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

Introduction

Package Leaflet: Information for the User

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

Instructions for use of the Ulunar Breezhaler inhaler

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

What Ulunar Breezhaler is

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

What Ulunar 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 Ulunar Breezhaler

Do not use Ulunar 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 starting to use Ulunar 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 of Ulunar Breezhaler (see section "Using Ulunar Breezhaler with other medicines").

During treatment with Ulunar Breezhaler

• Stop using this medicine and seek medical help immediately if 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 an acute attack of narrow-angle glaucoma.

Ulunar Breezhaler is used as ongoing treatment for your COPD. Do not use this medicine to treat a sudden attack 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 Ulunar 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 Ulunar 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 problem with the eyes called glaucoma (such as timolol).
• medicines that lower 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 information 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 Ulunar Breezhaler, may inhibit labor 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 should not use Ulunar 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.

Ulunar 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, consult your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

3. How to use Ulunar Breezhaler

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

How much Ulunar 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 since the effect of this medicine lasts 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 Ulunar Breezhaler

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

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

How to inhale Ulunar Breezhaler

• Ulunar 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 (Ulunar 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 Ulunar 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 Ulunar 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 center. Show the pack of Ulunar Breezhaler. Medical attention may be necessary. You may notice that your heart beats faster than normal, or you may have a headache, feel drowsy, feel sick, or need to vomit, or you may notice changes in vision, constipation, or difficulty urinating.

If you forget to use Ulunar Breezhaler

If you forget to inhale a dose at the usual time, inhale it as soon as possible 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 treatment with Ulunar Breezhaler

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

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

Consult your doctor or pharmacistif you have any doubts about how long to continue treatment with this medicine.

If you have any further questions on the use of 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, skin rash – possible symptoms of an allergic reaction.

? feeling tired or very thirsty, with increased appetite without gaining weight and frequent urination – possible symptoms 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 symptoms 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, coughing, headache with or without fever – possible symptoms of an upper respiratory tract infection.

Common

? combination of sore throat and runny nose – possible symptoms of rhinopharyngitis.

? frequent urination and pain while urinating – possible symptoms of a urinary tract infection called cystitis.

? feeling of pressure or pain in cheeks and forehead – possible symptoms of sinusitis.

? runny or stuffy nose.

? dizziness.

? headache.

? cough.

? sore throat.

? upset stomach, indigestion.

? tooth decay.

? difficulty and pain while urinating – possible symptoms 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 skin 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 via 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. Storage of Ulunar 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 is the last day of the month stated.

Do not store 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 pack should be discarded once you have used all the capsules.

Do not use this medicine if you notice that 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

Composition of Ulunar Breezhaler

• 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 released from 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 powder for inhalation are lactose monohydrate and magnesium stearate (see section 2 in the "Ulunar Breezhaler contains lactose" heading).
• The components of the capsule shell are hypromellose, calcium chloride, tartrazine (E102), and black printing ink (cap) and blue (body).

• The components of the black printing ink (cap) are shellac (E904), propylene glycol, ammonium hydroxide, potassium hydroxide, and black iron oxide (E172).
• The components of the blue printing ink (body) are shellac (E904), carmine indigo (E132), and titanium dioxide (E171).

Appearance of Ulunar Breezhaler and Container Contents

The hard capsules of Ulunar 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.

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 package sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin

Ireland

Manufacturer

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:

Date of Last Revision of this Leaflet:

Other Sources of Information

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