Ultibro Breezhaler (Indacaterol/Glycopyrronium Bromide)
Ultibro Breezhaler (Indacaterol/Glycopyrronium Bromide) Dosage and Side Effects
ULTIBRO BREEZHALER is used long term once daily to treat breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD).
Warnings and Precautions
Serious Warnings and Precautions
ULTIBRO BREEZHALER should only be used to treat COPD.
ULTIBRO BREEZHALER should not be used to treat asthma.
You are advised that in patients with asthma, long-acting beta2-agonist (LABA) medicines, may increase the chance of death from asthma problems. In a large asthma study, more patients who used another LABA medicine (salmeterol) died from asthma problems compared with patients who did not use that LABA medicine. This finding with salmeterol is considered a class effect of LABA, including indacaterol maleate, one of the active ingredients of ULTIBRO BREEZHALER.
BEFORE you use ULTIBRO BREEZHALER talk to your doctor, nurse or pharmacist if you:
- Are pregnant or planning to become pregnant;
- Are a breast-feeding mother;
- Are an asthmatic (in this case you should not be treated with ULTIBRO BREEZHALER);
- Have heart problems, such as rapid or irregular heart beat or abnormal electrical signal called “prolongation of the QT interval”;
- Have high blood pressure;
- Have seizures;
- Have thyroid gland problems or disease;
- Suffer from diabetes;
- Are taking similar medicines for your lung disease;
- Are taking any medications including eye drops, this includes medications you can buy without prescription;
- Have problems with your kidneys;
- Have severe liver problems;
- Have eye problems, such as glaucoma or eye pain, blurred vision, see halos around lights or coloured images;
- Have an enlarged prostate, problems passing urine, or painful urination;
- Have a severe allergy to milk proteins. Ask your doctor if you are not sure;
- Have had allergies to atropine or related medicines, for example ipratropium or tiotropium;
- Have allergies to food or drugs.
These capsules are intended for inhalation only.
DO NOT SWALLOW.
ULTIBRO BREEZHALER should not be used more frequently than once daily. Do not exceed the prescribed dose.
This medication has been prescribed for you and should not be given to other people.
Avoid getting the drug powder into your eyes. This may result in eye pain and/or discomfort, temporary blurring of vision, and/or coloured images in association with red eyes. These may be signs of acute narrow-angle glaucoma. Should any of these symptoms develop, consult a doctor immediately.
Remember to tell any other doctor, nurse, dentist or pharmacist you consult that you are taking this medication.
Driving and Using Machines:
The occurrence of dizziness or blurred vision may influence the ability to drive and use machinery.
During the treatment with ULTIBRO BREEZHALER, tell your doctor immediately if you experience any of the following symptoms:
- stop taking ULTIBRO BREEZHALER and tell your doctor immediately if you experience a tightness of the chest, coughing, wheezing or breathlessness immediately after inhalation of ULTIBRO BREEZHALER (signs of bronchospasm)
- stop taking ULTIBRO BREEZHALER and tell your doctor immediately if you experience difficulties in breathing or swallowing, swelling of tongue, lips and face, hives or itching, skin rash (signs of hypersensitivity reaction). Do not use ULTIBRO BREEZHALER again before speaking with your doctor.
- if your COPD symptoms (breathlessness, wheezing, cough) do not improve or if they worsen during your treatment.
- stop taking ULTIBRO BREEZHALER and tell your doctor immediately if you experience eye pain or discomfort, temporary blurring of vision, visual halos or colored images in association with red eyes; these may be signs of an acute attack of narrow-angle glaucoma.
ULTIBRO BREEZHALER does not relieve sudden symptoms of COPD. Always have a short-acting bronchodilator medicine with you to treat acute symptoms. If you do not have an inhaled, short-acting bronchodilator, contact your healthcare provider to have one prescribed for you.
Get emergency medical care if:
- breathing problems worsen quickly
- you use your short-acting bronchodilator medicine, but it does not relieve your breathing problems
Ask your doctor, nurse or pharmacist for advice before taking any additional medicine.
As with all medicines, patients using ULTIBRO BREEZHALER may experience side effects, although not everybody gets them.
Side effects may include:
- Feeling of pressure or pain in the cheeks and forehead (possible symptoms of sinusitis)
- Runny or stuffy nose, sneezing
- Sore throat/or mouth
- Upset stomach, indigestion
- Pain in muscles, bones or joints
- Pain in extremities (e.g. arms or legs)
- Chest pain
- Problem falling asleep
- Tingling or numbness
- Nose bleeds
- Dry mouth
- Skin itching/rash
- Muscle spasm
- Shakiness or trembling
- Nausea, vomiting, diarrhea and abdominal pain (possible symptoms of gastroenteritis)
- High blood pressure
If any of these affects you severely, tell your doctor, nurse or pharmacist.
ULTIBRO BREEZHALER can cause abnormal blood test results such as decreased levels of potassium and increased blood sugar. Your doctor will decide when to perform blood tests and will interpret the results.
Interactions with this medication
Tell your doctor, nurse or a pharmacist if you are taking or have recently taken any other medicines, including prescription and non-prescription drugs, eye drops, vitamins, and herbal supplements.
The following may interact with ULTIBRO BREEZHALER:
Medicines used in the treatment of depression or sad mood (e.g. tricyclic antidepressants, monoamine oxidase inhibitors);
Medicines for your lung disease which contain active substances similar (same class) to those in ULTIBRO BREEZHALER (use of these may increase the risk of experiencing possible side effects);
Medicines that decrease the level of potassium in your blood. These include diuretics (also known as “water tablets” and used to treat high blood pressure, e.g. hydrochlorothiazide), other bronchodilators such as methylxanthines used for breathing problems (e.g. theophylline) or steroids (e.g. prednisolone).
Beta-blockers used in the treatment of high blood pressure or other heart problems (e.g. propranolol) or in the treatment of glaucoma (e.g. timolol);
Ketoconazole (used to treat fungal infections);
Ritonavir (Anti-HIV medicine);
Erythromycin (used to treat bacterial infections);
Verapamil (used to treat high blood pressure, severe chest pain, irregular heartbeat).
Proper Use of this medication
Always use this medicine exactly as your doctor, nurse or pharmacist has told you. Check with your doctor, nurse or pharmacist if you are not sure.
You can inhale ULTIBRO BREEZHALER before or after food or drink.
Usual adult dose:
Inhale the contents of one capsule through the mouth each day, every day at the same time. Inhaling ULTIBRO BREEZHALER at the same time each day will help to minimize your symptoms throughout the day and night and will also help you to remember to use it.
You only need to inhale once a day to help you breathe easier because the effects of ULTIBRO BREEZHALER last for 24 hours.
Use ULTIBRO BREEZHALER even when you have no breathing problems or other symptoms of COPD.
How long to continue to take ULTIBRO BREEZHALER:
Keep using ULTIBRO BREEZHALER for as long as your doctor tells you.
COPD is a long-term disease and you should use ULTIBRO BREEZHALER 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 ULTIBRO BREEZHALER, talk to your doctor or your pharmacist.
Each ULTIBRO BREEZHALER pack contains:
- Do not swallow ULTIBRO BREEZHALER capsules.
- Only use the ULTIBRO BREEZHALER inhaler contained in this pack.
- ULTIBRO BREEZHALER capsules must always be stored in the blister, and only removed immediately before use.
- Never place a ULTIBRO BREEZHALER capsule directly into the mouthpiece of the ULTIBRO BREEZHALER inhaler.
- Do not press the piercing buttons more than once.
- Never blow into the mouthpiece of the ULTIBRO BREEZHALER inhaler.
- Always release the push buttons before inhalation.
- Never wash the ULTIBRO BREEZHALER inhaler with water. Keep it dry. See below “How to clean your inhaler:”.
- Never take the ULTIBRO BREEZHALER inhaler apart.
- Always keep the ULTIBRO BREEZHALER inhaler and ULTIBRO BREEZHALER capsules in a dry place.
- Avoid getting the drug powder in your eyes.
How to clean your inhaler:
Never wash your inhaler with water. If you want to clean your inhaler wipe the mouthpiece inside and outside with a clean, dry, lint-free cloth to remove any powder residue. Keep the inhaler dry.
If you think you have inhaled too much ULTIBRO BREEZHALER, contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
If you accidentally take a larger dose of ULTIBRO BREEZHALER you may feel shaky, have a headache, or feel like your heart is beating faster than usual. Talk to your doctor or pharmacist right away if this occurs.
If you forget to inhale a dose, inhale a dose as soon as possible on the same day. However, do not inhale two doses on the same day. Then inhale the next dose as usual.
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The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.