ENUREV 44 MCG Inhalation powder, hard capsule

Зміст інструкції

1. Enurev Breezhaler 44 micrograms powder for inhalation, hard capsules
   1. What is Enurev Breezhaler and what is it 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. Content of the pack and other information

Enurev Breezhaler 44 micrograms powder for inhalation, hard capsules

glycopyrronium
(as glycopyrronium bromide)

Read this leaflet carefully before you start to use 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 may 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 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
• 4. Possible side effects
• 5. How to store Enurev Breezhaler
• 6. Contents of the pack and other information

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

What is Enurev Breezhaler
This medicine contains the active ingredient glycopyrronium bromide, which belongs to a group of
medicines called bronchodilators.

What is Enurev Breezhaler used for
This medicine is used to make breathing easier 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 Enurev Breezhaler

Do not use Enurev Breezhaler

• if you are allergic to glycopyrronium bromide or 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 applies to you:

• you have kidney problems
• you have an eye condition called closed-angle glaucoma
• you have difficulty urinating

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

• if shortly after using Enurev Breezhaler you feel tightness in the chest, have coughing, wheezing or shortness of breath (signs of bronchospasm);
• if you feel difficulty breathing and swallowing, swelling of the tongue, lips or face, skin rash, itching and hives (signs of an allergic reaction);
• if you experience eye pain or discomfort, temporary blurred vision, visual halos or coloured images in association with red eyes. These may be signs of an acute attack of closed-angle glaucoma.

Enurev Breezhaler is used as maintenance therapy for 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 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 undesirable effects have been reported when Enurev Breezhaler has been used 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, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
There are no data on the use of this medicine in pregnancy and it is not known whether the active ingredient of this medicine passes into breast milk.

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

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

3. How to use Enurev 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 Enurev Breezhaler to use
The usual dose is to inhale the contents of one capsule each 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
If you are 75 years of age or older, you can use this medicine at the same doses as other adults.

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

How to inhale Enurev Breezhaler

• 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 provided in this package (the Enurev Breezhaler inhaler). The capsules must remain in the blister until you use them.
• Do not push the capsules through the protective foil.
• When you start a new package, use the new Enurev Breezhaler inhaler contained in the new package.
• Dispose of the inhaler contained in each package after using all the capsules in the package.
• Do not swallow the capsules.

to use the inhaler.

If you use more Enurev 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 package of Enurev
Breezhaler. Medical care may be needed.

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 in the
same day. Then take the next dose as usual.

For how long to continue treatment withEnurev Breezhaler

• Continue to use this medicine until your doctor tells you to stop.
• COPD is a long-term illness and you must take this medicine every day and not only when you have difficulty breathing or other COPD symptoms. If you have 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 but are uncommon

(may affect up to 1 in 100 people)

• Irregular heartbeat
• High blood sugar level (hyperglycemia: 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, especially of the tongue, lips, face or throat (possible signs of angioedema) If any of these side effects occur, tell your doctor immediately.

Some side effects can be serious, but their frequency is not known

(frequency cannot be estimated based on available data)

• Difficulty breathing 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 blocked nose, sneezing, sore throat
• Diarrhea 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 expectoration
• Dental caries
• Feeling of pressure or pain in the cheeks and forehead
• Nosebleed
• Pain in the arms or legs
• Pain in the muscles, bones or chest joints
• Stomach discomfort after meals
• Throat irritation
• Fatigue
• Weakness
• Itching
• Voice change (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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system detailed in Annex V. By reporting side effects you can help
to 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 package and on the 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. Remove the capsules from the blister
only immediately before use.
The inhaler contained in each pack must be discarded after using all the capsules
in the pack.
Do not use this medicine if you notice that the package is damaged or shows signs of tampering.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Enurev Breezhaler contains

• The active ingredient 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.

Description of the appearance of Enurev Breezhaler and contents of the pack
The hard capsules of Enurev Breezhaler 44 micrograms powder for inhalation are transparent and
orange and contain a white powder. They have a black band and the product code “GPL50”
printed in black above the band and the company logo ( ) printed in black below the band.
Each pack contains a device called an inhaler and blisters with the capsules. Each
blister strip contains 6 or 10 capsules.
The following packs are available:
Packs containing 6 x 1, 10 x 1, 12 x 1 or 30 x 1 hard capsules and an inhaler.
Multipack containing 90 (3 packs of 30 x 1) hard capsules and 3 inhalers.
Multipack containing 96 (4 packs of 24 x 1) hard capsules and 4 inhalers.
Multipack containing 150 (15 packs of 10 x 1) hard capsules and 15 inhalers.
Multipack 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
Roonstraße 25
D-90429 Nuremberg
Germany
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: +30 210 281 17 12

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
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

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
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

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

Instructions for use of the Enurev Breezhaler inhaler
Read the instructions for usecarefully before using Enurev Breezhaler.

InsertPierce and releaseInhale
deeply
Check that the
capsule is empty
123
Verify

Step 1a:

Remove the cap
Step 2a:

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

Exhale
completely
Do not blow into
the mouthpiece.

Check 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 once
only.
If powder remains in the
capsule:

• close the inhaler;
• repeat steps 3a to 3c.

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.

With powderEmpty
Step 2b:

Release the side
buttons

Inhale as
quickly and
deeply as possible.
During inhalation you
will feel a buzzing.
When inhaling you may
feel the taste of the
medicine.

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
replace the cap.
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 pack 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 Enurev Breezhaler capsules with

any other inhaler.

• Do not use the Enurev Breezhaler inhaler to take capsules of any other medicine.
• Do not put the Step 1e: Close the inhalercapsule in your mouth or into 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.
• Do not wash the inhaler with water.

The Enurev Breezhaler pack contains:

• An Enurev Breezhaler inhaler
• One or more blister packs, each containing 6 or Frequently asked questionsWhy didn’t the inhaler make a
  noise when I inhaled?The capsule may be stuck in the chamber. If this happens, gently move the capsule by tapping the bottom 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. I coughed after inhalation -
  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. Do not wash the inhaler with water 10 Enurev Breezhaler capsules for use 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.