ANORO

Main information

  • Trade name:
  • ANORO ELLIPTA 62.5/25 umeclidinium (as bromide)/vilanterol (as trifenatate) 62.5 microgram/25 microgram powder for inhalation
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANORO ELLIPTA 62.5/25 umeclidinium (as bromide)/vilanterol (as trifenatate) 62.5 microgram/25 microgram powder for inhalation
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207529
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207529

ANORO ELLIPTA 62.5/25 umeclidinium (as bromide)/vilanterol (as trifenatate) 62.5 microgram/25

microgram powder for inhalation

ARTG entry for

Medicine Registered

Sponsor

GlaxoSmithKline Australia Pty Ltd

Postal Address

PO Box 18095,Melbourne, VIC, 8003

Australia

ARTG Start Date

4/07/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ANORO ELLIPTA 62.5/25 umeclidinium (as bromide)/vilanterol (as trifenatate) 62.5 microgram/25

microgram powder for inhalation

Product Type

Single Medicine Product

Effective date

15/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Anoro Ellipta is indicated as a long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive

pulmonary disease (COPD).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Inhaler - dry powder

Other plastic

laminate/Al

24 Months

Store below 30

degrees Celsius

Not recorded

See Product

information for shelf

life

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

7 (sample pack)

(S4) Prescription Only Medicine

Components

1. ANORO ELLIPTA 62.5/25 umeclidinium (as bromide)/vilanterol (as trifenatate) 62.5 microgram/25 microgram powder for inhalation

Dosage Form

Inhalation, powder for

Route of Administration

Inhalation

Visual Identification

A plastic inhaler with a light grey body and red mouthpiece cover containing

two strips of blisters each containing a white powder

Active Ingredients

umeclidinium bromide

74.2 microgram

Vilanterol trifenatate

40 microgram

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 12:24:31 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

ANORO

®

ELLIPTA

®

Umeclidinium (as bromide) 62.5 micrograms and vilanterol (as trifenatate) 25 micrograms per inhalation

Australia and New Zealand Consumer

Medicine Information

What is in this leaflet

Please read this leaflet carefully

before you start using ANORO

ELLIPTA.

This leaflet answers some common

questions about ANORO ELLIPTA.

It does not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking ANORO

ELLIPTA against the benefits they

expect it will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What ANORO

ELLIPTA is used for

ANORO ELLIPTA is used to treat

chronic obstructive pulmonary

disease (COPD). To use ANORO

ELLIPTA, you breathe it into your

lungs through your mouth using the

ELLIPTA inhaler.

Chronic obstructive pulmonary

disease (COPD) is a long-term

condition that slowly gets worse.

Symptoms include shortness of

breath, cough, chest discomfort and

coughing up mucus.

ANORO ELLIPTA contains two

active ingredients: umeclidinium

bromide and vilanterol trifenatate.

Umeclidinium bromide and

vilanterol trifenatate belongs to a

group of medicines called

bronchodilators. Umeclidinium and

vilanterol work together to help open

the airways and make it easier for air

to get in and out of the lungs. This

will help relieve symptoms of COPD.

When ANORO ELLIPTA is used

regularly, it can help to control the

breathing difficulties related to your

disease and minimise the effects of

the disease on your everyday life.

ANORO ELLIPTA should not be

used to relieve a sudden attack of

breathlessness or wheezing. If you

get this sort of attack you must use

a quick-acting inhaler (such as

VENTOLIN

®

).

Your doctor may have prescribed

ANORO ELLIPTA for another

reason.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

This medicine is not addictive.

This medicine is available only with

a doctor's prescription.

ANORO ELLIPTA should not be

given to children or adolescents

below the age of 18 years.

Before you use

ANORO ELLIPTA

When you must not use it

Don't use ANORO ELLIPTA

if you are allergic

(hypersensitive) to lactose or

milk protein

if you are allergic

(hypersensitive) to

umeclidinium bromide,

vilanterol trifenatate or any

other ingredients of ANORO

ELLIPTA (listed at the end of

this leaflet).

If you think either of these applies

to you, don't use ANORO

ELLIPTA until you have checked

with your doctor.

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

ANORO ELLIPTA contains lactose .

If you have been diagnosed with an

intolerance to some sugars, or to milk

protein, talk to your doctor before

you use ANORO ELLIPTA.

If you are pregnant, if you think

you may be pregnant or if you are

planning to have a baby, don't use

ANORO ELLIPTA without asking

your doctor.

Your doctor will consider the benefit

to you and the risk to your baby of

taking ANORO ELLIPTA while you

are pregnant.

If you are breast-feeding, check

with your doctor before you take

ANORO ELLIPTA.

It is not known whether the

ingredients of ANORO ELLIPTA

can pass into breast milk.

Do not take this medicine after the

expiry date printed on the pack or

ANORO

ELLIPTA

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to use it

Talk to your doctor before you use

ANORO ELLIPTA:

-

if you have asthma (do not use

ANORO ELLIPTA to treat

asthma)

-

if you have heart problems or

high blood pressure

-

if you have an eye problem

called narrow-angle glaucoma

-

if you have an enlarged

prostate, difficulty passing

urine or a blockage in your

bladder.

Check with your doctor before you

use ANORO ELLIPTA if you

think any of these apply to you.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Your doctor can discuss with you the

risks and benefits involved.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines may affect how

ANORO ELLIPTA works, or make it

more likely that you'll have side

effects. These include:

medicines called beta blockers, to

treat high blood pressure or other

heart problems

ketoconazole, to treat fungal

infections.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to use ANORO

ELLIPTA

Follow all directions given to you

by your doctor or pharmacist

carefully.

If you do not understand the

instructions in the user leaflet, ask

your doctor or pharmacist for

help.

How much to use

Always use ANORO ELLIPTA

exactly as your doctor has told you

to. Check with your doctor, nurse

or pharmacist if you're not sure.

The dose is one inhalation every day

at the same time of day.

How to use the inhaler

The full instructions for using

ANORO ELLIPTA are given on a

leaflet inside the pack.

ANORO ELLIPTA is ready to use

straight away. No preparation or

checks of the inhaler are required.

Do not open ANORO ELLIPTA

until you are ready to use it for the

first time.

After using ANORO ELLIPTA,

you may clean the mouthpiece,

using a dry tissue, before you close

the cover. Do not immerse

ANORO ELLIPTA in water.

When to use it

Use ANORO ELLIPTA regularly.

It is very important that you use

ANORO ELLIPTA every day, as

instructed by your doctor. This will

help to keep you free of symptoms

throughout the day and night.

If you feel you are getting

breathless or wheezy more often

than normal, or if you are using

your quick-acting inhaler (such as

VENTOLIN) more than usual, see

your doctor.

How long to use it

Don't stop ANORO ELLIPTA

without medical advice.

Use ANORO ELLIPTA for as long

as your doctor recommends. It will

only be effective as long as you are

using it. Don't stop unless your

doctor advises you to, even if you

feel better.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

use your next dose when you are

meant to. Otherwise, use it as soon

as you remember, then go back to

using it as you would normally.

Don't take an extra dose to make

up for a missed dose.

If you are not sure what to do, ask

your doctor or pharmacist.

If you become wheezy or

breathless, or develop any other

symptoms of an asthma attack, use

your quick-acting inhaler (e.g.

VENTOLIN), then seek medical

advice.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

In New Zealand, immediately

telephone your doctor or the

National Poisons Centre (telephone

0800 POISON or 0800 764 766) if

you think that you or anyone else

may have taken too much ANORO

ELLIPTA.

In Australia, immediately

telephone your doctor or the

Poisons Information Centre

(telephone 13 11 26) for advice, if

you think that you or anyone else

may have taken too much ANORO

ELLIPTA. Do this even if there are

no signs of discomfort or

poisoning.

If you accidentally take a larger dose

of ANORO ELLIPTA than your

doctor has instructed, you may notice

that your heart is beating faster than

usual, you feel shaky or have a

headache.

ANORO

ELLIPTA

While you are using

ANORO ELLIPTA

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking ANORO ELLIPTA.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Keep all of your doctor's

appointments so that your progress

can be checked.

Things you must not do

Do not take ANORO ELLIPTA to

treat any other complaints unless

your doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or lower the dosage without

checking with your doctor.

Do not take any other medicines

for your breathing problems

without checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

ANORO ELLIPTA affects you.

Side effects

Like all medicines, ANORO

ELLIPTA can cause side effects,

although not everybody gets them.

If you get tightness of the chest,

coughing, wheezing or

breathlessness immediately after

using your ANORO ELLIPTA,

stop using it immediately, and seek

medical help immediately.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Common side effects

These may affect up to 1 in 10

people:

sore throat with or without runny

nose

cough

constipation

dry mouth

painful and frequent urination

(may be signs of a urinary tract

infection)

feeling of pressure or pain in the

cheeks and forehead (may be

signs of inflammation of the

sinuses called sinusitis)

pain and irritation in the back of

the mouth and throat

infection of the upper airways.

Uncommon side effects

These may affect up to 1 in 100

people:

irregular heartbeat

faster heart beat

awareness of heart beat

(palpitations)

anxiety

tremor

taste disturbance

muscle spasms

rash (allergic reactions).

Rare side effects

These may affect up to 1 in 1,000

people:

allergic reactions

immediate breathing difficulties

and wheezing

decrease in vision or pain in your

eyes due to high pressure

(possible signs of glaucoma)

blurred vision

increase of the measured eye

pressure

difficulties passing urine (urinary

retention)

pain or discomfort when passing

urine (dysuria)

hoarseness.

If you think you are having an

allergic reaction to ANORO

ELLIPTA, stop using this medicine

and tell your doctor immediately

or go the accident and emergency

department at your nearest

hospital. Symptoms of an allergic

reaction usually include some or all

of the following:

wheezing, coughing

swelling of the lips/mouth,

tongue or throat

difficulty in breathing

hay fever lumpy rash ("hives")

or redness

fainting, suddenly feeling weak

or light headed

If you get any side effects, talk to

your doctor, pharmacist or nurse.

This includes any possible side

effects not listed in this leaflet.

After using ANORO

ELLIPTA

Storage

Do not use ANORO ELLIPTA

after the expiry date shown on the

pack.

Store in the original package

container in order to protect from

moisture and do not open the foil

lid until ready to inhale for the

first time.

Safely throw away ANORO

ELLIPTA six weeks after you open

the foil tray or when your counter

reads "0", whichever comes first.

Write the date the inhaler should

ANORO

ELLIPTA

be discarded on the label in the

space provided. The date should be

added as soon as the inhaler has

been removed from the tray.

Keep your inhaler in cool dry place

where the temperature stays below

30°C.

If you store in a refrigerator allow

the inhaler to return to room

temperature for at least an hour

before use.

Do not store ANORO ELLIPTA or

any other medicine in the

bathroom or near a sink. Do not

leave it on a window sill or in the

car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

ANORO ELLIPTA is inhaled

through the mouth using the

ELLIPTA device. The active

substances are in separate blisters in

powder form inside the device. There

are either 7 or 30 blisters on each

strip, and so each device contains

either 7 or 30 doses depending on

which pack size you have been

given.

The ELLIPTA device itself is a

plastic inhaler with a light grey body,

a red mouthpiece cover and a dose

counter. It is packaged in a foil

laminate tray with a peelable foil lid.

The tray contains a desiccant sachet,

to reduce the moisture in the

packaging. Once you have opened

the lid of the tray, throw the

desiccant away - do not open, eat or

inhale it.

Ingredients

The active ingredients in ANORO

ELLIPTA are umeclidinium (as

bromide) and vilanterol (as

trifenatate).

Each dose contains 62.5 micrograms

of the active ingredient

umeclidinium. Each dose also

contains 25 micrograms of the active

ingredient vilanterol.

ANORO ELLIPTA also contains the

inactive ingredients:

lactose monohydrate (which

contains milk proteins)

magnesium stearate.

Supplier

Your ANORO ELLIPTA is

supplied in Australia by:

GlaxoSmithKline Australia Pty Ltd

Level 4, 436 Johnston Street

Abbotsford Victoria 3067

Australia.

Your ANORO ELLIPTA is

supplied in New Zealand by:

GlaxoSmithKline NZ Limited

Private Bag 106600

Downtown

Auckland

New Zealand.

Where to go for further

information

Pharmaceutical companies are not in

a position to give people an

individual diagnosis or medical

advice. Your doctor or pharmacist is

the best person to give you advice on

the treatment of your condition. You

may also be able to find general

information about your disease and

its treatment from patient information

groups and books, for example in

public libraries.

This leaflet was prepared on 4 April

2017.

The information provided applies

only to: ANORO

ELLIPTA

ANORO and ELLIPTA are

registered trade marks of the GSK

group of companies.

ANORO ELLIPTA 62.5/25

micrograms - AUST R 207529

© 2017 GSK group of companies.

All rights reserved.

Version 7.0

ANORO

ELLIPTA

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

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Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

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Europe -DG Health and Food Safety

7-8-2018

Duaklir Genuair (AstraZeneca AB)

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Duaklir Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5419 of Tue, 07 Aug 2018

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Brimica Genuair (AstraZeneca AB)

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Seebri Breezhaler (Novartis Europharm Limited)

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Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4526 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2690/T/30

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Enurev Breezhaler (Novartis Europharm Limited)

Enurev Breezhaler (Novartis Europharm Limited)

Enurev Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4342 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2691/T/27

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Revinty Ellipta (Glaxo Group Ltd)

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Revinty Ellipta (Active substance: fluticasone furoate / vilanterol) - Corrigendum - Commission Decision (2014)3040 of Tue, 03 Jul 2018

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Relvar Ellipta (Glaxo Group Ltd)

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Incruse (Glaxo Group Ltd)

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Xoterna Breezhaler (Novartis Europharm Limited)

Xoterna Breezhaler (Novartis Europharm Limited)

Xoterna Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Renewal - Commission Decision (2018)3265 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3755/R/27

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Ulunar Breezhaler (Novartis Europharm Limited)

Ulunar Breezhaler (Novartis Europharm Limited)

Ulunar Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3058 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3875/T/24

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Trydonis (Chiesi Farmaceutici S.p.A.)

Trydonis (Chiesi Farmaceutici S.p.A.)

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Riarify (Chiesi Farmaceutici S.p.A.)

Riarify (Chiesi Farmaceutici S.p.A.)

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