RELVAR 92 MICROGRAMS/22 MICROGRAMS Inhalation powder

Зміст інструкції

1. Relvar Ellipta 92 micrograms/22 micrograms powder for inhalation, in container
2. Relvar Ellipta 184 micrograms/22 micrograms powder for inhalation, in container
   1. What is Relvar Ellipta and what is it used for
   2. What you need to know before you use Relvar Ellipta
   3. How to use Relvar Ellipta
   4. Possible side effects
   5. How to store Relvar Ellipta
   6. Package contents and other information
   7. Read the following before starting
   8. Prepare a dose
   9. Inhale the medicine
   10. Close the inhaler and rinse your mouth

Relvar Ellipta 92 micrograms/22 micrograms powder for inhalation, in container

single dose

Relvar Ellipta 184 micrograms/22 micrograms powder for inhalation, in container

single dose
fluticasone furoate/vilanterol

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Relvar Ellipta is and what it is used for
• 2. What you need to know before you use Relvar Ellipta
• 3. How to use Relvar Ellipta
• 4. Possible side effects
• 5. How to store Relvar Ellipta
• 6. Contents of the pack and other information Step-by-step instructions for use.

1. What is Relvar Ellipta and what is it used for

Relvar Ellipta contains two active ingredients: fluticasone furoate and vilanterol. Two different dosages of Relvar Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.
The 92/22 microgram dosage is used for the normal treatment of chronic obstructive pulmonary disease (COPD) in adults and of asthmain adults and adolescents aged 12 years and over.
The 184/22 microgram dosage is used to treat asthmain adults and adolescents aged 12 years and over.
The 184/22 microgram dosage is not authorised for the treatment of COPD.

Relvar Ellipta must be used every day and not only when you have breathing problems or other symptoms of COPD and asthma. It should not be used to relieve a sudden attack of shortness of breath or wheezing.If this type of attack occurs, you should use a fast-acting inhaler (such as salbutamol). Contact your doctor if you do not have a fast-acting inhaler.
Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Corticosteroids reduce inflammation. They reduce swelling and irritation in the small airways in the lungs and thus gradually relieve breathing problems. Corticosteroids also help to prevent asthma and COPD exacerbations.
Vilanterol belongs to a group of medicines called long-acting bronchodilators.
It relaxes the muscles of the small airways in the lungs. This helps to open the airways and makes it easier for air to enter and leave the lungs. When taken regularly, it helps the small airways to remain open.
Regular intake of the two active ingredients combined allows for better control of breathing difficulties compared to regular intake of the two active ingredients individually.
Asthmais a serious and persistent respiratory disease, where the muscles surrounding the smallest airways constrict (bronchoconstriction) and become inflamed. Symptoms come and go and include difficulty breathing, wheezing, chest tightness and coughing. Relvar Ellipta has been shown to reduce asthma attacks and symptoms.

Chronic obstructive pulmonary disease (COPD)is a serious and persistent lung disease in which the airways become inflamed and thickened. Symptoms include shortness of breath, cough, chest discomfort and coughing up mucus. Relvar Ellipta has been shown to reduce COPD symptom exacerbations.

2. What you need to know before you use 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 this applies to you, do not use Relvar Elliptabefore consulting your doctor.

Warnings and precautions
Talk to your doctor before using Relvar Ellipta:

• if you have liver disease, as you are more likely to have undesirable effects. If you have moderate or severe liver disease, your doctor will advise the lowest dose of Relvar Ellipta (92/22 micrograms once a day).
• if you have heart problemsor high blood pressure.
• if you have tuberculosis, or any long-standing or untreated infection.
• if you have been told you have diabetes or high blood sugar levels.
• if you have thyroid problems.
• if you have low potassiumin your blood.
• if you have blurred vision or other visual disturbances.

Talk to your doctorbefore using this medicine if you think any of these apply to you.

While you are using Relvar Ellipta
Immediate breathing difficulties
If you experience chest tightness, coughing, wheezing or shortness of breath immediately after using
the Relvar Ellipta inhaler:

stop using this medicine and seek immediate medical attention,as this could
be a sign of a serious condition called paradoxical bronchospasm.

• talk to your doctor if you experience blurred vision or other visual disturbances.
• talk to your doctor if you experience increased thirst, frequent urination or unexplained fatigue (signs of high blood sugar levels).

Lung infection
If you are using this medicine for COPD you may be at increased risk of developing
a lung infection known as pneumonia. See section 4 for information on the symptoms
to watch out for while using this medicine. Tell your doctor as soon as possible if
you experience any of these symptoms.

Children and adolescents
Do not give this medicine to children under 12 years of age for the treatment of asthma, or in
children and adolescents of any age for the treatment of COPD.

Other medicines and Relvar Ellipta
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. If you are unsure about what medicine contains, ask your doctor or
pharmacist.
Some medicines can affect the way this medicine works, or make it more
likely that you have undesirable effects.
These include:

• medicines called beta-blockers, such as metoprolol, used to treat high blood pressureor heart problems.
• ketoconazole, for the treatment of fungal infections.
• ritonavir or cobicistat, for the treatment of HIV infections.
• Long-acting beta-agonists, such as salmeterol.

Tell your doctor or pharmacistif you are taking any of these medicines. Your doctor may decide
to check you more carefully if you are taking any of these medicines as they
can increase the undesirable effects of Relvar Ellipta.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before taking this medicine. Do not use this
medicine if you are pregnant unless your doctor tells you it is safe to do so.
It is not known whether the ingredients of this medicine pass into breast milk. If you are
breastfeeding you should consult a doctor before using Relvar Ellipta. Do not use this
medicine if you are breastfeeding unless your doctor tells you it is safe to do so.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machines.

Relvar Ellipta contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

3. How to use Relvar Ellipta

Use this medicine following the doctor's instructions exactly at all times. If you have doubts
consult your doctor or pharmacist.

Asthma
The recommended dosefor the treatment of asthma is one inhalation (92 micrograms of fluticasone
furoate and 22 micrograms of vilanterol) once a day, every day, at the same time.
In case of severe asthma, the doctor may decide to prescribe one inhalation of the higher dosage
(184 micrograms of fluticasone furoate and 22 micrograms of vilanterol). This dose must also
be taken once a day, every day, at the same time.

COPD
The recommended dosefor the treatment of COPD is one inhalation (92 micrograms of
fluticasone furoate and 22 micrograms of vilanterol) once a day, every day, at the same time.
The higher dosage of Relvar Ellipta (184 micrograms of fluticasone furoate and 22 micrograms of
vilanterol) is not suitable for the treatment of COPD.
Relvar Ellipta is for oral inhalation use.

Use Relvar Ellipta at the same time every day as it is effective for 24 hours
It is very important to use this medicine every day, as directed by your doctor. This will
help to avoid symptoms during the day and night.

Relvar Ellipta should not be used to relieve a sudden attack of shortness of breath
or wheezing. If you have this type of attack, you should use a fast-acting inhaler (such as
salbutamol).
If you feel short of breath and wheezing more often than usual, or if you use the fast-acting
inhaler more than usual, consult your doctor.

How to use Relvar Ellipta
detailed information.
Relvar Ellipta is for inhalation use. It is not necessary to prepare Relvar Ellipta in any special way,
not even the first time you use it.

If symptoms do not improve
If symptoms (wheezing, shortness of breath, cough) do not improve or worsen, or if you use the fast-acting
inhaler more often:

contact your doctor as soon as possible.
If you use more Relvar Ellipta than you should
If you accidentally use more Relvar Ellipta than your doctor has prescribed, contact your doctor or
pharmacist. If possible, show them the inhaler, the packaging or this leaflet. You may notice that your
heart beats faster than usual, feeling unsteady or having a headache.

If you have used more and for a long period of time than instructed, it is particularly
important that you contact your doctor or pharmacist. This is because high doses ofRelvar Ellipta
can reduce the amount of steroid hormones produced naturally by the body.

If you forget to use Relvar Ellipta
Do not inhale a double dose to make up for a missed dose. It is sufficient to take the
next dose the following day at the usual time.
If you become wheezy or breathless, or if one of the other symptoms of an asthma attack occurs,

use the fast-acting inhaler(such as salbutamol), then consult your doctor.

Do not stop using Relvar Ellipta without advice
Use this medicine for the time recommended by your doctor. It will be effective as long as you
use it. Do not stop unless your doctor advises you to, even if you feel better.
If you have any doubts about the use of this medicine, contact your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions
Allergic reactions are rare (may affect up to 1 in 1,000 people).
If you experience any of the following symptoms after taking Relvar Ellipta, stop taking this
medicine and seek immediate medical attention.

• Skin rash ( hives) or redness
• Swelling, sometimes of the face or mouth ( angioedema)
• If you become very breathless, cough or have difficulty breathing
• Sudden feeling of weakness or dizziness (which can lead to collapse or loss of consciousness)

Immediate breathing difficulties
Immediate breathing difficulties after using Relvar Ellipta are rare.
If your breathing or wheezing gets worse immediately after using this medicine, stop using it
and seek immediate medical help.

Pneumonia (lung infection)(common side effect, may affect up to 1 in 10 people)

Tell your doctorif you have any of the following symptoms while using Relvar Ellipta - they may be
symptoms of a lung infection:

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

Other side effects:

Very common side effects
May affect more than 1 in 10 people:

• headache
• common cold

Common side effects
May affect up to 1 in 10 people:

• raised, sore patches in the mouth or throat caused by a fungal infection ( oral thrush). Rinsing your mouth with water immediately after using Relvar Ellipta may help to stop this side effect developing.
• inflammation of the lungs ( bronchitis)
• sinus or throat infection
• flu
• pain and irritation in the back of the mouth and throat
• inflammation of the nasal sinuses
• itchy, runny or blocked nose
• cough
• voice changes
• weakening of bones which may lead to fractures
• stomach pain
• back pain
• fever
• joint pain
• muscle spasms.

Uncommon side effects
May affect up to 1 in 100 people:

• irregular heartbeat
• blurred vision
• increased blood sugar levels ( hyperglycemia).

Rare side effects
May affect up to 1 in 1,000 people:

• fast heartbeat ( tachycardia)
• feeling your heartbeat ( palpitations)
• tremor
• anxiety

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.You can also report side effects directly
through the national reporting system listed in Annex V . By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Relvar 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 pack, tray and inhaler
after “Exp.”. The expiry date refers to the last day of that month.
Keep the inhaler in the sealed tray to protect from moisture and only remove it
immediately before first use.
Once opened, the inhaler can be used for 6 weeks, starting from the date the tray is opened.
Write the date on which the inhalator must be discarded on the label in the designated space.
The date must be written as soon as the inhaler has been removed from the tray.
Do not store at a temperature above 25°C.
If stored in a refrigerator, leave the inhaler at room temperature for at least one hourbefore
use.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Relvar Ellipta contains

• The active ingredients are fluticasone furoate and vilanterol.
• For the 92/22 mcg dose: each single inhalation provides an inhaled dose (dose released from the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as triphenatate).
• For the 184/22 mcg dose: each single inhalation provides an inhaled dose (dose released from the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as triphenatate).
• The other ingredients are lactose monohydrate (See section 2 under “Relvar Ellipta contains lactose”) and magnesium stearate.

Description of the appearance of Relvar Ellipta and package contents
Relvar Ellipta is a powder for inhalation, in a single-dose container.
The Ellipta inhaler consists of a light grey inhaler with a yellow mouthpiece cover and a dose counter. It is packaged in an aluminum laminate tray with a removable lid. The tray contains a desiccant sachet to reduce moisture in the package. Once the tray lid is opened, discard the desiccant - do not eat or inhale it. The inhaler does not need to be stored in the aluminum laminate tray once opened.
Relvar Ellipta is available in packs of 1 inhaler containing 14 or 30 doses (supply of 14 or 30 days) and in multipacks containing 90 (3 inhalers of 30) doses (supply of 90 days).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
D24 YK11

Manufacturer:
Glaxo Wellcome Production
Zone Industrielle No.2
23 Rue Lavoisier
27000 Evreux
France
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0) 10 85 52 00

Lietuva
UAB “BERLIN-CHEMIE MENARINI BALTIC”
Tel: +370 52 691 947
[email protected]

България
“Берлин-Хеми/А. Менарини България” EООД
Teл.: +359 2 454 0950
[email protected]

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111
[email protected]

Magyarország
Berlin-Chemie/A. Menarini Kft.
Tel.: +36 23501301
[email protected]

Danmark
GlaxoSmithKline Pharma A/S
Tlf.: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline Trading Services Limited
Tel: +356 80065004

Deutschland
BERLIN-CHEMIE AG
Tel: +49 (0) 30 67070

Nederland
GlaxoSmithKline BV
Tel: + 31 (0) 33 2081100

Eesti
OÜ Berlin-Chemie Menarini Eesti
Tel: +372 667 5001
[email protected]

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
Menarini Hellas A.E.
Τηλ: +30 210 83161 11-13

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000

France
Laboratoire GlaxoSmithKline
Tél.: + 33 (0)1 39 17 84 44
[email protected]

Portugal
GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]

Hrvatska
Berlin-Chemie Menarini Hrvatska d.o.o.
Tel: +385 1 4821 361
[email protected]

România
GlaxoSmithKline Trading Services Limited
Tel: +40 800672524

Ireland
GlaxoSmithKline Trading Services Limited
Tel: + 353 (0)1 4955000

Slovenija
Berlin-Chemie / A. Menarini Distribution
Ljubljana d.o.o.
Tel: +386 (0)1 300 2160
[email protected]

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
Berlin-Chemie / A. Menarini Distribution
Slovakia s.r.o.
Tel: +421 2 544 30 730
[email protected]

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
GlaxoSmithKline Trading Services Limited
Τηλ: +357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103210
[email protected]

Other sources of information
More detailed information on this medicine 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, and it does not need to be prepared for use in any particular way. Simply follow these step-by-step instructions.

Your pack of Relvar Ellipta contains
The inhaler is packaged in a tray. Do not open the tray until you are ready to inhale the dose of medicine.When you are ready to use the inhaler, open the lid by pulling the tab.
The tray contains a desiccant sachet to reduce moisture. Discard this desiccant sachet, without opening, eating or inhaling it.

Desiccant
When the inhaler is removed from its tray, it will be in the “closed” position. Do not open the inhaler until you are ready to inhale a dose of medicine. After opening the tray, write the “Discard by” date on the inhaler label in the appropriate space. The “Discard by” date is 6 weeks from the date the tray was opened. After this date the inhaler should no longer be used. The tray can be discarded after the first opening.
If stored in the refrigerator, allow the inhaler to return to room temperature for at least one hour before use.
The step-by-step instructions below for the Ellipta inhaler containing 30 doses (supply for 30 days) also apply to the Ellipta inhaler containing 14 doses (supply for 14 days).

1. Read the following before starting

If the inhaler cap is opened and closed without the medicine being inhaled, the dose
will be lost.
The missed dose will be held firmly inside the inhaler, but will no longer be available for inhalation.
It is not possible to accidentally take the medicine or a double dose in a single inhalation.

2. Prepare a dose

Wait to open the cap until you are ready to inhale the dose. Do not shake
the inhaler.

• Slide the cap down until you hear a 'click'.

“Click”
The medicine is now ready to be inhaled.
The dose counter counts down from 1for confirmation.

• If the dose counter does not count down when you hear the 'click', the inhaler will not releasethe medicine. Return it to the pharmacist for advice.

3. Inhale the medicine

• With the inhaler away from your mouth, exhale as much as possible. Donot exhale into the inhaler.
• Place the mouthpiece between your lips and close your lips firmly around it. Donot obstruct the air inlets with your fingers.

• Inhale slowly, steadily, and deeply. Hold this breath for as long as possible (at least 3-4 seconds).
• Remove the inhaler from your mouth.
• Exhale slowly and gently.

You may not taste the medicine or feel its texture, even when using the inhaler correctly.
If you wish to clean the mouthpiece, use a dry cloth, beforeclosing the cover.

4. Close the inhaler and rinse your mouth

• Slide the cover upwards all the way to cover the mouthpiece.

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

This will reduce the likelihood of developing undesirable effects such as pain in the
mouth or throat.