92 micrograms/55 micrograms/22 micrograms inhalation powder, divided dose
fluticasone furoate/umeclidinium/vilanterol
What Trelegy Ellipta is and what it is used for
What Trelegy Ellipta is
Trelegy Ellipta contains three active substances: fluticasone furoate, umeclidinium bromide, and vilanterol. Fluticasone furoate belongs to a group of drugs called corticosteroids, or simply cortisone. Umeclidinium bromide and vilanterol belong to a group of medicines called bronchodilators.
What Trelegy Ellipta is used for
Trelegy Ellipta is used to treat chronic obstructive pulmonary disease ( COPD ) in adults. COPD is a chronic disease characterized by breathing difficulties that slowly worsen.
In COPD, the muscles around the airways contract, making it difficult to breathe. This medicine widens these muscles, reduces swelling and irritation in the small airways, and allows air to pass into and out of the lungs more easily. When used regularly, the medicine can help ease your breathing and reduce the effects of COPD on your daily life.
Trelegy Ellipta should be used every day and not just when you have breathing problems or other symptoms of COPD. It should not be used to relieve an acute attack of shortness of breath or wheezing. If you have such an attack, you must use a fast-acting inhaler (eg salbutamol ). Contact your doctor if you do not have a fast-acting inhaler.
What you need to know before using Trelegy Ellipta
Do not use Trelegy Ellipta
- if you are allergic to fluticasone furoate, umeclidinium, vilanterol, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before using Trelegy Ellipta
- if you have asthma (do not use Trelegy Ellipta to treat asthma )
- if you have heart problems or high blood pressure
- if you have liver problems
- if you have pulmonary tuberculosis (TB) or any other long-term or untreated infection
- if you have an eye disease called narrow-angle glaucoma
- if you have an enlarged prostate, difficulty urinating, or an obstruction in the bladder
- if you have epilepsy
- if you have thyroid problems
- if you have a low level of potassium in your blood
- if you have diabetes
- if you experience blurred vision or other visual disturbances.
Talk to your doctor if you think any of these apply to you.
Acute breathing difficulties
If you experience chest tightness, cough, wheezing, or shortness of breath immediately after using the Trelegy Ellipta inhaler:
- stop using this medicine and seek medical attention immediately. This can be a serious condition called paradoxical bronchospasm.
Eye problems during treatment with Trelegy Ellipta
If you experience eye pain or discomfort, temporary blurred vision, see light rings or colored dots, or red eyes during treatment with Trelegy Ellipta:
- stop using this medicine and seek medical attention immediately. These may be symptoms of acute narrow-angle glaucoma.
Infection in the lungs
Because you are using this medicine for COPD, the risk of getting an infection in the lungs, ie pneumonia, is elevated. See section 4 “Possible side effects” for information on which symptoms to look out for when using this medicine.
- Tell your doctor as soon as possible if you get any of these symptoms.
Children and young people
This medicine should not be given to children and adolescents under 18 years of age.
Other medicines and Trelegy Ellipta
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Talk to your doctor or pharmacist if you do not know what your medicines contain.
Some medicines can affect the function of this medicine or increase the risk of side effects. These medicines are:
- beta-blockers (such as propranolol) to treat high blood pressure and other heart problems
- ketoconazole and itraconazole, to treat fungal infections
- clarithromycin and telithromycin to treat bacterial infections
- ritonavir and cobicistat to treat HIV infection
- medicines that lower the level of potassium in the blood, e.g. certain diuretics (water tablets) or certain medicines used to treat chronic obstructive pulmonary disease and asthma (for example methylxanthine or steroids )
- other long-acting medicines similar to this medicine are used to treat breathing problems, e.g. tiotropium and indacaterol. Do not use Trelegy Ellipta if you are already taking such medicines.
Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may want to monitor you closely if you are taking any of these medicines as they may increase the side effects of Trelegy Ellipta.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. Do not use this medicine if you are pregnant unless your doctor has told you that you can.
It is not known whether the ingredients of this medicine can pass into breast milk. If you are breastfeeding, you must consult your doctor before using Trelegy Ellipta. Do not use this medicine if you are breastfeeding unless your doctor has told you that you can.
Driving ability and use of machinery
This medicine is unlikely to affect your ability to drive or use machines.
Trelegy Ellipta contains lactose
If you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Trelegy Ellipta
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one inhalation once a day at the same time every day. You only need to inhale once a day because the effect of this medicine lasts for 24 hours.
Do not use more medicine than the doctor tells you to use.
Use Trelegy Ellipta regularly
You must use Trelegy Ellipta every day as directed by your doctor. It helps you to be symptom-free throughout the day and night.
Trelegy Ellipta should not be used to relieve an acute attack of breathlessness or wheezing. If you have such an attack, you must use a fast-acting inhaler (eg salbutamol ).
How to use the inhaler
Full details can be found in ‘Step-by-step instructions’ at the end of this leaflet.
Trelegy Ellipta is intended for inhalation.
Once the tray is opened, the Trelegy Ellipta is ready to use.
If your symptoms do not improve
If your COPD symptoms (shortness of breath, wheezing, cough) do not improve or get worse, or if you use your rapid-acting inhaler more often than usual:
- contact a doctor as soon as possible.
If you have used too much Trelegy Ellipta
If you use too much of this medicine, contact your doctor or pharmacist immediately for advice. You may need medical attention. If possible, show the inhaler, the package, or this leaflet. Your heart may beat faster than normal, you may feel shaky, have blurred vision, dry mouth, or have a headache.
If you forget to use Trelegy Ellipta
Do not inhale a double dose to make up for a missed dose. Just inhale the next dose at the usual time. If you experience wheezing or shortness of breath, use your rapid-acting inhaler (eg salbutamol ) and then seek medical attention.
If you stop using Trelegy Ellipta
Use this medicine for as long as your doctor recommends. Do not stop using it unless your doctor tells you to, even if you feel better. Your symptoms may worsen.
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.
Allergic reactions
Allergic reactions to Trelegy Ellipta are rare (may affect up to 1 in 1,000 people).
If you get any of the following symptoms after taking Trelegy Ellipta, stop using it and see a doctor immediately:
- skin rash or redness, hives ( urticaria )
- swelling, sometimes of the face or mouth ( angioedema )
- wheezing, coughing, or difficulty breathing
- a sudden feeling of weakness or dizziness (may lead to collapse or unconsciousness)
Acute breathing difficulties
If your breathing or wheezing worsens immediately after using this medicine, stop using it and seek medical attention immediately.
Pneumonia in COPD patients (common side effect )
Tell your doctor if you get any of the following symptoms while taking Trelegy Ellipta as they may be symptoms of pneumonia:
- fever or chills
- increased mucus production changed the color of the mucus
- increased coughing or increased breathing difficulties.
Other side effects ar
Usual
(may affect up to 1 in 10 people)
- sore raised spots in the mouth or throat caused by a fungal infection (candida infection). By rinsing your mouth with water immediately after taking Trelegy Ellipta, you can prevent this side effect.
- infection in the nose, sinuses, or throat
- upper respiratory tract infection
- itchy, runny, or stuffy nose
- pain further back in the mouth and the throat
- sinusitis
- inflammation of the lungs ( bronchitis )
- influenza
- common cold
- headache
- cough
- painful and frequent urination (may be a sign of a urinary tract infection)
- joint pain
- back pain
- constipation.
Less common
(may affect up to 1 in 100 people)
- irregular heartbeats
- faster heartbeat
- huskiness
- weakened bones, which can lead to fractures
- dry mouth
- taste disturbance
- blurred vision
- increased pressure in the eye
- eye pain.
Rare
(may affect up to 1 in 1,000 people)
- allergic reactions (see section 4 above)
How to store Trelegy Ellipta
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton, tray, and inhaler after “EXP”. The expiration date is the last day of the specified month.
Store at a maximum of 30 °C.
Keep the inhaler in a sealed package to protect it from moisture and do not take it out until just before the first use. Moisture sensitive. Once the foil package has been opened, the inhaler can be used for up to 6 weeks from the day the foil package has been opened. Record the date when the inhaler should be discarded in the designated place on the label. The date must be recorded as soon as the inhaler has been removed from the packaging.
If the medicine is stored in a refrigerator, the inhaler should be allowed to reach room temperature for at least one hour before use.
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
Contents declaration
The active substances are fluticasone furoate, umeclidinium, and vilanterol.
Every single inhalation provides a delivered dose (the dose that leaves the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms of umeclidinium bromide, equivalent to 55 micrograms of umeclidinium, and 22 micrograms of vilanterol (as tridentate).
Other ingredients are lactose monohydrate (see section 2 under “Trelegy Ellipta contains lactose”) and magnesium stearate.
Appearance and package sizes of the medicine
Trelegy Ellipta is an inhalation powder, divided dose.
The Ellipta inhaler is made of light gray plastic and has a beige protective cap over the mouthpiece and a dose counter. It is packaged in a foil tray with a foil lid that can be pulled off. In the package, there is a bag with desiccant to reduce humidity.
The active substances are white powders in separate blister strips inside the inhaler. Trelegy Ellipta is available in packs containing 1 inhaler with either 14 or 30 doses (14 or 30 days’ use) and in multiple packs of 90 doses (3 inhalers with every 30 doses ) (90 days’ use). Not all pack sizes may be marketed.
Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer
Glaxo Wellcome Production
Zone Industrielle No.2
23 Rue Lavoisier
27000 Evreux
France
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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