150 micrograms / 300 micrograms inhalation powder, hard capsules
indacaterol
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 the medicine, it relaxes the muscles in the small airways of the lungs. This helps to open the airways so that it is easier to breathe in and out.
What Onbrez Breezhaler is used for
Onbrez Breezhaler is used to make breathing easier in adult patients who have difficulty breathing due to lung disease, chronic obstructive pulmonary disease (COPD). In COPD, the muscles around the airways contract, making it difficult to breathe. This medicine relaxes the muscles in the lungs and makes it easier for the air to pass in and out of the lungs.
What you need to know before using 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 cautions
Talk to your doctor or pharmacist before using Onbrez Breezhaler
- if you have asthma (in which case do not use Onbrez Breezhaler)
- if you have heart problems
- if you have epilepsy
- if you have thyroid problems ( thyrotoxicosis )
- if you have diabetes .
Undertreatment with Onbrez Breezhaler
- Stop using the medicine and tell your doctor immediately if you become tight in the chest, cough, have wheezing or shortness of breath immediately after using the medicine. This may be a sign of a condition called bronchospasm .
- Tell your doctor immediately if your COPD symptoms (shortness of breath, wheezing, coughing) do not improve or if they worsen.
Children and young people
Onbrez Breezhaler should not be given to children or adolescents under 18 years of age.
Other drugs and Onbrez Breezhaler
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are taking:
- medicines for respiratory problems that are of the same type as Onbrez Breezhaler (eg salmeterol and formoterol) as the risk of side effects may increase.
- so-called beta-blockers , which are used for high blood pressure or heart problems (such as propranolol) or for the eye disease glaucoma (such as timolol ).
- drugs that lower potassium levels in the blood. These include:
- steroid er (eg prednisolone )
- diuretics (liquid tablets) used for high blood pressure , such as hydrochlorothiazide
- medicines for respiratory problems, such as theophylline.
Pregnancy and breastfeeding
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 taking this medicine.
You should not use Onbrez Breezhaler unless your doctor tells you to.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Onbrez Breezhaler is unlikely to affect your ability to drive or 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 taking this medicine.
How to use Onbrez Breezhaler
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much Onbrez Breezhaler to use
- The usual dose is to inhale the contents of one capsule a day. Your doctor may prescribe a 150 microgram capsule or a 300 microgram capsule depending on your condition and how you respond to the medicine. Do not use more than your doctor prescribes.
- Use the inhaler at the same time each day. The effect lasts for 24 hours. This ensures that there is always enough medicine in your body so that you can breathe easier throughout the day and night. It also makes it easier to remember to take the medicine.
How to use Onbrez Breezhaler
- The package contains an inhaler and capsules (in blister cards), with the medicine in the form of inhalation powder . The Onbrez Breezhaler inhaler enables inhalation of the drug into the capsule.
- Use only the capsules with the inhaler provided with the package (Onbrez Breezhaler inhaler ). The capsules should remain in the blister until you use them.
- When starting a new pack, use the new Onbrez Breezhaler inhaler that comes with the pack.
- The inhaler in each package should be discarded after all the capsules in the package have been used.
- Do not swallow the capsules.
- Read the instructions at the end of this leaflet for more information on using the inhaler.
If you take more Onbrez Breezhaler than you should
If you have inhaled too much Onbrez Breezhaler or if someone else has used the capsules, tell your doctor immediately or go to the nearest emergency department. Show the package with Onbrez Breezhaler. Medical care may be needed. You may feel that your heart is beating faster than usual or that you have a headache, feel drowsy, feel unwell, or vomit.
If you forget to use Onbrez Breezhaler
If you forget to inhale a dose, inhale a dose at the usual time the next day. Do not inhale a double dose to compensate for a missed dose.
How long to continue treatment with Onbrez Breezhaler
- Continue to use Onbrez Breezhaler for as long as your doctor prescribes it.
- COPD is a chronic disease and you should use Onbrez Breezhaler every day and not when you have occasional breathing problems or other symptoms of COPD.
If you have any further questions on the use of Onbrez Breezhaler, ask your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious. Inform a doctor immediately
- If you get very severe chest pain (common).
- If you get high blood sugar ( diabetes ). In that case, you feel tired, very thirsty and hungry (without gaining weight) and urinate more than usual (normal).
- If you get an irregular heartbeat (less common).
- If you get 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 (less common).
Other side effects can be:
Very common side effects (may affect more than 1 in 10 people)
- cold-like symptoms – you may have all or most of the following: sore throat, runny nose, nasal congestion, sneezing, cough and headache.
Common side effects (may affect up to 1 in 10 people)
- depressive sensation or pain under the eyes or on the forehead (sinusitis)
- Runny nose
- cough
- sore throat
- headache
- dizziness
- palpitation
- muscle spasm
- swollen hands, ankles and feet ( edema )
- itching / rash
- chest pain
- muscle, skeletal or joint pain
Uncommon side effects (may affect up to 1 in 100 people)
- fast heartbeat
- tingling or numbness
- muscle pain
Some people may sometimes have a short-term cough shortly after inhaling the medicine. Cough is a common symptom of COPD. If you cough for a short time after inhaling the medicine, you do not need to worry. Check the inhaler to see if the capsule is empty. This means that you have received the entire dose one and do not need to do anything further. If the capsule is not empty, inhale again according to the instructions.
How to store Onbrez 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. that. ” respectively “EXP”. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Store in the original package. Moisture sensitive. Take out of the package immediately before use.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
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.
Contents of the pack and other information
Content declaration
- Each Onbrez Breezhaler 150 microgram capsule contains 150 micrograms indacaterol as indacaterol maleate. The other ingredient is lactose and the capsule is made of gelatin.
- Each Onbrez Breezhaler 300 microgram capsule contains 300 micrograms indacaterol as indacaterol maleate. The other ingredient is lactose and the capsule is made of gelatin.
What the medicine looks like and contents of the pack
This pack contains an inhaler along with capsules in blister cards. The capsules are clear (unstained) and contain a white powder.
- Onbrez Breezhaler 150 microgram capsules have a black product code “ IDL 150 ” printed above a black line and a black company logo ( ) printed below the black line.
- Onbrez Breezhaler 300 microgram capsules have a blue product code “ IDL 300 ” printed above a blue line and a blue company logo ( ) printed below the blue line.
The following pack sizes are provided:
Carton containing 10 capsules and one inhaler.
Carton containing 30 capsules and one inhaler.
Multiple packs consisting of 2 packs (each containing 30 capsules and 1 inhaler ).
Multiple packs consisting of 3 packs (each containing 30 capsules and 1 inhaler ).
Multiple packs consist of 30 packs (each containing 10 capsules and 1 inhaler ).
Not all pack sizes or strengths may be available in your country.
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
Gran Via de les Corts Catalanes, 764
08013 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 |
| .ΠροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | SwedenNovartis Sverige ABTel: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsTel: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370 |