Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - oslif

Document Subject

Generated Narrative: MedicinalProductDefinition mp69ba7123d300a992a466115b331a7218

identifier: http://ema.europa.eu/identifier/EU/1/09/586/001-005

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Oslif 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-69ba7123d300a992a466115b331a7218

identifier: http://ema.europa.eu/identifier/EU/1/09/586/001-005

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - oslif

Attesters

What is in this leaflet:

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

What Oslif Breezhaler is Oslif 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 Oslif Breezhaler is used for Oslif 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 Oslif 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 Oslif Breezhaler

if you have asthma (in this case you should not use Oslif Breezhaler).

if you have heart problems.

if you have epilepsy.

if you have thyroid gland problems (thyrotoxicosis).

if you have diabetes.

During treatment with Oslif 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 Oslif Breezhaler should not be given to children or adolescents below the age of 18 years

Other medicines and Oslif 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 Oslif 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 Oslif 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 Oslif Breezhaler will affect your ability to drive and use machines.

Oslif 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 Oslif 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 Oslif Breezhaler

In this pack, you will find an inhaler and capsules (in blister) that contain the medicine as inhalation powder. The Oslif Breezhaler inhaler enables you to inhale the medicine contained in a capsule.

Only use the capsules with the inhaler provided in this pack (Oslif Breezhaler inhaler). The capsules should remain in the blister until you need to use them.

When you start a new pack, use the new Oslif Breezhaler inhaler that is supplied in the pack.

Dispose of each inhaler after 30 days of use.

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 Oslif Breezhaler than you should If you have inhaled too much Oslif Breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit. Show the pack of Oslif 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 Oslif 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 Oslif Breezhaler

Keep using your treatment with Oslif Breezhaler for as long as your doctor tells you.

COPD is a long-term disease and you should use Oslif 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 Oslif 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 Oslif Breezhaler contains

• Each Oslif Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate. The other ingredients include lactose and the capsule is made of gelatin.
• Each Oslif Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate. The other ingredients include lactose and the capsule is made of gelatin.

What Oslif Breezhaler looks like and content of the pack In this pack, you will find an inhaler, together with capsules in blister. The capsules are transparent (uncoloured) and contain a white powder.

Oslif 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.

Oslif 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 Ferrer Internacional, S.A. Tel: +34 93 600 37 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Pierre Fabre M dicament T l: +33 1 49 10 96 Portugal Laborat rio Medinfar - Produtos Farmac uticos, S.A. Tel: +351 21 499 7Hrvatska 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 website: http://www.ema.europa.eu INSTRUCTIONS FOR USE OF OSLIF BREEZHALER INHALER

Please read the full Instructions for Use before using the Oslif Breezhaler.

Insert Pierce and release Inhale deeply Check capsule is empty

Step 1a: Pull off cap Step 2a: Pierce capsule once Hold the inhaler upright. Pierce capsule by firmly pressing both side buttons at the same time. Step 3a: Breathe out fully Do not blow into the inhaler. Check capsule is empty Open the inhaler to see if any powder is left in the capsule.

You should hear a noise as the capsule is pierced. Only pierce the capsule once.

If there is powder left in the capsule:

Close the inhaler.

Repeat steps 3a to 3c. Step 1b: Open inhaler

Step 2b: Release side buttons 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.

Powder Empty remaining 1

2

3

Check

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 1c: Remove capsule Remove one capsule from the blister. Do not swallow the capsule.

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.

Step 1d: Insert capsule Never place a capsule directly into the mouthpiece.

Important Information Oslif Breezhaler capsules must always be stored in the blister card and only removed immediately before use. Do not swallow the capsule. Do not use the Oslif Breezhaler capsules with any other inhaler. Do not use the Oslif Breezhaler inhaler to take any other capsule medicine. Never place the capsule into your mouth or the mouthpiece of the inhaler. Do not press the side buttons more than once. Do not blow into the mouthpiece. Do not press the side buttons while inhaling through the mouthpiece. Do not handle capsules with wet hands. Never wash your inhaler with water.

Step 1e: Close inhaler

Your Oslif Breezhaler Inhaler pack contains:

One Oslif Breezhaler inhaler

One or more blister cards, each containing either 6 or 10 Oslif Breezhaler capsules to be used in the inhaler

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.

Cap Mouthpiece Blister Side buttons Inhaler Inhaler base Blister Card Capsule chamber Screen Base