Seebri Breezhaler
glycopyrronium bromide
glycopyrronium
(as glycopyrronium bromide)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What Seebri Breezhaler is and what it is used for
What you need to know before you use Seebri Breezhaler
How to use Seebri Breezhaler
Possible side effects
How to store Seebri Breezhaler
Contents of the pack and other information
This medicine contains an active substance called glycopyrronium bromide. This belongs to a group of
medicines called bronchodilators.
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.
if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine
(listed in section 6).
Talk to your doctor before using Seebri 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.
if you experience tightness of the chest, coughing, wheezing or breathlessness immediately after
using Seebri 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.
Seebri Breezhaler is used as a maintenance treatment for your COPD. Do not use this medicine to treat a sudden attack of breathlessness or wheezing.
Do not give this medicine to children or adolescents below the age of 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines similar to Seebri Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).
No specific side effects have been reported when Seebri 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).
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.
It is unlikely that this medicine will affect your ability to drive and use machines.
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.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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.
You can use this medicine if you are aged 75 years and over at the same dose as for other adults.
Use this medicine at the same time each day. This will also help you to remember to use it.
You can inhale this medicine any time before or after food or drink.
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 (Seebri 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 Seebri 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 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 Seebri
Breezhaler. Medical attention may be needed.
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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
(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.
(frequency cannot be estimated from the available data)
Difficulty breathing with wheezing or coughing (signs of paradoxical bronchospasm)
(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
(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).
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.
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.
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.
Seebri 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 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.
Multipacks containing 90 (3 packs of 30x1) hard capsules and 3 inhalers. Multipacks containing 96 (4 packs of 24x1) hard capsules and 4 inhalers. Multipacks containing 150 (15 packs of 10x1) hard capsules and 15 inhalers. Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.
Not all pack sizes may be available in your country.
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road Dublin 4
Ireland
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764 08013 Barcelona
Spain
Novartis Pharma GmbH Roonstraße 25
D-90429 Nuremberg Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50
Novartis Bulgaria EOOD Тел.: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Healthcare A/S
Tlf: +45 39 16 84 00
Novartis Pharma Services Inc.
Tel: +356 2122 2872
Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Pharma B.V. Tel: +31 88 04 52 111
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810
Novartis Norge AS
Tlf: +47 23 05 20 00
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12
Novartis Pharma GmbH
Tel: +43 1 86 6570
Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00
Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Novartis Ireland Limited
Tel: +353 1 260 12 55
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A.
Tel: +39 02 96 54 1
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Novartis Pharma Services Inc. Τηλ: +357 22 690 690
Novartis Sverige AB Tel: +46 8 732 32 00
SIA Novartis Baltics Tel: +371 67 887 070
Novartis Ireland Limited Tel: +44 1276 698370
Please read the full Instructions for Use before using the Seebri Breezhaler.
Step 1a:
Step 2a:
Pierce capsule once Hold the inhaler upright. Pierce capsule by firmly pressing both side buttons at the same time. You should hear a noise as the capsule is pierced. Only pierce the capsule once.
Step 3a:
Breathe out fully Do not blow into the inhaler.
If there is powder left in the capsule:
Close the inhaler.
Repeat steps 3a to 3c.
Step 1b:
Step 2b:
Step 3b:
Do not press the side buttons.
Breathe in quickly and as deeply as you can. During inhalation you will hear a whirring noise. You may taste the medicine as you inhale. Step 3c: Hold breath Hold your breath for up to 5 seconds. | Remove empty capsule Put the empty capsule in your household waste. Close the inhaler and replace the cap. |
Seebri 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 Seebri Breezhaler capsules with any other inhaler.
Do not use the Seebri 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.
Your Seebri Breezhaler Inhaler pack contains:
Capsule Mouthpiece Cap chamber Screen Side buttons Base Blister Inhaler Inhaler base Blister Card | Frequently Asked Questions Why didn’t the inhaler make a noise when I inhaled? The capsule may be stuck in the capsule chamber. If this happens, carefully loosen the capsule by tapping the base of the inhaler. Inhale the medicine again by repeating steps 3a to 3c. What should I do if there is powder left inside the capsule? You have not received enough of your medicine. Close the inhaler and repeat steps 3a to 3c. I coughed after inhaling – does this matter? This may happen. As long as the capsule is empty you have received enough of your medicine. I felt small pieces of the capsule on my tongue – does this matter? This can happen. It is not harmful. The chances of the capsule breaking into small pieces will be increased if the capsule is pierced more than once. | Cleaning the inhaler Wipe the mouthpiece inside and outside with a clean, dry, lint-free cloth to remove any powder residue. Keep the inhaler dry. Never wash your inhaler with water. |
Disposing of the inhaler after use Each inhaler should be disposed of after all capsules have been used. Ask your pharmacist how to dispose of medicines and inhalers that are no longer required. |