Tovanor Breezhaler

Package leaflet: Information for the user

Tovanor 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

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

Do not use Tovanor 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 Tovanor Breezhaler if any of the following apply to you:

• you have kidney problems
• you have a condition in the eyes called closed-angle glaucoma
• you have difficulty urinating

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

• if, shortly after using Tovanor 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, together with red eyes. These may be signs of an acute attack of closed-angle glaucoma.

Tovanor Breezhaler is used as maintenance therapy for COPD. Do not use this medicine to treat a sudden attack 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 Tovanor Breezhaler
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines similar to Tovanor Breezhaler used for lung diseases, such as ipratropium, oxitropium or tiotropium (called anticholinergics).
No specific adverse effects have been reported when Tovanor 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 will affect your ability to drive or operate machinery.
Tovanor Breezhaler contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to use Tovanor Breezhaler

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How much Tovanor Breezhaler to use
The usual dose is inhalation of the contents of one capsule daily.
It is sufficient to inhale only once a day, 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 can use this medicine at the same dose as other adults.
When to inhale Tovanor 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 Tovanor Breezhaler

• This pack contains an inhaler and capsules (in blisters) containing the medicine as a powder for inhalation. Use the capsules only with the inhaler provided in this pack (the Tovanor 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 Tovanor Breezhaler inhaler provided in the new pack.
• Dispose of the inhaler from 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 Tovanor 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 department. Show the Tovanor
Breezhaler packaging. Medical treatment may be necessary.
If you forget to use Tovanor 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 Tovanor 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 doubts about how long to continue treatment with this medicine, ask your doctor or pharmacist.

If you have any questions about how to use 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 (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, especially of the tongue, lips, face or throat (possible signs of angioedema)
  If any of these side effects affect you, 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 phlegm
• Dental caries
• Feeling of pressure or pain in the cheeks and forehead
• Nosebleed
• Pain in arms or legs
• Pain in muscles, bones or joints of the chest
• Stomach discomfort after meals
• Sore throat
• Fatigue
• Weakness
• Itching
• Voice changes (hoarseness)
• Nausea
• Vomiting

Some elderly patients aged over 75 years have experienced headache (common frequency) and urinary tract infections (common frequency).
Reporting of side effects
If you get 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 listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Tovanor Breezhaler

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp" or "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 pack to protect them from moisture. Remove the capsules from the blister pack only immediately before use.
The inhaler supplied in each pack must be discarded after using all the capsules from that pack.
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 in use. This will help protect the environment.

6. Package contents and other information

What Tovanor 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 components of the inhalation powder are lactose monohydrate and magnesium stearate.
• The ingredients of the capsule shell 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 Tovanor Breezhaler and contents of the pack
Tovanor Breezhaler 44 microgram inhalation powder hard capsules are transparent and orange, containing 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 pack 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 S.A.
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 medicine, 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 28 11 712 Tel: +43 1 86 6570
or
INNOVIS PHARMA ΑΕΒΕ
Τηλ: +30 210 66 64 805-6

España Polska
Laboratorios Gebro Pharma, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 205 86 86 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Laboratório Medinfar - Produtos Farmacêuticos,
Tél: +33 1 55 47 66 00 S.A.
Tel: +351 21 499 7400

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
Alfasigma S.p.A. Novartis Finland Oy
Tel: +39 06 91 39 4666 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 medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Instructions for use of the Tovanor Breezhaler inhaler

Read the instructions for use completely before using Tovanor Breezhaler.

Insert Pierce and release Inhale Check that the
deeply capsule is empty
Check
1 2 3
ca