125 micrograms / 62.5 micrograms inhalation powder, hard capsules 125 micrograms / 127.5 micrograms inhalation powder, hard capsules 125 micrograms / 260 micrograms inhalation powder, hard capsules indacaterol / mometasone furoate (indacaterol / mometasone. Fur).

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Atectura Breezhaler is and what it is used for 
2. What you need to know before you use 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 

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: indacaterol and mometasone furoate.

Indacaterol belongs to a group of medicines called bronchodilators. This relaxes the muscles in the small airways in the lungs. This helps to dilate the airways so that it is easier for the air to get in and out of the lungs. If the medicine is taken regularly, it helps to keep the small airways continuously open.

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

What Atectura Breezhaler is used for

Atectura Breezhaler is regularly used to treat asthma in adults and adolescents (from 12 years of age).

Asthma is a serious, chronic lung disease that involves the muscles around the small airways contracting ( bronchoconstriction ) and becoming inflamed. The symptoms come and go and can be shortness of breath, wheezing, tightness in the chest, and cough.

Use Atectura Breezhaler every day as prescribed by your doctor, not only when you have difficulty breathing or have other asthma symptoms. That way, you can have good control over your asthma. This medicine should not be used to relieve a sudden attack of shortness of breath or wheezing.

Ask your doctor if you are wondering how Atectura Breezhaler works or why the medicine has been prescribed for you.

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). Ask your doctor if you think you may be allergic.

Warnings and cautions

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

  • you have heart problems, e.g. irregular or rapid heartbeat
  • you have thyroid problems
  • you have ever been informed that you have diabetes or high blood sugar
  • you have seizures
  • you have low potassium in your blood
  • you have severe liver problems
  • you have pulmonary tuberculosis or any other long-term or untreated infection.

During treatment with Atectura Breezhaler

Stop using this medicine and seek immediate medical attention if you have any of the following:

  • chest tightness, coughing, wheezing, or shortness of breath shortly after using Atectura Breezhaler (signs that the medicine has caused an unexpected narrowing of the airways, called paradoxical bronchospasm )
  • difficulty breathing or swallowing, swelling of the tongue, lips, or face, rash, itching hives (signs of allergic reaction ).

Children and young people

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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is especially important that you tell your doctor or pharmacist if you are taking:

  • drugs that lower potassium levels in the blood. These include diuretics (so-called ” diuretics ” that increase urine production and can be used for high blood pressure, such as hydrochlorothiazide ), other bronchodilators such as methylxanthines used for respiratory problems (eg theophylline), or corticosteroids (eg prednisolone ).
  • tricyclic antidepressants or monoamine oxidase inhibitors ( antidepressants ).
  • any medicine that may be similar to Atectura Breezhaler (contains the same active substances). Using both medicines at the same time may increase the risk of side effects.
  • so-called beta-blockers used for high blood pressure and other heart problems (eg propranolol), or for the treatment of glaucoma (eg timolol ).
  • ketoconazole or itraconazole (used to treat fungal infections).
  • ritonavir, nelfinavir, or cobicistat (used for HIV – infection ).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will tell you if you can take Atectura Breezhaler or not.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines.

Atectura Breezehaler contains lactose

This medicine contains approximately 25 mg of lactose per capsule. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

3. How to use Atectura Breezhaler

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How much Atectura Breezhaler to inhale

The Atectura Breezhaler capsules are available in three different strengths. The doctor decides which is best for you.

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

Use Atectura Breezhaler every day, even if you do not experience any problems with your asthma.

When to inhale Atectura Breezhaler

Inhale Atectura Breezhaler at the same time each day. It helps keep your symptoms under control around the clock. It also makes it easier to remember to take the medicine.

How to inhale Atectura Breezhaler

  • Atectura Breezhaler should be used for inhalation .
  • This pack contains an inhaler and capsules that contain the medicine. Using the inhaler, you can inhale the medicine into the capsule. Only use the capsules together with the inhaler provided in the package. The capsules should remain in the blister until you use them.
  • Pull the back of the blister to open it, do not push the capsule through the foil.
  • When you start with a new pack, use the new inhaler in the new pack.
  • Discard the inhaler provided in the package when all the capsules in the package have been used.
  • Do not swallow the capsules.
  • Read the instructions on the other side of this leaflet for more information on using the inhaler.

If your symptoms do not improve

If your asthma does not improve or you get worse after starting Atectura Breezhaler, talk to your doctor.

If you use more Atectura Breezhaler than you should 

If you have inhaled too much of this medicine, contact your doctor or hospital immediately for advice. You may need medical attention.

If you forget to use Atectura Breezhaler

If you forget to inhale a dose at the usual time, inhale a dose as soon as possible that day. Then inhale the next dose at the usual time the next day. 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 the medicine.

If you have any further questions on the use of this product, 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 can be serious

Stop using Atectura Breezhaler and seek medical attention immediately if you get any of the following:

Common: may affect up to 1 in 10 users

  • 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 are

Other side effects that may occur are listed below. If these side effects get serious, talk to your doctor, pharmacist, or nurse.

Very common: may affect more than 1 user in 10

  • sore throat
  • Runny nose
  • sudden difficulty breathing and feeling of pressure over the chest with wheezing or coughing

Common: may affect up to 1 in 10 users

  • voice changes (hoarseness)
  • stuffy nose
  • sneezing, coughing
  • headache
  • pain in muscles, bones, or joints (signs of musculoskeletal pain)

Uncommon: may affect up to 1 in 100 people

  • fast heartbeat
  • oral cod ( oral candidiasis)
  • high blood sugar
  • muscle spasm
  • itching of the skin
  • rash
  • cloudiness in the lens of the eye (signs of cataracts)
  • dimsyn

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.
  • No special temperature instructions.
  • Store the capsules in the original package (blister). Sensitive to light and moisture. Take out of the package immediately before use.
  • Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

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

Atectura Breezhaler 125 micrograms / 62.5 micrograms

Each capsule contains 173 micrograms indacaterol acetate (equivalent to 150 micrograms indacaterol) and 80 micrograms of mometasone furoates. Each dose delivered (the dose leaving the mouthpiece of the inhaler) corresponds to 125 micrograms indacaterol and 62.5 micrograms mometasone furoates.

Atectura Breezhaler 125 micrograms / 127.5 micrograms

Each capsule contains 173 micrograms indacaterol acetate (equivalent to 150 micrograms indacaterol) and 160 micrograms mometasone furoates. Each dose delivered (the dose leaving the inhaler mouthpiece) corresponds to 125 micrograms indacaterol and 127.5 micrograms mometasone furoates.

Atectura Breezhaler 125 micrograms / 260 micrograms

Each capsule contains 173 micrograms indacaterol acetate (equivalent to 150 micrograms indacaterol) and 320 micrograms mometasone furoates. Each dose delivered (the dose leaving the inhaler mouthpiece) is equivalent to 125 micrograms indacaterol and 260 micrograms mometasone furoate.

  • The other ingredient is lactose monohydrate (see “Atectura Breezhaler contains lactose” in section 2).

What the medicine looks like and the contents of the pack

This pack contains an inhaler together with blister capsules. The capsules are transparent and contain a white powder.

  • The Atectura Breezhaler capsules with 125 micrograms / 62.5 micrograms have the product code “IM150‑80” printed in blue above a blue line on the lower part and a logo printed in blue surrounded by two blue lines on the upper part.
  • The Atectura Breezhaler capsules with 125 micrograms / 127.5 micrograms have the product code “IM150‑160” printed in gray on the lower part and a logo printed in gray on the upper part.
  • The Atectura Breezhaler capsules with 125 micrograms / 260 micrograms have the product code “IM150‑320” printed in black above two black lines on the lower part and a logo printed in black surrounded by two black lines on the upper part.

Pack sizes:

Pack of 10 x 1 or 30 x 1 hard capsules and 1 inhaler.

Multipack consisting of 3 cartons, with 30 x 1 hard capsules and 1 inhaler in each carton.

Multipack consisting of 15 cartons, with 10 x 1 hard capsules and 1 inhaler in each carton.

Not all pack sizes may be available in your country.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Novartis Pharmacéutica, SA

Ronda de Santa Maria, 158

08210 Barberà del Vallés (Barcelona)

Spain

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690
LatviaSIA Novartis BalticsTel: +371 67 887 070 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

Muhammad Nadeem

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