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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

indacaterol/glycopyrronium

Read all of 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if the side effects are not listed in this leaflet. See section 4.

Contents of this leaflet

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

Instructions for use of 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 known as 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 tighten, making it difficult to breathe. This medicine blocks the tightening of these muscles in the lungs, allowing air to flow in and out more easily.

If you take this medicine once daily, it will help reduce the impact of COPD on your daily life.

2. What you need to know before using Xoterna Breezhaler

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

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

• you have asthma – this medicine should not be used for the treatment of asthma.
• you have heart problems.
• you have seizures or fits.
• you have a thyroid gland problem (thyrotoxicosis).
• you have diabetes.
• you are using any other medicine for your lung disease that contains active ingredients similar (same class) to those in Xoterna Breezhaler (see section "Use of Xoterna Breezhaler with other medicines").
• you have kidney problems.
• you have severe liver problems.
• you have a type of eye disorder known as narrow-angle glaucoma.
• you have difficulty passing urine.

If any of the above apply to 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 immediate medical help if you experience any of the following:
• eye pain or discomfort, temporary blurred vision, visual halos or colored images along with redness of the eye – 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, or hives (signs of an allergic reaction).
• chest tightness, cough, wheezing, or difficulty breathing immediately after using this medicine – these may be signs of a condition called paradoxical bronchospasm.
• Tell your doctor immediately if your COPD symptoms, such as shortness of breath, wheezing, or cough, do not improve or worsen.

Xoterna Breezhaler is used as a long-term treatment for your COPD. Do not use this medicine to treat a sudden attack of breathlessness 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 taking, have recently taken, or might need to take any other medicines.

In particular, tell your doctor or pharmacist if you are taking:

• any medicine that may be similar to Xoterna Breezhaler (containing 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 reduce the amount of potassium in the blood. These include:
• corticosteroids (e.g. prednisolone),
• diuretics used for high blood pressure (e.g. hydrochlorothiazide),
• medicines for breathing problems (e.g. theophylline).

Pregnancy and breastfeeding

There are no data 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 in Xoterna Breezhaler, may inhibit childbirth due to its effect on the uterus.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You must 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 operate machinery.

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.

3. How to use Xoterna Breezhaler

Follow exactly the instructions given by your doctor or pharmacist for using this medicine. If you are unsure, consult your doctor or pharmacist again.

Amount of 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 (aged 75 years 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 take it.

You may inhale Xoterna Breezhaler at any time before or after eating or drinking.

How to inhale Xoterna Breezhaler

• Xoterna Breezhaler is for inhalation use only.
• This pack contains an inhaler and capsules (in blisters) containing the medicine as a powder for inhalation. Use the capsules only with the inhaler provided in this pack (Xoterna Breezhaler inhaler). The capsules should remain in the blister until you are ready to use them.
• Peel the foil from the blister to open it – 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 all capsules have been used.
• 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 accidentally uses your capsules, inform your doctor immediately or go to the nearest emergency department. Show the Xoterna Breezhaler pack. Medical attention may be required. You may notice your heart beating faster than normal, or you may have a headache, feel drowsy, feel nauseous or have vomiting, or you may experience visual disturbances, constipation, or difficulty urinating.

If you forget to use Xoterna Breezhaler

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

How long you should continue treatment with Xoterna Breezhaler

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

• COPD is a long-term condition and you must use Xoterna Breezhaler every day, not only when you have breathing problems or other COPD symptoms.

Consult your doctor or pharmacist if you have any questions about how long you should continue treatment with this medicine.

If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Some adverse effects may be serious:

Frequent (may affect up to 1 in 10 patients)

• difficulty breathing or swallowing, swelling of the tongue, lips or face, hives, 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 levels (hyperglycaemia).

Uncommon (may affect up to 1 in 100 patients)

• tightness or pressure in the chest with increased sweating – this may be a serious heart problem (coronary ischaemia).
• swelling mainly of the tongue, lips, face or throat (possible signs of angioedema).
• difficulty breathing with wheezing or coughing.
• eye pain or discomfort, transient blurred vision, visual halos or coloured images associated with redness of the eyes – possible symptoms of glaucoma.
• irregular heartbeat.

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

Other adverse effects may include:

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

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

Frequent

• combination of sore throat and nasal discharge – possible symptoms of rhinopharyngitis.
• frequent urination and pain when urinating – possible symptoms of a urinary tract infection called cystitis.
• feeling of pressure or pain in cheeks and forehead – possible symptoms of sinus inflammation called sinusitis.
• nasal discharge or congestion.
• dizziness.
• headache.
• cough.
• sore throat.
• nausea, indigestion.
• dental caries.
• difficulty and pain when urinating – possible symptoms of bladder obstruction or urinary retention.
• fever.
• chest pain.

Uncommon

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

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

• tingling or numbness.

Reporting of adverse effects

If you experience any kind of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Xoterna 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 «CAD»/«EXP». The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep the capsules in the original blister pack to protect them from moisture, and do not remove them until immediately before use.

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

Do not use this medicine if the packaging is damaged or shows any signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment. 45

6. Contents of the pack and other information

Composition of Xoterna Breezhaler

• 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 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 components of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under the heading “Xoterna Breezhaler contains lactosa”).

Appearance of Xoterna Breezhaler and contents of the pack

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard 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.

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

The following pack sizes are available:

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

Multiple pack containing 96 (4 packs of 24x1) 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 6x1) hard capsules and 25 inhalers.

Only some pack sizes may be commercially available.

Marketing Authorization 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 further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

Read the complete Instructions for Use before using Xoterna Breezhaler.