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HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE)

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About the medicine

How to use HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE)

Translated with AI

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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Contents of the leaflet

  1. Introduction
  2. What is Hirobriz Breezhaler and what is it used for
  3. What you need to know before taking Hirobriz Breezhaler
  4. How to use Hirobriz Breezhaler
  5. Possible side effects
  6. Storage of Hirobriz Breezhaler
  7. Package Contents and Additional Information

Introduction

Package Leaflet: Information for the User

Hirobriz Breezhaler 150 micrograms inhalation powder (hard capsule)

Hirobriz Breezhaler 300 micrograms inhalation powder (hard capsule)

indacaterol

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

  • Keep this package leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Hirobriz Breezhaler and what is it used for
  2. What you need to know before taking Hirobriz Breezhaler
  3. How to use Hirobriz Breezhaler
  4. Possible side effects
  5. Storage of Hirobriz Breezhaler
  6. Package contents and additional information

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

What is Hirobriz Breezhaler

Hirobriz Breezhaler contains the active ingredient indacaterol, which belongs to a group of medications called bronchodilators. When inhaled, it relaxes the muscles of the small airways in the lungs. This helps to open up the airways, making it easier to breathe in and out.

What Hirobriz Breezhaler is used for

Hirobriz Breezhaler is used to facilitate breathing in adult patients who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD). In COPD, the muscles surrounding the airways contract, making breathing difficult. This medication relaxes these muscles in the lungs, making it easier to breathe in and out.

Doctor consultation

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2. What you need to know before taking Hirobriz Breezhaler

Do not use Hirobriz Breezhaler

  • if you are allergic to indacaterol or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hirobriz Breezhaler

  • if you have asthma (in this case, you should not use Hirobriz Breezhaler).
  • if you have heart problems.
  • if you have epilepsy.
  • if you have thyroid gland problems (thyrotoxicosis).
  • if you have diabetes.

During treatment with Hirobriz Breezhaler,

  • Stop using the medication and inform your doctor immediatelyif you notice chest tightness, coughing, wheezing, or difficulty breathing immediately after using the medication. These may be signs of a condition called bronchospasm.
  • Inform your doctor immediatelyif your COPD symptoms (difficulty breathing, wheezing, coughing) do not improve or worsen.

Children and adolescents

Hirobriz Breezhaler should notbe administered to children or adolescents under 18 years of age.

Other medications and Hirobriz Breezhaler

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Especially, inform your doctor if you are using:

  • medications for respiratory problems that are similar to Hirobriz Breezhaler (i.e., medications such as salmeterol and formoterol). You may be more likely to experience side effects.
  • medications called beta-blockers that are used for high blood pressure or other heart problems (such as propranolol), or for a eye problem called glaucoma (such as timolol).
  • medications that decrease the amount of potassium in the blood. These include:
    • corticosteroids (e.g., prednisolone),
    • diuretics used for high blood pressure, such as hydrochlorothiazide,
    • medications for respiratory problems such as theophylline.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use Hirobriz Breezhaler unless your doctor advises you to. Consult your doctor or pharmacist before using any medication.

Driving and using machines

Hirobriz Breezhaler is unlikely to affect your ability to drive or use machines.

Hirobriz Breezhaler contains lactose

This medication contains lactose (milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to use Hirobriz Breezhaler

Follow the instructions for administration of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Amount of Hirobriz Breezhaler to use

  • The usual dose is to inhale the contents of one capsule each day. Your doctor will indicate whether you should use the 150 microgram or 300 microgram capsule depending on your condition and response to treatment. Do not use more than the amount indicated by your doctor.
  • Use your inhaler at the same time each day, the effects last for 24 hours. This ensures that there is always enough medication in your body to help you breathe more easily throughout the day and night. It will also help you remember to use it.

How to use Hirobriz Breezhaler

  • In this package, you will find an inhaler and capsules (in a blister pack) that contain the medication in powder form for inhalation. The Hirobriz Breezhaler inhaler will allow you to inhale the medication contained in one capsule.
  • Use the capsules only with the inhaler provided in this package (Hirobriz Breezhaler inhaler). The capsules should be kept in the blister pack until you need to use them.
  • When starting a new package, use the new Hirobriz Breezhaler inhaler provided in the package.
  • Discard the inhaler once all the capsules have been used.
  • Do not swallow the capsules.
  • For more information on how to use the inhaler, read the instructions at the end of this package leaflet.

If you use more Hirobriz Breezhaler than you should

If you have inhaled too much Hirobriz Breezhaler or if someone uses your capsules, inform your doctor immediately or go to the nearest emergency center. Show the Hirobriz Breezhaler package. Medical attention may be necessary. You may notice that your heart beats faster than normal, or you may have a headache, feel drowsy, nauseous, or vomit.

If you forget to use Hirobriz Breezhaler

If you forget to inhale a dose, inhale one at the usual time the next day. Do not inhale a double dose to make up for missed doses.

How long you should continue your treatment with Hirobriz Breezhaler

  • Continue using your treatment with Hirobriz Breezhaler for the time indicated by your doctor.
  • COPD is a long-term disease, and you should use Hirobriz Breezhaler every dayand not just when you have breathing problems or other COPD symptoms.

Consult your doctor or pharmacist if you have any doubts about how long you should continue your treatment with Hirobriz Breezhaler.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Medicine questions

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4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Some side effects can be serious. Inform your doctor immediately

  • if you have chest pain (frequent).
  • if you have high blood sugar levels (diabetes). You will feel tired, very thirsty, and hungry (without gaining weight) and urinate more than usual (frequent).
  • if you have irregular heartbeats (uncommon).
  • if you have symptoms of an allergic reaction such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness (uncommon).
  • if you have difficulty breathing with wheezing or coughing (uncommon).

Other side effects may include:

Very common side effects (may affect more than 1 in 10 patients)

  • flu-like symptoms. You may have all or most of the following effects: sore throat, runny nose, stuffy nose, sneezing, coughing, headache.

Common side effects (may affect up to 1 in 10 patients)

  • feeling of pain or pressure in the cheeks and forehead (sinusitis)
  • runny nose
  • coughing
  • sore throat
  • headache
  • dizziness
  • palpitations
  • muscle spasms
  • swelling of hands, ankles, and feet (edema)
  • itching/skin rash
  • chest pain
  • pain in muscles, bones, or joints

Uncommon side effects (may affect up to 1 in 100 patients)

  • rapid heartbeat
  • tingling or numbness
  • muscle pain

Some people may occasionally cough shortly after inhaling the medication. Coughing is a common symptom in COPD. If you experience coughing shortly after inhaling the medication, do not worry. Check your inhaler to see if the capsule is empty and that you have received the full dose. If the capsule is empty, there is no need to worry. If the capsule is not empty, inhale again as indicated.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Hirobriz Breezhaler

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton and blister pack after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Store in the original packaging to protect from moisture and do not remove until just before use. Do not use this medication if you notice that the packaging is damaged or shows signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Hirobriz Breezhaler Composition

  • Each 150 microgram Hirobriz Breezhaler capsule contains 150 micrograms of indacaterol as indacaterol maleate. The other ingredients include lactose and gelatin capsule.
  • Each 300 microgram Hirobriz Breezhaler capsule contains 300 micrograms of indacaterol as indacaterol maleate. The other ingredients include lactose and gelatin capsule.

Appearance of Hirobriz Breezhaler and Package Contents

In this package, you will find an inhaler, along with capsules in a blister pack. The capsules are transparent (colorless) and contain a white powder.

  • The 150 microgram Hirobriz Breezhaler capsules have a product code

"IDL 150" printed in blackabove a blackline and the company logo () printed in blackbelow it.

  • The 300 microgram Hirobriz Breezhaler capsules have a product code "IDL 300" printed in blueabove a blueline and the company logo () printed in bluebelow it.

The following package sizes are available:

Carton containing 10 capsules and 1 inhaler. Carton containing 30 capsules and 1 inhaler.

Multiple package containing 2 packages (each containing 30 capsules and 1 inhaler). Multiple package containing 3 packages (each containing 30 capsules and 1 inhaler). Multiple package containing 30 packages (each containing 10 capsules and 1 inhaler).

Only some package sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited Vista Building

Elm Park, Merrion Road Dublin 4

Ireland

ManufacturerNovartis Pharma GmbH Roonstraße 25

D-90429 Nuremberg Germany

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

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

Text in a foreign language with the name of the company Novartis Bulgaria Eood and its phone number

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. Pharma

Tel.: +36 1 457 65 00

Denmark

Novartis Healthcare A/S

Tlf: +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

Tlf: +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 Farmacéuticos ROVI, S.A.

Tel.: +34 91 375 62 30

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

HIROBRIZ BREEZHALER INHALER INSTRUCTIONS FOR USE

Read the complete Instructions for Use before using Hirobriz Breezhaler.

Inhaler device with mouthpiece and transparent cartridge showing an arrow indicating the direction of insertion

Insert

Hand holding a white inhaler with mouthpiece and curved arrows indicating the direction of rotation of the device

Pierce and release

Needle inserted into a blood vessel with a gray arrow indicating the direction of flow and lines representing veins

Inhale

deeply

White and blue inhaler device with mouthpiece and dosing valve visible

Check that the capsule is empty

Gray arrow pointing down with a white number one in the center

Gray arrow pointing down with a white number two in the center of the figure

Gray arrow pointing down with a white number three in the center

Gray arrow pointing down with the word

Hand pressing the auto-injector downwards with an arrow indicating the direction of pressure

Step 1a:

Remove the cap.

Auto-injector device with partially removed protective cover by fingers of a hand

Step 1b:

Open the inhaler

Hand holding a white applicator device with arrows indicating pressure and release of the plunger

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.

You should hear a noise when the capsule is pierced.

Pierce the capsule only once.

White and blue auto-injector device held by a hand with arrows indicating the direction of rotation

Step 2b:

Release the buttons completely

Needle injecting into the arm at a 45-degree angle with arrows indicating the direction of insertion and movement of the liquid

Step 3a:

Exhale completely

Do not blow into the inhaler.

Hand applying pressure on the injection site with a cotton swab while removing the needle from the skin

Step 3b:

Inhale the medicine 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

White and blue nasal inhaler device with mouthpiece and nasal wings for holding

Check that the capsule is empty

Open the inhaler to check if there is any powder left in the capsule.

If there is powder left in the capsule:

  • Close the inhaler.
  • Repeat steps 3a to 3c.

Open capsule showing powder residue on one side and empty capsule on the other with explanatory text

Capsule on the tongue with the mouth slightly open showing the back of the throat

Step 1c:

Remove the capsule

Remove a capsule from the blister pack.

Do not swallow the capsule.

Inhale quickly and as deeply as possible.

During inhalation, you will hear a humming noise.

You may notice the taste of the medicine when you inhale.

Head and neck in profile showing the position of the tongue and trachea

Step 3c:

Hold your breath

Hold your breath for 5 seconds.

Auto-injector device with removed protective cover showing transparent window and retracted plunger, arrow indicates direction

Remove the empty capsule

Discard the empty capsule in your household trash.

Close the inhaler and put the cap back on.

Preloaded needle with retracted plunger and partially removed transparent protector showing the tip

Step 1d:

Insert the capsule

Never place the capsule directly into the mouthpiece.

Applicator device with transparent protective cover rotating to expose the needle and prepare for injection

Step 1e:

Close the inhaler

Important Information

  • The Hirobriz Breezhaler capsules should always be stored in the blister pack and removed only immediately before use.
  • Do not swallow the capsule.
  • Do not use the Hirobriz Breezhaler capsules with another inhaler.
  • Do not use the Hirobriz Breezhaler inhaler with another medicine in capsules.
  • Never place the capsule in your mouth or in the inhaler mouthpiece.
  • Do not press the side buttons more than once.
  • Do not blow into the mouthpiece.
  • Do not press the buttons while inhaling through the mouthpiece.
  • Do not handle the capsules with wet hands.
  • Never wash your inhaler with water.

Your Hirobriz Breezhaler package contains:

  • a Hirobriz Breezhaler inhaler
  • one or more blister strips, each containing 6 or 10 Hirobriz Breezhaler capsules for use with the inhaler

Inhaler with base and blister pack of capsules showing cap, side buttons, filter, and blister strip

Frequently Asked Questions

Why did the inhaler not make a noise when I inhaled?

The capsule may be stuck in the compartment. If this happens, carefully release the capsule by tapping the base of the inhaler. Inhale the medicine again, repeating steps 3a to 3c.

What should I do if there is powder left in the capsule?

You have not received enough of your medicine. Close the inhaler and repeat steps 3a to 3c.

I coughed after inhaling, is it important?

It may happen. If the capsule is empty, it means you have received enough of your medicine.

I notice small fragments of the capsule on my tongue, is it important?

It may happen. It is not harmful. The likelihood of the capsules breaking into pieces increases if the capsule is pierced more than once.

Cleaning the Inhaler

Wipe the mouthpiece from the inside and outside with a clean, dry cloth that does not leave lint to remove any powder residue.

Keep the inhaler dry. Never wash your inhaler with water.

Disposal of the Inhaler after Use

Each inhaler should be discarded after all the capsules have been used. Ask your pharmacist how to dispose of medicines and inhalers that are no longer needed.

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General medicine 9 years exp.

Dr. Karim Ben Harbi is a licensed general practitioner based in Italy. He provides online consultations for adults and children, combining international clinical experience with evidence-based medicine. His care approach is focused on accurate diagnosis, preventive care, and personalised health guidance.

Dr. Ben Harbi received his medical degree from Sapienza University in Rome. His training included hands-on experience in diverse settings — tropical medicine, rural healthcare, and urban outpatient practice. He also conducted clinical research in microbiology, exploring the role of the gut microbiome in chronic gastrointestinal issues.

You can consult Dr. Ben Harbi for:

  • General health concerns, prevention, and primary care.
  • Hypertension, type 1 and type 2 diabetes, metabolic issues.
  • Cold, cough, flu, respiratory infections, sore throat, fever.
  • Chronic digestive issues: bloating, gastritis, IBS, microbiome imbalance.
  • Skin rashes, mild allergic reactions, basic dermatological complaints.
  • Medication guidance, treatment adjustments, prescription review.
  • Paediatric concerns — fever, infections, general well-being.
  • Lifestyle optimisation: stress, sleep, weight, and diet counselling.

Dr. Ben Harbi offers reliable, accessible medical support through online consultations, helping patients make informed decisions about their health with a clear, structured, and compassionate approach.
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€79
0.0 (0)
Doctor

Liudmyla Boichuk

Family medicine 11 years exp.

Dr Liudmyla Boichuk is a family medicine doctor providing diagnosis and treatment for a wide range of acute and chronic conditions in adults and children. She works with respiratory, cardiovascular and digestive system disorders and has extensive experience caring for patients with multiple coexisting conditions, where coordinated, whole-person management is essential.

She treats adults with respiratory illnesses such as pneumonia, COPD and bronchial asthma, as well as cardiovascular conditions including hypertension and ischaemic heart disease. Her practice also covers gastrointestinal complaints and chronic comorbidities that require careful, structured medical supervision.

Dr Boichuk provides care for children from birth, including acute respiratory viral infections, infectious diseases, pneumonia, bronchitis, bronchial obstruction syndromes and allergic reactions. She offers clear, evidence-based guidance to parents and ensures safe follow-up throughout the child’s recovery.

Her work also includes developing personalised immunisation plans and supporting families with long-term preventive care.

Known for her structured clinical approach and clear communication, Dr Liudmyla Boichuk offers patients of all ages comprehensive, reliable and evidence-based medical care.
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€55
5.0 (2)
Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
  • Second opinion and decision-making support.
  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.
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€55
3

Frequently Asked Questions

Is a prescription required for HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE)?
HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE) requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE)?
The active ingredient in HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE) is indacaterol. This information helps identify medicines with the same composition but different brand names.
How much does HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE) cost in pharmacies?
The average pharmacy price for HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE) is around 50.13 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE)?
HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE) is manufactured by Novartis Europharm Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE) online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE) is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE)?
Other medicines with the same active substance (indacaterol) include HIROBRIZ BREEZHALER 300 micrograms INHALATION POWDER (HARD CAPSULE), ONBREZ BREEZHALER 150 micrograms INHALATION POWDER (HARD CAPSULE), ONBREZ BREEZHALER 300 micrograms INHALATION POWDER (HARD CAPSULE). These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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