Anoro Ellipta 55 mcg/22 mcg powder for inhalation (single dose): detailed information

Brand name Anoro Ellipta 55 mcg/22 mcg powder for inhalation (single dose)

Form powder for inhalation, single-dose

Active substance / Dosage

UMECLIDINIUM BROMIDE · 74,2 µg

VILANTEROL TRIFENILACETATE · 40 µg

Prescription type Prescription Only Medicine

ATC code

R03A R03AL R03AL03

Registration number 113898002

Manufacturer Glaxosmithkline Trading Services Limited

Anoro Ellipta 55 mcg/22 mcg powder for inhalation (single dose) powder for inhalation, single-dose

Table of Contents

Package leaflet: Information for the user
Introduction
1. What ANORO ELLIPTA is and what it is used for
2. What you need to know before using ANORO ELLIPTA
3. How to use ANORO ELLIPTA
4. Possible adverse effects
5. Storage of ANORO ELLIPTA
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder (single dose)

umeclidinium/vilanterol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

What ANORO ELLIPTA is and what it is used for
What you need to know before using ANORO ELLIPTA
How to use ANORO ELLIPTA
Possible side effects
How to store ANORO ELLIPTA
Contents of the pack and other information

Step-by-step instructions for use

1. What ANORO ELLIPTA is and what it is used for

What ANORO ELLIPTA is

ANORO ELLIPTA contains two active substances, umeclidinium bromide and vilanterol. These belong to a group of medicines called bronchodilators.

What ANORO ELLIPTA is used for

ANORO ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic, slowly worsening disease characterized by difficulty breathing.

In COPD, the muscles around the airways tighten. This medicine prevents the tightening of these muscles in the lungs, making it easier for air to flow in and out of the lungs. When used regularly, it helps control breathing difficulties and reduces the impact of COPD on daily life.

ANORO ELLIPTA must not be used to relieve a sudden attack of breathlessness or wheezing (whistling sounds when breathing). If you experience such attacks, you should use a fast-acting "rescue" inhaler (such as salbutamol). If you do not have a fast-acting inhaler, contact your doctor.

2. What you need to know before using ANORO ELLIPTA

Do not use ANORO ELLIPTA:

if you are allergic to umeclidinium, vilanterol, or any of the other ingredients of this medicine (listed in section 6).

If you think any of the above applies to you, do not use this medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor before starting to use this medicine:

if you have asthma (Do not use ANORO ELLIPTA for the treatment of asthma)
if you have heart problems or high blood pressure
if you have an eye condition called closed-angle glaucoma
if you have an enlarged prostate, difficulty urinating, or a bladder obstruction
if you have epilepsy
if you have thyroid gland problems
if you have low potassium levels in the blood
if you have diabetes
if you have severe liver problems.

Talk to your doctor if you think any of the above conditions apply to you.

Urgent breathing difficulties

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

stop using this medicine and seek immediate medical attention, as you may be experiencing a serious condition called paradoxical bronchospasm.

Eye problems during treatment with ANORO ELLIPTA

If you experience eye pain or discomfort, blurred vision, visual halos, or colored images associated with eye redness during treatment with ANORO ELLIPTA:

stop using this medicine and seek immediate medical help, as these symptoms may indicate an acute attack of closed-angle glaucoma.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age.

Other medicines and ANORO ELLIPTA

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. If you are unsure about the contents of your medication, consult your doctor or pharmacist.

Some medicines may affect how this medicine works, 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 conditions
ketoconazole or itraconazole, used to treat fungal infections
clarithromycin or telithromycin, used to treat bacterial infections
ritonavir, used to treat HIV
medicines that reduce potassium levels in the blood, such as certain diuretics or certain medicines used to treat asthma (such as methylxanthines or steroids)
other long-acting medicines for respiratory conditions similar to this medicine, for example, tiotropium, indacaterol. Do not use ANORO ELLIPTA if you are already taking these medicines.

Talk to your doctor or pharmacist if you are taking any of these medicines. Your doctor may need to monitor you closely, as these medicines may increase the risk of adverse effects from ANORO ELLIPTA.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. If you are pregnant, do not use this medicine unless your doctor has instructed you to do so.

It is unknown whether the components of ANORO ELLIPTA are excreted in human breast milk. If you are breastfeeding, you must consult your doctor before using ANORO ELLIPTA. If you are breastfeeding, do not use this medicine unless your doctor has instructed you to do so.

Driving and using machines

ANORO ELLIPTA is unlikely to affect your ability to drive or operate machinery.

ANORO ELLIPTA contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before using this medicine.

3. How to use ANORO ELLIPTA

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose is one inhalation every day, at the same time each day. You only need one inhalation per day, as the effect of this medicine lasts for 24 hours.

Do not use more doses than your doctor has prescribed.

Use ANORO ELLIPTA regularly

It is very important that you use ANORO ELLIPTA every day as directed by your doctor. This will help you to remain symptom-free throughout the day and night.

Do not use ANORO ELLIPTA to relieve a sudden attack of breathlessness or wheezing. If you have such an attack, you must use a fast-acting "rescue" inhaler (such as salbutamol).

How to use the inhaler

For complete information, read the "Step-by-step instructions for use" at the end of this leaflet.

ANORO ELLIPTA is for inhalation use. To use ANORO ELLIPTA, inhale it into your lungs through your mouth using the ELLIPTA inhaler.

If symptoms do not improve

If your COPD symptoms (breathlessness, wheezing, cough) do not improve or worsen, or if you are using your fast-acting "rescue" inhaler more often than usual:

contact your doctor as soon as possible.

If you use more ANORO ELLIPTA than you should

If you accidentally use too much medicine, contact your doctor or pharmacist immediately, as you may require medical attention. If possible, show them the inhaler, the packaging, or this leaflet. You may notice that your heart beats faster than normal, visual disturbances, dry mouth, or headache.

If you forget to use ANORO ELLIPTA

Do not inhale a double dose to make up for forgotten doses. Inhale the next dose at your usual time.

If you have wheezing or breathlessness, use your fast-acting "rescue" inhaler (such as salbutamol) and seek medical advice.

If you stop using ANORO ELLIPTA

Use this medicine for the length of time recommended by your doctor. It will only be effective for as long as you continue using it. Do not stop using it unless your doctor tells you to, even if you feel better, because your symptoms may worsen.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Allergic reactions

If you experience any of the symptoms listed below after taking ANORO ELLIPTA, stop using this medicine and contact your doctor immediately.

Uncommon adverse effects (may affect up to 1 in 100 people):

skin rash (hives) or redness.

Rare adverse effects (may affect up to 1 in 1,000 people):

swelling, sometimes of the face or mouth (angioedema)
increased wheezing (whistling sound when breathing), cough or difficulty breathing
sudden feeling of weakness or dizziness (which may lead to collapse or loss of consciousness).

Urgent breathing difficulties

Urgent breathing difficulties after using ANORO ELLIPTA are rare. If you experience chest tightness, cough, wheezing or difficulty breathing immediately after using this medicine:

stop using this medicine and seek immediate medical attention, as you may have a serious condition called paradoxical bronchospasm.

Other adverse effects

Common (may affect up to 1 in 10 people)

frequent and painful urination (may be a sign of urinary tract infection)
combination of sore throat and runny nose
sore throat
feeling of pressure or pain in the cheeks and forehead (may be a sign of sinus inflammation called sinusitis)
headache
cough
pain and irritation in the back of the mouth and throat
constipation
dry mouth
upper respiratory tract infection.

Uncommon (may affect up to 1 in 100 people)

irregular heartbeat
faster heartbeat
awareness of heartbeats (palpitations)
muscle spasms
tremor
taste disturbance
hoarseness.

Rare (may affect up to 1 in 1,000 people)

blurred vision
increased intraocular pressure
decreased vision or eye pain (possible signs of glaucoma)
difficulty and pain when urinating, which may be signs of bladder obstruction or urinary retention.

Not known (frequency cannot be estimated from available data)

dizziness.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ANORO 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 the month indicated.

Keep the inhaler within the sealed tray to protect it from moisture, and only remove it immediately before first use. Once the tray has been opened, the inhaler may be used for up to 6 weeks from the date the tray was opened. Write the date by which the inhaler should be discarded in the space provided on the inhaler label. This date should be recorded as soon as the inhaler is removed from the tray.

Do not store above 30 °C.

If stored in the refrigerator, allow the inhaler to reach room temperature for at least one hour before use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of ANORO ELLIPTA

The active substances are umeclidinium bromide and vilanterol.

Each inhalation provides a delivered dose (dose released from the mouthpiece) of 55 micrograms of umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenilatate).

The other components are lactose monohydrate (see section 2, “ANORO ELLIPTA contains lactose”) and magnesium stearate.

Nature and contents of the product and pack

ANORO ELLIPTA is an inhalation powder (single dose).

The Ellipta inhaler device consists of a light grey plastic body, a red mouthpiece cover, and a dose counter. It is packaged in a laminated aluminum tray. The tray contains a desiccant bag to reduce moisture within the package.

The active substances are presented as a white powder in separate blisters inside the inhaler. ANORO ELLIPTA is available in packs containing 1 inhaler with either 7 or 30 doses, and in multiple packs containing 90 doses (3 inhalers of 30 doses each). Not all pack sizes may be marketed.

Marketing Authorization 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgien

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tel/Tel: + 32 (0) 10 85 52 00

Lithuania

UAB “BERLIN-CHEMIE MENARINI BALTIC”

Tel: +370 52 691 947