Riltrava Aerosphere

Package leaflet: Information for the patient

Riltrava Aerosphere 5 micrograms/7.2 micrograms/160 micrograms, pressurised suspension for inhalation

formoterol fumarate dihydrate/glycopyrronium/budesonide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful to them.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Riltrava Aerosphere is and what it is used for
2. What you need to know before using Riltrava Aerosphere
3. How to use Riltrava Aerosphere
4. Possible side effects
5. How to store Riltrava Aerosphere
6. Contents of the pack and other information
   Instructions for use

1. What Riltrava Aerosphere is and what it is used for

Riltrava Aerosphere contains three active substances called: formoterol fumarate dihydrate, glycopyrronium, and budesonide.

• Formoterol fumarate dihydrate and glycopyrronium belong to a group of medicines called "bronchodilators". They work in different ways to prevent the contraction of muscles around the airways, making it easier for air to move in and out of the lungs.
• Budesonide belongs to a group of medicines called "corticosteroids". These work by reducing inflammation in the lungs.

Riltrava Aerosphere is an inhaler used in adults with a lung disease called "chronic obstructive pulmonary disease" (or "COPD"), a long-term disease of the airways in the lungs.
Riltrava Aerosphere is used to make breathing easier and to improve COPD symptoms such as shortness of breath, wheezing, and cough. Riltrava Aerosphere may also prevent exacerbations (flare-ups) of COPD.
Riltrava Aerosphere releases the active substances into the lungs during inhalation. Using this medicine regularly twice daily will help reduce the impact of COPD on your daily life.

2. What you need to know before using Riltrava Aerosphere

Do not use Riltrava Aerosphere

• if you are allergic to formoterol fumarate dihydrate, glycopyrronium, budesonide, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Riltrava Aerosphere is used as a long-term maintenance treatment for COPD. Do not use it to treat
an attack of shortness of breath or wheezing.
Sudden breathing difficulties
If you experience chest tightness, cough, shortness of breath, or wheezing immediately after using
Riltrava Aerosphere, stop using it immediately and contact your doctor right away (see "Serious
unwanted effects" at the beginning of section 4 for more information).
If shortness of breath, chest tightness, wheezing, or cough worsens while using Riltrava Aerosphere,
continue using Riltrava Aerosphere but contact your doctor as soon as possible, as additional treatment
may be needed.
Talk to your doctor before using Riltrava Aerosphere if:

• you have heart problems or high blood pressure
• you have diabetes
• you have a lung infection
• you have thyroid problems
• you have low levels of potassium in your blood
• you have prostate problems or any difficulty urinating
• you have an eye condition called “closed-angle glaucoma”
• you have liver or kidney problems
  Talk to your doctor if you think any of these conditions apply to you.

Children and adolescents
Riltrava Aerosphere has not been studied in children and adolescents. Do not administer this
medicine to children or adolescents under 18 years of age.

Other medicines and Riltrava Aerosphere
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. This includes over-the-counter medicines and herbal supplements. Riltrava Aerosphere
may affect how some medicines work. Also, some medicines may affect how Riltrava Aerosphere
works, or increase the likelihood of you experiencing side effects.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines called beta-blockers (such as atenolol or propranolol), which may be used for high blood pressure or heart problems, or for the treatment of glaucoma (such as timolol)
• medicines used to treat fungal infections, such as ketoconazole or itraconazole
• medicines used to treat HIV infections, such as ritonavir or cobicistat
• medicines that reduce potassium levels in the blood such as:
• oral corticosteroids (such as prednisolone),
• diuretic medicines that increase urine production (such as furosemide or hydrochlorothiazide), which may be used to treat high blood pressure,
• some medicines used to treat breathing problems (such as theophylline), called “methylxanthines”,
• any medicine that works similarly to Riltrava Aerosphere, such as tiotropium, ipratropium, aclidinium, umeclidinium, or salmeterol, arformoterol, vilanterol, olodaterol, or indacaterol. Do not use Riltrava Aerosphere if you are already using these medicines
• medicines used to treat heart rhythm problems, such as amiodarone
• medicines that may alter the heart's electrical activity (called “QT interval”), for example medicines for:
• depression (such as monoamine oxidase inhibitors or tricyclic antidepressants),
• bacterial infections (such as erythromycin, clarithromycin, or telithromycin),
• allergic reactions (antihistamines).

If you fall into any of the above categories, or if you are unsure, consult your doctor or pharmacist
before using Riltrava Aerosphere.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not use Riltrava Aerosphere during pregnancy unless specifically instructed by your doctor.
Do not use this medicine while breastfeeding unless specifically instructed by your doctor.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery. However, dizziness
is an uncommon side effect that should be taken into account when driving or operating machinery.

3. How to use Riltrava Aerosphere

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
How much medicine to take
The recommended dose is two sprays twice a day: two sprays in the morning and two sprays in the evening.
It is important to use Riltrava Aerosphere every day, even if you do not currently have symptoms of COPD.
Warning: always rinse your mouth with water after using Riltrava Aerosphere. This helps remove any medicine that may remain in your mouth. Spit out the rinsing water—do not swallow it.
How to use it
Riltrava Aerosphere is for inhalation use only.
Please read the "Instructions for use" at the end of this leaflet carefully. If you are not sure how to use Riltrava Aerosphere, ask your doctor or pharmacist.
Using Riltrava Aerosphere with a spacer
You may find it difficult to inhale and press the inhaler at the same time. In this case, consult your doctor or pharmacist. Using a "spacer" device with the inhaler may help.
If you use more Riltrava Aerosphere than you should
If you have used more Riltrava Aerosphere than prescribed, contact your doctor or a pharmacist immediately. You may require medical treatment. You may notice your heart beating faster than usual, tremors, vision problems, dry mouth, headache, or a feeling of discomfort (nausea).
If you forget to use Riltrava Aerosphere
Do not take a double dose to make up for a forgotten dose. Take the medicine as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose. Do not take more than two sprays twice a day on the same day.
If you stop using Riltrava Aerosphere
This medicine is intended for long-term use. Use this medicine for as long as your doctor has told you. It will only be effective as long as you continue using it.
Do not stop treatment unless your doctor tells you to, even if you feel better, because your symptoms may worsen. If you plan to stop treatment, consult your doctor first.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Serious side effects
Uncommon (may affect up to 1 in 100 people)
Sudden breathing difficulties :

• if you experience difficulty breathing immediately after using Riltrava Aerosphere, such as chest tightness, cough, wheezing or shortness of breath, stop using this medicine and contact your doctor immediately .

Allergic reactions :

• swelling of the face, particularly around the mouth (swelling of the tongue or throat which may make swallowing difficult)
• skin rash or hives with difficulty breathing
• sudden feeling of fainting
  These symptoms could be signs of an allergic reaction which may become severe. Stop using this medicine and contact your doctor immediately if you notice any of the serious side effects listed above.

Other side effects
Tell your doctor or pharmacist if you notice any of the following side effects:
Common (may affect up to 1 in 10 people)

• oral candidiasis (a fungal infection in the mouth). Rinsing your mouth with water immediately after using Riltrava Aerosphere may help prevent this condition
• feeling of anxiety
• difficulty sleeping
• malaise (nausea)
• headache
• cough or hoarseness
• muscle cramps
• awareness of heartbeat (palpitations)
• elevated blood sugar levels (as shown in tests)
• painful and frequent urination (may be a sign of a urinary tract infection)
• pneumonia (lung infection). Inform your doctor if you experience any of the following symptoms while using Riltrava Aerosphere, as they may be signs of a lung infection:
• fever or chills
• increased mucus production, change in mucus colour,
• worsening cough or breathing difficulties. Uncommon (may affect up to 1 in 100 people)
• tremor or dizziness
• dry mouth or mild throat irritation
• bruising of the skin
• feeling restless, nervousness or agitation
• depression
• rapid heartbeat or irregular heartbeat
• chest pain or chest tightness (angina pectoris) Very rare (may affect up to 1 in 10,000 people)
• changes in behaviour
• an effect on the adrenal gland Not known (frequency cannot be estimated from the available data):
• blurred vision
• clouding of the lens of the eye (signs of cataract)
• increased pressure in the eye (glaucoma)
• swelling of the face, particularly around the mouth (swelling of the tongue or throat which may make swallowing difficult)

Reporting of side effects If you experience any side effect, including those not listed in this leaflet, tell your doctor. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Riltrava Aerosphere

Keep this medicine out of the sight and reach of children.
Do not use Riltrava Aerosphere after the expiry date stated on the carton, the bag, and the pressurised container after “Exp”. The expiry date refers to the last day of that month.
After opening the bag, the inhaler must be used within 3 months.
Keep the inhaler inside the sealed bag; remove the inhaler from the sealed bag only immediately before first use. On the day the bag is opened, write the date on the label of the inhaler in the space provided.
Do not store above 30°C. Store in a dry place.
For best results, the inhaler should be at room temperature before use.
Do not pierce, break, or burn the pressurised container, even if it appears empty. Do not use or store near sources of heat or open flames.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Riltrava Aerosphere contains
The active substances are formoterol fumarate dihydrate, glycopyrronium and budesonide.
Each single inhalation delivers a metered dose (the dose emitted from the mouthpiece) of
5 micrograms of formoterol fumarate dihydrate, 9 micrograms of glycopyrronium bromide, equivalent
to 7.2 micrograms of glycopyrronium, and 160 micrograms of budesonide.
The other ingredients are norflurane, 1,2-distearoyl-sn-glycero-3-phosphocholine and calcium chloride.

Description of the appearance of Riltrava Aerosphere and contents of the pack
Riltrava Aerosphere is a pressurised suspension for inhalation.
Riltrava Aerosphere consists of a pressurised canister with a dose indicator, fitted with a yellow plastic actuator and a white mouthpiece. The mouthpiece is covered with a removable grey protective cap.
Riltrava Aerosphere is supplied in an aluminium pouch containing a desiccant sachet (drying agent), and is packaged in a cardboard box.
Each inhaler contains 120 sprays. There are also multiple packs containing 3 pressurised canisters with 120 sprays each.

Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer
AstraZeneca Dunkerque Production
224 Avenue de la Dordogne
Dunkerque
France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AstraZeneca S.A./N.V.
Tel: +32 2 370 48 11

България (Bulgaria)
АстраЗенека България ЕООД
Тел.: +359 24455000

Česká republika (Czech Republic)
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111

Danmark (Denmark)
AstraZeneca A/S
Tlf: +45 43 66 64 62

Deutschland (Germany)
AstraZeneca GmbH
Tel: +49 40 809034100

Eesti (Estonia)
AstraZeneca
Tel: +372 6549 600

Ελλάδα (Greece)
AstraZeneca A.E.
Τηλ: +30 210 6871500

España (Spain)
AstraZeneca Farmacéutica Spain, S.A.
Tel: +34 91 301 91 00

France
AstraZeneca
Tél: +33 1 41 29 40 00

Hrvatska (Croatia)
AstraZeneca d.o.o.
Tel: +385 1 4628 000

Ireland
AstraZeneca Pharmaceuticals (Ireland) DAC
Tel: +353 1609 7100

Ísland (Iceland)
Vistor hf.
Sími: +354 535 7000

Italia (Italy)
AstraZeneca S.p.A.
Tel: +39 02 00704500

Κύπρος (Cyprus)
Αλέκτωρ Φαρµακευτική Λτδ
Τηλ: +357 22490305

Latvija (Latvia)
SIA AstraZeneca Latvija
Tel: +371 67377100

Lietuva (Lithuania)
UAB AstraZeneca Lietuva
Tel: +370 5 2660550

Luxembourg/Luxemburg
AstraZeneca S.A./N.V.
Tél/Tel: +32 2 370 48 11

Magyarország (Hungary)
AstraZeneca Kft.
Tel.: +36 1 883 6500

Malta
Associated Drug Co. Ltd
Tel: +356 2277 8000

Nederland (Netherlands)
AstraZeneca BV
Tel: +31 85 808 9900

Norge (Norway)
AstraZeneca AS
Tlf: +47 21 00 64 00

Österreich (Austria)
AstraZeneca Österreich GmbH
Tel: +43 1 711 31 0

Polska (Poland)
AstraZeneca Pharma Poland Sp. z o.o.
Tel.: +48 22 245 73 00

Portugal
Técnimede - Sociedade Técnico-Medicinal, S.A.
Tel: +351 21 041 41 00

România (Romania)
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41

Slovenija (Slovenia)
AstraZeneca UK Limited
Tel: +386 1 51 35 600

Slovenská republika (Slovakia)
AstraZeneca AB, o.z.
Tel: +421 2 5737 7777

Suomi/Finland (Finland)
AstraZeneca Oy
Puh/Tel: +358 10 23 010

Sverige (Sweden)
AstraZeneca AB
Tel: +46 8 553 26 000

United Kingdom (Northern Ireland)
AstraZeneca UK Ltd
Tel: +44 1582 836 836

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

Read before using the inhaler

INSTRUCTIONS FOR USE

RILTRAVA AEROSPHERE
( formoterol fumarate dihydrate, glycopyrronium, and budesonide )
Pressurized inhalation, suspension
For oral inhalation only
Please read these instructions carefully.
Riltrava Aerosphere (referred to as “inhaler” in this leaflet) may be different from the
inhalers you have used before.

Important information

• For oral inhalation only
• Prepare the inhaler for first use by priming it
• Rinse the yellow actuator weekly
• Take 2 puffs of medicine in the morning and 2 puffs of medicine in the evening

Storage of the inhaler

• Do not store above 30°C. Store in a dry place
• Do not store in a humid environment, such as a bathroom
• Keep the inhaler and all medicines out of sight and reach of children

Components of the inhaler
Dose indicator

Attached to the top of the pressurized canister.
Pressurized canister (inside)
Contains the medicine.
Actuator
Holds the pressurized canister.
Mouthpiece
Delivers the medicine.
Mouthpiece cap
Protects the mouthpiece when the inhaler is not in use.

Reading the dose indicator

The dose indicator will count down by 1 each time you take
a puff of medicine.

Pointer
Indicates the number of puffs remaining
Yellow zone
Order a new inhaler when the
pointer is in the yellow zone
Red zone
Discard the inhaler when the pointer
is at 0 in the red zone

Do not attempt to take a puff when the pointer is at 0 as you will not receive a complete dose.
Order a new inhaler

• Order a new inhaler when the dose indicator pointer enters the yellow zone.

Disposal of the inhaler
Dispose of the inhaler according to local guidelines when:

• the dose indicator shows 0, or
• 3 months after the inhaler has been removed from the aluminium pouch

Do not reuse or use the actuator with medicine canisters from other inhalers.
Do not pierce or burn the canister or dispose of it in fire or an incinerator.

BEFORE FIRST USE – Prime the inhaler 4 times before first use

• Before using the inhaler for the first time, prime it to ensure the correct amount of medicine is delivered when you use it.

Priming step 1
Remove the cap from the mouthpiece.

Priming step 2
Shake the inhaler well and release one test puff into the air, pointing it away from you. Repeat for a total of 4 test puffs, shaking before each test puff.

4 times in total
Shake and release the
test puffs

Extra puffs are provided for priming. Do not skip priming.

Re-priming the inhaler: To re-prime, release 2 test puffs,

• after rinsing the actuator, shaking it before each test puff.
• if the inhaler has been dropped
• if not used for more than 7 days

2 times in total
Shake and release
the test puffs

DAILY USE, morning and evening – Inhaling the medicine

• Daily dose: 2 puffs in the morning and 2 puffs in the evening.
• Rinse your mouth with water after the 2 puffs to prevent fungal infection.

Step 1
Remove the cap from the mouthpiece. Check for foreign objects in the mouthpiece and
remove them before use.

WEEKLY RINSE – Rinse the dispenser once a week

• Rinse the yellow dispenser weekly to prevent the medicine from building up and blocking the spray through the mouthpiece.
• Do not let the container get wet.
• Re-prime after rinsing.

Rinse 7 Rinse 8
When dry, first reposition the Reload the inhaler by performing 2 test actuations,
mouthpiece cap, then gently push the canister into the actuator,
into the actuator, shaking well before each test actuation.

2 times in total
Shake and perform
the test actuations