Relvar ellipta 92 mcg/22 mcg polvo para inhalacion (unidodis)

Package Insert: Information for the Patient

Relvar Ellipta 92 micrograms/22micrograms Powder for Inhalation (Single-Dose)

Relvar Ellipta 184 micrograms/22micrograms Powder for Inhalation (Single-Dose)

furoate of fluticasone/vilanterol

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,even if they are not listed in this package insert. See section 4.

Step-by-Step Instructions for Use

Relvar Ellipta contains two active ingredients: fluticasone furoate and vilanterol. There are two different concentrations of Relvar Ellipta: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.

The 92/22 microgram concentration is used for the regular treatment of chronic obstructive pulmonary disease (COPD) in adults, as well as for the treatment of asthma in adults and adolescents 12 years of age and older.(COPD)in adults, as well as for the treatment of asthma in adults and adolescents 12 years of age and older.

The 184/22 microgram concentration is used for the treatment of asthma in adults and adolescents 12 years of age and older.

The 184/22 microgram concentration is not approved for the treatment of COPD.

Relvar Ellipta should be used every day and not only when you have difficulty breathing or other symptoms of asthma and COPD. It should not be used to relieve a sudden attack of shortness of breath or wheezing.. If you have this type of attack, use a rescue inhaler with quick action (such as salbutamol). Contact your doctor if you do not have a quick-action rescue inhaler.

Fluticasone furoate belongs to a group of medications called corticosteroids, often simply called steroids. Corticosteroids reduce inflammation. They also reduce swelling (inflammation) and irritation of the small airways in the lungs and gradually alleviate respiratory problems. Corticosteroids also help prevent asthma attacks and the worsening of COPD.

Vilanterol belongs to a group of medications called long-acting bronchodilators. It acts by relaxing the muscles of the small airways in the lungs. This helps to open the airways and facilitate the entry and exit of air from the lungs. When used regularly, it helps to keep the small airways of the lungs open.

The regular use of these two active ingredients together will help you control your breathing difficulties, more than either medication alone.

Asthma,is a chronic severe lung disease in which the muscles surrounding the smaller airways constrict (bronchoconstriction) and become swollen and irritated (inflammation). Symptoms come and go and include difficulty breathing, wheezing, chest tightness, and coughing. It has been shown that Relvar Ellipta reduces asthma attacks and symptoms.

Chronic obstructive pulmonary disease (COPD), is a chronic severe lung disease in which the airways become inflamed and thickened. Symptoms include difficulty breathing, coughing, chest discomfort, and coughing with mucus. Relvar Ellipta has demonstrated reducing the exacerbations of symptoms that accompany COPD.

Do not use Relvar Ellipta

• if you areallergicto fluticasone furoate, vilanterol, or any of the other ingredients in this medication (listed in section 6)
• if you think you may beallergic, do not use Relvar Ellipta until you have consulted with your doctor.

Warnings and precautions

Consult your doctor before starting to use Relvar Ellipta:

• if you haveliver problems, as you may be more prone to side effects. If you have moderate to severe liver problems, your doctor will limit your dose to the lowest concentration of Relvar Ellipta (92/22 micrograms once a day)
• if you haveheart problemsorhigh blood pressure
• if you havelung tuberculosis (TB)or any other infection that has not been treated
• if you have ever been told you havediabetesor high blood sugar
• if you haveproblems with your thyroid gland
• if you havelow potassium levels
• if you experienceblurred visionor other visual disturbances.

Consult your doctorbefore using this medication if you think any of the above conditions apply to you.

While using Relvar Ellipta

Immediate breathing difficulties

If you experience chest tightness, cough, wheezing, or difficulty breathing immediately after using your Relvar Ellipta inhaler:

stop using this medicationand seek medical attention immediately, as you may have a serious condition called paradoxical bronchospasm.

• Contact your doctor if you experienceblurred visionor other visual disturbances.
• Contact your doctor if you experience increased thirst, frequent urination, or unexplained fatigue (signs of high blood sugar).

Pulmonary infection

If you are using this medication for COPD, you may be at a higher risk of developing a lung infection called pneumonia.See section 4 for information on symptoms to watch for while using this medication.Consult your doctor as soon as possible if you develop any of these symptoms.

Children and adolescents

Do not administer this medication for asthma treatment in children under 12 years old, or for COPD treatment in children and adolescents of any age.

Other medications and Relvar Ellipta

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication. Consult your doctor or pharmacist if you are unsure what is in your medication.

Some medications may affect the way this medication works, or make it more likely that you will experience side effects. These include:

• medications called beta-blockers, such as metoprolol, used to treathigh blood pressureorheart disease
• ketoconazole, to treatfungal infections
• ritonavir or cobicistat to treatHIV
• long-acting?2-adrenergic agonists, such as salmeterol.

Consult your doctor or pharmacistif you are taking any of these medications.

Some medications may increase the effects of Relvar Ellipta, so your doctor may perform regular checks if you are taking these medications.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. If you are pregnant, do not use this medication unless your doctor tells you to.

The safety of this medication for use during pregnancy has not been established.Consult your doctorbefore using Relvar Ellipta if you are breastfeeding. If you are breastfeeding, do not use this medication unless your doctor tells you to.

Driving and operating machinery

It is unlikely that this medication will affect your ability to drive or operate machinery.

Relvar Ellipta contains lactose

If your doctor has told you that you have a lactose intolerance, consult them before using this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult with your doctor or pharmacist.

Asthma

Recommended dosein the treatment of asthma is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once a day, administered at the same time every day.

If you have severe asthma, your doctor may decide to administer one inhalation of the inhaler containing the highest concentration (184 micrograms of fluticasone furoate and 22 micrograms of vilanterol). This dose is also used once a day, at the same time every day.

Chronic Obstructive Pulmonary Disease (COPD)

Recommended dosein the treatment of COPD is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once a day, administered at the same time every day.

The highest concentration of Relvar Ellipta (184 micrograms of fluticasone furoate and 22 micrograms of vilanterol) is not suitable for the treatment of COPD.

Relvar Ellipta is administered by oral inhalation.

Use Relvar Ellipta at the same time every day, as it is effective for 24 hours

It is very important that you use this medication every day, as recommended by your doctor. This will help you not to have symptoms during the day or at night.

Relvar Ellipta should not be used to relieve a sudden attack of shortness of breath or wheezing. If you have this type of attacks, use a rescue inhaler with quick action (such as salbutamol).

If you feel you are out of breath or have wheezing more frequently than usual, or if you are using your rescue inhaler with quick action more often than usual, see your doctor.

How to use Relvar Ellipta

To get the complete information, read the "Step-by-Step Instructions for Use" included after section 6 of this leaflet.

Relvar Ellipta administration is only by oral inhalation.No special preparation of Relvar Ellipta is required, not even the first time it is going to be used.

If symptoms do not improve

If symptoms (shortness of breath, wheezing, cough) do not improve or worsen, or if you are using your rescue inhaler with quick action more often than usual:contact your doctor as soon as possible.

If you use more Relvar Ellipta than you should

If you accidentally inhale more Relvar Ellipta than recommended by your doctor, consult with your doctor or pharmacist. If possible, show them the inhaler, the package or this leaflet. You may notice that your heart beats faster than usual, feel shaky or have a headache.

If you have used more medication than indicated for a prolonged period, it is especially important that you receive advice from your doctor or pharmacist. This is because higher doses ofRelvar Ellipta may reduce the amount of naturally produced hormones by your body.

If you forgot to use Relvar Ellipta

Do not inhale a double dose to compensate for the missed doses.Take the next dose at your usual time.

If you have wheezing or shortness of breath, or develop any other symptoms of an asthma attack,use your rescue inhaler with quick action(for example salbutamol), and seek medical advice.

Do not stop using Relvar Ellipta without consulting

Use this medication for the time recommended by your doctor. It will only be effective for the time you continue to use it. Do not stop using it until your doctor tells you to, even if you feel better.

If you haveanydoubts about the useof this medication, ask yourdoctor, pharmacist ornurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions

Allergic reactions are rare (they can affect up to 1 in 1,000 people)

If after taking Relvar Ellipta, you experience any of the following symptoms, stop using this medicine and contact your doctor immediately:skin rash(hives)or redness

Immediate respiratory difficulties

Immediate respiratory difficulties after using Relvar Ellipta are rare.

If your breathing or wheezing worsens immediately after using this medicinestop using itandseek medical helpimmediately.

Pneumonia (lung infection)in patients with COPD (a frequent side effect, which can affect up to 1 in 10 people).

If you experience any of the following symptoms while using Relvar Ellipta, consult your doctor.They may be symptoms of a lung infection:

• fever or chills
• increased mucus production, change in mucus color
• increased cough or difficulty breathing.

Other side effects:

Very frequent side effects

Can affect more than 1 in 10 people:

• headache
• common cold.

Frequent side effects

Can affect up to 1 in 10 people:

• mouth ulcers, growths in the mouth or throat caused by a fungal infection (candidiasis). Rinsing your mouth with water immediately after using Relvar Ellipta may help prevent this side effect
• inflammation of the lungs (bronchitis)
• nasal or throat infection
• flu
• pain and irritation in the back of the mouth and throat
• inflammation of the breasts
• itching, runny nose or stuffy nose
• cough
• voice changes
• bone weakening that can cause fractures
• stomach pain
• back pain
• high temperature (fever)
• joint pain
• muscle spasms.

Rare side effects

Can affect up to 1 in 100 people:

• irregular heartbeat
• blurred vision
• high blood sugar (hyperglycemia).

Rare side effects

Can affect up to 1 in 1,000 people

• rapid heartbeat(tachycardia)
• feel the beat of your heart(palpitations)
• shaking
• anxiety.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through thenational reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, tray, and inhaler after CAD. The expiration date is the last day of the month indicated.

Keep the inhaler inside the sealed tray to protect it from moisture and only remove it immediately before the first use. Once the tray is opened, the inhaler can be used for a period of 6 weeks, counting from the date the tray was opened.Write the date when the inhaler should be discardedin the designated space on the label. The date should be noted as soon as the inhaler is removed from the tray.

Do not store at a temperature above 25°C.

If you store it in the refrigerator,let the inhaler return to room temperature for at least one hourbefore using it.

Medications should not be disposed of through the drains or trash.Ask your pharmacist how to dispose ofthe packaging and medications that you no longerneed.This will help protect the environment.

Composition of Relvar Ellipta

• The active ingredients are fluticasone furoate and vilanterol.
• For the 92/22 microgram dose: each inhalation provides a released dose (the dose that comes out of the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
• For the 184/22 microgram dose: each inhalation provides a released dose (the dose that comes out of the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
• The other components are lactose monohydrate (see section 2 “Relvar Ellipta contains lactose”) and magnesium stearate.

Appearance of the product and contents of the pack

Relvar Ellipta is a dry powder inhaler (single-dose).

The Ellipta inhaler is a light grey-coloured inhaler with a yellow-coloured mouthpiece protector and a dose counter. It is packaged in a laminated aluminium blister pack with a foldable aluminium lid. The blister pack contains a desiccant to reduce humidity in the pack. Once the lid of the blister pack is opened, remove the desiccant, do not ingest or inhale it. The inhaler does not need to be stored and the laminated aluminium blister pack once opened.

Relvar Ellipta is available in packs containing 14 or 30 doses (for a treatment of 14 or 30 days) and in clinical packs of 90 doses (3 inhalers of 30 doses, for a treatment of 90 days). Only some pack sizes may be marketed.

Marketing authorisation holder:

GlaxoSmithKline (Ireland) Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Responsible for manufacturing:

Glaxo Wellcome Production

Zone Industrielle No.2

23 Rue Lavoisier

27000 Evreux

France

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

Step-by-step instructions for use

What is the Ellipta inhaler?

The first time you use Relvar Ellipta, you do not need to check that it works correctly, it is already ready to be used. Just follow these step-by-step instructions.

Your Relvar Ellipta inhaler box contains:

The inhaler is packagedin ablister pack.Do not open the blister pack until you are ready to start using your new medicine. When you are ready to use your inhaler, remove the lid to open the blister pack. The blister pack containsa desiccantto reduce humidity.Remove the desiccant, do not open it, ingest it orinhale it.

When you take the inhaler out of the blister pack,it will be in the"closed"position.Do not open the inhaleruntil you are readyto inhale a dose of the medicine.When the blister pack is opened, note the date of “Dispose of” in the space provided on the inhaler label. The date of “Dispose of” is 6 weeks from the date of opening the blister pack. After this date the inhaler should not be used any more. The blister pack can be disposed of after the first opening.

If you store it in the fridge, let the inhaler reach room temperature for at least one hour before use.

The step-by-step instructions for use of the Ellipta inhaler for 30 doses (30 days of treatment) also apply to the Ellipta inhaler for 14 doses (14 days of treatment).

1. Read the following instructions before usingthe inhaler

If you open and close the lid without inhaling the medicine, you will lose the dose.

The lost dose will be retained safely inside the inhaler, but it will not be available to be inhaled.

You cannotaccidentally administeran additional dose or a double dose by asingle inhalation.

1. Prepare a dose

Before opening the lid, wait until you are ready to inhale a dose. Do not shake the inhaler.

• Slide the lid down until you hear a “click”.

The medicine is now ready to be inhaled.

As confirmation, the dose counter decreases by1unit.

• If the dose counter does not decrease when you hear the “click”, the inhaler will not release the medicine.Take it to your pharmacist and ask for help.

1. Inhale the medicine

• Keep the inhaler away from your mouth, breathe out as much as possible. Do notbreathe out into the inhaler.
• Place the mouthpiece between your lips, and close them firmly around the mouthpiece.Do notblock the ventilation slots with your fingers.

• Take a deep, prolonged, and continuous breath. Keep your breath as long as possible (at least 3-4 seconds).
• Remove the inhaler from your mouth.
• Breathe out slowly and gently.

You may not be able to taste or notice the medicine, even when using the inhaler correctly.

If you want to clean the mouthpiece, use adry cloth beforeclosing the lid.

1. Close the inhaler and rinse your mouth

• Slide the lid up to the top to protect the mouthpiece.

• Rinse your mouth with water after using the inhaler, do not swallow.

This will make it less likely to cause side effects such as mouth or throat ulcers.