Incruse Ellipta 55 mcg inhalation powder for single dose: detailed information

Brand name Incruse Ellipta 55 mcg inhalation powder for single dose

Form powder for inhalation, single-dose

Active substance / Dosage

UMECLIDINIUM BROMIDE · 74,2 µg

Prescription type Prescription Only Medicine

ATC code

R03B R03BB R03BB07

Registration number 114922002

Manufacturer Glaxosmithkline Trading Services Limited

Incruse Ellipta 55 mcg inhalation powder for single dose powder for inhalation, single-dose

Table of Contents

Patient Information Leaflet
Introduction
1. What Incruse Ellipta is and what it is used for
2. What you need to know before using Incruse Ellipta
3. How to use Incruse Ellipta
4. Possible adverse effects
5. Storage of Incruse Ellipta
6. Contents of the pack and other information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Incruse Ellipta 55 micrograms powder for inhalation (single dose)

umeclidinium (umeclidinium)

Please read all of this leaflet carefully before you start using this medicine, as 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 side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

Step-by-step instructions for use

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

What Incruse Ellipta is

Incruse Ellipta contains the active substance umeclidinium (as bromide), which belongs to a group of medicines called bronchodilators.

What Incruse Ellipta is used for

This medicine is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic disease that slowly worsens over time, in which the airways and air sacs in the lungs gradually become obstructed or damaged, causing difficulty in breathing. This breathing difficulty is compounded by the contraction of the muscles surrounding the airways, causing them to narrow and restrict airflow.

This medicine prevents the contraction of these muscles in the lungs, making it easier for air to move in and out of the lungs. When used regularly, it helps control breathing difficulties and reduces the impact of COPD on your daily life.

Incruse 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 Incruse Ellipta

Do not use Incruse Ellipta

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

If you think this 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 Incruse Ellipta:

if you have asthma (do not use Incruse Ellipta to treat asthma)
if you have heart problems
if you have an eye condition called closed-angle glaucoma
if you have an enlarged prostate, difficulty passing urine, or a bladder obstruction
if you have severe liver problems.

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

Immediate breathing difficulties

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

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

Eye problems during treatment with Incruse Ellipta

If you experience eye pain or discomfort, blurred vision, visual halos, or colored images associated with red eyes during treatment with Incruse 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 Incruse 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.

In particular, inform your doctor or pharmacist if you are taking other long-acting medicines for respiratory problems similar to this one, for example, tiotropium. Do not use Incruse Ellipta together with these medicines.

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 tells you to.

It is unknown whether the components of Incruse Ellipta are excreted in human breast milk. If you are breastfeeding, you must consult your doctor before using Incruse Ellipta.

If you are breastfeeding, do not use this medicine unless your doctor tells you to.

Driving and using machines

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

Incruse Ellipta contains lactose

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

3. How to use Incruse Ellipta

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

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 Incruse Ellipta regularly

It is very important that you use Incruse Ellipta every day, as directed by your doctor. This will help you to avoid symptoms throughout the day and night.

Do not use this medicine 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.

Incruse Ellipta is administered by inhalation. To use Incruse 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 Incruse 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 the leaflet. You may notice that your heart beats faster than normal, visual disturbances, or dry mouth.

If you forget to use Incruse Ellipta

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

If you experience wheezing or breathlessness, use your fast-acting "rescue" inhaler (e.g., salbutamol), and seek medical advice.

If you stop using Incruse Ellipta

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

Allergic reactions

If, after using Incruse Ellipta, you experience any of the following symptoms, stop using this medicine and inform your doctor immediately:

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

itching
skin rash (hives) or redness.

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

wheezing (a whistling sound when breathing), cough, or difficulty breathing
sudden feeling of weakness or dizziness (which may lead to collapse or loss of consciousness)

Other adverse effects:

Common (may affect up to 1 in 10 people):

faster heartbeat
pain when urinating and increased frequency (may be signs of a urinary tract infection)
common cold
nose and throat infection
cough
feeling of pressure or pain in the cheeks and forehead (may be symptoms of inflammation of the sinuses called sinusitis)
headache
constipation
mouth and throat pain.

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

irregular heartbeat
sore throat
dry mouth
altered taste
hoarseness.

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

eye pain.

Frequency not known (frequency cannot be estimated from the available data):

decreased vision or eye pain due to increased intraocular pressure (possible signs of glaucoma)
blurred vision
increased intraocular pressure
difficulty and pain during urination, which may indicate bladder obstruction or urinary retention
dizziness.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Incruse Ellipta

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

Do not use this medicine after the expiry date stated on the packaging, 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 a period of 6 weeks from the date the tray was opened. Write the date on which the inhaler should be discarded in the space provided for this purpose 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Incruse Ellipta

The active substance is umeclidinium (as bromide).

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

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

Nature and contents of the container

Incruse Ellipta is a powder for inhalation (single dose).

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

The active substance is presented as a white powder in a blister inside the inhaler. Incruse Ellipta is available in packs containing one inhaler with 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

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium

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