Enurev Breezhaler

Novartis Europharm Limited

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3.	aᵘ EXPIRY DATE
EXP	eʳ
4.	BATCH NUMBER nᵍ
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5.	OTHER nᵒ

Inhalation use only t

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LEAFLETg

B. PACKAGE

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Package leaflet: Information for the user

Enurev Breezhaler 44 micrograms inhalation powder, hard capsules glycopyrronium

(as glycopyrronium bromide)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. eᵈ - Keep this leaflet. You may need to read it again.

s - If you have any further questions, ask your doctor, pharmacist or nurse.

i - This medicine has been prescribed for you only. Do not pass it on to others. It mayr harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible hᵒ side effects not listed in this leaflet. See section 4.

What is in this leaflet ᵗ aᵘ

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

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

3. How to use Enurev Breezhaler

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4. Possible side effects

5. How to store Enurev Breezhaler

6. Contents of the pack and other information nᵍ o l 1. What Enurev Breezhaler is and what it is used for

What Enurev Breezhaler is

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This medicine contains an active substance called glycopyrronium bromide. This belongs to a group of medicines called bronchodilators.

t c What Enurev 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).

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o 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. pʳ

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

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2. What you nneed to know before you use Enurev Breezhaler i Do not use EncureecvtiBonreezhaler

• if youi are allergic to glycopyrronium bromide or any of the other ingredients of this medicine (lisdtednidn s 6).

Warniengs

a precautions

ᵀᵃMˡᵏ to your doctor before using Enurev Breezhaler, if any of the following applies to you:

• you have kidney problems.
• you have an eye problem called narrow-angle glaucoma.
• you have difficulty passing urine.

During treatment with Enurev Breezhaler, stop taking this medicine and tell your doctor immediately:

• if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after using Enurev Breezhaler (signs of bronchospasm).
• if you experience difficulties in breathing or swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of allergic reaction).
• if you experience 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-angeleᵈ glaucoma.

s i Enurev Breezhaler is used as a maintenance treatment for your COPD. Do not use this mredicine to treat a sudden attack of breathlessness or wheezing.

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Children and adolescents

Do not give this medicine to children or adolescents below the age of 18 years.

ᵗ Other medicines and Enurev Breezhaler

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Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines similar to Enurev Breezhaler usedr for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).

ᵉ No specific side effects have been reported when Enurev Breezhaler has been used together with other medicines used to treat COPD such as reliever inhalers (e.g. snalbᵍutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).

o l Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask o your doctor or pharmacist for advice before taking this medicine.

n There are no data from the use of this medicine in pregnant women and it is not known whether the t active substance of this medicine passes into human milk.

c Driving and using machines

It is unlikely that this medicine will affect your ability to drive and use machines.

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o Enurev Breezhaler contains lactose

This medicine contains lactoser. If have been told by your doctor that you have an intolerance to some sugars, contact your dpoctor before taking this medicine.

l 3. How to use Enurev Breezhaler

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

i How o mnluycdh Enurev Breezhaler to use

usual dose is to inhale the content of one capsule each day.

e need to inhale once a day because the effect of this medicine lasts for 24 hours.

ᵀYᴰʰoᵒMᵉu not use more than your doctor tells you to use.

Elderly people

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

When to inhale Enurev Breezhaler

Use this medicine at the same time each day. This will also help you to remember to use it.

You can inhale this medicine anytime before or after food or drink.

How to inhale Enurev Breezhaler

• 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 (Enurev Breezhaler inhaler). The capsules should remain in the blister until you need to use them.
• Do not push the capsule through the foil.
• When you start a new pack, use the new Enurev Breezhaler inhaler that is supplied in the pack.
• Dispose of each inhaler after after all capsules in that pack have been used. eᵈ
• Do not swallow the capsules.

s - Please read the instructions at the end of this leaflet for more information on how to use the i inhaler. r

If you use more Enurev Breezhaler than you should hᵒ

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 Enurev Breezhaler. Medical attention may be needed. ᵗ aᵘ

If you forget to use Enurev Breezhaler

If you forget to inhale a dose, take one as soon as possible. However, dro not take two doses on the same day. Then take the next dose as usual.

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How long to continue your treatment with Enurev Breezhaler

• Keep using this medicine for as long as your doctor telnls yᵍou.
• COPD is a long-term disease and you should use this medicine every day and not only when o you have breathing problems or other symptoms of COPD.

l If you have questions about how long to continue your treatment with this medicine, talk to your doctor or pharmacist.

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

t c 4. Possible side effects

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

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o Some side effects may be serious are uncommon (may affect up to 1 in 100 peoprle)

• Irregular heart beat p
• High level of blood sugar (hyperglycaemia: typical symptoms include excessive thirst or hunger l and frequent urination)
• Rash, itching, hives, difficulty breathing or swallowing, dizziness (possible signs of allergic reaction) nᵃ
• Swelling miainly of the tongue, lips, face or throat (possible signs of angioedema)

If you get anyc of these side effects, tell your doctor immediately.

i side effects may be serious, but the frequency of these side effects is not known eᵈ cannot be estimated from the available data)

Difficulty breathing with wheezing or coughing (signs of paradoxical bronchospasm) S(•forMemqeuency

Some side effects are common

(may affect up to 1 in 10 people)

• Dry mouth
• Difficulty sleeping
• Runny or stuffy nose, sneezing, sore throat
• Diarrhoea or stomach ache
• Musculoskeletal pain

Some side effects are uncommon

(may affect up to 1 in 100 people)

• Difficulty and pain when passing urine
• Painful and frequent urination
• Palpitations
• Rash
• Numbness eᵈ
• Cough with sputum s
• Dental caries i r
• Feeling of pressure or pain in the cheeks and forehead
• Nose bleeds
• Pain in arms or legs hᵒ
• Pain in muscles, bones or joints of the chest
• Stomach discomfort after meals ᵗ
• Throat irritation aᵘ
• Tiredness
• Weakness r
• Itching
• Voice alteration (hoarseness) gᵉ
• Nausea
• Vomiting oⁿ

Some elderly patients above 75 years of age experienced headache (frequency common) and urinary l tract infection (frequency common).

Reporting of side effects

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If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report stide effects directly via the national reporting system listed in Appendix V. By reporting side efcfects you can help provide more information on the safety of this medicine.

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5. How to store Enurev Bₜrₕeoezhaler

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Keep this medicine out of the sight and reach of children.

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Do not use this medicinel after expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.

capsulesnᵃ

Do not store above 25°C.

i c Store the in the original blister in order to protect from moisture. Do not remove from the i blister until immediately before use.

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

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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 Enurev Breezhaler contains

• The active substance is glycopyrronium bromide. Each capsule contains 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms glycopyrronium). The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 44 micrograms of glycopyrronium.
• The other ingredients of the inhalation powder are lactose monohydrate and magnesium eᵈ stearate.

s - The ingredients of the capsule shell are hypromellose, water, purified, carrageenan, potassium i chloride, sunset yellow FCF (E110) and printing ink.

• The ingredients of the printing ink are shellac (E904), propylene glycol, ammʳonium hydroxide, potassium hydroxide and iron oxide, black (E172).

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t What Enurev Breezhaler looks like and contents of the pack

Enurev Breeyhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder. They have the product code “GPL50” printed in black above and a company aᵘ

logo ( ) printed in black below a black bar.

Each pack contains a device called an inhaler, together with capsulees iʳn blisters. Each blister strip contains either 6 or 10 hard capsules.

The following pack sizes are available: nᵍ

Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.

o l Multipacks containing 90 (3 packs of 30x1) hard capsules and 3 inhalers.

Multipacks containing 96 (4 packs of 24x1) hard capsules and 4 inhalers.

Multipacks containing 150 (15 packs of 10x1) hard capsules and 15 inhalers.

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Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.

t Not all pack sizes may be available in your country.

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Marketing Authorisation Holder

Novartis Europharm Limited dᵘ

Vista Building

o Elm Park, Merrion Road

r Dublin 4

p Ireland

Caltalanes, 764

Manufacturer

a Novartis Farmacéutica SA

Gran Via de les Conrts

08013 Barcelonai

c Spain

i Pharma GmbH

eᵈ 10

Nuremberg

NS⁹G⁰ooeM⁴prvm⁴ha³iraetni-sGy ermain-Strasse

For any 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 eᵈ
Novartis Bulgaria EOOD	Novartis Pharma N.V. s
Тел.: +359 2 489 98 28	Tél/Tel: +32 2 246 16 11 i r
Česká republika	Magyarország
Novartis s.r.o.	Novartis Hungária Kft. hᵒ
Tel: +420 225 775 111	Tel.: +36 1 457 65 00
Danmark	Malta ᵗ
Novartis Healthcare A/S	Novartis Pharma Seracᵘ Inc.vi es
Tlf: +45 39 16 84 00	Tel: +356 2122 2872 r
Deutschland	Nederland
Novartis Pharma GmbH	Novartis Pharma B.V.
Tel: +49 911 273 0	Tel: +31 8gᵉ 2 1118 04 5 n
Eesti	Norge o
SIA Novartis Baltics Eesti filiaal	Novartis Norge AS l
Tel: +372 66 30 810	Tlf: +47 23 05 20 00
Ελλάδα nᵒ	Österreich
Novartis (Hellas) A.E.B.E.	Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 t	Tel: +43 1 86 6570
c
España	Polska
Ferrer Internacional, S.A.	Novartis Poland Sp. z o.o.
Tel: +34 93 600 37 00 dᵘ	Tel.: +48 22 375 4888
France o	Portugal
Novartis Pharma S.A.S.	Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 pʳ	Tel: +351 21 000 8600
Hrvatska l	România
Novartis Hrvatska d.o.o.	Novartis Pharma Services Romania SRL
Tel. +385 1 6274nᵃ 22⁰ i	Tel: +40 21 31299 01
Ireland c	Slovenija
Ireiand Limitedl	Novartis Pharma Services Inc.
Tel: +353d 260 12 55 1	Tel: +386 1 300 75 50
Novaretis
	Slovenská republika
ÍsMdhf.Vistnrla o	Novartis Slovakia s.r.o.
Sími: +354 535 7000	Tel: +421 2 5542 5439
Italia	Suomi/Finland
Novartis Farma S.p.A.	Novartis Finland Oy
Tel: +39 02 96 54 1	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	eᵈ

s i This leaflet was last revised in r

hᵒ Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu ᵗ aᵘ

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Instructions for use of Enurev Breezhaler inhaler

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

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Insert	Pierce and release	Inhale deeply	capsule is empty
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1	2	3	Check
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Step 1a:	Step 2a:	o tep 3a: S	Check capsule is empty
Pull off cap	Pierce capsule once n Hold the inhaler upright. Pierce capsule by firmly t pressing both side c buttons at the same time.	Breathe out fully Do not blow into the inhaler.	Open the inhaler to see if any powder is left in the capsule.
	You shouldu r a noise hea the capsule is pierced. pierce the capsule ᵃˢⁿce.odᴼn ˡʸo pʳ		If there is powder left in the capsule: • Close the inhaler. • Repeat steps 3a to 3c.
Step 1b:Open inhaler aˡnicid	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

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		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.	d e s
Step 1c:			emity capsulep
Remove capsule			Put the emrty capsule inp
Separate one of the blisters from the blister card.			household waste. ᴿᵉᵐᵒᵛᵉ the inhaler and ʸᵒohᵒe cap.Clᵘse thʳ
Peel open the blister and remove the capsule.			replace ᵗ
Do not push the capsule through the foil.		Step 3c: aᵘ Hold breath
Do not swallow the capsule.		Hold your breath for up r to 5 seconds.
		ᵉ nᵍ o l	Important Information • Enurev Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
Step 1d:			• Do not push the capsule
Insert capsule			through the foil to
Never place a capsule directly into the mouthpiece.	nᵒtuᶜoᵈrp		remove it from the blister. • Do not swallow the capsule. • Do not use the Enurev Breezhaler capsules with any other inhaler. • Do not use the Enurev 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 l nᵃ i c dⁱ Mᵉ

Your Enurev Breezhaler Inhaler pack contains:	Frequently Asked	Cleaning the inhaler
• One Enurev Breezhaler inhaler	Questions	Wipe the mouthpiece
• One or more blister cards, each containing either		inside and outside with a
6 or 10 Enurev Breezhaler capsules to be used in the inhaler	Why didn’t the inhaler make a noise when I	clean, dry, lint-free cloth to remove any powder
Mouthpiece	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 a enough of your medicine. Close the inhaler anrd repeat steps 3a tec.o 3 g I coughed after inhaling does thn matter?is may happen. As long – theopsule is empty ca ᵀˢʰᵘˢlave received enoughᵃᵒⁱ hʸ of your medicine. nᵒ elt small pieces of theI f 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.	residue. Keep the inhaler dry. Never wash your inhaler with water. eᵈ s i oʳ
Capsule chamber Cap Screen Side buttons
Blister Base
Inhaler Inhaler base Blister Card t uᶜ oᵈ
		Dihsing of the inhalerspo atter usef uᴱiᵃᶜʰ sndaler should bedₒskoiehAspₜ of after all capsules have been used. your pharmacist how dispose of medicines and inhalers that are no longer required.

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