Xoterna Breezhaler - patient leaflet, side effects, dosage

1. What Xoterna Breezhaler is and what it is used for

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.

2. What you need to know before you use Xoterna Breezhaler

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.

3. How to use Xoterna Breezhaler

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.

4. Possible side effects

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.

5. How to store Xoterna Breezhaler

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.

6. Contents of the pack and other information

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 (6) 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 6×1, 10×1, 12×1, 30×1 or 90×1 hard capsules, together with 1 inhaler.

Multipacks containing 96 (4 packs of 24×1) hard capsules and 4 inhalers.

Multipacks containing 150 (15 packs of 10×1) hard capsules and 15 inhalers.

Multipacks containing 150 (25 packs of 6×1) 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

Roonstrahe 25

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:

België/Belgiqu­e/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11	Lietuva SIA „ovartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Et^rapuH Novartis Bulgaria EOOD Tea: +359 2 489 98 28	Luxembourg/Lu­xemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11
Česká republika Novartis s.r.o. Tel: +420 225 775 111	Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00
Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Deutschland Novartis Pharma GmbH Tel: +49 911 273 0	Nederland Novartis Pharma B.V. Tel: +31 88 04 52 111
Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810	Norge Novartis Norge AS Tlf: +47 23 05 20 00
E/./.úňa Novartis (Hellas) A.E.B.E. Tqk +30 210 28 11 712 n INNOVIS PHARMA AEBE Tqk +30 210 66 64 805–6	Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
España Ferrer Internacional, S.A. Tel: +34 93 600 37 00	Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00	Portugal Laboratório Medinfar – Produtos Farmacêuticos, S.A. Tel: +351 21 499 7400
Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55	Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

United Kingdom (Northern Ireland)

Novartis Ireland Limited

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

Instructions for Use

before using the Xoterna Breezhaler.

Insert Pierce and release Inhale deeply Check capsule is empty

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.

Step 1c:

Remove capsule

Separate one of the blisters from the blister card.

Peel open the blister and remove the capsule.

Do not push the capsule through the foil.

Do not swallow the capsule.

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

• Xoterna Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
• Do not push the capsule through the foil to remove it from the blister.
• Do not swallow the capsule.
• Do not use the Xoterna Breezhaler capsules with any other inhaler.
• Do not use the Xoterna 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.
• One Xoterna Breezhaler inhaler
• One or more blister cards, each containing either 6 or 10 Xoterna Breezhaler capsules to be used in the inhaler

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