Tovanor Breezhaler 44 micrograms powder for inhalation

Introduction

Package Leaflet: Information for the User

Tovanor Breezhaler44microgramsinhalation powder (hard capsule)

glycopyrronium

(as glycopyrronium bromide)

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Tovanor Breezhaler and what is it used for
2. What you need to know before taking Tovanor Breezhaler
3. How to use Tovanor Breezhaler
4. Possible side effects
5. Storage of Tovanor Breezhaler
6. Package contents and additional information

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

What is Tovanor Breezhaler

This medication contains an active ingredient called glycopyrronium bromide, 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, making it easier for air to enter and leave the lungs.

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

2. What you need to know before taking Tovanor Breezhaler

Do not use Tovanor Breezhaler

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

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 taking this medication and inform your doctor immediately:

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

Tovanor Breezhaler is used as a maintenance treatment for your COPD. Do not use this medication to treat a sudden attack of shortness of breath or wheezing.

Children and adolescents

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

Other medications and Tovanor Breezhaler

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

No specific side 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 or inhaled steroids (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.

There are no data 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 using machines

This medication is unlikely to affect your ability to drive or use machines.

Tovanor Breezhaler contains lactose

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

3. How to use Tovanor Breezhaler

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much Tovanor Breezhaler to use

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

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

Do not use more than the dose indicated by your doctor.

Elderly patients

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 each day. This will help you remember to use it.

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

How to inhale Tovanor Breezhaler

• In this package, you will find an inhaler and capsules (in blisters) that contain the medication in powder form for inhalation. Use the capsules only with the inhaler provided in this package (Tovanor Breezhaler inhaler). The capsules should 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.
• Discard 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 package leaflet.

If you use more Tovanor Breezhaler than you should

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

If you forget to use Tovanor Breezhaler

If you forget 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 as long as your doctor indicates.
• COPD is a long-term disease, and you should use this medication every day, not just when you have breathing problems or other symptoms of COPD.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

Some side effects can be serious but are rare

(may affect up to 1 in 100 patients)

• Irregular heartbeat
• High blood sugar levels (hyperglycemia: typical symptoms include excessive thirst or hunger and frequent urination)
• Skin rash, itching, hives, 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 can be serious but the frequency is unknown

(cannot be estimated from the available data)

• Difficulty breathing with wheezing (high-pitched sounds when breathing) or coughing (signs of paradoxical bronchospasm)

Some side effects are common

(may affect up to 1 in 10 patients)

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

Some side effects are uncommon

(may affect up to 1 in 100 patients)

• Difficulty and pain when urinating
• Painful and frequent urination
• Palpitations
• Skin rash
• Numbness
• Coughing with sputum
• Tooth decay
• Pain or pressure in the cheeks and forehead
• Nosebleeds
• Pain in arms or legs
• Pain in the muscles, bones, or joints of the chest
• Stomach upset after meals
• Sore throat
• Fatigue
• Weakness
• Itching
• Voice changes (hoarseness)
• Nausea
• Vomiting

Some patients over 75 years of age experienced headache (frequently) and urinary tract infections (frequently).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tovanor Breezhaler

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

Do not use this medication after the expiration date stated on the carton and blister after "EXP". The expiration date is the last day of the month indicated.

Do not store above 25°C.

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

The inhaler from each package should be discarded once you have used all the capsules.

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

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the package and any unused medication. This will help protect the environment.

6. Contents of the pack and additional information

Composition ofTovanor Breezhaler

• 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 delivered by the inhaler mouthpiece) is equivalent to 44 micrograms of glycopyrronium.
• The other ingredients of the powder for inhalation are lactose monohydrate and magnesium stearate.

Appearance of Tovanor Breezhaler and pack contents

The hard capsules of Tovanor Breezhaler 44 micrograms powder for inhalation are transparent and orange in color 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 pack contains a device known as an inhaler, along with capsules in blisters. Each blister strip contains 6 or 10 hard capsules.

The following pack sizes are available:

Packs containing 6 x 1, 10 x 1, 12 x 1 or 30 x 1 hard capsules, along with 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.

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

You can request more information about this medicinal product from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu

Instructions for use of the Tovanor Breezhaler inhaler