Enurev Breezhaler

Package leaflet: Information for the user

Enurev Breezhaler 44 micrograms inhalation powder, hard capsules

glycopyrronium
(as glycopyrronium bromide)
Please read all of this leaflet carefully before you start using this medicine because 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

What this leaflet contains

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

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

What Enurev Breezhaler is
This medicine contains the active substance glycopyrronium bromide, which belongs to a group of
medicines called bronchodilators.
What Enurev Breezhaler is used for
This medicine is used to help adult patients 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, making breathing difficult. This medicine prevents the tightening of these muscles in the lungs, making it easier for air to move in and out of the lungs.
If you use this medicine once daily, it will help reduce the effects of COPD in your daily activities.

2. What you need to know before using Enurev Breezhaler

Do not use Enurev Breezhaler

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

Warnings and precautions
Talk to your doctor before using Enurev Breezhaler if any of the following apply to you:

• you have kidney problems
• you have a condition affecting your eyes called narrow-angle glaucoma
• you have difficulty urinating

During treatment with Enurev Breezhaler, stop taking the medicine and contact your doctor immediately:

• if, shortly after using Enurev Breezhaler, you experience chest tightness, cough, wheezing or shortness of breath (signs of bronchospasm);
• if you experience difficulty breathing or swallowing, swelling of the tongue, lips or face, rash, itching or hives (signs of an allergic reaction);
• if you develop eye pain or discomfort, temporary blurred vision, visual halos, or colored images, associated with red eyes. These could be signs of an acute attack of narrow-angle glaucoma.

Enurev Breezhaler is used as maintenance therapy for COPD. Do not use this medicine to treat sudden attacks of breathlessness or shortness of breath.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age.
Other medicines and Enurev Breezhaler
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines similar to Enurev Breezhaler used for lung diseases, such as ipratropium, oxitropium or tiotropium (called anticholinergics).
No specific adverse effects have been reported when Enurev Breezhaler has been used together with other medicines used in the treatment of COPD, such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There are no data on the use of this medicine during pregnancy and it is not known whether the active substance of this medicine passes into breast milk.
Driving and using machines
It is unlikely that this medicine affects your ability to drive or operate machinery.
Enurev Breezhaler contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to use Enurev Breezhaler

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Enurev Breezhaler to use
The usual dose is the inhalation of the contents of one capsule daily.
Inhaling once a day is sufficient, as the effect of this medicine lasts for 24 hours.
Do not use more medicine than your doctor has recommended.
Elderly patients
If you are aged 75 years or older, you may use this medicine at the same dosage as other adults.
When to inhale Enurev Breezhaler
Use this medicine every day at the same time. This will help you remember to take it.
You may inhale this medicine at any time before or after eating or drinking.
How to inhale Enurev Breezhaler

• This pack contains an inhaler and capsules (in blisters) containing the medicine as powder for inhalation. Use the capsules only with the inhaler provided in this pack (the Enurev Breezhaler inhaler). The capsules must remain in the blister until you are ready to use them.
• Do not push the capsules through the protective foil.
• When starting a new pack, use the new Enurev Breezhaler inhaler provided in the new pack.
• Dispose of the inhaler supplied in 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 Enurev 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 room. Show the Enurev
Breezhaler packaging. Medical treatment may be necessary.
If you forget to use Enurev Breezhaler
If you forget to inhale a dose, take it as soon as possible. However, do not take two doses on the
same day. Then take the next dose as usual.
How long to continue treatment with Enurev Breezhaler

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

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Some side effects can be serious but are uncommon
(may affect up to 1 in 100 people)

• Irregular heartbeat
• High blood sugar level (hyperglycaemia: typical symptoms include excessive thirst or hunger and frequent need to urinate)
• Skin rash, itching, hives, difficulty breathing or swallowing, dizziness (possible signs of an allergic reaction)
• Swelling, particularly of the tongue, lips, face or throat (possible signs of angioedema)
  If you experience any of these side effects, inform your doctor immediately.

Some side effects can be serious, but their frequency is unknown
(frequency cannot be estimated from the available data)

• Breathing difficulty with wheezing or cough (signs of paradoxical bronchospasm)

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 pain
• Musculoskeletal pain

Some side effects are uncommon
(may affect up to 1 in 100 people)

• Difficulty and pain when urinating
• Painful and frequent urination
• Palpitations
• Skin rash
• Numbness
• Cough with sputum
• Dental caries
• Feeling of pressure or pain in the cheeks and forehead
• Nosebleeds
• Pain in arms or legs
• Pain in muscles, bones or joints of the chest
• Stomach discomfort after meals
• Throat irritation
• Fatigue
• Weakness
• Itching
• Voice changes (hoarseness)
• Nausea
• Vomiting

Some elderly patients over 75 years of age have experienced headache (common frequency) and urinary tract infections (common frequency).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enurev 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
“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. Remove the capsules from the blister
only immediately 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 Enurev Breezhaler contains

• The active substance is glycopyrronium bromide. Each capsule contains 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms of glycopyrronium). The delivered dose (the dose released from the inhaler mouthpiece) is equivalent to 44 micrograms of glycopyrronium.
• The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate.
• The capsule shell ingredients are: hypromellose, carrageenan, potassium chloride, sunset yellow FCF (E110), and printing ink.
  The ingredients of the printing ink are: shellac (E904), propylene glycol, ammonium hydroxide, potassium hydroxide, and black iron oxide (E172).

Description of the appearance of Enurev Breezhaler and package contents
Enurev Breezhaler 44 microgram inhalation powder hard capsules are transparent and orange and contain a white powder. They have a black band with the product code “GPL50”

printed in black above the band and the company logo ( ) printed in black below the band.
Each package contains a device called an inhaler and blisters with capsules. Each blister strip contains 6 or 10 capsules.
The following pack sizes are available:
Packs containing 6 x 1, 10 x 1, 12 x 1 or 30 x 1 hard capsules and one inhaler.
Multiple pack containing 90 (3 packs of 30 x 1) hard capsules and 3 inhalers.
Multiple pack containing 96 (4 packs of 24 x 1) hard capsules and 4 inhalers.
Multiple pack containing 150 (15 packs of 10 x 1) 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 Authorization 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
Roonstraße 25
D-90429 Nuremberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization 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: +30 210 281 17 12 Tel: +43 1 86 6570

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. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

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
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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu

Instructions for the use of Enurev Breezhaler inhaler

Read the instructions for use completely before using Enurev Breezhaler.

Insert Pierce and release Inhale Check that the
deeply capsule is empty
Verif
1 2 3
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 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, a clicking sound capsule:
should be heard. • close the inhaler;
Pierce the capsule only • repeat steps from 3a to
once. 3c.
Step 1b: Step 3b:

Open the inhaler Inhale deeply
With powder Empty
the medicine
Hold the inhaler as
shown in the picture.
Place the mouthpiece in
your mouth and close
Step 2b:
your lips firmly around
Release the side buttons
the mouthpiece.
Do not press the side
buttons.
Breathe in as quickly and

deeply as possible.
You will hear a buzzing
sound during inhalation.
You may taste the
medicinal product while
inhaling.
Step 1c: Remove the empty capsule

Remove the empty 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

• Enurev 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 Enurev Breezhaler capsules with any other inhaler.

• Do not use the Enurev Breezhaler inhaler to take capsules of any other medicinal product.

• 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 Enurev Breezhaler package contains: Frequently asked questions How to clean the inhaler

• One Enurev Breezhaler inhaler
• One or more blisters, each containing 6 or 10 Enurev Breezhaler capsules for use with the inhaler Why didn’t the inhaler make Wipe the outside and
  a sound when I inhaled? inside of the mouthpiece
  The capsule may become lodged with a clean, dry, lint-free
  cloth to remove any

in the compartment. If powder residue remains,
gently shake the capsule. Keep the inhaler dry.
Never wash

this happens,

tapping the base of the inhaler with water
of the inhaler. Inhale
the medicine again
by repeating steps 3a to
3c.
Disposal
What should I do if there of the inhaler after use
is still powder left in the After using all the
capsule? capsules, the inhaler must
You have not taken a be disposed of. Ask your
sufficient dose of medicine. pharmacist how to dispose
Close the inhaler and repeat of medicines and inhalers
steps 3a to 3c. you no longer use.
After inhalation I
coughed – what does this mean?
This may 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 may happen. It is not
harmful. The likelihood of
the capsule breaking into
small pieces increases if
the capsule is pierced more
than once.