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What Relvar Ellipta is and what it is used for
Relvar Ellipta contains two active substances: fluticasone furoate and vilanterol. Relvar Ellipta is available with a different amount of the active substances: fluticasone furoate 92 micrograms / vilanterol 22 micrograms and fluticasone furoate 184 micrograms / vilanterol 22 micrograms.
Relvar Ellipta 92/22 micrograms is used to treat chronic obstructive pulmonary disease (COPD) in adults and asthma in adults and adolescents over 12 years of age.
Relvar Ellipta 184/22 micrograms is used to treat asthma in adults and adolescents at or above 12 years of age.
Relvar Ellipta should be used every day, not just when you have breathing problems or other symptoms of COPD and asthma. The medicine should not be used to relieve a sudden dyspnoea or wheezing. If you experience an attack, you should use a fast-acting inhaled medicine (such as salbutamol).
Fluticasone furoate belongs to a group of medicines called corticosteroids, often referred to as steroids only. Corticosteroids reduce inflammation. They reduce swelling and irritation in small airways in the lungs and thus gradually relieve breathing problems. Corticosteroids also help prevent asthma attacks and COPD deterioration.
Vilanterol belongs to a group of medicines called long-acting bronchodilators. It relaxes the muscles of the small airways in the lungs. It helps the airways to open and facilitates penetration and exhalation of the air from the lungs. When taken regularly, it helps small airways remain open.
When you regularly take these two active substances together, they will help you better control breathing problems than if you were taking the medicines alone.
Asthma is a serious, prolonged lung disease where muscles in the walls of smaller airways narrow down (bronchoconstriction), swell and irritate (inflammation). Symptoms may appear and disappear and include shortness of breath, wheezing, tightness in the chest and coughing.
Chronic Obstructive Pulmonary Disease (COPD) is a serious, prolonged lung disease where airways become inflamed and thickened. Symptoms include shortness of breath, cough, chest discomfort and mucus sputum. Relvar Ellipta has been shown to reduce the exacerbations of COPD symptoms.
2. What you need to know before using Relvar Ellipta
Do not use Relvar Ellipta:
if you are allergic to fluticasone furoate, vilanterol or any of the other ingredients of this medicine (listed in section 6);
if you think the above applies to you, do not use Relvar Ellipta before discussing it with your doctor.
Take special care with Relvar Ellipta
Before using Relvar Ellipta, your doctor should know:
if you have liver disease because you are more likely to get side effects;
if you have heart problems or high blood pressure;
if you have tuberculosis of the lungs or any long-term or untreated infections;
if you have a history of diabetes.
Check with your doctor before using this medicine if you think any of the above applies to you.
Breathing problems immediately after administration
If breathing or wheezing gets worse, immediately after using Relvar Ellipta, stop using the medicine and seek immediate medical attention.
Infection of the lungs
If you use this medicine to treat COPD, you may be at an increased risk of developing a lung infection called pneumonia. See section 4 "Possible side effects" for information on the symptoms you should be following while using this medicine. Tell your doctor as soon as possible if you develop any of these symptoms.
Children and adolescents
This medicine is not recommended in children under 12 years of age for the treatment of asthma or in children and adolescents at any age for COPD treatment.
Other medicines and Relvar Ellipta
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can affect the way this medicine works or make it likely to develop side effects.
beta-blockers such as metoprolol used to treat high blood pressure or heart disease;
ketoconazole used to treat fungal infections;
ritonavir used to treat HIV infections;
long-acting beta2-adrenergic agonists such as salmeterol.
Tell your doctor or pharmacist if you are taking any of these medicines.
Relvar Ellipta should only be used in pregnant women if the expected benefits outweigh the possible risks.
If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before using
What dose to take
The recommended dose for asthma treatment is one inhalation (92 micrograms fluticasone furoate and 22 micrograms vilanterol) once daily, taken at the same time each day.
If you have severe asthma, your doctor may consider taking one inhalation of the higher concentration (184 micrograms of fluticasone furoate and 22 micrograms of vilanterol). This dose should also be taken once daily, at the same time, every day.
The recommended dose for COPD treatment is one inhalation (92 micrograms fluticasone furoate and 22 micrograms vilanterol) once daily, taken at the same time each day.
The higher concentration of Relvar Ellipta is not suitable for COPD treatment.
Apply Relvar Ellipta at the same time each day as it works for 24 hours.
It is very important to take this medicine every day, just as your doctor told you. This will help you avoid the presence of symptoms during the day and at night.
Relvar Ellipta should not be used to relieve a sudden dyspnea or wheezing. If you experience such an attack, you should use a fast-acting inhaled medicine (such as salbutamol).
Consult your doctor if you have shortness of breath or wheezing more often than normal or if you use a more frequent, fast-acting inhaled medicine.
How to use Relvar Ellipta
Read the "Step by Step Instructions for Use" section after 6 in this leaflet for full details.
You should not prepare Relvar Ellipta in any special way, even when you use it for the first time.
If your symptoms do not improve
If your symptoms (shortness of breath, wheezing, coughing) do not improve or worsen, or if you use a more frequent medication to relieve symptoms quickly, contact your doctor as soon as possible.
If you use more Relvar Ellipta than you should
Contact your doctor or pharmacist if you accidentally take a dose higher than prescribed. You may feel that your heart beats faster than usual, that you are trembling or have a headache.
It is especially important to ask your doctor or pharmacist for advice if you are taking a higher dose than prescribed over a prolonged period of time. This is because the higher doses of Relvar Ellipta can lower levels of steroid hormones normally produced by your body.
If you forget to take Relvar Ellipta
Do not take a double dose to make up for the missed dose. Inhale the next dose when the time is over.
If you get wheezing or shortness of breath or develop other symptoms of asthma, use a fast-acting inhaled medicine (such as salbutamol) and then seek medical attention.
Do not stop taking Relvar Ellipta without a doctor's advice
Take this medicine for as long as your doctor has recommended. It will be effective while you apply it. Do not stop treatment, even if you feel better unless your doctor advises you.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Breathing problems immediately after administration
If your breathing or wheezing gets worse right after using this medicine, stop taking it and seek immediate medical attention.
Infection of the lungs (common side effect)
Tell your doctor if you get any of the following while you are taking Relvar Ellipta - these may be symptoms of a pulmonary infection:
fever or chills;
increased sputum formation or change in sputum color;
increase coughing or increase breathing problems.
Other side effects are:
Very common side effects: These may affect more than 1 in 10 people:
Common side effects: These may affect up to 1 in 10 people:
inflamed, raised areas in the mouth or throat caused by fungal infection (candidiasis). The development of this side effect can be avoided if you rinse your mouth with water right after taking Relvar Ellipta;
inflammation of the lungs (bronchitis);
infection of the nasal sinuses or throat;
pain and irritation in the back of the mouth and throat;
inflammation of the sinuses;
itching in the nose, runny nose or stuffy nose;
change in voice;
thinning of the bones leading to fractures;
Uncommon side effects: These may affect up to 1 in 100 people:
Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.
5. How to store Relvar Ellipta
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Store in the original package in order to protect from moisture and do not open the film before you are ready for inhalation.
If stored in a refrigerator, the inhaler should be left at room temperature for at least one hour before use.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Relvar Ellipta contains
The active substances are: fluticasone furoate and vilanterol. Each inhalation delivers a delivered dose of 92 micrograms or 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (such as trifenate), a delivered dose (the dose delivered by the mouthpiece).
The other ingredients are: lactose monohydrate and magnesium stearate.
What Relvar Ellipta looks like and contents of the pack
Relvar Ellipta is a white powder. The Ellipta device is a light gray inhaler with a pale blue mouthpiece cover and a dose counter. Relvar Ellipta is packaged in a socket of laminated foil with a removable foil coating. The nest contains a sachet to reduce moisture in the package. After removing the cover of the nest, dispose of the desiccant - do not swallow or inhale it. After opening, the device should not be stored in the laminate film slot.
The inhaler contains two aluminum strips coated with laminated foil with 14 or 30 doses.
Group packs contain 3 inhalers containing 30 doses.
Step by step instructions for use
What is Ellipta inhaler?
When using the Ellipta inhaler for the first time, you do not have to check if it is working properly and preparing it for use in some special way. Just follow the step-by-step instructions for use.
The inhaler is packaged in a sachet containing a sachet with a desiccant to reduce moisture. Discard the sachet - do not swallow or inhale it.
When you remove the inhaler from the socket, it will be in the "closed" position. Do not open it until you are ready to inject a dose of the medicine.
1. Read this before you start
If the inhaler lid opens and closes without inhaled drug, the dose will be lost. The lost dose will be retained inside the inhaler but will no longer be inhaled.
It is by accident not possible to take more than the necessary medicine or a double dose with one inhalation.
It shows how many doses of medicine have remained in the inhaler.
Before the inhaler was used, the counter showed exactly 30 doses.
That counts down 1 less every time you open the lid.
When less than 10 doses are left, half of the counter shows red.
After using the last dose, half of the counter shows red and a figure of 0. Your inhaler is now empty.
If you then open the inhaler lid, the dose counter will change from half red to full red.
Each time you open it, you prepare a dose of the medicine.
2. How to prepare a single dose
Open the lid when you are ready to take a dose. Do not shake the inhaler.
Slide the cover down until you hear a click.
Now the drug is ready for inhalation.
For confirmation, the dose counter counts with 1 less.
If the counter does not count, you hear a click, the inhaler will not release a medicine. Take it back to the pharmacist and ask him / her.
3. How to inject the medicine
Keep the inhaler away from your mouth and exhale as much as possible.
Do not breathe into the inhaler.
Put the mouthpiece between your lips and close them tightly around it.
Do not block the air holes with your fingers.
Inhale continuously, evenly and deeply. Hold your breath as long as you can (at least 3-4 seconds).
Remove the inhaler from your mouth.
Exhale slowly and calmly.
It may not be possible to try the taste or feel the medicine even when you use the inhaler properly.
4. Close the inhaler and rinse your mouth
If you want to clean the mouthpiece, use a dry cloth before closing the lid.
Slide the lid up as far as it will to cover the mouthpiece.
Once you have used the inhaler, rinse your mouth with water.
This will reduce the likelihood
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