55 micrograms inhaled powder, divided dose of
umeclidinium (umeclidinium bromide) umeclidinium (umeclidinium bromide)
1. What Incruse Ellipta is and what it is used for
What Incruse Ellipta is
Incruse Ellipta contains the active substance umeclidinium bromide, which belongs to a group of medicines called bronchodilators.
What Incruse Ellipta is used for
This medicine is used to treat chronic obstructive pulmonary disease ( COPD ) in adults. COPD is a chronic (long-term) disease in which the airways and alveoli of the lungs gradually become blocked or damaged. This leads to breathing difficulties that slowly worsen. The breathing difficulties are further aggravated due to the muscles around the airways contract, which makes the airways narrower and thereby impedes airflow.
This medicine prevents these muscles from contracting and makes it easier for air to pass in and out of the lungs. Regular use can help control your breathing problems and reduce the effects of COPD on your daily life.
Incruse Ellipta should not be used to relieve an acute attack of shortness of breath or wheezing.
If you have such a seizure, you must use a fast-acting inhaler (such as salbutamol ). Contact your doctor if you do not have a fast-acting inhaler.
2. What you need to know before using Incruse Ellipta
Do not use Incruse Ellipta:
- if you are allergic to umeclidinium or any of the other ingredients of this medicine ( listed in section 6 ).
If you think this applies to you, do not use this medicine until you have talked to your doctor.
Warnings and cautions
Talk to your doctor before using this medicine:
- if you have asthma (do not use Incruse Ellipta to treat asthma )
- if you have heart problems
- if you have an eye disease called narrow-angle glaucoma
- if you have an enlarged prostate , difficulty urinating or any obstruction in the bladder
- if you have severe liver disease .
Talk to your doctor if you think any of these may apply to you.
Acute breathing difficulties
If you feel tight in the chest, have a cough, wheeze, or become short of breath immediately after using the Incruse Ellipta inhaler:
- Stop using this medicine and seek medical attention immediately. It can be a serious condition called paradoxical bronchospasm .
Eye problems during treatment with Incruse Ellipta
If you experience eye pain or discomfort, temporarily blurred vision, see light rings or colored dots in combination with red eyes during treatment with Incruse Ellipta:
- Stop using this medicine and seek medical attention immediately . This may be a symptom of acute narrow-angle glaucoma .
Children and young people
Do not give this medicine to children and adolescents under 18 years of age.
Other medicines and Incruse Ellipta
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If you are not sure what your medicine contains, talk to your doctor or pharmacist.
It is especially important to talk to your doctor if you are taking other long-acting medicines that are similar to this medicine and are used for breathing problems, e.g. tiotropium. Do not use both Incruse Ellipta and these medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Do not use this medicine during pregnancy unless your doctor advises you to do so.
It is not known whether the ingredients in Incruse Ellipta can pass into breast milk. If you are breastfeeding, you must consult your doctor before using Incruse Ellipta.
Driving and using machines
This medicine is unlikely to have any effect on your ability to drive or use machines.
Incruse Ellipta 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 Incruse Ellipta
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one inhalation at the same time each 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 recommends.
Use Incruse Ellipta regularly
You must use Incruse Ellipta every day according to your doctor’s instructions. It helps you to be asymptomatic throughout the day and night.
Do not use this medicine to relieve an acute attack of shortness of breath or wheezing. If you have such a seizure, you must use a fast-acting inhaler (such as salbutamol ).
How to use the inhaler
For complete information, see ” Step-by-Step Instructions for Use ” in this leaflet.
Incruse Ellipta is for inhalation only. To use Incruse Ellipta, breathe into your lungs through your mouth with the Ellipta inhaler.
If your symptoms do not get better
If your COPD symptoms (shortness of breath, wheezing, coughing) do not improve or get worse, or if you use your fast-acting inhaler more often than before:
Contact your doctor as soon as possible.
If you use more Incruse Ellipta than you should
If you have inadvertently used too much of the medicine, contact your doctor or pharmacist immediately for advice as you may need medical attention. If possible, show the inhaler, the package, or this leaflet. You may notice that your heart beats faster than normal, that you get visual disturbances, or that your mouth becomes dry.
If you forget to use Incruse Ellipta
Do not inhale any extra dose to make up for a forgotten dose. Only inhale the next dose at the usual time.
If you experience wheezing or shortness of breath, use your fast-acting inhaler (eg salbutamol ), then seek medical attention.
If you stop using Incruse Ellipta
Use the medicine for as long as your doctor recommends. It only does well as long as you use it. Do not stop using it unless your doctor tells you to, not even if you feel better, as your symptoms may get worse.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A llergiska reactions
Allergic reactions are less common (may affect up to 1 in 100 people).
If you have any of the following symptoms after taking Incruse Ellipta, stop taking this medicine and seek medical attention immediately :
- itching
- skin rash ( hives ) or redness .
Common side effects are
These can occur in up to 1 in 10 people:
- faster heartbeat
- painful and frequent urination (this may be a sign of urinary tract infection)
- common cold
- infection of the nose and throat
- cough
- feeling of pressure or pain in cheeks or forehead (may be a sign of sinusitis, so-called sinusitis )
- headache
- constipation.
Uncommon side effects are
These can occur in up to 1 in 100 people:
- irregular heartbeats
- sore throat
- dry mouth
- rash
- changed taste experience.
Rare side effects are
These can occur in up to 1 in 1,000 people:
- eye pain.
Other side effects are
Other side effects have occurred in a very small number of people but the exact occurrence is unknown (occurs in an unknown number of users):
- impaired vision or pain in your eyes due to high pressure (possible signs of glaucoma )
- dimsyn
- increase in the measured pressure in the eye
- difficulty and pain when urinating – this may be a sign of bladder obstruction or urinary retention
- dizziness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Incruse Ellipta
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, tray, and inhaler after “EXP”. The expiration date is the last day of the specified month.
Store the inhaler in the sealed trough to protect it from moisture. Do not remove the inhaler before first use. Once the foil package has been opened, the inhaler can be used for up to 6 weeks, starting from the day the foil package has been opened. Write the date on which the inhaler is to be disposed of in the space provided on the label. The date should be written as soon as the inhaler has been removed from the foil package.
Do not store above 30 ° C.
If the inhaler is stored in a refrigerator, allow it to reach room temperature for at least one hour before use.
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.
6. Contents of the packaging and other information
What Incruse Ellipta contains
The active substance is umeclidinium bromide.
Each inhalation provides a dose (the dose leaving the mouthpiece) of 55 micrograms of umeclidinium (equivalent to 65 micrograms of umeclidinium bromide).
The other ingredients are lactose monohydrate (see section 2 under “Incruse Ellipta contains lactose”) and magnesium stearate.
What Incruse Ellipta looks like and what the package contains
Incruse Ellipta is an inhalation powder, divided dose.
The Ellipta inhaler consists of a gray plastic body and a light green protective cap over the mouthpiece and a dose counter. It is packed in a foil-laminated tray with a peel-off foil lid. The tray contains a bag of desiccant to reduce the moisture in the package.
The active substance consists of a white powder in a blister strip inside the inhaler. Each inhaler contains either 7 or 30 doses. Multipacks containing 90 doses (3 packs x 30) are also available. Not all pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer
Glaxo Wellcome Production
Industrial Zone No.2,
23 Rue Lavoisier,
27000 Evreux,
France
Contact the representative of the marketing authorization holder to find out more about this medicine:
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