HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE)
How to use HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (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
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
- What is Hirobriz Breezhaler and what is it used for
- What you need to know before taking Hirobriz Breezhaler
- How to use Hirobriz Breezhaler
- Possible side effects
- Storage of Hirobriz Breezhaler
- 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.
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.
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 |
| 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.
Insert |
Pierce and release |
Inhale deeply |
Check that the capsule is empty |
|
|
|
|
Step 1a: Remove the cap.
Step 1b: Open the inhaler |
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.
Step 2b: Release the buttons completely |
Step 3a: Exhale completely Do not blow into the inhaler.
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 |
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:
|
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.
Step 3c: Hold your breath Hold your breath for 5 seconds. |
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.
Step 1e: Close the inhaler | Important Information
|
Your Hirobriz Breezhaler package contains:
| 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. |
- Country of registration
- Average pharmacy price50.13 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 HIROBRIZ BREEZHALER 150 micrograms POWDER FOR INHALATION (HARD CAPSULE)Dosage form: PULMONARY INHALATION, 300 µgActive substance: indacaterolManufacturer: Novartis Europharm LimitedPrescription requiredDosage form: PULMONARY INHALATIONActive substance: indacaterolManufacturer: Novartis Europharm LimitedPrescription requiredDosage form: PULMONARY INHALATIONActive substance: indacaterolManufacturer: Novartis Europharm LimitedPrescription required
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