Prospecto: information for the user

Tovanor Breezhaler44microgramspowder for inhalation (hard capsule)

glicopirronio

(as bromide of glicopirronio)

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

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

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

2.What you need to know before starting to use Tovanor Breezhaler

3.How to use Tovanor Breezhaler

4.Possible adverse effects

5.Storage of Tovanor Breezhaler

6.Contents of the package and additional information

What is Tovanor Breezhaler

This medication contains an active ingredient called bromuro de glicopirronio, which belongs to a class of medications called bronchodilators.

What is Tovanor 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 them.

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

Do not use Tovanor Breezhaler

• if you are allergic to glycopirronium bromide or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor before starting to use Tovanor 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 Tovanor Breezhaler,stop administering this medication and inform your doctor immediately:

• if you experience chest tightness, cough, wheezing, or immediate difficulty breathing after using Tovanor 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 an allergic reaction).
• if you experience eye pain or discomfort, transient blurred vision, halos, or colored images associated with eye redness. These may be signs of an acute attack of narrow-angle glaucoma.

Tovanor 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 18years of age.

Other medications and Tovanor 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 Tovanor Breezhaler used for your lung disease, such as ipratropium, oxitropium, or tiotropium (also known as anticholinergics).

No specific adverse effects have been reported when Tovanor 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 the active ingredient of this medication is unknown to pass into breast milk.

Driving and operating machinery

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

Tovanor Breezhaler contains lactose

This medication contains lactose. If your doctor has indicated 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 Tovanor 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 Tovanor 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 Tovanor 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 (Tovanor 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 Tovanor 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 Tovanor 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 Tovanor Breezhaler package. Medical attention may be necessary.

If you forgot to use Tovanor 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 Tovanor 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 the use of this medication, ask your doctor, pharmacist, or nurse.

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

Some side effects may be serious but are rare

(they may affect up to 1 in 100 patients)

• Irregular heartbeat
• High blood sugar (hypoglycemia: typical symptoms include excessive thirst or hunger and frequent urination)
• Rash, itching, urticaria, difficulty breathing or swallowing, dizziness (possible signs of an 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 may 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 coughing (signs of paradoxical bronchospasm)

Some side effects are common

(they may affect up to 1 in 10 patients)

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

Some side effects are rare

(they may affect up to 1 in 100 patients)

• Difficulty and pain while urinating
• Painful and frequent urination
• Palpitations
• 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 headache (frequently) and urinary tract infections (frequently).

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 prospectus.You can also report them directly throughthe national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about 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 above25°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 disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packages and medications that you no longer need. This will help protect the environment.

Composition ofTovanor Breezhaler

• The active ingredient is bromide ofglicopirronio. Each capsule contains 63micrograms of bromide of glicopirronio (equivalent to 50micrograms of glicopirronio). The released dose (the dose that releases the inhaler mouthpiece) is equivalent to 44micrograms of glicopirronio.
• The other components of the inhalation powder arelactose monohydrate and magnesium stearate.

Appearance of Tovanor Breezhaler and contents of the package

The hard capsules of Tovanor Breezhaler 44 micrograms inhalation powder,are transparent and orange in color and contain a white powder.They have the product code«GPL50»printed inblackabove a black lineand the company logo () printed inblackbelow the same.

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

The following package sizes are available:

Packages containing 6x1,10x1,12x1 or 30x1capsules, along with an inhaler.

Multiple package containing 90(3packages of 30x1)capsules and 3inhalers.

Multiple package containing 96(4packages of 24x1)capsules and 4inhalers.

Multiple package containing 150(15packages of10x1)capsules and15inhalers.

Multiple package containing 150(25packages of 6x1)capsules and 25inhalers.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Irlanda

Responsible for manufacturing

Novartis Farmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

España

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Alemania

For more information about this medicine, please contact 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 Tovanor Breezhaler inhaler