Tovanor Breezhaler - patient leaflet, side effects, dosage

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

What Tovanor Breezhaler is

This medicine contains an active substance called glycopyrronium bromide. This 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 breathing difficulties 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 blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs.

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

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

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

• – you have kidney problems.

• – you have an eye problem called narrow-angle glaucoma.

• – you have difficulty passing urine.

During treatment with Tovanor Breezhaler, stop taking this medicine and tell your doctor immediately:

• – if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after

using Tovanor Breezhaler (signs of bronchospasm).

• – if you experience difficulties in breathing or swallowing, swelling of the tongue, lips or face,

skin rash, itching and hives (signs of allergic reaction).

• – if you experience eye pain or discomfort, temporary blurring of vision, visual halos or coloured

images in association with red eyes. 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 medicine to treat a sudden attack of breathlessness or wheezing.

Children and adolescents

Do not give this medicine to children or adolescents below the age of 18 years.

Other medicines and Tovanor Breezhaler

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines similar to Tovanor Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).

No specific side effects have been reported when Tovanor Breezhaler has been used together with other medicines used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There are no data from the use of this medicine in pregnant women and it is not known whether the active substance of this medicine passes into human milk.

Driving and using machines

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

Tovanor 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 Tovanor Breezhaler

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much Tovanor Breezhaler to use

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

You only need to inhale once a day because the effect of this medicine lasts for 24 hours.

Do not use more than your doctor tells you to use.

Elderly people

You can use this medicine if you are aged 75 years and over at the same dose as for other adults.

When to inhale Tovanor Breezhaler

Use this medicine at the same time each day. This will also help you to remember to use it.

You can inhale this medicine anytime before or after food or drink.

How to inhale Tovanor Breezhaler

• – In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine as

inhalation powder. Only use the capsules with the inhaler provided in this pack (Tovanor Breezhaler inhaler). The capsules should remain in the blister until you need to use them.

• – Do not push the capsule through the foil.

• – When you start a new pack, use the new Tovanor Breezhaler inhaler that is supplied in the pack.

• – Dispose of each inhaler after after all capsules in that pack have been used.

• – Do not swallow the capsules.

• – Please read the instructions at the end of this leaflet for more information on how to use the

inhaler.

If you use more Tovanor Breezhaler than you should

If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit. Show the pack of Tovanor Breezhaler. Medical attention may be needed.

If you forget to use Tovanor Breezhaler

If you forget to inhale a dose, take one 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 your treatment with Tovanor Breezhaler

• – Keep using this medicine for as long as your doctor tells you.

• – COPD is a long-term disease and you should use this medicine every day and not only when

you have breathing problems or other symptoms of COPD.

If you have questions about how long to continue your treatment with this medicine, talk to your doctor or pharmacist.

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 may be serious but are uncommon

(may affect up to 1 in 100 people )

• Irregular heart beat
• High level of blood sugar (hyperglycaemia: typical symptoms include excessive thirst or hunger

and frequent urination)

• Rash, itching, hives, 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 get any of these side effects, tell your doctor immediately.

Some side effects may be serious, but the frequency of these side effects is not known

(frequency cannot be estimated from the available data )

• Difficulty breathing with wheezing or coughing (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 ache
• Musculoskeletal pain

Some side effects are uncommon

(may affect up to 1 in 100 people)

• Difficulty and pain when passing urine
• Painful and frequent urination
• Palpitations
• Rash
• Numbness
• Cough with sputum
• Dental caries
• Feeling of pressure or pain in the cheeks and forehead
• Nose bleeds
• Pain in arms or legs
• Pain in muscles, bones or joints of the chest
• Stomach discomfort after meals
• Throat irritation
• Tiredness
• Weakness
• Itching
• Voice alteration (hoarseness)
• Nausea
• Vomiting

Some elderly patients above 75 years of age experienced headache (frequency common) and urinary tract infection (frequency common).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you 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 which is stated on the carton and blister after “EXP”.

The expiry date refers to the last day of that month.

Do not store above 25°C.

Store the capsules in the original blister in order to protect from moisture. Do not remove from the blister until immediately before use.

The inhaler in each pack should be disposed of after all capsules in that pack have been used.

Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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 glycopyrronium). The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 44 micrograms of glycopyrronium.

• – The other ingredients of the inhalation powder are lactose monohydrate and magnesium

stearate.

What Tovanor Breezhaler looks like and contents of the pack

Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder. They have the product code “GPL50” printed in black above and a company logo (&) printed in black below a black bar.

Each pack contains a device called an inhaler, together with capsules in blisters. Each blister strip contains either 6 or 10 hard capsules.

The following pack sizes are available:

Packs containing 6×1, 10×1, 12×1 or 30×1 hard capsules, together with one inhaler.

Multipacks containing 90 (3 packs of 30×1) hard capsules and 3 inhalers.

Multipacks containing 96 (4 packs of 24×1) hard capsules and 4 inhalers.

Multipacks containing 150 (15 packs of 10×1) hard capsules and 15 inhalers.

Multipacks containing 150 (25 packs of 6×1) hard capsules and 25 inhalers.

Not all pack sizes may be available 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

RoonstraBe 25

D-90429 Nuremberg

Germany

For any information about this medicine, please 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
Efc^rapufl Novartis Bulgaria EOOD Ten.: +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
EXÀàôa Novartis (Hellas) A.E.B.E. Tql: +30 210 28 11 712 n INNOVIS PHARMA AEBE Tql: +30 210 66 64 805–6	Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
España Laboratorios Gebro Pharma, S.A. Tel: +34 93 205 86 86	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 Laboratório Medinfar – Produtos Farmacêuticos, S.A. Tel: +351 21 499 7400
Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	România Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
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

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

United Kingdom (Northern Ireland)

Novartis Ireland Limited

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

Instructions for use of Tovanor Breezhaler inhaler

Instructions for Use

before using the Tovanor Breezhaler.

Important Information

• Tovanor Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
• Do not push the capsule through the foil to remove it from the blister.
• Do not swallow the capsule.
• Do not use the Tovanor Breezhaler capsules with any other inhaler.
• Do not use the Tovanor Breezhaler inhaler to take any other capsule medicine.
• Never place the capsule into your mouth or 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 capsules with wet hands.
• Never wash your inhaler with water.
• One Seebri Breezhaler inhaler
• One or more blister cards, each containing either 6 or 10 Seebri Breezhaler capsules to be used in the inhaler

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