Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - xoterna

Document Subject

Generated Narrative: MedicinalProductDefinition mp3b71bf691692fb082e86656309cb3d56

identifier: http://ema.europa.eu/identifier/EU/1/13/863/001-008

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3b71bf691692fb082e86656309cb3d56

identifier: http://ema.europa.eu/identifier/EU/1/13/863/001-008

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - xoterna

Attesters

Instructions for use of Xoterna Breezhaler inhaler

What is in this leaflet

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

What Xoterna Breezhaler is This medicine contains two active substances called indacaterol and glycopyrronium. These belong to a group of medicines called bronchodilators.

What Xoterna Breezhaler is used for This medicine 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 blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs.

If you use this medicine once a day, it will help to reduce the effects of COPD on your everyday life.

Do not use Xoterna Breezhaler

• if you are allergic to indacaterol or glycopyrronium or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor, pharmacist or nurse before using Xoterna Breezhaler if any of the following applies to you:

• you have asthma - this medicine should not be used as a treatment for asthma.
• you have heart problems.
• you have seizure or fits.
• you have thyroid gland problems (thyrotoxicosis).
• you have diabetes.
• you are using any medicines for your lung disease which contain active substances similar (same class) to those in Xoterna Breezhaler (see section Other medicines and Xoterna Breezhaler ).
• you have kidney problems.
• you have severe liver problems.
• you have an eye problem called narrow-angle glaucoma.
• you have difficulty passing urine. If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before using this medicine.

During treatment with Xoterna Breezhaler

• Stop using this medicine and seek medical help immediately if you experience any of the following:

• eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes these may be signs of an acute attack of narrow-angle glaucoma.

• difficulty breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of an allergic reaction).

• tightness of the chest, coughing, wheezing or breathlessness immediately after using this medicine these may be signs of a condition called paradoxical bronchospasm.

• Tell your doctor immediately if your COPD symptoms such as breathlessness, wheezing or cough do not improve or get worse.

Xoterna Breezhaler is used as an ongoing treatment for your COPD. Do not use this medicine to treat a sudden attack of breathlessness or wheezing.

Children and adolescents Do not give this medicine to children or adolescents below the age of 18 years. This is because it has not been studied in this age group.

Other medicines and Xoterna Breezhaler Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, please tell your doctor or pharmacist if you are using:

• any medicines that may be similar to Xoterna Breezhaler (contain similar active substances).

• medicines called beta blockers that may be used for high blood pressure or other heart problems (such as propranolol), or for an eye problem called glaucoma (such as timolol).

• medicines that lower the amount of potassium in your blood. These include:

• steroids (such as prednisolone),

• diuretics (water tablets) used for high blood pressure (such as hydrochlorothiazide),

• medicines for breathing problems (such as theophylline).

Pregnancy and breast-feeding There are no data on the use of this medicine in pregnant women and it is not known whether the active substances of this medicine pass into human milk. Indacaterol, one of the active substances in Xoterna Breezhaler, may prevent labour due to its effect on the uterus.

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 Xoterna Breezhaler unless your doctor tells you to do so. Driving and using machines It is unlikely that this medicine will affect your ability to drive and use machines. However, this medicine may cause dizziness (see section 4). If you feel dizzy while taking this medicine, do not drive or use machines.

Xoterna Breezhaler contains lactose This medicine contains lactose (23.5 mg per capsule). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.

Ask your doctor or pharmacist for advice before using any medicine.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much Xoterna Breezhaler to use The usual dose is to inhale the content of one capsule each day. You only need to inhale once a day because the effect of this medicine lasts for 24 hours. Do not use more than your doctor tells you to use.

Elderly (age 75 years and over) You can use this medicine if you are aged 75 years and over at the same dose as for other adults.

When to inhale Xoterna Breezhaler Use this medicine at the same time each day. This will also help you to remember to use it. You can inhale Xoterna Breezhaler any time before or after food or drink.

How to inhale Xoterna Breezhaler

• Xoterna Breezhaler is for inhalation use.
• In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as inhalation powder. Only use the capsules with the inhaler provided in this pack (Xoterna Breezhaler inhaler). The capsules should remain in the blister until you need to use them.
• Peel the backing away from the blister to open it - do not push the capsule through the foil.
• When you start a new pack, use the new Xoterna Breezhaler inhaler that is supplied in the pack.
• Dispose of the inhaler ineach pack after all capsules in that pack have been used.
• Do not swallow the capsules.
• Please read the instructions at the end of this leaflet for more information on how to use the inhaler.

If you use more Xoterna Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit. Show the pack of Xoterna 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, or you may notice visual disturbances, feel constipated or have difficulty when passing urine.

If you forget to use Xoterna Breezhaler If you forget to inhale a dose at the usual time, inhale one as soon as possible that day. Then, inhale the next dose as usual the next day. Do not inhale more than one dose on the same day.

How long to continue your treatment with Xoterna Breezhaler

Keep using Xoterna Breezhaler for as long as your doctor tells you.

COPD is a long-term disease and you should use Xoterna 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 this medicine, talk to your doctor or pharmacist.

If you have further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious:

Common (may affect up to 1 in 10 people)

difficulty breathing or swallowing, swelling of tongue, lips or face, urticaria, skin rash these may be signs of an allergic reaction.

feeling tired or very thirsty, having an increased appetite without gaining weight and passing more urine than usual these may be signs of high level of sugar in the blood (hyperglycaemia).

Uncommon (may affect up to 1 in 100 people)

crushing chest pain with increased sweating this may be a serious heart problem (ischaemic heart disease).

swelling mainly of the tongue, lips, face or throat (possible signs of angioedema).

difficulty breathing with wheezing or coughing.

eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes these may be signs of glaucoma.

irregular heartbeat.

If you get any of these serious side effects, seek medical help immediately.

Other side effects may include:

Very common (may affect more than 1 in 10 people)

blocked nose, sneezing, cough, headache with or without fever - these may be signs of an upper respiratory tract infection.

Common

combination of sore throat and runny nose - these may be signs of nasopharyngitis.

painful and frequent urination these may be signs of a urinary tract infection called cystitis.

feeling of pressure or pain in the cheeks and forehead these may be signs of inflammation of the sinuses called sinusitis.

runny or stuffy nose.

dizziness.

headache.

cough.

sore throat.

upset stomach, indigestion.

dental caries.

difficulty and pain when passing urine these may be signs of a bladder obstruction or urinary retention.

fever.

chest pain.

Uncommon

difficulty sleeping.

fast heart beat.

palpitations signs of abnormal heart beat.

voice alteration (hoarseness).

nose bleeds.

diarrhoea or stomach ache.

dry mouth.

itching or rash.

pain that affects the muscles, ligaments, tendons, joints and bones.

muscle spasm.

muscle pain, aches or tenderness.

pain in arms or legs.

swollen hands, ankles and feet.

tiredness.

Rare (may affect up to 1 in 1000 people)

tingling or numbness.

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 25 C.

Store the capsules in the original blister in order to protect from moisture and do not remove until immediately before use.

The inhaler in each pack should be disposed of after all capsules in that pack have been used.

Do not use this medicine if you notice that the pack is damaged or shows 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 Xoterna Breezhaler contains

• The active substances are indacaterol (as maleate) and glycopyrronium bromide. Each capsule contains 143 micrograms of indacaterol maleate equivalent to 110 micrograms of indacaterol and 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium. The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 85 micrograms of indacaterol (equivalent to 110 micrograms of indacaterol maleate) and 43 micrograms of glycopyrronium (equivalent to 54 micrograms of glycopyrronium bromide).
• The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under Xoterna Breezhaler contains lactose ).

What Xoterna Breezhaler looks like and contents of the pack

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules are transparent and yellow and contain a white to almost white powder. They have the product code IGP110.50
printed in blue under two blue bars on the body and the company logo ( ) printed in black on the cap.

In this pack, you will find a device called an inhaler together with capsules in blister strips. Each blister contains either 6 or 10 hard capsules.

The following pack sizes are available: Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules, together with 1 inhaler.

Multipacks containing 96 (4 packs of 24x1) hard capsules and 4 inhalers. Multipacks containing 150 (15 packs of 10x1) hard capsules and 15 inhalers. Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.

Not all pack sizes 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 ovartis 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 28 11
INNOVIS PHARMA
: +30 210 66 64 805-6

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 Novartis Pharma S.A.S. T l: +33 1 55 47 66 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 Alfasigma S.p.A. Tel: +39 06 91 39 4Suomi/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: