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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

indacaterol/glycopyrronium/mometasone furoate

Read all of this 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

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

Instructions for use of the Zimbus Breezhaler inhaler

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

What Zimbus Breezhaler is and how it works

Zimbus 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 into 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 Zimbus Breezhaler is used for

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

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

2. What you need to know before using Zimbus Breezhaler

Follow all your doctor's instructions carefully.

Do not use Zimbus 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 Zimbus 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 a type of eye disorder 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 Zimbus Breezhaler

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

• chest tightness, cough, wheezing, or breathing difficulty immediately after using Zimbus 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, associated with red eyes (signs of an acute narrow-angle glaucoma attack).

Children and adolescents

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

Other medicines and Zimbus 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 Zimbus 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 are planning to become pregnant, consult your doctor before using this medicine. Your doctor will decide whether you can use Zimbus Breezhaler.

Driving and using machines

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

Zimbus Breezhaler contains lactose

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

3. How to use Zimbus Breezhaler

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

Amount of Zimbus 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 should use Zimbus Breezhaler every day, even if you do not feel any asthma-related discomfort.

When to inhale Zimbus Breezhaler

Inhale Zimbus 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 Zimbus Breezhaler

• Zimbus 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 even worsens after you have started using Zimbus Breezhaler, consult your doctor.

If you use more Zimbus 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 Zimbus 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 Zimbus Breezhaler

Do not stop using Zimbus 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Some side effects may be serious

Stop using Zimbus Breezhaler and get 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 side effects

The following side effects are listed below. If these side effects become severe, please consult your doctor, pharmacist or nurse.

Very frequent: may affect more than 1 in 10 people

• sore throat, nasal discharge (nasopharyngitis)
• sudden difficulty breathing and 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
• fast heartbeat
• cough
• voice changes (hoarseness)
• diarrhoea, abdominal cramps, nausea and vomiting (gastroenteritis)
• pain in 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 side effects

If you experience any side effect, talk to your doctor, pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them 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. Storage of Zimbus 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 «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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zimbus 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 “Zimbus Breezhaler contains lactose” in section 2).

• 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.

Nature 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:

Unit 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

For further information on this medicinal product, please contact 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 website of the European Medicines Agency: https://www.ema.europa.eu.

Instructions for use of the Zimbus Breezhaler inhaler

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