Atecura Breezhaler 125 micrograms/260 micrograms powder for inhalation (hard capsule)

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atectura Breezhaler 125 micrograms/62.5 micrograms powder for inhalation (hard capsule)

Atectura Breezhaler 125 micrograms/127.5 micrograms powder for inhalation (hard capsule)

Atectura Breezhaler 125 micrograms/260 micrograms powder for inhalation (hard capsule)

indacaterol/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 others, 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.

Contents of the leaflet

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

Instructions for use of the Atectura Breezhaler inhaler

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

What Atectura Breezhaler is and how it works

Atectura Breezhaler contains two active substances called indacaterol and mometasone furoate.

Indacaterol belongs to a group of medicines known as bronchodilators. It relaxes the muscles in the small airways of the lungs. This helps open the airways and makes it easier for air to flow into and out of the lungs. When used regularly, it helps 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 and thereby gradually relieve breathing problems. Corticosteroids also help prevent asthma attacks.

What Atectura Breezhaler is used for

Atectura Breezhaler is used as a regular treatment for asthma in adults and adolescents (12 years of age and older).

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 must use Atectura Breezhaler every day as directed by your doctor, not only when you have breathing difficulties 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.

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

2. What you need to know before using Atectura Breezhaler

Follow all instructions from your doctor carefully.

Do not use Atectura Breezhaler

• if you are allergic to indacaterol, mometasone furoate, or to 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

Consult your doctor, pharmacist, or nurse before using Atectura 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 suffer from seizures or fits,
• if you have low potassium levels in your blood,
• if you have severe kidney problems,
• if you have pulmonary tuberculosis (TB) or any other long-standing or untreated infection.

During treatment with Atectura 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 Atectura 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).

Children and adolescents

Do not give this medicine to children under 12 years of age, as it has not been studied in this age group.

Other medicines and Atectura Breezhaler

Inform 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 Atectura 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 advise you whether you can use Atectura Breezhaler.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or operate machinery.

Atectura Breezhaler contains lactose

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

3. How to use Atectura Breezhaler

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

Amount of Atectura Breezhaler to inhale

There are three different strengths of Atectura Breezhaler capsules. Your doctor will decide which one is best for you.

The usual dose is to inhale the contents of one capsule every 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 Atectura Breezhaler every day, even if your asthma does not bother you.

When to inhale Atectura Breezhaler

Inhale Atectura 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 Atectura Breezhaler

• Atectura 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. Keep the capsules 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 inhalator 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 Atectura Breezhaler, consult your doctor.

If you use more Atectura 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 Atectura 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 Atectura Breezhaler

Do not stop using Atectura 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 experiences them.

Some adverse effects may be serious

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

Common: 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).

Uncommon: may affect up to 1 in 100 people

• swelling of the tongue, lips, face or throat (possible signs of angioedema)

Other adverse effects

The following is a list of other adverse effects. If any of these adverse effects become severe, please consult your doctor, pharmacist or nurse.

Very common: may affect more than 1 in 10 people

• sore throat, nasal discharge (nasopharyngitis)
• sudden breathing difficulty and chest tightness with wheezing or cough (asthma exacerbation)
• oropharyngeal pain

Common: may affect up to 1 in 10 people

• voice disorder (hoarseness)
• nasal congestion, sneezing, cough (upper respiratory tract infection)
• headache
• pain in muscles, bones or joints (signs of musculoskeletal pain)

Uncommon: may affect up to 1 in 100 people

• rapid heartbeat
• mouth ulcers (signs of candidiasis)
• high blood sugar levels (hyperglycaemia)
• muscle spasms
• itching
• skin rash
• clouding of the lenses in your eyes (signs of cataract)
• blurred vision

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 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 Atectura 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging when they are no longer needed. This helps protect the environment.

6. Contents of the pack and other information

Composition of Atectura Breezhaler

• The active substances are indacaterol (as acetate) and mometasone furoate.

Atectura Breezhaler 125 micrograms/62.5 micrograms

Each capsule contains 173 micrograms of indacaterol as acetate (equivalent to 150 micrograms of indacaterol) and 80 micrograms of mometasone furoate. The delivered dose (the dose released by the inhaler mouthpiece) is equivalent to 125 micrograms of indacaterol and 62.5 micrograms of mometasone furoate.

Atectura Breezhaler 125 micrograms/127.5 micrograms

Each capsule contains 173 micrograms of indacaterol as acetate (equivalent to 150 micrograms of indacaterol) and 160 micrograms of mometasone furoate. The delivered dose (the dose released by the inhaler mouthpiece) is equivalent to 125 micrograms of indacaterol and 127.5 micrograms of mometasone furoate.

Atectura Breezhaler 125 micrograms/260 micrograms

Each capsule contains 173 micrograms of indacaterol as acetate (equivalent to 150 micrograms of indacaterol) and 320 micrograms of mometasone furoate. The delivered dose (the dose released by the inhaler mouthpiece) is equivalent to 125 micrograms of indacaterol and 260 micrograms of mometasone furoate.

• The other component of the inhalation powder is lactose monohydrate (see section 2, “Atectura Breezhaler contains lactose”) and gelatin (capsule shell).

• The ingredients of the printing ink are:

Atectura Breezhaler 125 micrograms/62.5 micrograms

Shellac, brilliant blue FCF (E133), propylene glycol (E1520), titanium dioxide (E171) and black iron oxide (E172).

Atectura Breezhaler 125 micrograms/127.5 micrograms

Shellac, titanium dioxide (E171), black iron oxide (E172), propylene glycol (E1520), yellow iron oxide (E172) and ammonium hydroxide (E527).

Atectura Breezhaler 125 micrograms/260 micrograms

Shellac, black iron oxide (E172), propylene glycol (E1520) and ammonium hydroxide (E527).

Presentation 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.

• The capsules of Atectura Breezhaler 125 micrograms/62.5 micrograms have a product code “IM150-80” printed in blue above a blue bar on the body, and a logo printed in blue surrounded by two blue bars on the cap.
• The capsules of Atectura Breezhaler 125 micrograms/127.5 micrograms have a product code “IM150-160” printed in grey on the body and a logo printed in grey on the cap.
• The capsules of Atectura Breezhaler 125 micrograms/260 micrograms have a product code “IM150-320” printed in black above two black bars on the body and a logo printed in black surrounded by two black bars on the cap.

The following pack sizes are available:

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

Multiple packs containing 3 boxes, each with 30 x 1 capsules together with 3 inhalers.

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

Only certain pack sizes may be marketed.

Marketing Authorization 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

Instructions for use of the Atectura Breezhaler inhaler

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