Xoterna Breezhaler

Patient Information Leaflet: Important Information for the User

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules

indacaterol/glycopyrronium
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Xoterna Breezhaler is and what it is used for
2. What you need to know before using 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
   Instructions for use of the Xoterna Breezhaler inhaler

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, which belong to
a group of medicines known as bronchodilators.
What Xoterna Breezhaler is used for
This medicine is used to help adults breathe more easily when they have difficulty breathing 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 prevents the tightening of these muscles in the lungs, making it easier for air to flow in and out of the lungs.
If you take this medicine once daily, it will help reduce the effects of COPD in your daily activities.

2. What you need to know before using Xoterna Breezhaler

Do not use Xoterna Breezhaler

• if you are allergic to indacaterol or glycopyrronium, or to 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 apply to you:

• you suffer from asthma – this medicine must not be used for the treatment of asthma;
• you have heart problems;
• you have seizures or convulsions;
• you have a problem with your thyroid gland (thyrotoxicosis);
• you have diabetes;
• you are taking medicines for your lung disease containing active substances similar (belonging to the 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 a condition of the eye called closed-angle glaucoma;
• you have difficulty urinating. If any of these apply to you (or you think they might), talk to your doctor, pharmacist, or nurse before using this medicine.

During treatment with Xoterna Breezhaler

• Stop using the medicine and seek immediate medical help if you experience any of the following:
• eye pain or discomfort, temporary blurred vision, halos or colored images around lights, associated with red eyes – these may be signs of an acute attack of closed-angle glaucoma;
• difficulty breathing or swallowing, swelling of the tongue, lips or face, rash, itching or hives (signs of an allergic reaction);
• chest tightness, cough, wheezing or shortness of breath immediately after using this medicine – these may be signs of a condition called paradoxical bronchospasm.
• Inform your doctor immediately if your COPD symptoms, such as shortness of breath, wheezing or cough, do not improve or worsen.

Xoterna Breezhaler is used as a maintenance therapy for COPD. Do not use this medicine to treat a sudden attack of shortness of breath or wheezing.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age. This is because this medicine has not been studied in this age group.
Other medicines and Xoterna Breezhaler
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• any medicine that may be similar to Xoterna Breezhaler (contains similar active substances).
• medicines called beta-blockers, which may be used for high blood pressure or other heart problems (such as propranolol), or for an eye disease called glaucoma (such as timolol).
• medicines that lower potassium levels in the blood. These include:
• steroids (e.g. prednisolone),
• diuretics used for high blood pressure, such as hydrochlorothiazide,
• medicines for respiratory problems (such as theophylline).

Pregnancy and breastfeeding
There are no data on the use of this medicine during pregnancy, and it is not known whether the active substances of this medicine pass into breast milk. Indacaterol, one of the active substances in Xoterna Breezhaler, may inhibit labour due to its effect on the uterus.
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. You must not take Xoterna Breezhaler unless advised by your doctor.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.
However, this medicine may cause dizziness (see section 4). If you experience dizziness when taking this medicine, do not drive or operate machinery.
Xoterna Breezhaler contains lactose
This medicine contains lactose (23.5 mg per capsule). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Xoterna Breezhaler

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

How much Xoterna Breezhaler to use
The usual dose is the inhalation of the contents of one capsule daily.
It is sufficient to inhale only once a day, as the effect of this medicine lasts for 24 hours.
Do not use more medicine than your doctor has recommended.

Elderly (aged 75 years and over)
If you are aged 75 years or over, you can use this medicine at the same dose as other adults.

When to inhale Xoterna Breezhaler
Use this medicine every day at the same time. This will help you remember to take it.
You may inhale Xoterna Breezhaler at any time before or after eating or drinking.

How to inhale Xoterna Breezhaler

• Xoterna Breezhaler is for inhalation use only.
• This pack contains an inhaler and capsules (in blisters) containing the medicine as a powder for inhalation. Use the capsules only with the inhaler provided in this pack (the Xoterna Breezhaler inhaler). The capsules must remain in the blister until you are ready to use them.
• Remove the foil from the blister to open it – do not push the capsules through the protective foil.
• When starting a new pack, use the new Xoterna Breezhaler inhaler provided in the new pack.
• Dispose of the inhaler supplied with each pack after using all the capsules in the pack.
• Do not swallow the capsules.
• Read the instructions at the end of this leaflet for further information on how to use the inhaler.

If you use more Xoterna Breezhaler than you should
If you have inhaled too much medicine or if someone else has accidentally used your capsules, inform your doctor immediately or go to the nearest emergency department. Show the Xoterna Breezhaler packaging. Medical treatment may be necessary. You may feel your heart beating faster than usual, have a headache, feel drowsy, feel nauseous or need to vomit, or you may experience visual disturbances, constipation, or difficulty urinating.

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

How long to continue treatment with Xoterna Breezhaler

• Continue using Xoterna Breezhaler for as long as your doctor tells you to.
• COPD is a long-term condition and you must take Xoterna Breezhaler every day, not only when you have difficulty breathing or other COPD symptoms. If you have any doubts about how long to continue treatment with this medicine, ask your doctor or pharmacist.

If you have any questions about how to use 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 can be serious:
Common (may affect up to 1 in 10 people)

• difficulty breathing or swallowing, swelling of the tongue, lips or face, hives, skin rash – may be signs of an allergic reaction.
• feeling tired or very thirsty, increased appetite without weight gain, and urinating more than usual – may be signs of high blood sugar levels (hyperglycaemia).

Uncommon (may affect up to 1 in 100 people)

• crushing chest pain with increased sweating – may indicate a serious heart problem (ischaemic heart disease).
• swelling, particularly of the tongue, lips, face or throat (possible signs of angioedema).
• difficulty breathing with shortness of breath or cough.
• eye pain or discomfort, temporary blurred vision, seeing halos or coloured images, associated with red eyes – may be signs of glaucoma.
• irregular heartbeat.

If you experience any of these serious side effects, seek immediate medical help.
Other side effects may include:
Very common (may affect more than 1 in 10 people)

• stuffy nose, sneezing, cough, headache with or without fever – may be signs of an upper respiratory tract infection.

Common

• combination of sore throat and runny nose – may be signs of nasopharyngitis.
• painful and frequent urination – may be signs of a urinary tract infection called cystitis.
• feeling of pressure or pain in the cheeks and forehead – may be signs of sinus congestion.
• stuffy or runny nose.
• dizziness.
• headache.
• cough.
• sore throat.
• upset stomach, indigestion.
• dental caries.
• difficulty and pain when urinating – may be signs of bladder obstruction or urinary retention.
• fever.
• chest pain.

Uncommon

• difficulty sleeping.
• fast heartbeat.
• palpitations – signs of an abnormal heartbeat.
• altered voice (hoarseness).
• nosebleeds.
• diarrhoea or stomach ache.
• dry mouth.
• itching or skin rash.
• pain in muscles, ligaments, tendons, joints and bones.
• muscle spasm.
• muscle pain, aches or soreness.
• pain in arms or legs.
• swelling of the hands, ankles and feet.
• fatigue.

Rare (may affect up to 1 in 1000 people)

• tingling or numbness.

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly through the national reporting system listed in Annex 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 stated on the carton and blister after "Scad"/"EXP". The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the capsules in the original blister to protect them from moisture and remove them only just before use.
The inhaler contained in each pack must be discarded after all capsules in the pack have been used.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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 released from the inhaler mouthpiece) 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 components of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2, under “Xoterna Breezhaler contains lactose”).
• The capsule shell ingredients are hypromellose, calcium chloride, tartrazine (E102), and black printing ink (on the capsule cap) and blue printing ink (on the capsule body).
  o The ingredients of the black printing ink (capsule cap) are shellac (E904), propylene glycol, ammonium hydroxide, potassium hydroxide, and black iron oxide (E172).
  o The ingredients of the blue printing ink (capsule body) are shellac (E904), indigo carmine (E132), and titanium dioxide (E171).

Description of the appearance of Xoterna Breezhaler 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. The product code “IGP110.50” is printed in blue under two blue bands on the body of the capsule, and the company logo

( ) is printed in black on the cap of the capsule.
In this pack, together with the capsules contained in a blister, you will find a device called an inhaler. Each blister contains 6 or 10 hard capsules.
The following pack sizes are available:
Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules and 1 inhaler.
Multiple pack containing 96 (4 packs of 24 x 1) hard capsules and 4 inhalers.
Multiple pack containing 150 (15 packs of 10x1) hard capsules and 15 inhalers.
Multiple pack containing 150 (25 packs of 6 x 1) hard capsules and 25 inhalers.
Not all pack sizes may be marketed in your country.

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

Manufacturer
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

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

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50
България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11
Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00
Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872
Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111
Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00
Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 28 11 712 Tel: +43 1 86 6570
or
INNOVIS PHARMA ΑΕΒΕ
Τηλ: +30 210 66 64 805-6
España Polska
Ferrer Internacional, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 600 37 00 Tel.: +48 22 375 4888
France Portugal
Novartis Pharma S.A.S. Laboratório Medinfar - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 499 7400
Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01
Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50
Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439
Italia Suomi/Finland
Alfasigma S.p.A. Novartis Finland Oy
Tel: +39 06 91 39 4666 Puh/Tel: +358 (0)10 6133 200
Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00
Latvija
SIA “Novartis Baltics”
Tel: +371 67 887 070

Further sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Please read the instructions for use completely before using Xoterna Breezhaler.

Insert Pierce and release Inhale Check that the
deeply capsule is empty
1 Verif
y

Step 1a: Step 2a: Step 3a: Check that the capsule
Remove the cap Pierce the capsule only Breathe out is empty
once completely Open the inhaler to
Hold the inhaler in an Do not blow into the see if any powder remains
upright position. mouthpiece. in the capsule.
Pierce the capsule
by firmly pressing
both side buttons
simultaneously.
When the capsule is If powder remains in the
pierced, you should hear capsule:
a clicking sound. close the inhaler;
Pierce the capsule only repeat steps 3a to 3c.
once.

With powder Empty
Step 1b: Step 3b:

Open the inhaler Inhale deeply
the medicine
Hold the inhaler as
shown in the picture.
Place the mouthpiece in
your mouth and close
your lips firmly around it.
Step 2b: Do not press the side
Release the side buttons buttons.
Inhale as quickly and
deeply as possible.
You will hear a buzzing
sound during inhalation.
You may taste the
medicine while inhaling.

Step 1c: Remove the empty capsule

Remove the capsule Discard the empty capsule
Separate one blister cavity into household waste.
from the rest of the blister. Close the inhaler and
Peel off the protective replace the cap.
foil and remove the capsule.
Do not push the capsule
through the foil.
Do not swallow the capsule.
Step 3c:
Hold your breath
Hold your breath for up
to 5 seconds.
Important information

• Xoterna Breezhaler capsules must always be stored in the blister and removed only immediately before use. Never insert the capsule directly into the mouthpiece. Do not push the capsule through the foil to remove it from the blister.

• Do not swallow the capsule.

• Do not use Xoterna Breezhaler capsules with any other inhaler.

• Do not use the Xoterna Breezhaler inhaler to take capsules of any other medicine.

• Never place the capsule in your mouth or into the inhaler mouthpiece.

• 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 the capsules with wet hands.

• Never wash the inhaler with water.
  The Xoterna Breezhaler pack contains: Frequently asked questions How to clean the inhaler

• One Xoterna Breezhaler inhaler Wipe the outside and

• One or more blisters, each containing 6 or Why didn’t the inhaler the inside of the mouthpiece 10 Xoterna Breezhaler capsules to be used with make a sound when I with a clean, dry, lint-free the inhaler inhaled? cloth to remove any powder
  The capsule may become residue. Keep the inhaler
  lodged in the chamber. If dry. Never wash the inhaler
  this occurs, gently tap the with water.
  base of the inhaler to
  dislodge the capsule.

of the inhaler. Inhale
the medicine again by
repeating steps 3a to 3c.
Disposal
What should I do if of the inhaler after use
powder remains in the After using all capsules,
capsule? the inhaler must be
You have not taken a discarded. Ask your
sufficient dose of pharmacist how to dispose
medicine. Close the of medicines and inhalers
inhaled and repeat steps you no longer use.
3a to 3c.
I coughed after
inhalation – what does it
mean?
This may happen.
As long as the capsule is
empty, you have taken a
sufficient dose of medicine.
I felt small pieces of the
capsule on my tongue –
what does it mean?
This may happen. It is not
harmful. The likelihood that
the capsule breaks into small
pieces increases if the
capsule is pierced more than
once.