XOTERNA BREEZHALER 85/43 micrograms powder for inhalation (hard capsule)

Introduction

Package Leaflet: Information for the User

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

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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

Instructions for using the Xoterna Breezhaler inhaler

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

What Xoterna Breezhaler is

This medicine contains two active substances called indacaterol and glycopyrronium, which belong to a class of medicines called bronchodilators.

What Xoterna 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 contract, making it difficult to breathe. This medicine blocks the contraction of these muscles in the lungs, making it easier for air to enter and leave the lungs.

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

2. What you need to know before you use Xoterna Breezhaler

Do not use Xoterna Breezhaler

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Xoterna Breezhaler if any of the following apply to you:

• you have asthma – this medicine should not be used to treat asthma.
• you have heart problems.
• you have seizures or fits.
• you have thyroid problems (thyrotoxicosis).
• you have diabetes.
• you are using any other medicine for your lung disease that contains active substances similar to those in Xoterna Breezhaler (see section "Using Xoterna Breezhaler with other medicines").
• you have kidney problems.
• you have severe liver problems.
• you have a eye problem called narrow-angle glaucoma.
• you have difficulty urinating.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before using this medicine.

While using Xoterna Breezhaler

• Stop using this medicine and seek medical help immediatelyif you experience any of the following:
• eye pain or discomfort, blurred vision, halos, or colored images in association with eye redness – these may be signs of acute narrow-angle glaucoma.
• difficulty breathing or swallowing, swelling of the tongue, lips, or face, hives, rash, or itching – possible signs of an allergic reaction.
• chest tightness, cough, wheezing, or difficulty breathing immediately after using this medicine – these may be signs of paradoxical bronchospasm.
• Tell your doctor immediatelyif your COPD symptoms, such as difficulty breathing, wheezing, or coughing, do not improve or worsen.

Xoterna Breezhaler is used as ongoing treatment for your COPD. Do not use this medicine to treat sudden attacks 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 its use has not been studied in this age group.

Other medicines and Xoterna Breezhaler

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• any medicine that may be similar to Xoterna Breezhaler (containing similar active substances).
• medicines called beta-blockers that may be used for high blood pressure or other heart problems (such as propranolol), or for a 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

There is no data on the use of this medicine in pregnant women, and it is not known whether the active substance of this medicine passes into breast milk. Indacaterol, one of the active substances of Xoterna Breezhaler, may inhibit labor due to its effect on the uterus.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should not use Xoterna Breezhaler unless your doctor tells you to.

Driving and using machines

This medicine is unlikely to affect your ability to drive or 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 some sugars, talk to your doctor before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Xoterna Breezhaler

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

How much Xoterna Breezhaler to use

The usual dose is to inhale the contents of one capsule each day.

You only need to inhale the medicine once a day, as the effect of this medicine lasts for 24 hours. Do not use more than the dose prescribed by your doctor.

Elderly patients (75 years of age and older)

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

When to inhale Xoterna Breezhaler

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

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

How to inhale Xoterna Breezhaler

• Xoterna Breezhaler is for inhalation use only.
• In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine in powder form for inhalation. Use the capsules only with the inhaler provided in this pack (Xoterna Breezhaler inhaler). The capsules should be kept in the blister until you need to use them.
• Peel off the foil to open the blister - do not push the capsule through the foil.
• When starting a new pack, use the new Xoterna Breezhaler inhaler provided in the pack.
• Discard the inhaler from each pack 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 medicine or if someone uses your capsules accidentally, tell your doctor immediately or go to the nearest emergency room. Show the pack of Xoterna Breezhaler. Medical attention may be needed. You may notice that your heart beats faster than normal, or you may have a headache, feel drowsy, feel sick, or have to vomit, or you may notice changes in vision, constipation, or difficulty urinating.

If you forget to use Xoterna Breezhaler

If you forget to inhale a dose at the usual time, inhale it as soon as you can on that 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 using Xoterna Breezhaler

• Continue using Xoterna Breezhaler for as long as your doctor tells you.

• COPD is a long-term disease, and you should use Xoterna Breezhaler every dayand not just when you have breathing problems or other symptoms of COPD.

Ask your doctor or pharmacist if you have any questions about how long to use this medicine.

If you have any other questions about using this medicine, ask 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 may be serious:

Common (may affect up to 1 in 10 people)

• difficulty breathing or swallowing, swelling of the tongue, lips, or face, hives, rash, or itching – possible signs of an allergic reaction.

• feeling tired or very thirsty, with increased appetite without gaining weight and frequent urination – possible signs of high blood sugar (hyperglycemia).

Uncommon (may affect up to 1 in 100 people)

• chest pain or discomfort 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 in association with eye redness – possible signs of glaucoma.
• irregular heartbeat.

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

Other side effects may include:

Very common (may affect more than 1 in 10 people)

• stuffy nose, sneezing, cough, headache with or without fever – possible signs of a upper respiratory tract infection.

Common

• combination of sore throat and runny nose – possible signs of pharyngitis.
• frequent urination and pain while urinating – possible signs of a urinary tract infection called cystitis.
• feeling of pressure or pain in cheeks and forehead – possible signs of sinusitis.
• nasal discharge or congestion.
• dizziness.
• headache.
• cough.
• sore throat.
• upset stomach, indigestion.
• tooth decay.
• difficulty and pain while urinating – possible signs of bladder obstruction or urinary retention.
• fever.
• chest pain.

Uncommon

• difficulty sleeping.
• fast heartbeat.
• palpitations – signs of abnormal heartbeats.
• voice changes (hoarseness).
• nosebleeds.
• diarrhea or stomach pain.
• dry mouth.
• itching or rash.
• pain affecting muscles, ligaments, tendons, joints, and bones.
• muscle spasms.
• muscle pain, pain, or tenderness.
• pain in arms or legs.
• swelling of hands, ankles, and feet.
• fatigue.

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

• tingling or numbness.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Xoterna 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". The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Keep the capsules in the original blister to protect them from moisture and do not remove them until you are about to use them.

The inhaler from each pack should be discarded once you have used all the capsules.

Do not use this medicine if you notice the pack is damaged or shows signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Xoterna Breezhaler Composition

• The active ingredients 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 delivered by the inhaler mouthpiece) 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 ingredients of the powder for inhalation are lactose monohydrate and magnesium stearate (see section 2 in the "Xoterna Breezhaler contains lactose" heading).

Appearance of Xoterna Breezhaler and Container Contents

The hard capsules of Xoterna Breezhaler 85 micrograms/43 micrograms powder for inhalation 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.

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

The following package sizes are available:

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

Multipack containing 96 (4 packs of 24x1) hard capsules and 4 inhalers.

Multipack containing 150 (15 packs of 10x1) hard capsules and 15 inhalers.

Multipack containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.

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

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

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

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu

Read the Instructions for Usecarefully before using Xoterna Breezhaler.