Patient leaflet - Onbrez Breezhaler 300 microgram inhalation powder, hard capsules
1. What Onbrez Breezhaler is and what it is used for
What Onbrez Breezhaler is
Onbrez Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators. When you inhale it, it relaxes the muscles in the walls of the small air passages in the lungs. This helps open up the airways, making it easier to get air in and out.
What Onbrez Breezhaler is used for
Onbrez Breezhaler is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD). In COPD the muscles around the airways tighten. This makes breathing difficult. This medicine relaxes these muscles in the lungs, making it easier for air to get in and out of the lungs.
2. What you need to know before you use Onbrez Breezhaler
Do not use Onbrez Breezhaler
- if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Onbrez Breezhaler
- if you have asthma (in this case you should not use Onbrez Breezhaler).
- if you have heart problems.
- if you have epilepsy.
- if you have thyroid gland problems (thyrotoxicosis).
- if you have diabetes.
During treatment with Onbrez Breezhaler,
Stop using the medicine and tell your doctor immediately if you get tightness of the chest,
coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called bronchospasm.
Tell your doctor immediately if your COPD symptoms (breathlessness, wheezing, cough) do not
improve or get worse.
Children and adolescents
Onbrez Breezhaler should not be given to children or adolescents below the age of 18 years.
Other medicines and Onbrez Breezhaler
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, please tell your doctor if you are using:
medicines for breathing problems that are similar to Onbrez Breezhaler (i.e. medicines such as
salmeterol and formoterol). You may be more likely to get side effects.
medicines called beta blockers that are used for high blood pressure or other heart problems (such as
propranolol), or for the eye problem called glaucoma (such as timolol).
medicines that lower the amount of potassium in your blood. These include:
o steroids (e.g. prednisolone),
o diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide,
o medicines for breathing problems such as theophylline.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
You should not use Onbrez Breezhaler unless your doctor tells you so.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Onbrez Breezhaler will affect your ability to drive and use machines.
Onbrez Breezhaler contains lactose
This medicine contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
3. How to use Onbrez Breezhaler
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much Onbrez Breezhaler to use
The usual dose is to inhale the content of one capsule each day. Your doctor may tell you to use the
150 microgram capsule or the 300 microgram capsule depending on your condition and on how you respond to the treatment. Do not use more than your doctor tells you to use.
Use your inhaler at the same time each day, the effects last for 24 hours. This ensures that there is
always enough medicine in your body to help you breathe more easily throughout the day and night. It will also help you to remember to use it.
How to use Onbrez Breezhaler
In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation
powder. The Onbrez Breezhaler inhaler enables you to inhale the medicine contained in a capsule.
Only use the capsules with the inhaler provided in this pack (Onbrez Breezhaler inhaler). The capsules
should remain in the blister until you need to use them.
- When you start a new pack, use the new Onbrez Breezhaler inhaler that is supplied in the pack.
- Dispose of each inhaler after all capsules have been used.
- Do not swallow the capsules.
- Please read the instructions at the end of this leaflet for more information about how to use the inhaler.
If you use more Onbrez Breezhaler than you should
If you have inhaled too much Onbrez Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit. Show the pack of Onbrez Breezhaler. Medical attention may be needed. You may notice that your heart is beating faster than usual, or you may have a headache, feel drowsy, feel nauseous or have to vomit.
If you forget to use Onbrez Breezhaler
If you forget to inhale a dose, inhale just one dose at the usual time the next day. Do not inhale a double dose to make up for a forgotten dose.
How long to continue your treatment with Onbrez Breezhaler
- Keep using your treatment with Onbrez Breezhaler for as long as your doctor tells you.
COPD is a long-term disease and you should use Onbrez Breezhaler every day and not only when
you have breathing problems or other symptoms of COPD.
If you have questions about how long to continue your treatment with Onbrez Breezhaler, talk to your doctor or pharmacist.
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. Tell your doctor immediately
- if you get crushing chest pain, (common).
if you get high levels of sugar in your blood (diabetes). You will feel tired, very thirsty and hungry
(without gaining weight) and will pass more urine than usual (common).
- if you get irregular heart beat (uncommon).
- if you get symptoms of an allergic reaction such as 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 people)
- cold-like symptoms. You may get all or most of the following: sore throat, runny nose, blocked nose, sneezing, coughing, headache.
Common side effects (may affect up to 1 in 10 people)
- feeling of pressure or pain in the cheeks and forehead (inflammation of the sinuses)
- runny nose
- cough
- sore throat
- headache
- dizziness
- palpitations
- muscle spasm
- swollen hands, ankles and feet (oedema)
- itching/rash
- chest pain
- pain in muscles, bones or joints
Uncommon side effects (may affect up to 1 in 100 people)
- fast heart beat
- tingling or numbness
- muscle pain
Some people occasionally cough soon after inhaling the medicine. Cough is a common symptom in COPD. If you experience coughing briefly after inhaling the medicine, 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 for concern. If the capsule is not empty then inhale again as directed.
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Onbrez Breezhaler
Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture and do not remove until immediately before use.
Do not use the inhaler after the expiry date which is stated on the carton and canister label after ‘Exp’. The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the pack is damaged or show signs of tampering. If the Inhaler shows any signs of damage, seek the advice of your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Onbrez Breezhaler contains
The active ingredient in the Onbrez Breezhaler is indacaterol.
Each capsule contains 300 microgram indacaterol as indacaterol maleate.
The other ingredients include lactose and the capsule is made of gelatin.
What Onbrez Breezhaler looks like and content of the pack
Onbrez Breezhaler comes in a pack with an inhaler and capsules in blister together. The capsules are transparent (uncoloured) and contain a white powder and have a blue product code ‘IDL 300’ printed above a blue bar and a blue company logo ( ) printed below the blue bar.
It is available in pack size of 30 capsules and 1 inhaler.
Manufactured by: Novartis Pharma GmbH, Sophie-Germain-Strasse 10, 90443 Nuremberg, Germany. OR
Novartis Farmaceutica SA, Ronda de Santa Maria 158, 08210 Barbera del Valles, Barcelona, Spain. OR
Novartis Pharma GmbH, Roonstrasse 25, D-90429 Nuremberg, Germany.
Procured from within the EU & repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Onbrez® Breezhaler® 300 microgram inhalation powder, hard capsules; PLGB 18799/3732
Leaflet date: 09.05.2025
For any information about this medicine, please contact the Product Licence Holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Tel: 0800 049 9401
Email: regulatoryaffairs@bnsthamelabs.co.uk
Onbrez and Breezhaler are the registered trademark of Novartis AG.
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POM INSTRUCTIONS FOR USE OF ONBREZ BREEZHALER INHALER
Please read the full Instructions for Use before using the Onbrez Breezhaler.
Step 1a: Pull off cap Step 1b: Open inhaler Step 1c: Remove capsule Remove one capsule from the blister. Do not swallow the capsule. Step 1d: Insert capsule Never place a capsule directly into the mouthpiece. Step 1e: Close inhaler | Step 2a: Pierce capsule once Hold the inhaler upright. Pierce capsule by firmly pressing both side buttons at the same time. You should hear a noise as the capsule is pierced. Only pierce the capsule once. Step 2b: Release side buttons | Step 3a: Breathe out fully Do not blow into the inhaler. Step 3b: Inhale medicine deeply Hold the inhaler as shown in the picture. Place the mouthpiece in your mouth and close your lips firmly around it. Do not press the side buttons. Breathe in quickly and as deeply as you can. During inhalation you will hear a whirring noise. You may taste the medicine as you inhale. Step 3c: Hold breath Hold your breath for up to 5 seconds. | Check capsule is empty Open the inhaler to see if any powder is left in the capsule. If there is powder left in the capsule:
Remove empty capsule Put the empty capsule in your household waste. Close the inhaler and replace the cap. |
Insert Pierce and release Inhale deeply Check capsule is empty 
Powder remaining Empty |
Check 3
Important Information
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2
1
Your Onbrez Breezhaler Inhaler pack contains:
| Frequently Asked Questions Why didn’t the inhaler make a noise when I inhaled? The capsule may be stuck in the capsule chamber. If this happens, carefully loosen the capsule by tapping the base of the inhaler. Inhale the medicine again by repeating steps 3a to 3c. What should I do if there is powder left inside the capsule? You have not received enough of your medicine. Close the inhaler and repeat steps 3a to 3c. I coughed after inhaling – does this matter? This may happen. As long as the capsule is empty you have received enough of your medicine. I felt small pieces of the capsule on my tongue – does this matter? This can happen. It is not harmful. The chances of the capsule breaking into small pieces will be increased if the capsule is pierced more than once. | Cleaning the inhaler Wipe the mouthpiece inside and outside with a clean, dry, lint-free cloth to remove any powder residue. Keep the inhaler dry. Never wash your inhaler with water. |
Disposing of the inhaler after use Each inhaler should be disposed of after all capsules have been used. Ask your pharmacist how to dispose of medicines and inhalers that are no longer required. |
