Atectura Breezhaler

Package leaflet: Information for the user

Atectura Breezhaler 125 micrograms/62.5 micrograms powder for inhalation, hard capsules
Atectura Breezhaler 125 micrograms/127.5 micrograms powder for inhalation, hard capsules
Atectura Breezhaler 125 micrograms/260 micrograms powder for inhalation, hard capsules
indacaterol/mometasone furoate

Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this 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 called bronchodilators and relaxes the muscles in the small airways of the lungs. This helps to open the airways, making breathing easier. When taken regularly, it helps keep the small airways in 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 difficulties. Corticosteroids also help prevent asthma attacks.

What Atectura Breezhaler is used for
Atectura Breezhaler is used regularly as a treatment for asthma in adults and adolescents (aged 12 years and older).
Asthma is a serious, chronic lung disease in which the muscles surrounding the small airways of the lungs become constricted (bronchoconstriction) and inflamed. Symptoms come and go and include shortness of breath, wheezing, chest tightness and cough.
You must use Atectura Breezhaler every day as instructed by your doctor, not only when you have breathing difficulties or other asthma symptoms. This will allow you to achieve adequate asthma control.
Do not use this medicine to relieve a sudden attack of breathlessness or wheezing.
If you have any questions about how Atectura Breezhaler works or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before using Atectura Breezhaler

Follow your doctor's instructions carefully.
Do not use Atectura Breezhaler

• If you are allergic to indacaterol, 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 Atectura Breezhaler if any of the following apply to you:

• if you have heart problems, including irregular or rapid heartbeat;
• if you have problems with your thyroid gland;
• if you have been diagnosed with diabetes or have high blood sugar levels;
• if you suffer from epilepsy or seizures;
• if you have low levels of potassium in your blood;
• if you have severe liver problems;
• if you have active or untreated pulmonary tuberculosis (TB), or any long-standing or untreated infection.

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

• chest tightness, cough, wheezing, or shortness of breath immediately after using Atectura Breezhaler (signs that the medicine is unexpectedly narrowing the airways, known as paradoxical bronchospasm);
• difficulty breathing or swallowing, swelling of the tongue, lips, or face, rash, itching, or hives (signs of an allergic reaction).

Children and adolescents
This medicine must not be given 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 take any other medicines. In particular, inform your doctor or pharmacist if you are taking:

• medicines that lower 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 problems (e.g. theophylline), or corticosteroids (e.g. prednisolone);
• tricyclic antidepressants or monoamine oxidase inhibitors (medicines used to treat depression);
• any medicine that is similar to Atectura Breezhaler (containing similar active substances); using them together may increase the risk of possible side effects;
• medicines called beta-blockers, used to treat high blood pressure or other heart problems (e.g. 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 infections).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking 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 diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Atectura Breezhaler

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Atectura Breezhaler to inhale
Atectura Breezhaler capsules are available in three different strengths. Your doctor will decide which
strength is most suitable for you.
The usual dose is inhaling the contents of one capsule every day. One inhalation per day is sufficient. Do not use more medicine than your doctor has prescribed.
You must use Atectura Breezhaler every day, even when your asthma is not causing you problems.
When to inhale Atectura Breezhaler
Use Atectura Breezhaler every day at the same time. This will help you control symptoms during the day and night, and will also help you remember to use 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. The capsules must remain in the blister until you are ready to use them.
• To open the blister, peel back the protective film; do not push the capsule through the film.
• When starting a new pack, use the new inhaler provided in that pack.
• Discard the inhaler from each pack after using all the capsules in the pack.
• Do not swallow the capsules.
• Read the instructions on the other side of this leaflet for further information on how to use the inhaler.

If the pack contains a sensor for Atectura Breezhaler

• The sensor for Atectura Breezhaler can only be used by adult patients. It must not be used by adolescents (aged 12 years and older) because the App does not have the functionality to verify patient consent or allow access for caregivers.
• The sensor and App are not essential for taking the medicine. It is not necessary for the sensor to be connected to the App when taking the medicine.
• Your doctor will decide whether using the sensor and App is appropriate for you.
• The electronic sensor for Atectura Breezhaler must be attached to the base of the Atectura Breezhaler inhaler.
• The sensor confirms that you have used the Atectura Breezhaler inhaler by recording and monitoring inhaler actuations and the sound of the capsule spinning during inhalation, but it does not monitor medicine dose intake.
• The sensor must be used with the Propeller App, downloaded onto a smartphone or other compatible device. The sensor connects to the Propeller App via Bluetooth.
• For further information on how to use the sensor for Atectura Breezhaler and the App, read the instructions for use provided in the sensor packaging and within the App.
• When all the capsules in a pack of Atectura Breezhaler have been used, transfer the sensor to the new inhaler in the next pack of Atectura Breezhaler.

If symptoms do not improve
If your asthma does not improve or worsens after starting Atectura Breezhaler, consult your doctor.
If you use more Atectura Breezhaler than you should
If you accidentally inhale too much medicine, contact your doctor or the nearest hospital immediately. Medical treatment may be required.
If you forget to use Atectura Breezhaler
If you have forgotten to inhale a dose at your usual time, inhale one as soon as possible on the same day. Then inhale your next dose the following day 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 without first consulting your doctor. Asthma symptoms may return if you stop using it.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can 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, rash, itching and hives (signs of allergic reaction).

Uncommon: may affect up to 1 in 100 people

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

Other side effects
Other side effects are included in the list below. If these side effects become severe, consult your doctor, pharmacist or nurse.
Very common: may affect more than 1 in 10 people

• sore throat
• runny nose (nasopharyngitis)
• sudden difficulty breathing and tightness in the chest with wheezing or coughing (worsening of asthma)
• oropharyngeal pain

Common: may affect up to 1 in 10 people

• voice disorder (hoarseness)
• blocked nose
• sneezing, cough (upper respiratory tract infection)
• headache
• muscle, bone or joint pain (signs of musculoskeletal pain)

Uncommon: may affect up to 1 in 100 people

• fast heartbeat
• oral thrush (sign of candidiasis)
• high blood sugar levels (hyperglycaemia)
• muscle spasm
• skin itching
• skin rash
• clouding of the eye lens (sign of cataract)
• blurred vision

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store 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 “exp”/“EXP”. The expiry date refers to the last day of that month.
• Do not store above 30 °C.
• Keep the capsules in the original blister to protect them from light and moisture, and only remove them from the blister just before use.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
• If the pack contains an electronic sensor for Atectura Breezhaler, read the instructions for use supplied in the sensor pack for detailed information on how to store and dispose of the sensor.

6. Package contents and other information

What Atectura Breezhaler contains

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

Atectura Breezhaler 125 micrograms/62.5 micrograms
Each capsule contains 173 micrograms of indacaterol acetate (equivalent to
150 micrograms of indacaterol) and 80 micrograms of mometasone furoate. The delivered dose
(the dose released from the mouthpiece of the inhaler) 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 acetate (equivalent to
150 micrograms of indacaterol) and 160 micrograms of mometasone furoate. The delivered dose
(the dose released from the mouthpiece of the inhaler) 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 acetate (equivalent to
150 micrograms of indacaterol) and 320 micrograms of mometasone furoate. The delivered dose
(the dose released from the mouthpiece of the inhaler) is equivalent to 125 micrograms of indacaterol
and 260 micrograms of mometasone furoate.
The other components are monohydrate lactose (see “Atectura Breezhaler contains lactose” in
section 2) and gelatin (capsule shell).

• Components of the printing ink:

Atectura Breezhaler 125 micrograms/62.5 micrograms
Lacquer, brilliant blue FCF (E133), propylene glycol (E1520), titanium dioxide (E171) and black iron oxide (E172).
Atectura Breezhaler 125 micrograms/127.5 micrograms
Lacquer, titanium dioxide (E171), black iron oxide (E172), propylene glycol (E1520), yellow iron oxide (E172) and ammonium hydroxide (E527).
Atectura Breezhaler 125 micrograms/260 micrograms
Lacquer, black iron oxide (E172), propylene glycol (E1520) and ammonium hydroxide (E527).

Description of the appearance of Atectura Breezhaler and contents of the pack
In this pack you will find an inhaler and capsules in blisters. Some packs also contain a sensor. The capsules are transparent and contain a white powder.

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

The following pack sizes are available:
Single pack containing 10 x 1 or 30 x 1 hard capsules and 1 inhaler.
Pack containing 30 x 1 hard capsules, 1 inhaler and 1 sensor.
Multiple pack consisting of 3 cartons, each containing 30 x 1 hard capsules and 1 inhaler.
Multiple pack consisting of 15 cartons, each containing 10 x 1 hard capsules and 1 inhaler.
Not all 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
Roonstraße 25
D-90429 Nuremberg
Germany
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 Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
APONTIS PHARMA Deutschland GmbH & Co. KG Novartis Pharma B.V.
Tel: +49 2173 8955 4949 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Laboratorios Menarini, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 462 88 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu

Instructions for the use of Atectura Breezhaler

Before using the Atectura Breezhaler inhaler, read these instructions for use thoroughly.
These instructions are also available by scanning the QR code or visiting the website
www.breezhaler-asthma.eu/atectura
“QR code to be inserted”.

Insert Pierce and release Inhale Check that the
deeply capsule is empty
2 3