XOTERNA 85 MCG/43 MCG Inhalation powder, hard capsule

Содержание инструкции

1. Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder, hard capsules
   1. What is Xoterna Breezhaler and what is it 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

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

indacaterol/glycopyrronium

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 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 Instructions for use of the Xoterna Breezhaler inhaler

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

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

What is Xoterna Breezhaler used for
This medicine is used to make it easier to breathe for adult patients who 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 enter and leave the lungs.
If you use this medicine once a day, it will help you 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 applies to you:

• you suffer from asthma - this medicine should not be used as treatment for asthma;
• you have heart problems;
• you have seizures or convulsions;
• you have problems with your thyroid gland (thyrotoxicosis);
• you have diabetes;
• you are using medicines for your lung disease that contain active ingredients similar (belonging to the same class) to those of Xoterna Breezhaler (see the section “Other medicines and Xoterna Breezhaler”);
• you have kidney problems;
• you have severe liver problems
• you have an eye problem called closed-angle glaucoma;
• you have difficulty urinating. If any of these applies to you (or you think it might), talk to your doctor, yourpharmacist or nurse before using this medicine.

During treatment with Xoterna Breezhaler

• Stop using the medicine and seek immediate medical helpif any of the following occurs:
• eye pain or discomfort, temporary blurred vision, visual halos or coloured images 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, skin rash, itching and hives (signs of an allergic reaction);
• chest tightness, coughing, wheezing or shortness of breath immediately after using this medicine - these may be signs of a condition called paradoxical bronchospasm.
• Tell your doctor immediately if your COPD symptomssuch as shortness of breath, wheezing or cough do not improve or get worse.

Xoterna Breezhaler is used as 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. The reason is that this
medicine has not been studied in this age group.

Other medicines and Xoterna Breezhaler
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking:

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

Pregnancy and breastfeeding
There are no data on the use of this medicine in pregnancy and it is not known whether the active ingredients of this
medicine pass into breast milk. Indacaterol, one of the active ingredients contained in Xoterna
Breezhaler, may inhibit labour due to its effect on the uterus.
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask
your doctor or pharmacist for advice before taking this medicine. You should not take Xoterna
Breezhaler unless your doctor has told you to.

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 when
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 diagnosed with
lactose intolerance, contact your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Xoterna Breezhaler

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

How much Xoterna Breezhaler to use
The usual dose is to inhale the contents of one capsule every day.
It is sufficient to inhale only once a day because the effect of this medicine lasts 24 hours.
Do not use more medicine than has been advised by your doctor.

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

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

How to inhale Xoterna Breezhaler

• Xoterna Breezhaler is for inhalation use only
• In this package you will find an inhaler and capsules (in blisters) that contain the medicine as a powder for inhalation. Use the capsules only with the inhaler supplied in this package (the Xoterna Breezhaler inhaler). The capsules must remain in the blister until you use them.
• Remove the foil from the blister to open it - do not push the capsules through the protective foil.
• When you start a new pack, use the new Xoterna Breezhaler inhaler contained in the new pack.
• Dispose of the inhaler contained in each pack after using all the capsules in the pack.
• Do not swallow the capsules.

use the inhaler.

If you use more Xoterna Breezhaler than you should
If you have inhaled too much medicine or if others have accidentally used your capsules, inform
your doctor immediately or go to the nearest emergency room. Show the Xoterna
Breezhaler pack. Medical care may be needed. You may feel that your heart is beating
faster than usual, have a headache, feel sleepy, feel nauseous or need to vomit, or you may
experience visual disturbances, feel constipated or have difficulty urinating.

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

How long to continue treatment with Xoterna Breezhaler

• Continue to use Xoterna Breezhaler until your doctor tells you to stop.
• COPD is a long-term illness and you must take Xoterna Breezhaler every dayand not just when you have difficulty breathing or other COPD symptoms. If you have any doubts about the duration of treatment with this medicine, ask your doctor or pharmacist for advice.

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

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

Uncommon (may affect up to 1 in 100 people)

• oppressive chest pain with increased sweating - this may be a serious heart problem (ischaemic heart disease).
• swelling, especially of the tongue, lips, face or throat (possible signs of angioedema).
• difficulty breathing with wheezing or cough.
• eye pain or discomfort, temporary blurred vision, visual halos or coloured images in association with red eyes - these may be signs of glaucoma.
• irregular heartbeat.

If any of these serious side effects happen to you, seek medical help immediately.
Other side effects can 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 sinus congestion.
• blocked or runny nose.
• dizziness.
• headache.
• cough.
• sore throat.
• upset stomach, indigestion.
• tooth decay.
• difficulty and pain when urinating - these 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 (hoarse voice).
• nosebleed.
• diarrhoea or stomach pain.
• dry mouth.
• itching or rash.
• muscle, ligament, tendon, joint and bone pain
• muscle spasm.
• muscle pain, aches or soreness.
• arm or leg pain.
• 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 effects, talk to your doctor or 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 which is stated on the box and blister after
“Scad”/“EXP”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Store the capsules in the original blister pack to protect them from moisture and only remove them at the time
of use.
The inhaler contained in each pack must be discarded after use of all the capsules
in the pack.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Xoterna Breezhaler contains

• The active ingredients 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).
• The other components of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2, under “Xoterna Breezhaler contains lactose”).

Description of the appearance of Xoterna Breezhaler and contents of the pack
Xoterna Breezhaler 85 micrograms/43 micrograms powder for inhalation capsules,
are transparent and yellow, and contain powder from white to almost white. They have the product code “IGP110.50” printed in blue under two blue bands on the capsule body and the company logo
( ) printed in black on the capsule cap.
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 capsules.
The following packs are available:
Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 capsules and 1 inhaler.
Multipack containing 96 (4 packs of 24 x 1) capsules and 4 inhalers.
Multipack containing 150 (15 packs of 10x1) capsules and 15 inhalers.
Multipack containing 150 (25 packs of 6 x 1) 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 Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
For further information on this medicine, 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 Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел: +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

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 28 11 712
ή
INNOVIS PHARMA ΑΕΒΕ
Τηλ: +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

Italia
Alfasigma S.p.A.
Tel: +39 06 91 39 4666

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA“Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Read the instructions for usecarefully before using Xoterna Breezhaler.

InsertPierce and releaseInhale
deeply
Check that the
capsule is empty
ca
13Verify

Step 1a:

Remove the cap
Step 2a:

Pierce the capsule once
Hold the inhaler in
a vertical position.
Pierce the capsule
by firmly pressing
both side buttons
simultaneously.
Step 3a:

Exhale
completely
Do not blow into
the mouthpiece.

Verify that the capsule
is empty
Open the inhaler to
see if any powder remains
in the capsule.

When the capsule is
pierced, you should hear a
noise.
Pierce the capsule
only once.
If powder remains in the
capsule:
close the inhaler;
repeat steps 3a to 3c.

With powderEmpty

Step 1b:

Open the inhaler
Step 3b:

Inhale the medicine deeply
Hold the inhaler as
shown in the figure.
Bring the mouthpiece to
your mouth and close
your lips firmly
around the mouthpiece.
Do not press the side buttons.
Step 2b:

Release the side
buttons
Inhale as
quickly and
deeply as possible.
You will hear a buzzing sound during inhalation.
You may feel the taste of the
medicine when inhaling.

Step 1c:

Remove the capsule
Separate one of the blisters
from the rest of the blister pack.
Remove the protective film
from the blister and
remove the capsule.
Do not push the capsule
through the film.
Do not swallow the capsule.

Remove the empty capsule
Dispose of the empty capsule
in household waste.
Close the inhaler and
put the cap back on.
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 only removed immediately before use.
• Do not push the capsule through the film to remove it from the blister.
• Do not swallow the capsule.
• Do not use capsules of

Xoterna Breezhaler with
any other inhaler.

• Do not use the Xoterna Breezhaler inhaler to take capsules of any other medicine.
• Never put the Step 1e: Close the inhalercapsule in your mouth or in 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 the capsules with wet hands.
• Never wash the inhaler with water.

The Xoterna Breezhaler pack contains:

• A Xoterna Breezhaler inhaler
• One or more blisters, each containing 6 or Frequently asked questionsWhy didn’t the inhaler make a
  noise when I inhaled?The capsule may be stuck in the housing. If this happens, gently move the capsule by tapping the base of the inhaler. Inhale the medicine again by repeating steps 3a to 3c. What should I do if
  powder remains in the
  capsule?You have not taken a sufficient dose of medicine. Close the inhaler and repeat steps 3a to 3c. After inhalation I
  coughed - what does this mean?This can happen. As long as the capsule is empty, you have taken a sufficient dose of medicine. I felt small pieces of
  capsule on my tongue - what
  does this mean?This can happen. It is not harmful. The possibility of the capsule breaking into small pieces increases if the capsule is pierced more than once. How to clean the inhalerWipe the outside and inside of the mouthpiece with a clean, dry, lint-free cloth to remove any powder residue. Keep the inhaler dry. Never wash the inhaler with water. 10 Xoterna Breezhaler capsules to be used with the inhaler

Disposal
of the inhaler after use
After using all
the capsules, the inhaler must
be disposed of. Ask your
pharmacist how to dispose of
medicines and inhalers
that you no longer use.