ATECTURA BREEZHALER 125/127.5 micrograms INHALATION POWDER (HARD CAPSULE)
How to use ATECTURA BREEZHALER 125/127.5 micrograms INHALATION POWDER (HARD CAPSULE)
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder (hard capsule)
Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder (hard capsule)
Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder (hard
capsule)
indacaterol/mometasone furoate
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
- What Atectura Breezhaler is and what it is used for
- What you need to know before you use Atectura Breezhaler
- How to use Atectura Breezhaler
- Possible side effects
- Storing Atectura Breezhaler
- Contents of the pack and other information
Instructions for using 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. It relaxes the muscles of the small airways in the lungs. This helps to open up the airways and makes it easier to breathe in and out. When used regularly, it helps to keep the small airways in the lungs open.
Mometasone furoate belongs to a group of medicines called corticosteroids (or steroids). Corticosteroids reduce the swelling and irritation (inflammation) of the small airways in the lungs and in this way gradually relieve breathing problems. Corticosteroids also help to 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 around the smaller airways tighten (bronchoconstriction) and become inflamed. The symptoms come and go and include difficulty breathing, wheezing, chest tightness, and coughing.
You should use Atectura Breezhaler every day, as directed by your doctor, and not just when you have breathing problems or other symptoms of asthma. This will help to control your asthma in the right way. Do not use this medicine to relieve a sudden attack of shortness of breath or wheezing.
Ask your doctor if you have any questions about how Atectura Breezhaler works or why you have been prescribed this medicine.
2. What you need to know before you use 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
Consult your doctor, pharmacist, or nurse beforeusing Atectura Breezhaler if any of the following apply to you:
- if you have heart problems, including a fast or irregular heartbeat,
- if you have thyroid problems,
- if you have been told you have diabetes or high blood sugar levels,
- if you have 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 medical help immediatelyif you experience any of the following:
- chest tightness, coughing, wheezing, or difficulty breathing immediately after using Atectura Breezhaler (signs that the medicine has unexpectedly tightened the airways, known as paradoxical bronchospasm),
- difficulty breathing or swallowing, swelling of the tongue, lips, or face, skin rash, itching, and hives (signs of an allergic reaction).
Children and adolescents
Do not give this medicine to children under 12 years of age because it has not been studied in this age group.
Other medicines and Atectura Breezhaler
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. In particular, tell your doctor or pharmacist if you are using:
- medicines that lower the amount of potassium 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 that may be similar to Atectura Breezhaler (which contains similar active substances); as their combined use 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 have a baby, ask your doctor for advice before using this medicine. Your doctor will decide whether you can use Atectura Breezhaler.
Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines.
Atectura Breezhaler contains lactose
This medicine contains approximately 25 mg of lactose per capsule. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
3. How to use Atectura Breezhaler
Follow the instructions for using this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist again.
How much Atectura Breezhaler to inhale
There are three different doses 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 each day. You only need to inhale the medicine once a day. Do not use more doses than your doctor has prescribed.
You should use Atectura Breezhaler every day, even if your asthma is not bothering 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 use it.
How to inhale Atectura Breezhaler
- Atectura Breezhaler is for inhalation use only.
- In this pack, you will find an inhaler and capsules that contain the medicine. The inhaler allows you to inhale the medicine in the capsule. Use the capsules only with the inhaler provided in this pack. The capsules should be kept in the blister pack until you need to use them.
- Open the blister pack by peeling off the foil, do not push the capsule through the foil.
- When starting a new pack, use the new 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 your pack contains an Atectura Breezhaler sensor
- The Atectura Breezhaler sensor is only for adults. It must not be used in adolescents (12 years and older) as the application does not have the function of patient consent or caregiver account verification.
- The sensor and application are not necessary for you to take your medicine. It is not necessary for the sensor to be connected to the application when you use your medicine.
- Your doctor will decide if using the sensor and application is suitable for you.
- The electronic sensor for Atectura Breezhaler attaches to the base of the Atectura Breezhaler inhaler.
- The sensor confirms that you have used the Atectura Breezhaler inhaler by recording and monitoring the actions and noise made by the capsule when it is turned during inhalation, but it does not monitor whether you have received your dose of medicine.
- The sensor must be used with the Propeller application on your mobile phone or any other suitable device. The sensor links to the Propeller application via Bluetooth.
- For more information on how to use the Atectura Breezhaler sensor and application, please read the instructions for use provided with the sensor and application pack.
- Once you have used all the Atectura Breezhaler capsules from one pack, transfer the sensor to the new inhaler in the next pack of Atectura Breezhaler.
If your symptoms do not improve
If your asthma does not improve or even gets worse 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 necessary.
If you forget to use Atectura Breezhaler
If you forget to inhale a dose at the usual time, inhale it as soon as you can on that day.
Then, on the next day, inhale the next dose at the 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. The symptoms of your asthma may come back if you stop using it.
If you have any further questions on 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 everybody gets them.
Some side effects may be serious
Stop using Atectura Breezhaler and seek medical help immediately 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 side effects
The following are other side effects. If these side effects become serious, please consult your doctor, pharmacist, or nurse.
Very common:may affect more than 1 in 10 people
- throat pain
- nasal discharge
- sudden difficulty breathing and feeling of chest tightness with wheezing or coughing
Common:may affect up to 1 in 10 people
- voice changes (hoarseness)
- nasal congestion
- sneezing, coughing
- headache
- pain in the muscles, bones, or joints (signs of musculoskeletal pain)
Uncommon:may affect up to 1 in 100 people
- fast heartbeat
- mouth sores (signs of oral candidiasis)
- high blood sugar levels
- muscle spasms
- itching
- skin rash
- clouding of the lenses in your eyes (signs of cataract)
- blurred vision
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, including any possible side effects 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. Storing Atectura 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 pack after ‘EXP’. The expiry date refers to the last day of that month.
- Do not store above 30°C.
- Store the capsules in the original blister pack to protect them from light and moisture, and do not remove them until just before use.
- 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.
- If your pack contains an electronic sensor for Atectura Breezhaler, please consult the instructions for use provided with the sensor pack for detailed instructions on how to store it and when to discard it.
6. Container Contents and Additional Information
Composition of Atectura Breezhaler
- The active ingredients 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 that is released from 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 that is released from 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 that is released from the inhaler mouthpiece) is equivalent to 125 micrograms of indacaterol and 260 micrograms of mometasone furoate.
- The other component of the powder for inhalation is (see the section "Atectura Breezhaler contains lactose" in section 2).
Appearance of the Product and Container Contents
In this container, you will find an inhaler along with capsules in blisters. Some containers also contain a sensor. 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 the logo printed in blue and 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 gray on the body and a logo printed in gray 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 and surrounded by two black bars on the cap.
The following container sizes are available:
Single container containing 10 x 1 or 30 x 1 hard capsules, along with 1 inhaler.
Container containing 30 x 1 hard capsules, along with 1 inhaler and 1 sensor.
Multiple containers that contain 3 boxes, each with 30 x 1 capsules along with 3 inhalers.
Multiple containers that contain 15 boxes, each with 10 x 1 capsules along with 1 inhaler.
Only some container 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
Roonstraße 25
D-90429 Nuremberg
Germany
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:
Belgium Novartis Pharma N.V. Tel: +32 2 246 16 11 | Lithuania SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50 |
| Luxembourg Novartis Pharma N.V. Tel: +32 2 246 16 11 |
Czech Republic Novartis s.r.o. Tel: +420 225 775 111 | Hungary Novartis Hungária Kft. Tel: +36 1 457 65 00 |
Denmark Novartis Healthcare A/S Tel: +45 39 16 84 00 | Malta Novartis Pharma Services Inc. Tel: +356 2122 2872 |
Germany Novartis Pharma GmbH Tel: +49 911 273 0 | Netherlands Novartis Pharma B.V. Tel: +31 88 04 52 111 |
Estonia SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810 | Norway Novartis Norge AS Tel: +47 23 05 20 00 |
Greece Novartis (Hellas) A.E.B.E. Tel: +30 210 281 17 12 | Austria Novartis Pharma GmbH Tel: +43 1 86 6570 |
Spain Laboratorios Menarini, S.A. Tel: +34 93 462 88 00 | Poland Novartis Poland Sp. z o.o. Tel: +48 22 375 4888 |
France Novartis Pharma S.A.S. Tel: +33 1 55 47 66 00 | Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600 |
Croatia Novartis Hrvatska d.o.o. Tel: +385 1 6274 220 | Romania Novartis Pharma Services Romania SRL Tel: +40 21 31299 01 |
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55 | Slovenia Novartis Pharma Services Inc. Tel: +386 1 300 75 50 |
Iceland Vistor hf. Tel: +354 535 7000 | Slovakia Novartis Slovakia s.r.o. Tel: +421 2 5542 5439 |
Italy Novartis Farma S.p.A. Tel: +39 02 96 54 1 | Finland Novartis Finland Oy Tel: +358 (0)10 6133 200 |
Cyprus Novartis Pharma Services Inc. Tel: +357 22 690 690 | Sweden Novartis Sverige AB Tel: +46 8 732 32 00 |
Latvia SIA Novartis Baltics Tel: +371 67 887 070 | United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698370 |
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.
Instructions for Use of the Atectura Breezhaler Inhaler
Please read the complete Instructions for Use of the Atectura Breezhaler inhaler before using it.These instructions are available by scanning the QR code or visiting the website: www.breezhaler-asthma.eu/atectura
"Include QR code"
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Insert | Pierce and Release | Inhale Deeply | Check that the Capsule is Empty |
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Step 1a: Remove the Cap | Step 2a: Pierce the Capsule Once Hold the inhaler in a vertical position. Pierce the capsule by pressing both buttons firmly at the same time. | Step 3a: Exhale Completely Do not blow into the inhaler. | Check that the Capsule is Empty Open the inhaler to check if there is powder left in the capsule. If there is powder left in the capsule:
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| You should hear a sound when the capsule is pierced. Pierce the capsule only once. |
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Remains PowderEmpty |
Step 1b: Open the Inhaler |
Step 2b: Release the Buttons Completely | Step 3b: Inhale the Medication Deeply Hold the inhaler as shown in the figure. Insert the mouthpiece into your mouth and close your lips firmly around it. Do not press the buttons. | |
| Inhale quickly and as deeply as possible. During inhalation, you will hear a humming sound. You may notice the taste of the medication when you inhale. |
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Step 1c: Remove the Capsule Separate one of the blisters from the blister strip. Open the blister and remove a capsule. Do not press the capsule through the foil. Do not swallow the capsule. |
Step 3c: Hold your Breath Hold your breath for 5 seconds. Step 3d: Rinse your Mouth Rinse your mouth with water after each dose and spit it out. | Remove the Empty Capsule Discard the empty capsule in your household trash. Close the inhaler and put the cap back on. | |
Step 1d: Insert the Capsule Never place the capsule directly into the mouthpiece. | Important Information
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Step 1e: Close the Inhaler |
- Country of registration
- Average pharmacy price41.28 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to ATECTURA BREEZHALER 125/127.5 micrograms INHALATION POWDER (HARD CAPSULE)Dosage form: PULMONARY INHALATION, 125/260 µgActive substance: indacaterol and mometasoneManufacturer: Novartis Europharm LimitedPrescription requiredDosage form: PULMONARY INHALATION, 125 micrograms/62.5 microgramsActive substance: indacaterol and mometasoneManufacturer: Novartis Europharm LimitedPrescription requiredDosage form: PULMONARY INHALATION, 125 micrograms/127.5 microgramsActive substance: indacaterol and mometasoneManufacturer: Novartis Europharm LimitedPrescription required
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