Temybric Ellipta

Patient Information Leaflet: Information for the User

Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, in

single-dose container
fluticasone furoate/umeclidinium/vilanterol
This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine, as it contains important information for you.

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

Contents of this leaflet

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

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

What Temybric Ellipta is
Temybric Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol.
Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply referred to as steroids. Umeclidinium and vilanterol belong to a group of medicines called bronchodilators.
What Temybric Ellipta is used for
Temybric Ellipta is used for the treatment of chronic obstructive pulmonary disease (COPD) in adults.
COPD is a chronic condition characterized by breathing difficulties that tend to worsen over time.
In COPD, the muscles surrounding the airways tighten, making breathing difficult. This medicine relaxes the muscles in the lungs, reducing swelling and irritation in the small air passages, thus making it easier for air to move in and out of the lungs. When used regularly, Temybric Ellipta helps control breathing problems and reduces the impact of COPD on daily life.
Temybric Ellipta must be used every day and not only when you have breathing problems or other COPD symptoms. It must not be used to relieve a sudden attack of breathlessness or wheezing.
If such an attack occurs, you should 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 Temybric Ellipta

Do not use Temybric 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 Temybric Ellipta:

• if you have asthma (Do not use Temybric 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 long-standing or untreated infection
• if you have an eye condition called narrow-angle glaucoma
• if you have an enlarged prostate, difficulty in urination, or urinary blockage
• if you suffer from epilepsy
• if you have thyroid problems
• if you have low levels of potassium in your blood
• if you have a history of diabetes
• if you have experienced blurred vision or other visual disturbances

Talk to your doctor if you think any of these situations apply to you.
Immediate breathing difficulties
If immediately after using your Temybric Ellipta inhaler you experience chest tightness, coughing, wheezing, or shortness of breath:
Stop using this medicine and seek immediate medical help, as you may have a serious condition called paradoxical bronchospasm.
Eye problems during treatment with Temybric Ellipta
If during treatment with Temybric Ellipta you experience eye pain or discomfort, temporary blurred vision, halos around lights, or colored images, associated with eye redness:
Stop using this medicine and seek immediate medical help, as these may be symptoms of an acute attack of narrow-angle glaucoma.
Lung infection
Since you are using this medicine for COPD, you may be at increased risk of developing a lung infection known as pneumonia. See section 4 “Possible side effects” for information about symptoms to watch for while using this medicine.
Inform your doctor as soon as possible if you experience any of these symptoms.
Children and adolescents
This medicine must not be given to children or adolescents under 18 years of age.
Other medicines and Temybric Ellipta
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If you are unsure what your medicine contains, speak with your doctor or pharmacist.
Some medicines may affect the action of this medicine or make it more likely that you will experience side effects.
These include:

• medicines called beta-blockers (such as propranolol), used to treat high blood pressure or other heart problems
• ketoconazole or itraconazole, used to treat fungal infections
• clarithromycin or telithromycin, used to treat bacterial infections
• ritonavir or cobicistat, used to treat HIV infection
• medicines that lower potassium levels in the blood, such as certain diuretics (water tablets) or certain medicines used to treat COPD and asthma (such as methylxanthines or steroids)
• other long-acting medicines similar to this one, used to treat breathing problems, e.g. tiotropium, indacaterol. Do not use Temybric Ellipta if you are already using these medicines. Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may decide to monitor you more closely if you are taking any of these medicines, as they may increase the side effects of Temybric Ellipta.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you might be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine. Do not use this medicine if you are pregnant unless your doctor tells you that you may do so.
It is not known whether the components of this medicine pass into breast milk. If you are breastfeeding, consult your doctor before using Temybric Ellipta. Do not use this medicine if you are breastfeeding unless your doctor tells you that you may do so.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machinery.
Temybric Ellipta contains lactose
If you have been diagnosed with an intolerance to certain sugars, talk to your doctor before using this medicine.

3. How to use Temybric Ellipta

Use this medicine exactly as your doctor has told you. If you are not sure, consult your
doctor or pharmacist.
The recommended dose is one inhalation once daily, at the same time each day. You must inhale
this medicine only once a day, as its effect lasts for 24 hours.
Do not use more than your doctor has prescribed.
Use Temybric Ellipta regularly
It is very important that you use Temybric Ellipta every day as prescribed by your doctor. This
will help keep your symptoms under control throughout the day and night.
Temybric Ellipta must not be used to relieve symptoms of a sudden attack of breathlessness or wheezing.
If such an attack occurs, you must use a fast-acting inhaler (such as salbutamol).
How to use the inhaler
See the “Step-by-step instructions” in this leaflet for detailed information.

Temybric Ellipta is for inhalation use only.

Once the tray is opened, Temybric Ellipta is ready to use.
If symptoms do not improve
If your COPD symptoms (shortness of breath, wheezing, coughing) do not improve or worsen, or if you are using your
reliever inhaler more often,
contact your doctor as soon as possible.
If you use more Temybric Ellipta than you should
If you take more medicine than your doctor has prescribed, contact your doctor or pharmacist
immediately for advice, as you may need medical monitoring. If possible, show them
the inhaler, the packaging, or this leaflet. You may notice that your heart beats faster than
usual, feel shaky, experience visual disturbances, dry mouth, or headache.
If you forget to use Temybric Ellipta
Do not take a double dose to make up for a forgotten dose. Simply take the next dose at your usual time the following day. If you become breathless or wheezy, use your reliever inhaler (such as salbutamol), then consult your doctor.
If you stop using Temybric Ellipta
Use this medicine for the length of time recommended by your doctor. Do not stop unless advised by your doctor, even if you feel better; your symptoms may worsen.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Allergic reactions
Allergic reactions to Temybric Ellipta are rare (may affect up to 1 in 1,000 people).
If, after taking Temybric Ellipta, you experience any of the following symptoms, stop using it and inform your doctor immediately:

• Skin rash or redness, hives
• swelling, sometimes of the face or mouth ( angioedema )
• sneezing, coughing, or breathing difficulties
• sudden feeling of weakness or dizziness (may lead to collapse or loss of consciousness)

Immediate breathing difficulties
If breathing becomes more difficult or wheezing worsens immediately after using this medicine, stop using it and seek immediate medical help.
Pneumonia (lung infection) in patients with COPD (common side effect)
Inform your doctor if you experience any of the following symptoms while using Temybric Ellipta – they could be signs of a lung infection:

• fever or chills
• increased mucus production, changes in mucus colour
• increased coughing or worsening of breathing difficulties

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

• sore, raised patches in the mouth or throat caused by a fungal infection ( candidiasis ). Rinsing the mouth with water immediately after using Temybric Ellipta may help prevent this side effect
• infection of the nose, sinuses, or throat
• upper respiratory tract infection
• itching, runny or blocked nose
• pain at the back of the mouth and throat
• sinus inflammation
• lung inflammation ( bronchitis )
• influenza
• common cold
• headache
• cough
• painful or frequent urination (may be signs of a urinary tract infection)
• joint pain
• back pain
• constipation

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

• irregular heartbeat
• increased heart rate
• hoarseness
• weakening of the bones, which may lead to fractures
• dry mouth
• altered taste
• blurred vision
• increased eye pressure
• eye pain

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

• allergic reactions (see above in Section 4)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 Temybric Ellipta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack, tray, and inhaler after “EXP.”. The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the inhaler within the sealed tray to protect it from moisture, and remove it only immediately before first use. Once the tray has been opened, the inhaler may be used for 6 weeks from the date the tray was opened. Write the date on which the inhaler should be discarded on the label in the designated space. This date should be added as soon as the inhaler is removed from the tray.
If stored in a refrigerator, allow the inhaler to reach room temperature for at least one hour before use.
Do not dispose of medicines via household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Temybric Ellipta contains
The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Each single inhalation delivers a dose (released from 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 trifenilate).
The other components are lactose monohydrate (see section 2 under the heading ‘Temybric Ellipta
contains lactose’) and magnesium stearate.

Description of the appearance of Temybric Ellipta and contents of the pack
Temybric Ellipta is a pre-dispensed powder for inhalation.
The Ellipta inhaler consists of a light grey plastic body, a beige-coloured mouthpiece cover, and a dose counter. It is packaged in a laminated aluminium tray with a removable lid. The tray contains a desiccant sachet to reduce moisture in the package.
The active substances are present as white powder in separate blister strips inside the inhaler. Each inhaler contains 14 or 30 doses (14- or 30-day supply). Multiple packs containing 90 doses (3 inhalers of 30 doses each, 90-day supply) are also available. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
Currabinny
Co. Cork
Ireland

Manufacturer
Glaxo Wellcome Production
Zone Industrielle No.2,
23 Rue Lavoisier,
27000 Evreux,
France

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. UAB “BERLIN-CHEMIE MENARINI BALTIC”
Tél/Tel: + 32 (0) 10 85 52 00 Tel: + 370 52 691 947
[email protected]

България Luxembourg/Luxemburg
“Берлин-Хеми/А. Менарини България” EООД GlaxoSmithKline Pharmaceuticals s.a./n.v.
Teл.: + 359 2 454 0950 Belgique/Belgien
[email protected] Tél/Tel: + 32 (0) 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline, s.r.o. Berlin-Chemie/A. Menarini Kft.
Tel: + 420 222 001 111 Tel.: + 36 23501301
[email protected] [email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Limited
Tlf: + 45 36 35 91 00 Tel: + 356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
OÜ Berlin-Chemie Menarini Eesti GlaxoSmithKline AS
Tel: + 372 667 5001 Tlf: + 47 22 70 20 00
[email protected]

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
Laboratorios Menarini, S.A. GSK Services Sp. z o.o.
Tel: + 34 934 628 800 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
Berlin-Chemie Menarini Hrvatska d.o.o. GlaxoSmithKline Trading Services Limited
Tel: + 385 1 4821 361 Tel: + 40 800672524
[email protected]

Ireland Slovenija
GlaxoSmithKline (Ireland) Limited Berlin-Chemie / A. Menarini Distribution
Tel: + 353 (0)1 4955000 Ljubljana d.o.o.
Tel: + 386 (0)1 300 2160
[email protected]

Ísland Slovenská republika
Vistor hf. Berlin-Chemie / A. Menarini Distribution
Sími: +354 535 7000 Slovakia s.r.o.
Tel: + 421 2 544 30 730
[email protected]

Italia Suomi/Finland
Laboratori Guidotti S.p.A. GlaxoSmithKline Oy
Tel: + 39 050 971011 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AB
Τηλ: + 357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
SIA Berlin-Chemie/Menarini Baltic GlaxoSmithKline Trading Service Limited
Tel: + 371 67103210 Tel: + 44 (0)800 221441
[email protected] [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

What is the inhaler?
When you first use Temybric Ellipta, there is no need to check that the inhaler is working correctly; the inhaler contains pre-dispensed doses and is ready for immediate use.

Your pack of Temybric Ellipta contains

The inhaler is packaged in a tray. Do not open the tray until you are ready to inhale
your dose of medicine. When you are ready to use the inhaler, remove the cover to open the tray. The tray contains a desiccant sachet to reduce moisture. Discard this desiccant sachet without opening, swallowing or inhaling it.

Desiccant
When the inhaler is removed from its sealed tray, it will be in the “closed” position. Do not open
the inhaler until you are ready to inhale a dose of medicine. Write the “Discard after” date on the label and on the inhaler packaging in the designated space. The “Discard after” date is 6 weeks from the date the tray is opened. After this date, the inhaler must not be used. The tray may be discarded after first opening.
The step-by-step instructions below for the Ellipta inhaler apply to both the 30-dose pack (30-day supply) and the 14-dose pack (14-day supply).

1. Read below before starting

If the inhaler cap is opened and closed without inhaling the medicine, the dose will be lost.
The missed dose will remain securely inside the inhaler but will no longer be available for inhalation.
It is not possible to accidentally inhale extra medicine or a double dose in a single inhalation.

For the 14-dose inhaler, the counter will also turn half red when fewer than 10 doses remain and will stay half red, displaying the number 0, after the last dose has been used.
If the cap is opened again, the counter will turn completely red.

2. Preparing a dose

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

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

The medicine is now ready to be inhaled.
The dose counter will decrease the number of doses by 1 unit as confirmation.

• If the dose counter does not decrease the number of doses when you hear the 'click', the inhaler will not release the medicine. Return it to the pharmacist for advice.
• Do not shake the inhaler at any time.

3. Inhaling the medicine

“Click”

• With the inhaler away from your mouth, breathe out fully, as much as possible. Do not breathe out into the inhaler.
• Place the mouthpiece between your lips and close your lips firmly around it. Do not block the air inlets with your fingers.

• Breathe in slowly and deeply through your mouth, steadily and fully. Hold 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 feel or taste the medicine, even when using the inhaler correctly.
If you wish to clean the mouthpiece, use a dry cloth, before closing the cover.

4. Close the inhaler and rinse the mouth

• Slide the cover upwards completely to cover the mouthpiece.

• Rinse the mouth with water after using the inhaler, do not swallow. This reduces the likelihood of developing unwanted effects such as mouth or throat pain.