ENERZAIR Breezhaler 114 micrograms/46 micrograms/136 micrograms powder for inhalation (hard capsule)

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enerzair Breezhaler 114 micrograms/46 micrograms/136 micrograms powder for inhalation

(hard capsule)

indacaterol/glycopyrronium/mometasone furoate

Read the entire leaflet carefully before you start using this medicine, because 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 adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

Instructions for use of the Enerzair Breezhaler inhaler

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

What Enerzair Breezhaler is and how it works

Enerzair Breezhaler contains three active substances:

• indacaterol
• glycopyrronium
• mometasone furoate

Indacaterol and glycopyrronium belong to a group of medicines called bronchodilators. They work in different ways to relax the muscles in the small airways of the lungs. This helps open up the airways and makes it easier for air to flow in and out of the lungs. When used regularly, they help keep the small airways of the lungs open.

Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids). Corticosteroids reduce swelling and irritation (inflammation) in the small airways of the lungs, thereby gradually relieving breathing problems. Corticosteroids also help prevent asthma attacks.

What Enerzair Breezhaler is used for

Enerzair Breezhaler is used as regular treatment for asthma in adults.

Asthma is a serious chronic lung disease in which the muscles surrounding the smaller airways become narrowed (bronchoconstriction) and inflamed. Symptoms come and go and include difficulty breathing, wheezing, chest tightness, and cough.

You should use Enerzair Breezhaler every day as directed by your doctor, not only when you have breathing problems or other asthma symptoms. This ensures proper control of your asthma. Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.

Consult your doctor if you have any questions about how Enerzair Breezhaler works or why this medicine has been prescribed for you.

2. What you need to know before using Enerzair Breezhaler

Follow all instructions from your doctor carefully.

Do not use Enerzair Breezhaler

• if you are allergic to indacaterol, glycopyrronium, mometasone furoate, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

Warnings and precautions

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

• if you have heart problems, including rapid or irregular heartbeat,
• if you have thyroid gland problems,
• if you have ever been told you have diabetes or high blood sugar levels,
• if you have seizures or fits,
• if you have severe kidney problems,
• if you have severe liver problems,
• if you have low levels of potassium in your blood,
• if you have an eye condition called narrow-angle glaucoma,
• if you have difficulty passing urine,
• if you have pulmonary tuberculosis (TB) or any other long-standing or untreated infection.

During treatment with Enerzair Breezhaler

Stop using this medicine and seek immediate medical help if you experience any of the following:

• chest tightness, cough, wheezing, or difficulty breathing immediately after using Enerzair Breezhaler (signs of unexpected narrowing of the airways, known as paradoxical bronchospasm),
• difficulty breathing or swallowing, swelling of the tongue, lips, or face, skin rash, itching, or hives (signs of an allergic reaction),
• eye pain or discomfort, temporary blurred vision, visual halos (bright circles around lights), or colored images, together with redness of the eyes (signs of an acute attack of narrow-angle glaucoma).

Children and adolescents

Do not give this medicine to children or adolescents (under 18 years of age) because it has not been studied in this age group.

Other medicines and Enerzair Breezhaler

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor or pharmacist if you are taking:

• medicines that reduce potassium levels in the blood. These include diuretics (which increase urine production and may be used to treat high blood pressure, e.g. hydrochlorothiazide), other bronchodilators such as methylxanthines used for respiratory disorders (e.g. theophylline), or corticosteroids (e.g. prednisolone).
• tricyclic antidepressants or monoamine oxidase inhibitors (medicines used to treat depression).
• any medicine similar to Enerzair Breezhaler (containing similar active substances); because using them together may increase the risk of side effects.
• medicines called beta-blockers, which may be used for high blood pressure or other heart problems (such as propranolol), or to treat glaucoma (e.g. timolol).
• ketoconazole or itraconazole (medicines used to treat fungal infections).
• ritonavir, nelfinavir, or cobicistat (medicines used to treat HIV infection).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will decide whether you can use Enerzair Breezhaler.

Driving and using machines

This medicine is unlikely to affect your ability to drive or operate machinery.

Enerzair Breezhaler contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to use Enerzair Breezhaler

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Amount of Enerzair Breezhaler to inhale

The usual dose is to inhale the contents of one capsule each day. You only need to inhale the medicine once a day. Do not use more than the dose prescribed by your doctor.

You must use Enerzair Breezhaler every day, even if you do not have any asthma symptoms.

When to inhale Enerzair Breezhaler

Inhale Enerzair Breezhaler at the same time each day. This will help you control your symptoms throughout the day and night. It will also help you remember to take it.

How to inhale Enerzair Breezhaler

• Enerzair Breezhaler is for inhalation use only.
• This pack contains an inhaler and capsules containing the medicine. The inhaler allows you to inhale the medicine from the capsule. Use the capsules only with the inhaler provided in this pack. The capsules should remain in the blister until you are ready to use them.
• Peel back the foil to open the blister, do not push the capsule through the foil.
• When starting a new pack, use the new inhaler provided in the pack.
• Dispose of 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 your symptoms do not improve

If your asthma does not improve or worsens after you have started using Enerzair Breezhaler, consult your doctor.

If you use more Enerzair Breezhaler than you should

If you accidentally inhale too much of this medicine, contact your doctor or hospital immediately. Medical attention may be required.

If you forget to use Enerzair 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 the next dose at your usual time. Do not inhale two doses on the same day.

If you stop using Enerzair Breezhaler

Do not stop using Enerzair Breezhaler unless your doctor tells you to. Your asthma symptoms may return if you stop using it.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Some adverse effects may be serious

Stop using Enerzair Breezhaler and seek immediate medical help if you experience any of the following:

Frequent: may affect up to 1 in 10 people

• difficulty breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of an allergic reaction).

Other adverse effects

The following lists other adverse effects. If these adverse effects become severe, please consult your doctor, pharmacist or nurse.

Very frequent: may affect more than 1 in 10 people

• sore throat, runny nose (nasopharyngitis)
• sudden difficulty breathing and feeling of tightness in the chest with wheezing or cough (asthma exacerbation)

Frequent: may affect up to 1 in 10 people

• mouth ulcers (signs of candidiasis). After inhaling your dose, rinse your mouth with water or a mouthwash solution and spit it out. This will help prevent mouth ulcers.
• frequent urge to urinate and pain or burning when urinating (signs of urinary tract infection)
• headache
• rapid heartbeat
• cough
• voice disturbance (hoarseness)
• diarrhoea, abdominal cramps, nausea and vomiting (gastroenteritis)
• pain in the muscles, bones or joints (signs of musculoskeletal pain)
• muscle spasms
• fever
• upper respiratory tract infection
• oropharyngeal pain

Uncommon: may affect up to 1 in 100 people

• dry mouth
• skin rash
• high blood sugar levels (hyperglycaemia)
• itching
• difficulty and pain when urinating (signs of dysuria)
• clouding of the lenses in your eyes (signs of cataract)

Reporting of adverse effects

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

5. Storage of Enerzair 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 30°C.
• Keep the capsules in the original blister pack to protect them from light and moisture, and do not remove them until immediately before use.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicine and its packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Enerzair Breezhaler

• The active substances are indacaterol (as acetate), glycopyrronium (as bromide) and mometasone furoate. Each capsule contains 150 micrograms of indacaterol (as acetate), 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms of glycopyrronium) and 160 micrograms of mometasone furoate. Each delivered dose (the dose released by the inhaler mouthpiece) contains 114 micrograms of indacaterol (as acetate), 58 micrograms of glycopyrronium bromide (equivalent to 46 micrograms of glycopyrronium) and 136 micrograms of mometasone furoate.

• The other components of the capsule are lactose monohydrate and magnesium stearate (see section 2, “Enerzair Breezhaler contains lactose”).

• The ingredients of the capsule shell are hypromellose, carrageenan, potassium chloride, yellow iron oxide (E172), indigo carmine (E132), purified water and printing ink.

• The ingredients of the printing ink are black iron oxide (E172), isopropyl alcohol, propylene glycol (E1520), hypromellose (E464) and purified water.

Appearance of the product and contents of the pack

This pack contains an inhaler together with capsules in blister packs. The capsules are transparent and contain a white powder. They have the product code “IGM150-50-160” printed in black above two black bars on the body, and the product logo printed in black surrounded by a black bar on the cap.

The following pack sizes are available:

Single pack containing 10 x 1, 30 x 1 or 90 x 1 hard capsules, together with 1 inhaler.

Multiple packs containing 15 boxes, each with 10 x 1 capsules together with 1 inhaler.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer

Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

More information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

Instructions for use of the Enerzair Breezhaler inhaler

Please read the complete Instructions for Use of the Enerzair Breezhaler inhaler before using it.