85 micrograms/43 micrograms inhalation powder, hard capsules
indacaterol/glycopyrronium (indacaterol./glycopyrronium.)
What Ultibro Breezhaler is and what it is used for
What Ultibro Breezhaler is
This medicine contains the two active substances indacaterol and glycopyrronium. They belong to a group of medicines called bronchodilators.
What Ultibro Breezhaler is used for
This medicine is used to help to breathe in adult patients who have breathing difficulties 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, making it easier for air to enter and leave 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 you use Ultibro Breezhaler
Do not use Ultibro Breezhaler
- if you are allergic to indacaterol or glycopyrronium or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ultibro Breezhaler if any of the following apply to you:
- you have asthma – this medicine should not be used as a treatment for asthma
- you have heart problems
- you have seizures
- you have thyroid problems ( thyrotoxicosis )
- you have diabetes
- you are using any medicine for your lung disease that contains similar active substances (belong to the same group of medicines) to those in Ultibro Breezhaler (see the section “Other medicines and Ultibro Breezhaler”)
- you have kidney problems
- you have serious liver problems
- you have an eye disease called narrow-angle glaucoma
- you have difficulty urinating.
If any of the above apply to you (or if you are not sure), talk to your doctor, pharmacist or nurse before using this medicine.
During treatment with Ultibro Breezhaler
- Stop using this medicine and seek medical attention immediately if you experience any of the following:
- Pain or discomfort in the eyes, temporary blurred vision, halo phenomena (colored rings around lights), or colored vision phenomena associated with red eyes – can be signs of acute narrow-angle glaucoma.
- Difficulty breathing or swallowing, swelling of the tongue, lips, or face, skin rash, itching, and hives (signs of an allergic reaction ).
- Chest tightness, coughing, wheezing, or shortness of breath soon after inhaling this medicine – may be signs of a condition called paradoxical bronchospasm.
- Tell your doctor immediately if your COPD symptoms, such as shortness of breath, wheezing, or cough, do not improve or worsen.
Ultibro Breezhaler is used as a continuous 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, as it has not been studied in this age group.
Other medicines and Ultibro Breezhaler
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
You must tell your doctor if you are taking:
- any medicine that may be similar to Ultibro Breezhaler (contains similar active substances)
- so-called beta blockers, which can be used against high blood pressure or heart problems (e.g. propranolol) or for the eye disease glaucoma (e.g. timolol )
- medicines that lower the potassium level in the blood – these include:
- steroids (eg prednisolone )
- diuretics (fluid-reducing tablets) used for high blood pressure (eg hydrochlorothiazide )
- medicines for respiratory problems, e.g. theophylline.
Pregnancy and breastfeeding
There are no data on the use of this medicine in pregnant women and it is not known whether the active substances of this medicine pass into breast milk. Indacaterol, one of the active substances in Ultibro Breezhaler, can prevent labor due to its effect on the uterus.
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 using this medicine.
You should not use Ultibro Breezhaler unless your doctor tells you to.
Driving ability and use of machinery
This medicine is unlikely to affect your ability to drive or use machines. However, this medicine may cause dizziness (see section 4). Do not drive or operate machinery if you feel dizzy while taking this medicine.
Ultibro Breezhaler contains lactose
This medicine contains lactose (23.5 mg per capsule). If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Consult a doctor or pharmacist before using any medicine.
How to use Ultibro Breezhaler
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
How much Ultibro 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 because the effect of this medicine lasts for 24 hours. Do not use more than prescribed by the doctor.
Elderly (age 75 and older)
If you are 75 years of age or older, you can use the same dose of this medicine as is recommended for adults.
When to inhale Ultibro Breezhaler
Use this medicine at the same time each day. Then it will also be easier to remember to use the medicine.
You can inhale Ultibro Breezhaler at any time before or after eating or drinking.
How to inhale Ultibro Breezhaler
- Ultibro Breezhaler should be used for inhalation.
- This package contains an inhaler and capsules (in blisters) containing the medicine in the form of inhalation powder. Only use the capsules with the inhaler that comes with the package (Ultibro Breezhaler inhaler ). The capsules should remain in the blister until you need to use them.
- Pull the backing away from the blister to open it – do not push the capsule through the foil.
- When you start a new pack, use the new Ultibro Breezhaler inhaler that comes with the pack.
- The inhaler in each pack should be thrown away after all the capsules in the pack have been used.
- Do not swallow the capsules.
- Read the instructions at the end of this leaflet for more information on how to use the inhaler.
If you have taken too much Ultibro Breezhaler
If you have inhaled too much of this medicine or if someone else uses your capsules by mistake, tell your doctor immediately or go to the nearest emergency department. Show the Ultibro Breezhaler package. Medical attention may be needed. Your heart may beat faster than usual and you may have a headache, feeling sleepy, nauseous, or vomit. Other symptoms may be visual disturbances, constipation or difficulty urinating.
If you forget to use Ultibro Breezhaler
If you forget to inhale a dose at the usual time, inhale one as soon as possible on that day. Then inhale the next dose, as usual, the next day. Do not inhale more than one dose on the same day.
How long to continue treatment with Ultibro Breezhaler
- Continue to use Ultibro Breezhaler as long as your doctor prescribes it.
- COPD is a chronic disease and you should use Ultibro Breezhaler every day, not just when you have breathing problems or other symptoms of COPD.
Consult a doctor or pharmacist if you wonder how long you should continue treatment with this medicine.
If you have any further questions about this medicine, 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 can be serious:
Common (may affect up to 1 in 10 people)
- difficulty breathing or swallowing, swelling of the tongue, lips, or face, hives, skin rash – these may be signs of an allergic reaction
- tiredness or strong thirst, increased appetite without weight gain, and more frequent urination – these may be signs of high blood sugar (hyperglycemia).
Uncommon (may affect up to 1 in 100 people)
- severe chest pain with increased sweating – this may be a serious heart condition (ischemic heart disease)
- swelling mainly of the tongue, lips, face, or throat (possible signs of angioedema )
- difficulty breathing along with wheezing or coughing
- pain or discomfort in the eyes, temporary blurred vision, halo phenomena (colored rings around lights), or colored vision phenomena associated with red eyes – these may be signs of glaucoma
- irregular heartbeat.
If you experience any of these serious side effects, seek medical attention immediately.
Other side effects can be:
Very common (may affect more than 1 in 10 people)
- stuffy nose, sneezing, cough, headache with or without fever – these can be signs of an upper respiratory tract infection.
Usual
- sore throat combined with a runny nose – this may be a sign of nasopharyngitis
- painful and frequent urination – this may be a sign of a urinary tract infection called cystitis
- pressure or pain under the eyes or in the forehead – this may be a sign of sinusitis ( sinusitis )
- runny or stuffy nose
- dizziness
- headache
- cough
- sore throat
- upset stomach, indigestion
- caries
- problems and pain when urinating – this may be a sign of bladder outflow obstruction or urinary retention
- fever
- chest pain.
Less common
- sleep difficulties
- fast heartbeat
- palpitations – signs of abnormal heart rhythm
- voice change (hoarseness)
- nosebleed
- diarrhea or stomach ache
- dry mouth
- itching or rash
- pain in muscles, ligaments, tendons, joints, and bones
- muscle spasm
- muscle pain, aches, or tenderness
- pain in arms or legs
- swollen hands, ankles, and feet
- fatigue.
Rare (may affect up to 1 in 1,000 people)
- tingling or numbness.
How to store Ultibro Breezhaler
Keep this medicine out of sight and reach of children.
Use before the expiry date stated on the carton and blister card after “EXP”. The expiration date is the last day of the specified month.
Store at a maximum of 25 ºC.
Store the capsules in the original packaging (blister). Moisture sensitive. Remove from the blister immediately before use.
The inhaler in each pack should be discarded after all the capsules in the pack have been used.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information. Instructions for use for Ultibro Breezhaler inhaler
Contents declaration
- The active substances are indacaterol (as maleate) and glycopyrronium bromide. Each capsule contains 143 micrograms of indacaterol maleate corresponding to 110 micrograms of indacaterol and 63 micrograms of glycopyrronium bromide corresponding to 50 micrograms of glycopyrronium. Delivered dose one (the dose that leaves the inhaler mouthpiece) corresponds to 85 micrograms of indacaterol (110 micrograms of indacaterol maleate) and 43 micrograms of glycopyrronium (54 micrograms of glycopyrronium bromide).
- Other ingredients in the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Ultibro Breezhaler contains lactose”).
Appearance and package sizes of the medicine
Ultibro Breezhaler 85 micrograms/43 micrograms, inhalation powder, hard capsules are transparent and yellow containing a white to almost white powder. They have the product code “IGP110.50” printed in blue under two blue lines on the lower part and the company logo ( ) printed in black on the upper part.
The package contains an inhaler together with capsules in a blister. Each blister contains either 6 or 10 hard capsules.
The following pack sizes are provided:
Pack containing 6×1, 10×1, 12×1, 30×1 or 90×1 hard capsules and 1 inhaler .
Multipack containing 96 (4 packs of 24×1) hard capsules and 4 inhalers.
Multipack containing 150 (15 packs of 10×1) hard capsules and 15 inhalers.
Multipack 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 Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Novartis Farmacéutica SA
Gran Via de Les Corts Catalanes, 764
08013 Barcelona
Spain
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienNovartis Pharma NVTél/Tel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lietuvos filialasPhone: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODPhone: +359 2 489 98 28 | Luxembourg/LuxembourgNovartis Pharma NVTél/Tel: +32 2 246 16 11 |
| Czech RepublicNovartis s.r.oPhone: +420 225 775 111 | MagyarországNovartis Hungária Kft.Tel.: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A/SPhone: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Phone: +356 2122 2872 |
| DeutschlandNovartis Pharma GmbHPhone: +49 911 273 0 | The NetherlandsNovartis Pharma BVPhone: +31 88 04 52 111 |
| EstoniaSIA Novartis Baltics Eesti branch phone: +372 66 30 810 | NorwayNovartis Norway iPhone: +47 23 05 20 00 |
| GreeceNovartis (Greece) AEBEPhone: +30 210 281 17 12 | AustriaNovartis Pharma GmbHPhone: +43 1 86 6570 |
| SpainNovartis Farmacéutica, SAPhone: +34 93 306 42 00 | PolishNovartis Poland Sp. z o. iPhone: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Produtos Farmacêuticos, SAPhone: +351 21 000 8600 |
| HrvatskaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLPhone: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedPhone: +353 1 260 12 55 | Slovenija Novartis Pharma Services Inc.Phone: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovenian RepublicNovartis Slovakia s.r.oPhone: +421 2 5542 5439 |
| ItalyNovartis Pharma SpAPhone: +39 02 96 54 1 | Finland/FinlandNovartis Finland OyTel: +358 (0)10 6133 200 |
| CyprusNovartis Pharma Services Inc.Phone: +357 22 690 690 | SwedenNovartis Sweden ABPhone: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsPhone: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland LimitedPhone: +44 1276 698370 |