blisters) containing the medicine as a powder for inhalation. Use the capsules only with the inhaler provided in this pack (the Ultibro 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 Ultibro Breezhaler inhaler supplied 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 Ultibro 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 Ultibro
Breezhaler packaging. Medical treatment may be required. You may notice your heart beating
faster than usual, headache, drowsiness, nausea or vomiting, or you may experience visual disturbances, constipation, or difficulty in urinating.
If you forget to use Ultibro Breezhaler
If you forget to inhale a dose at your usual time, inhale one as soon as possible on the same
day. Then inhale your next dose at the usual time the following day. Do not inhale more than one
dose in the same day.
How long to continue treatment with Ultibro Breezhaler

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

If you have any questions about using 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 (hyperglycaemia).

Uncommon (may affect up to 1 in 100 people)

• crushing chest pain with increased sweating – may be a serious heart problem (ischaemic heart disease).
• swelling, especially of the tongue, lips, face or throat (possible signs of angioedema).
• difficulty breathing with shortness of breath or cough.
• eye pain or discomfort, temporary blurred vision, visual halos or coloured 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.
• diarrhoea or stomach ache.
• 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 the hands, ankles and feet.
• fatigue.

Rare (may affect up to 1 in 1,000 people)

• tingling or numbness.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
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 Ultibro Breezhaler

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 carton and blister after
“Exp”/“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 remove them from the
blister only immediately before use.
The inhaler contained in each pack must be discarded after all 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 any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ultibro 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 “Ultibro 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), indigo carmine (E132), and titanium dioxide (E171).

Description of the appearance of Ultibro Breezhaler and package contents
Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard 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, together with 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 10x1) 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 Authorisation 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 Authorisation 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
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 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 Eesti filiaal
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Please read the instructions for use completely before using Ultibro Breezhaler.

Insert Pierce and release Inhale Check that the
deeply capsule is empty
1 3 Check