Leaflet: information for the user

Xoterna Breezhaler 85 micrograms/43 micrograms powder for inhalation (hard capsule)

indacaterol/glicopirronio

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Instructions for use of the Xoterna Breezhaler inhaler

What is Xoterna Breezhaler

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

What is Xoterna Breezhaler used for

This medication is used to help patients with adult respiratory difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). In COPD, the muscles surrounding the airways contract, making it difficult to breathe. This medication blocks the contraction of these muscles in the lungs, facilitating the entry and exit of air from them.

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

Do not use Xoterna 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

Consult your doctor, pharmacist or nurse before starting to use Xoterna Breezhaler if 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 convulsions or fits.
• you have thyroid gland problems (hyperthyroidism).
• you have diabetes.
• you are using any medicine for your lung disease that contains active principles similar (same class) to those of Xoterna Breezhaler (see section "Xoterna 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 with Xoterna Breezhaler

• Stop using this medicine and seek medical help immediatelyif you experience any of the following situations:
• eye pain or discomfort, blurred vision, halos around lights or coloured images associated 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.

Xoterna Breezhaler is 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 18 years of age. This is because its use has not been studied in this age group.

Other medicines and Xoterna Breezhaler

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

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

• any medicine that may be similar to Xoterna Breezhaler (containing active substances similar).
• medicines called beta-blockers that may be used for high blood pressure or other heart problems (such as propranolol), or for an eye problem called glaucoma (such as timolol).
• medicines that decrease the amount of potassium in the blood. These include:
• corticosteroids (e.g. prednisolone),
• diuretics used for 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 substances of Xoterna Breezhaler, may inhibit labour due to its effect on the uterus.

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

Driving and operating machines

This medicine is unlikely to affect your ability to drive and use machines. However, this medicine may cause dizziness (see section 4). If you feel dizzy while taking this medicine, do not drive or use machines.

Xoterna Breezhaler contains lactose

This medicine contains lactose (23.5 mg per capsule). If your doctor has told you that you have an intolerance to certain sugars, consult with him 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 Xoterna 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 or older

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

When to inhale Xoterna Breezhaler

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

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

How to inhale Xoterna Breezhaler

• Xoterna 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 (Xoterna 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 Xoterna 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 leaflet.

If you use more Xoterna 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 Xoterna 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 Xoterna 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 Xoterna Breezhaler

• Continue using Xoterna Breezhaler for the time your doctor indicates.

• COPD is a long-term disease, and you must use Xoterna Breezhalerevery dayand 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 questions about using this medication, ask your doctor, pharmacist, or nurse.

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

Some side effects can be serious:

Frequent (may 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).

Rare (may affect up to 1 in 100 patients)

• oppressive chest pain with increased sweating – this may 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 (may 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 discharge or congestion.
• dizziness.
• headache.
• coughing.
• sore throat.
• indigestion, stomach upset.
• tooth decay.
• difficulty and pain urinating – possible symptoms of bladder obstruction or urinary retention.
• fever.
• chest pain.

Rare

• difficulty sleeping.
• rapid 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 (may affect up to 1 in 1,000 patients)

• tingling or numbness.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in Appendix 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 after «CAD»/«EXP». The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store the capsules in the original blister 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.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packages and medications that you no longer need. This will help protect the environment.45

Composition of Xoterna Breezhaler

• The active principles are indacaterol (as maleate) and bromide of glycopyrrolate. Each capsule contains 143 micrograms of indacaterol maleate equivalent to 110 micrograms of indacaterol and 63 micrograms of bromide of glycopyrrolate equivalent to 50 micrograms of glycopyrrolate. The released dose (the dose released by the inhaler mouthpiece) is equivalent to 85 micrograms of indacaterol (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms of glycopyrrolate (equivalent to 54 micrograms of bromide of glycopyrrolate).

• The other components of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 in the heading "Xoterna Breezhaler contains lactose").

Appearance of Xoterna Breezhaler and contents of the package

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder capsules are transparent 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.

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

The following package sizes are available:

Single package containing 6x1, 10x1, 12x1, 30x1, or 90x1 hard capsules, along with 1 inhaler.

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

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

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

Last review date of this leaflet:

Other sources of information

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

Read theInstructions for Usecarefully before using Xoterna Breezhaler.