44 micrograms inhalation powder, hard capsules
glycopyrronium (as glycopyrronium bromide)
What Seebri Breezhaler is and what it is used for
What Seebri Breezhaler is
This medicine contains the active substance glycopyrronium bromide. It belongs to a group of medicines called bronchodilators.
What Seebri Breezhaler is used for
This medicine is used to facilitate breathing in adult patients who have difficulty breathing due to a disease called chronic obstructive pulmonary disease (COPD).
In COPD, the muscles around the airways contract. This makes it difficult to breathe. This medicine prevents the contraction of the muscles around the airways and it then becomes easier for the air to pass through the lungs.
If you use this medicine once a day, it will help reduce the impact that COPD has on your daily life.
What you need to know before using Seebri Breezhaler
Do not use Seebri Breezhaler
- if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before using Seebri Breezhaler if any of the following apply to you:
- you have kidney problems
- you have an eye disease called narrow-angle glaucoma
- you have difficulty urinating.
During treatment with Seebri Breezhaler, stop taking this medicine and tell your doctor immediately:
- If you experience chest tightness, coughing, wheezing, or shortness of breath shortly after inhaling Seebri 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 have pain or experience discomfort in the eyes, temporary blurred vision, halofenomena (colored rings around lights), or colored vision phenomena in connection with red eyes. This may be a sign of acute narrow-angle glaucoma.
Seebri Breezhaler is used as a maintenance treatment for COPD. Do not use this medicine to treat a sudden attack of shortness of breath or wheezing.
Children and young people
Do not give this medicine to children or adolescents under 18 years of age.
Other medicines and Seebri Breezhaler
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes drugs similar to Seebri Breezhaler that are used to treat lung disease, such as ipratropium, tiotropium, or tiotropium (so-called anticholinergics).
No specific side effects have been reported when Seebri Breezhaler has been used with other medicines used to treat COPD, such as bronchodilators ( eg salbutamol ), methylxanthines (eg theophylline), and/or oral and inhaled steroids. (eg prednisolone ).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, 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 on the use of this medicine in pregnant women and it is not known if the active substance in this medicine passes into breast milk.
Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines.
Seebri 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.
How to use Seebri Breezhaler
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How much Seebri Breezhaler to use
The usual dose is the inhalation of the contents of one capsule a day.
You only need to inhale once a day as the effect of this medicine lasts for 24 hours.
Do not use more than your doctor prescribes.
Older
If you are 75 years of age or older, you can use the same dose of this medicine that is recommended for adults.
When to inhale Seebri Breezhaler
Use this medicine at the same time each day. This will also make it easier to remember to use the medicine.
You can inhale this medicine at any time before or after eating or drinking.
How to inhale Seebri Breezhaler
- This pack contains an inhaler and capsules (in blisters) that contain the medicine in the form of inhalation powder. Use only the capsules with the inhaler provided with the package (Seebri Breezhaler inhaler ). The capsules should remain in the blister until you use them.
- Do not push the capsule through the foil.
- When starting a new pack, use the new Seebri Breezhaler inhaler that comes with the pack.
- The inhaler in each package should be discarded after all the capsules in the package have been used.
- Do not swallow the capsules.
- Read the instructions at the end of this leaflet for more information on using the inhaler.
If you take more Seebri Breezhaler than you should
If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, tell your doctor immediately or go to the nearest emergency department. Show the package to Seebri Breezhaler. Medical care may be needed.
If you forget to use Seebri Breezhaler
If you forget to inhale a dose, take it as soon as possible, but do not take two doses on the same day. Then take the next dose as usual.
How long to continue treatment with Seebri Breezhaler
- Continue to use this medicine for as long as your doctor prescribes it.
- COPD is a chronic disease and you should use this medicine every day, not just when you have breathing problems or other symptoms of COPD.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
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 less common
(may affect up to 1 in 100 people)
- irregular heartbeat
- high blood sugar levels (hyperglycemia: typical symptoms are increased 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 get any of these side effects, talk to your doctor immediately.
Some side effects may be serious but have no known frequency
(frequency can not be calculated from available data)
- difficulty breathing with wheezing or coughing (signs of paradoxical bronchospasm )
Some side effects are common
(may affect up to 1 in 10 users )
- dry mouth
- difficulty sleeping
- runny or stuffy nose, sneezing, sore throat
- diarrhea or abdominal pain.
- muscle pain
Some side effects are less common
(may affect up to 1 in 100 people )
- difficulty and pain when urinating
- painful and frequent urination
- palpitation
- rash
- numbness
- slimy cough
- caries
- pressure or pain under the eyes or on the forehead
- nosebleeds
- pain in arms or legs
- pain in muscles, bones, or joints in the chest
- stomach upset after meals
- throat irritation
- fatigue
- impotence
- itching
- voice changes (hoarseness)
- nausea
- vomiting
Some elderly patients over the age of 75 developed headaches (common) and urinary tract infections (common).
How to store Seebri 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 expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store the capsules in the blister card. Moisture sensitive. May only be removed from the blister card just before use.
The inhaler in each package should be discarded after all the capsules in the package have been used.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is glycopyrronium bromide. Each capsule contains 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms of glycopyrronium). The dose delivered (the dose leaving the mouthpiece of the inhaler) corresponds to 44 micrograms of glycopyrronium.
- The other ingredients in the inhalation powder are lactose monohydrate and magnesium stearate.
What the medicine looks like and the contents of the pack
Seebri Breezhaler 44 micrograms inhalation powder, hard capsules are clear, orange, and contain a white powder. They have “GPL 50” printed in black above, and a company logo ( ) printed in black below, a black line.
Each pack contains an inhaler together with blister capsules. Each blister contains either 6 or 10 hard capsules.
The following pack sizes are provided:
Packs containing 6 x 1, 10 x 1, 12 x 1 or 30 x 1 hard capsules and an inhaler .
Multipack containing 90 (3 packs of 30 x 1) hard capsules and 3 inhalers.
Multi-pack 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 available in your country.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Pharmacéutica SA
Gran Via de Les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 | SwedenNovartis Sverige ABTel: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsTel: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370 |