Prospect: information for the user

Ultibro Breezhaler 85micrograms/43microgramspowder for inhalation (hard capsule)

indacaterol/glicopirronio

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,even if they do not appear in this prospect. See section4.

1.What isUltibro Breezhalerand for what it is used

2.What you need to knowbefore starting to useUltibro Breezhaler

3.How to useUltibro Breezhaler

4.Possible adverse effects

5.Storage ofUltibro Breezhaler

6.Contents of the package and additional information

Instructions for use of the Ultibro Breezhaler inhaler

What isUltibro Breezhaler

This medication contains two active ingredients called indacaterol andglicopirronio, which belong to a class of medications called bronchodilators..

What is Ultibro Breezhaler used for

This medication is used to help patients with adult difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD).InCOPD, the muscles surrounding the airways constrict, making it difficult to breathe. This medication blocks the constriction of these muscles in the lungs, facilitating the entry and exit of air from the lungs.

If you use this medication once a day, it will help reduce the effects ofCOPDin your daily life.

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 section6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to useUltibro Breezhalerif any of the following situations affect you:

• you have asthma – this medicine should not be used as a treatment for asthma.
• you have heart problems.
• you have seizures or fits.
• you have thyroid gland problems (hyperthyroidism).
• you have diabetes.
• you are using any medicine for your lung disease that contains active ingredients similar to those of Ultibro Breezhaler (see section «Using Ultibro Breezhaler with other medicines»).
• you have kidney problems.
• you have severe liver problems.
• you have a known eye disorder called narrow-angle glaucoma.
• you have difficulty urinating.

If any of the above situations affect you (or you are unsure),consult your doctor, pharmacist or nurse before starting to use this medicine.

During treatment withUltibro Breezhaler

• Stop using this medicine and seek medical help immediatelyif you experience any of the following:
• dizziness or pain in the eyes, blurred vision, halos or coloured images in association with eye redness–these may be signs of an acute attack of narrow-angle glaucoma.
• difficulty breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and urticaria (signs of an allergic reaction).
• chest tightness, cough, wheezing or immediate difficulty breathing after using this medicine –these may be signs of a condition called paradoxical bronchospasm.
• Inform your doctor immediatelyif your COPD symptoms, such as difficulty breathing, rapid breathing or cough, do not improve or worsen.

Ultibro Breezhaleris used as continuous treatment for your COPD. Do not use this medicine to treat a sudden attack of dyspnea or wheezing.

Children and adolescents

Do not administer this medicine to children or adolescents under 18years of age. This is because its use has not been studied in this age group.

Other medicines and Ultibro Breezhaler

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

Especially, inform your doctor or pharmacist if you are using:

• any medicine that may be similar to Ultibro Breezhaler (containing active ingredients similar to those of Ultibro Breezhaler).
• medicines called beta-blockers that may be used to treat high blood pressure or other heart problems (such as propranolol), or to treat a condition called glaucoma (such as timolol).
• medicines that decrease the amount of potassium in the blood. These include:
• corticosteroids (e.g. prednisolone),
• diuretics used to treat high blood pressure (e.g. hydrochlorothiazide),
• medicines for respiratory problems (e.g. theophylline).

Pregnancy and breastfeeding

No data are available on the use of this medicine in pregnant women and it is unknown whether the active ingredient of this medicine passes into breast milk. Indacaterol, one of the active ingredients of Ultibro Breezhaler, may inhibit labour due to its effect on the uterus.

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.Do not use UltibroBreezhaler unless your doctor tells you to.

Driving and operating machinery

This medicine is unlikely to affect your ability to drive and use machines. However, this medicine may cause dizziness (see section4). If you feel dizzy while taking this medicine, do not drive or use machines.

Ultibro Breezhaler contains lactose

This medicine contains lactose(23.5mg per capsule).If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again..

Amount of Ultibro Breezhaler to use

The usual dose is to inhale the contents of a capsule every day.

You only need to inhale the medication once a day since the effect of this medication lasts 24 hours. Do not use more doses than indicated by your doctor.

Patients aged 75 years or older

If you are 75 years or older, you can use this medication at the same dose as other adults.

When to inhale Ultibro Breezhaler

Use this medication at the same time every day. This will help you remember to use it.

You can inhale Ultibro Breezhaler at any time before or after food or drinks.

How to inhale Ultibro Breezhaler

• Ultibro Breezhaler is for inhalation use.
• In this package, you will find an inhaler and capsules (in blisters) containing the medication powder for inhalation. Use the capsules only with the inhaler provided in this package (Ultibro Breezhaler inhaler). The capsules must be kept in the blister until you need to use them.
• Remove the foil from the blister to open it - do not press the capsule through the foil.
• When starting a new package, use the new Ultibro Breezhaler inhaler provided in the package.
• Dispose of the inhaler from each package once you have used all the capsules.
• Do not swallow the capsules.
• For more information on how to use the inhaler, please read the instructions at the end of this prospectus.

If you use more Ultibro Breezhaler than you should

If you have inhaled too much of this medication or if someone accidentally uses your capsules, inform your doctor immediately or go to the nearest emergency center. Show the Ultibro Breezhaler package. Medical attention may be necessary. You may notice that your heart beats faster than normal, or you may have a headache, feel drowsy, feel nauseous, or vomit, or you may notice visual disturbances, constipation, or difficulty urinating.

If you forgot to use Ultibro Breezhaler

If you forgot to inhale a dose at the usual time, inhale it as soon as possible on the same day. Then, the next day inhale the next dose at the usual time. Do not inhale more than one dose on the same day.

How long to continue treatment with Ultibro Breezhaler

• Continue using Ultibro Breezhaler for the time your doctor indicates.
• COPD is a long-term disease, and you must use Ultibro Breezhaler every day and not just when you have respiratory problems or other COPD symptoms.

Consult your doctor or pharmacist if you have doubts about how long you should continue treatment with this medication.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse..

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious:

Frequent (can affect up to 1 in 10 patients)

• Difficulty breathing or swallowing, swelling of the tongue, lips, or face, urticaria, skin rash – possible symptoms of an allergic reaction.
• Feeling tired or very thirsty, with increased appetite without weight gain and frequent urination – possible symptoms of high blood sugar (hyperglycemia).

Less frequent (can affect up to 1 in 100 patients)

• Pressure or pain in the chest with increased sweating – this can be a serious heart problem (coronary ischemia).
• Swelling mainly of the tongue, lips, face, or throat (possible signs of angioedema).
• Difficulty breathing with wheezing or coughing.

• Eye pain or discomfort, blurred vision, halos, or colored images associated with eye redness – possible symptoms of glaucoma.

• Irregular heartbeat.

If you experience any of these serious side effects, seek medical help immediately.

Other side effects may include:

Very frequent (can affect more than 1 in 10 patients)

• Stuffy nose, sneezing, coughing, headache with or without fever – possible symptoms of upper respiratory tract infection.

Frequent

• Combination of sore throat and nasal discharge – possible symptoms of pharyngitis.
• Frequent urination and painful urination – possible symptoms of urinary tract infection called cystitis.
• Sensation of pressure or pain in cheeks and forehead – possible symptoms of sinus inflammation called sinusitis.
• Nasal secretion or congestion.
• Dizziness.
• Headache.
• Coughing.
• Sore throat.
• Indigestion, stomach upset.
• Dental caries.
• Difficulty and pain urinating – possible symptoms of bladder obstruction or urinary retention.
• Fever.
• Chest pain.

Less frequent

• Difficulty sleeping.
• Fast heartbeat.
• Palpitations – signs of abnormal heartbeats.
• Voice changes (hoarseness).
• Nosebleed.
• Diarrhea or stomach pain.
• Dry mouth.
• Itching or skin rash.
• Pain affecting muscles, ligaments, tendons, joints, and bones.
• Muscle spasms.
• Muscle pain, pain, or sensitivity.
• Pain in arms or legs.

• Swelling of hands, ankles, and feet.
• Tiredness.

Rare (can affect up to 1 in 1,000 patients)

• Tickling or numbness.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's a possible side effect not listed in this prospectus.You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after«CAD»/«EXP». The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Store the capsules in the original blister pack to protect them from moisture and do not remove them until just before use.

The inhaler from each package must be discarded once all the capsules have been used.

Do not use this medication if you observe that the package is damaged or shows signs of deterioration.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition ofUltibro Breezhaler

• The active principles are indacaterol (as maleate) and bromide ofglicopirronio. Each capsule contains 143micrograms of maleate of indacaterol equivalent to 110micrograms of indacaterol and 63micrograms of bromide of glicopirronio equivalent to 50micrograms of glicopirronio. The released dose (the dose that releases the inhaler mouthpiece) is equivalent to85micrograms of indacaterol (equivalent to 110micrograms of maleate of indacaterol) and 43micrograms of glicopirronio (equivalent to 54micrograms of bromide of glicopirronio).
• The other components of the inhalation powder arelactosa monohydrate and magnesium stearate (see section2 in the heading “Ultibro Breezhaler contains lactose”).

Appearance of Ultibro Breezhaler and contents of the package

The hard capsules of Ultibro Breezhaler 85micrograms/43microgramsinhalation powder aretransparent and yellow and contain a white or almost white powder. They have the product code “IGP110.50” printed in blue under two blue bars on the body and the company logo()printed in black on the cap.

In this package, you will find a device known as an inhaler, along with capsules in blisters.Each blister contains 6 or 10hard capsules.

The following package sizes are available:

Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1hard capsules, along with

1inhaler.

Multiple pack containing 96(4packages of 24x1)hard capsules and 4inhalers.

Multiple pack containing 150(15packages of 10x1)hard capsules and 15inhalers.

Multiple pack containing 150(25packages of 6x1)hard capsules and 25inhalers.

Only some package sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublín 4

Irlanda

Responsible for Manufacturing

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Alemania

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

España

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Alemania

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

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