Hirobriz Breezhaler
indacaterol
Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Hirobriz Breezhaler is and what it is used for
What you need to know before you use Hirobriz Breezhaler
How to use Hirobriz Breezhaler
Possible side effects
How to store Hirobriz Breezhaler
Contents of the pack and other information
Hirobriz 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.
Hirobriz 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.
if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in
section 6).
Talk to your doctor or pharmacist before using 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.
of a condition called bronchospasm.
Hirobriz Breezhaler should not be given to children or adolescents below the age of 18 years.
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 Hirobriz 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:
steroids (e.g. prednisolone),
diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide,
medicines for breathing problems such as theophylline.
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 Hirobriz Breezhaler unless your doctor tells you so. Ask your doctor or pharmacist for advice before taking any medicine.
It is unlikely that Hirobriz Breezhaler will affect your ability to drive and use machines.
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.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
In this pack, you will find an inhaler and capsules (in blister) that contain the medicine as inhalation powder. The Hirobriz Breezhaler inhaler enables you to inhale the medicine
contained in a capsule.
Only use the capsules with the inhaler provided in this pack (Hirobriz Breezhaler inhaler). The capsules should remain in the blister until you need to use them.
When you start a new pack, use the new Hirobriz Breezhaler inhaler that is supplied in the pack.
Dispose of each inhaler after 30 days of use.
Do not swallow the capsules.
If you have inhaled too much Hirobriz Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit. Show the pack of Hirobriz 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 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.
Keep using your treatment with Hirobriz Breezhaler for as long as your doctor tells you.
COPD is a long-term disease and you should use Hirobriz 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 Hirobriz Breezhaler, talk to
your doctor or pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 expiry date refers to the last day of that month.
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 this medicine if you notice that the pack is damaged or show signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Each Hirobriz Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate. The other ingredients include lactose and the capsule is made of gelatin.
Each Hirobriz Breezhaler 300 microgram capsule contains 300 microgram indacaterol as
indacaterol maleate. The other ingredients include lactose and the capsule is made of gelatin.
In this pack, you will find an inhaler, together with capsules in blister. The capsules are transparent (uncoloured) and contain a white powder.
Hirobriz Breezhaler 150 microgram capsules have a black product code “IDL 150” printed above a black bar and a black company logo () printed below the black bar.
Hirobriz Breezhaler 300 microgram capsules have a blue product code “IDL 300” printed
above a blue bar and a blue company logo () printed below the blue bar.
The following pack sizes are available: Carton containing 10 capsules and 1 inhaler. Carton containing 30 capsules and 1 inhaler.
Multipack comprising 2 packs (each containing 30 capsules and 1 inhaler). Multipack comprising 3 packs (each containing 30 capsules and 1 inhaler). Multipack comprising 30 packs (each containing 10 capsules and 1 inhaler).
Not all pack sizes or strengths may be available in your country.
Novartis Europharm Limited Vista Building
Elm Park, Merrion Road Dublin 4
Ireland
D-90429 Nuremberg Germany
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764 08013 Barcelona
Spain
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Novartis Bulgaria EOOD Тел.: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Healthcare A/S Tlf: +45 39 16 84 00
Novartis Pharma Services Inc. Tel: +356 2122 2872
Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Pharma B.V. Tel: +31 88 04 52 111
SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12
Novartis Pharma GmbH Tel: +43 1 86 6570
Laboratorios Farmacéuticos ROVI, S.A.
Tel.: +34 91 375 62 30
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888
Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00
Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01
Novartis Ireland Limited Tel: +353 1 260 12 55
Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A. Tel: +39 02 96 54 1
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Novartis Pharma Services Inc. Τηλ: +357 22 690 690
Novartis Sverige AB Tel: +46 8 732 32 00
SIA Novartis Baltics Tel: +371 67 887 070
Novartis Ireland Limited Tel: +44 1276 698370
Please read the full Instructions for Use before using the Hirobriz Breezhaler.
Step 1a:
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 3a:
Breathe out fully Do not blow into the inhaler.
If there is powder left in the capsule:
Close the inhaler.
Repeat steps 3a to 3c.
Step 1b:
Step 2b:
Step 3b:
Do not press the side buttons.
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 | 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. | Remove empty capsule Put the empty capsule in your household waste. Close the inhaler and replace the cap. | |
Important Information
and only removed immediately before use. any other inhaler. inhaler. |
Your Hirobriz Breezhaler Inhaler pack contains:
Capsule chamber Mouthpiece Cap Screen Side buttons Blister Base Inhaler Inhaler base Blister Card | 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. |