Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - onbrez

Document Subject

Generated Narrative: MedicinalProductDefinition mp5a85179f4445f6400b4f1fbf3a650302

identifier: http://ema.europa.eu/identifier/EU/1/09/593/001-005

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5a85179f4445f6400b4f1fbf3a650302

identifier: http://ema.europa.eu/identifier/EU/1/09/593/001-005

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - onbrez

Attesters

What is in this leaflet

1. What Onbrez Breezhaler is and what it is used for
2. What you need to know before you use Onbrez Breezhaler
3. How to use Onbrez Breezhaler
4. Possible side effects
5. How to store Onbrez Breezhaler
6. Contents of the pack and other information

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.

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: * steroids (e.g. prednisolone), * diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide, * 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.

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.

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 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.

What Onbrez Breezhaler contains

• Each Onbrez Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate. The other ingredients include lactose and the capsule is made of gelatin.
• Each Onbrez Breezhaler 300 microgram 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 In this pack, you will find an inhaler, together with capsules in blisters. The capsules are transparent (uncoloured) and contain a white powder.

Onbrez 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.

Onbrez 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.

Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer Novartis Pharma GmbH Roonstra e D-90429 Nuremberg Germany

Novartis Farmac utica SA Gran Via de les Corts Catalanes, 08013 Barcelona Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD .: +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: