Leaflet: information for the user

Enurev Breezhaler 44 micrograms powder for inhalation (hard capsule)

glicopirronio

(as bromide of glicopirronio)

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

What is Enurev Breezhaler

This medication contains an active ingredient called glycopyrronium bromide, which belongs to a class of medications called bronchodilators.

What is Enurev Breezhaler used for

This medication is used to facilitate breathing in adult patients who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD).

In COPD, the muscles surrounding the airways contract, making breathing difficult. This medication blocks the contraction of these muscles in the lungs, facilitating the entry and exit of air from the lungs.

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

Do not use Enurev Breezhaler

• if you are allergic to glycopirronium bromide or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to use Enurev Breezhaler, if you have any of the following conditions:

• if you have kidney problems.
• if you have a known eye disorder called narrow-angle glaucoma.
• if you have difficulty urinating.

During treatment with Enurev Breezhaler,interrupt the administration of this medication and inform your doctor immediately:

• if you experience chest tightness, cough, wheezing, or immediate difficulty breathing after using Enurev Breezhaler (signs of bronchospasm).
• if you experience difficulty breathing or swallowing, swelling of the tongue, lips, or face, skin rash, itching, and urticaria (signs of allergic reaction).
• if you experience eye pain or discomfort, blurred vision, halos, or colored images in association with eye redness. These may be signs of an acute attack of narrow-angle glaucoma.

Enurev Breezhaler is used as maintenance treatment for COPD. Do not use this medication to treat a sudden attack of dyspnea (difficulty breathing) or wheezing.

Children and adolescents

Do not administer this medication to children or adolescents under 18 years of age.

Other medications and Enurev Breezhaler

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. These include medications similar to Enurev Breezhaler used for your lung disease, such as ipratropium, oxitropium, or tiotropium (also known as anticholinergics).

No specific adverse effects have been reported when Enurev Breezhaler is administered with other medications used to treat COPD, such as rescue inhalers (e.g., salbutamol), methylxanthines (e.g., theophylline), and/or oral and inhaled corticosteroids (e.g., prednisolone).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

No data are available on the use of this medication in pregnant women, and it is unknown whether the active ingredient of this medication passes into breast milk.

Driving and operating machinery

This medication is unlikely to affect your ability to drive and operate machinery.

Enurev Breezhaler contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Amount of Enurev Breezhaler to use

The usual dose is to inhale the contents of one capsule every day.

You only need to inhale the medication once a day since the effect of this medication lasts 24 hours.

Do not use more doses than indicated by your doctor.

Older adults

If you are 75 years or older, you can use this medication at the same dose as other adults.

When to inhale Enurev Breezhaler

Use this medication at the same time every day. This will help you remember to use it.

You can inhale this medication at any time before or after food or drinks.

How to inhale Enurev Breezhaler

• In this package, you will find an inhaler and capsules (in blisters) containing the medication powder for inhalation. Use the capsules only with the inhaler provided in this package (Enurev Breezhaler inhaler). The capsules must be kept in the blister until you need to use them.
• Do not press the capsule through the foil.
• When starting a new package, use the new Enurev Breezhaler inhaler provided in the package.
• Dispose of the inhaler from each package once you have used all the capsules.
• Do not swallow the capsules.
• For more information on how to use the inhaler, please read the instructions at the end of this leaflet.

If you use more Enurev Breezhaler than you should

If you have inhaled too much of this medication or if someone accidentally uses your capsules, inform your doctor immediately or go to the nearest emergency center. Show the Enurev Breezhaler package. Medical attention may be necessary.

If you forgot to use Enurev Breezhaler

If you forgot to inhale a dose, inhale it as soon as possible. However, do not inhale two doses on the same day. Then inhale the next dose at the usual time.

How long to continue treatment with Enurev Breezhaler

• Continue using your treatment with this medication for the time your doctor indicates.
• COPD is a long-term disease, and you must use this medication every day and not just when you have respiratory problems or other COPD symptoms.

Consult your doctor or pharmacist if you have doubts about how long you should continue your treatment with this medication.

If you have any other doubts about using this medication, ask your doctor, pharmacist, or nurse.

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

Some side effects can be serious but are rare

(may affect up to 1 in 100 patients)

• Irregular heartbeat
• High blood sugar (hyperglycemia: typical symptoms include excessive thirst or hunger and frequent urination)
• Skin rash, itching, urticaria, difficulty breathing or swallowing, dizziness (possible signs of allergic reaction)
• Swelling, mainly 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 the frequency is unknown

(the frequency cannot be estimated from the available data)

• Difficulty breathing with wheezing (whistling sounds produced while breathing) or cough (signs of paradoxical bronchospasm)

Some side effects are common

(may affect up to 1 in 10 patients)

• Dry mouth
• Difficulty sleeping
• Runny or congested nose, sneezing, sore throat
• Diarrhea or abdominal pain
• Musculoskeletal pain

Some side effects are rare

(may affect up to 1 in 100 patients)

• Difficulty and pain while urinating
• Painful and frequent urination
• Palpitations
• Skin rash
• Loss of sensation
• Cough with sputum
• Tooth decay
• Sensation of pain or pressure in the cheeks and forehead
• Nasal bleeding
• Pain in arms or legs
• Pain in the muscles, bones, or joints of the chest
• Indigestion after meals
• Irritation of the throat
• Fatigue
• Weakness
• Itching
• Alteration of voice (hoarseness)
• Nausea
• Vomiting

Some patients over 75 years of age experienced frequent headaches and frequent urinary tract infections.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister after «CAD»/«EXP». The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store the capsules in the original blister to protect them from moisture. Remove them from the blister just before use.

The inhaler from each package must be discarded once all the capsules have been used.

Do not use this medication if you observe that the package is damaged or shows signs of deterioration.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packages and medications that you no longer need. In this way, you will help protect the environment.

Composition of Enurev Breezhaler

• The active ingredient is bromide of glycopyrrolate. Each capsule contains 63 micrograms of bromide of glycopyrrolate (equivalent to 50 micrograms of glycopyrrolate). The released dose (the dose released by the inhaler mouthpiece) is equivalent to 44 micrograms of glycopyrrolate.
• The other components of the inhalation powder are lactose monohydrate and magnesium stearate.

Appearance of Enurev Breezhaler and contents of the package

The hard capsules of Enurev Breezhaler 44 micrograms inhalation powder are transparent and orange-colored and contain a white powder. They have the product code "GPL50" printed in black above a black line and the company logo () printed in black below the same.

Each package contains an inhaler device, along with capsules in blisters. Each blister strip contains 6 or 10 hard capsules.

The following package sizes are available:

Package sizes containing 6x1, 10 x 1, 12 x 1 or 30 x 1 hard capsules, along with an inhaler.

Multiple package containing 90 (3 packages of 30 x 1) hard capsules and 3 inhalers.

Multiple package containing 96 (4 packages of 24 x 1) hard capsules and 4 inhalers.

Multiple package containing 150 (15 packages of 10 x 1) hard capsules and 15 inhalers.

Multiple package containing 150 (25 packages of 6 x 1) hard capsules and 25 inhalers.

Only some package sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

The detailed information about 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 theInstructions for Usein full before using Enurev Breezhaler