Respimix Easyhaler 320 mikrogram/9 mikrogram/inhalation Inhalationspulver

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)


Produktens egenskaper Produktens egenskaper (SPC)


Aktiva substanser:
budesonid; formoterolfumaratdihydrat
Tillgänglig från:
Orion Corporation
INN (International namn):
budesonide; formoterol
320 mikrogram/9 mikrogram/inhalation
laktosmonohydrat Hjälpämne; formoterolfumaratdihydrat 9 mikrog Aktiv substans; budesonid 320 mikrog Aktiv substans
Receptbelagda typ:
Förpacknings: Inhalator, 60 doser; Inhalator, 60 doser med fodral; Inhalator, 180 (3 x 60) doser
Bemyndigande status:
Tillstånd datum:

Dokument på andra språk

Bipacksedel Bipacksedel - engelska


Produktens egenskaper Produktens egenskaper - engelska


Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska


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Package leaflet: Information for the patient

Respimix Easyhaler, 320 micrograms/9 micrograms/inhalation, Inhalation Powder

Budesonide/formoterol fumarate dihydrate

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Respimix Easyhaler 320/9 is and what it is used for

What you need to know before you use Respimix Easyhaler 320/9

How to use Respimix Easyhaler 320/9

Possible side effects

How to store Respimix Easyhaler 320/9

Contents of the pack and other information


What Respimix Easyhaler 320/9 is and what it is used for

Respimix Easyhaler is an inhaler that is used to treat asthma in adults and adolescents aged 12 - 17

years. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in

adults aged 18 years and older. It contains two different medicines: budesonide and formoterol

fumarate dihydrate.

Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and

preventing swelling and inflammation in your lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting


adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your

airways. This helps you to breathe more easily.


What you need to know before you use Respimix Easyhaler 320/9

Do not use Respimix Easyhaler 320/9:

if you are allergic to budesonide, formoterol or the other ingredient of this medicine (listed in

section 6), which is lactose (which contains small amounts of milk protein).

Warnings and precautions

Talk to your doctor or pharmacist before using Respimix Easyhaler if you:

are diabetic

have a lung infection

have high blood pressure or you have ever had a heart problem (including an uneven heart beat,

a very fast pulse, narrowing of the arteries or heart failure)

have problems with your thyroid or adrenal glands

have low levels of potassium in your blood

have severe liver problems.

Contact your doctor if you experience blurred vision or other visual disturbances.

Rinse your mouth after inhaling your dose in order to avoid fungal infection in the mouth.

Other medicines and Respimix Easyhaler

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, including medicines obtained without a prescription.

Some medicines may increase the effects of Respimix Easyhaler and your doctor may wish to monitor

you carefully if you are taking these medicines (including some medicines for HIV: ritonavir,


In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

Beta-blocker medicines (such as atenolol or propranolol for high blood pressure), including

eyedrops (such as timolol for glaucoma).

Medicines for a fast or uneven heart beat (such as quinidine).

Medicines like digoxin, often used to treat heart failure.

Diuretics, also known as ‘water tablets’ (such as furosemide). These are used to treat high blood


Steroid medicines that you take by mouth (such as prednisolone).

Xanthine medicines (such as theophylline or aminophylline). These are often used to treat


Other bronchodilators (such as salbutamol).

Tricyclic anti-depressants (such as amitriptyline) and the anti-depressant nefazodone.

Phenothiazine medicines (such as chlorpromazine and prochlorperazine).

Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, posaconazole,

clarithromycin and telithromycin).

Medicines for Parkinson’s disease (such as leva-dopa).

Medicines for thyroid problems (such as levo-thyroxine).

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using

Respimix Easyhaler.

Also tell your doctor or pharmacist if you are going to have a general anaesthetic for an operation or

for dental work.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,

ask your doctor or pharmacist before using this medicine

Do not use Respimix Easyhaler unless your doctor tells you to.

If you get pregnant while using Respimix Easyhaler, do not stop using Respimix Easyhaler but

talk to your doctor immediately.

Driving and using machines

Respimix Easyhaler has no or negligible effect on your ability to drive or to use tools or machines.

Respimix Easyhaler contains lactose

which is a type of sugar. If you have been told by your doctor

that you have an intolerance to some sugars, talk to your doctor before using this medicine. The

amount of lactose in this medicine does not normally cause problems in people who are lactose


The excipient lactose contains small amounts of milk proteins, which may cause allergic reaction.


How to use Respimix Easyhaler 320/9

Always use this medicine exactly as your doctor has told you. Check with your doctor or

pharmacist if you are not sure.

It is important to use Respimix Easyhaler every day, even if you have no asthma or COPD

symptoms at the time.

Your doctor will want to regularly check your asthma symptoms.

If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number

of tablets that you take, once you start to use Respimix Easyhaler. If you have been taking oral steroid

tablets for a long time, your doctor may want you to have blood tests from time to time. When

reducing oral steroid tablets, you may feel generally unwell even though your chest symptoms may be

improving. You might experience symptoms such as a stuffy or runny nose, weakness or joint or

muscle pain and rash (eczema). If any of these symptoms bother you, or if symptoms such as

headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor

immediately. You may need to take other medication if you develop allergic or arthritic symptoms.

Speak to your doctor if you are concerned as to whether you should continue to use Respimix


Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for

example, when you have a chest infection or before an operation).

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using Respimix Easyhaler, you should continue

to use Respimix Easyhaler but go to see your doctor as soon as possible, as you may need additional


Contact your doctor immediately if:

your breathing is getting worse or you often wake up at night with asthma.

your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

These signs could mean that your asthma or COPD is not being properly controlled and you may need

different or additional treatment immediately.


Use your Respimix Easyhaler every day.

This helps to prevent asthma symptoms from happening.

Adults (18 years and above)

The usual dose is 1 inhalation, twice a day.

Your doctor may increase this to 2 inhalations, twice a day.

If your symptoms are well controlled, your doctor may ask you to take your medicine once a


Adolescents (12 to 17 years)

The usual dose is 1 inhalation, twice a day.

If your symptoms are well controlled, your doctor may ask you to take your medicine once a


A lower strength of Respimix Easyhaler is available for children aged from 6 to 11 years.

Your doctor (or asthma nurse) will help you to manage your asthma. They will adjust the dose of this

medicine to the lowest dose that controls your asthma. However, do not adjust the dose without talking

to your doctor (or asthma nurse) first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen.

Always keep

your ‘reliever inhaler’ with you to use when you need it. Do not use Respimix Easyhaler to treat

asthma symptoms - use your reliever inhaler.

COPD (Chronic Obstructive Pulmonary Disease)

Only to be used by adults (aged 18 years and above).

The usual dose is 1 inhalation twice a day.

Your doctor may also prescribe other bronchodilator drugs, for example anticholinergics (such as

tiotropium or ipratropium bromide) for your COPD disease

If you use more Respimix Easyhaler than you should

It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor.

You should not exceed your prescribed dose without seeking medical advice.

The most common symptoms that may occur after if you use more Respimix Easyhaler 320/9 than you

should are trembling, headache or a rapid heart beat.

If you forget to use Respimix Easyhaler

If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for

your next dose, skip the missed dose.


take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

The instructions how to use the inhaler are at the end of the leaflet.


Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If either of the following happen to you, stop using Respimix Easyhaler and talk to your doctor


Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to

swallow) or hives together with difficulties to breath (angioedema) and/or sudden feeling of

faintness. This may mean that you are having an allergic reaction. This happens rarely, may

affect up to 1 in 1,000 people.

Sudden acute wheezing or shortness of breath immediately after using your inhaler.

If either of

these symptoms occur, stop using your Respimix Easyhaler inhaler straightaway and use

your ‘reliever’ inhaler. Contact your doctor immediately

as you may need to have your

treatment changed.

This happens very rarely, may affect up to 1 in 10,000 people.

Tell your doctor if you have any of the following while taking Respimix Easyhaler, they could be

symptoms of a lung infection:

fever or chills,

increased mucus production, change in mucus colour,

increased cough or increased breathing difficulties.

Pneumonia (infection of the lung) in COPD patients is a common side effect (may affect up to 1 in 10


Other possible side effects:

Common (may affect up to 1 in 10 people)

Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they

are usually mild and usually disappear as you continue to use Respimix Easyhaler.

Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with

water after using your Respimix Easyhaler.

Mild sore throat, coughing and a hoarse voice.


Uncommon (may affect up to 1 in 100 people)

Feeling restless, nervous or agitated.

Disturbed sleep.

Feeling dizzy.

Nausea (feeling sick).

Fast heart beat.

Bruising of the skin.

Muscle cramps.

Blurred vision.

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

Rash, itching.

Bronchospasm (tightening of the muscles in the airways which causes wheezing). If the

wheezing comes on suddenly after using Respimix Easyhaler stop using Respimix Easyhaler

and talk to your doctor immediately.

Low levels of potassium in your blood.

Uneven heart beat.

Very rare (may affect up to 1 in 10,000 people)


Changes in behaviour, especially in children.

Chest pain or tightness in the chest (angina pectoris).

An increase in the amount of sugar (glucose) in your blood.

Taste changes, such as an unpleasant taste in the mouth.

Changes in your blood pressure.

Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly

if you use high doses for a long time. The effects include:

changes in bone mineral density (thinning of the bones)

cataract (clouding of the lens in the eye)

glaucoma (increased pressure in the eye)

a slowing of the rate of growth of children and adolescents

an effect on the adrenal gland (a small gland next to the kidney).

These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via [to be completed nationally]. By

reporting side effects, you can help provide more information on the safety of this medicine.


How to store Respimix Easyhaler 320/9

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

Do not use this medicine after the expiry date that is stated on the carton, foil bag and label of your

inhaler after EXP. The expiry date refers to the last day of that month.

After opening the foil bag do not store above 25

C and store protected from moisture. It is

recommended to keep the Easyhaler in its protective cover.

If your Respimix Easyhaler gets damp you need to replace it with a new one.

Replace Respimix Easyhaler 4 months after you opened the foil bag


Write down the date you

opened the bag to help you remember.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how

to throw away medicines you no longer use. These measures will help to protect the environment.


Contents of the pack and other information

What Respimix Easyhaler 320/9 contains

The active substances are budesonide and formoterol fumarate dihydrate. Each inhaled dose

contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.

The other ingredient is lactose monohydrate (which contains milk proteins).

What Respimix Easyhaler 320/9 looks like and contents of the pack

Respimix Easyhaler 320/9 is an inhaler containing your medicine. The inhalation powder is white to

yellowish in colour. Each inhaler contains 60 doses and has a white body with red upper part.

Respimix Easyhaler 320/9 is available in packs of 1 or 3 inhaler(s).

Not all pack sizes may be marketed.

Your pack may contain a protective cover. If you need a protective cover, please contact the

Marketing Authorisation Holder (details given below).

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo



Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo


This leaflet was last revised in on 2021-03-17

How to use the Easyhaler inhaler

About your Easyhaler

Respimix Easyhaler may be different to inhalers you have used in the past. Therefore it is very

important that you use it properly as using incorrectly can lead to you not receiving the right amount

of medicine. This could make you very unwell or could lead to your asthma and COPD not being

treated as it should.

Your doctor, nurse or pharmacist will show you how to use your inhaler properly. Make sure you

understand the correct way to use the inhaler. If you are unsure contact your doctor, nurse or

pharmacist. As with all inhalers, caregivers should ensure that children prescribed Respimix Easyhaler

use correct inhalation technique, as described below.

When you first get your Easyhaler

The Easyhaler comes in a foil bag. Do not open the foil bag until

you are ready to start using the medicine as it helps to keep the

powder dry in the inhaler.

When you are ready to start treatment open the bag and record the

date e.g., in your calendar.

Use the inhaler within 4 months of removing from the foil bag.


Step 1:


Remove the dustcap

Shake the inhaler




holding it in the



SHAKE x 3-5

Important points to remember

It is important to keep the

inhaler in the upright position

If you accidentally click while

you shake the inhaler, empty the

powder from the mouthpiece as

shown below

Step 2


Keep holding the inhaler

upright between your forefinger

and thumb

Press down until you hear a

click, and let the inhaler click

back again. This releases a dose

Only click down once


Important points to remember

The inhaler will not click if the

dustcap is still on

Only click down once

If you accidentally click more

than once, empty the powder

from the mouthpiece, see below

Click to release dose before

you inhale, not at the same time

Keep the inhaler


when you click it and when you

inhale the dose. If you tip it, the

powder could fall out before

you are able to inhale it

Step 3


Keep holding the inhaler


Breathe out normally

Place the mouthpiece in your

mouth between your teeth and

close your lips tightly around

the mouthpiece

Take a strong and deep breath

Take the inhaler out of your

mouth, then breathe out



Important points to remember

Make sure the whole

mouthpiece is well inside your

mouth, so that the medication

gets into your lungs

Make sure your lips make a

good seal around the


Do not breathe out into the

inhaler. This is important: it

could clog up the inhaler. If you

breathed out into the inhaler,

empty the powder from

mouthpiece, see below

If you need to take another inhalation, please repeat the steps 1-3 Shake-Click-Inhale.

After you have used the inhaler:

Put the dust cap back on the mouthpiece. It stops the inhaler going off by accident.

After you have taken the dose, rinse your mouth with water, and spit it out.

How to empty the powder from the mouthpiece

If you click the inhaler by accident, or if you might have clicked

it more than once, or if you breathe out into it, empty the


Tap the mouthpiece to empty the powder onto a table top, or

the palm of your hand.

Then start again with steps Shake-Click-Inhale.

Cleaning the Easyhaler

Keep your inhaler dry and clean. If necessary you may wipe the mouthpiece of your inhaler with a dry

cloth or tissue. Do not use water: the powder in the Easyhaler is sensitive to moisture.

Using the Easyhaler with a protective cover

You may use a protective cover with your inhaler.This helps to

improve durability of the product. When you first insert your

inhaler in the protective cover make sure the dustcap is on the

inhaler as this stops it going off by accident. You can use the

inhaler without removing it from the protective cover.

Follow the same instructions as above,

1. Shake – 2. Click – 3.


Remember to:

Keep the

inhaler in the upright position when clicking it

Replace the dustcap after taking the dose as this stops the

inhaler going off by accident.

When to switch to a new Easyhaler

The dose counter shows the number of remaining doses. The

counter turns after every 5th click. When the dose counter starts

turning red, there are 20 doses left.

If you do not already have a new Easyhaler, contact your doctor

for a new prescription. When the counter reaches 0 (zero), you

need to replace the Easyhaler.

If you use the protective cover, you can keep it and insert your

new inhaler into it.


1. Shake – 2. Click – 3. Inhale.

After you have taken the dose, rinse your mouth with water and spit it out.

Do not get your inhaler wet, protect it from moisture.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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Respimix Easyhaler, 320 micrograms/9 micrograms/inhalation, inhalation powder.



Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide

320 micrograms/inhalation and formoterol fumarate dihydrate 9 micrograms/inhalation.

With the Easyhaler device the delivered dose (ex-actuator) contains similar quantity of active

substance as the metered dose (ex-reservoir).

Excipients with known effect: Lactose monohydrate 7600 micrograms per delivered dose.

For the full list of excipients, see section 6.1.



Inhalation powder in a device metered inhaler (Easyhaler).

White to yellowish powder.


Clinical particulars


Therapeutic indications


Respimix Easyhaler 320 micrograms/9 micrograms/inhalation is indicated in adults and adolescents

aged 12-17 years, for the regular treatment of asthma where use of a combination (inhaled

corticosteroid and long-acting β

-adrenoceptor agonist) is appropriate:

patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled

short-acting β

-adrenoceptor agonists.

patients already adequately controlled on both inhaled corticosteroids and long-acting β

adrenoceptor agonists.

Chronic Obstructive Pulmonary Disease (COPD)

Respimix Easyhaler 320 micrograms/9 micrograms/inhalation is indicated in adults, aged 18 years

and older, for the symptomatic treatment of patients with COPD with FEV

< 70% predicted normal

(post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy (see also

section 4.4).


Posology and method of administration



Respimix Easyhaler is not intended for the initial management of asthma. The dosage of the

components of Respimix Easyhaler is individual and should be adjusted to the severity of the disease.

This should be considered not only when treatment with combination products is initiated but also

when the maintenance dose is adjusted. If an individual patient should require a combination of doses

other than those available in the combination inhaler, appropriate doses of β

-adrenoceptor agonists

and/or corticosteroids by individual inhalers should be prescribed.

Recommended doses:

Adults (18 years and older):

1 inhalation twice daily. Some patients may require up to a maximum of

2 inhalations twice daily.

Paediatric population

Adolescents (12–17 years):

1 inhalation twice daily.

Children (6 years and older):

A lower strength (80 micrograms/4.5 micrograms/inhalation) is

available for children 6-11 years.

Children under 6 years

: As only limited data are available, Respimix Easyhaler is not recommended

for children younger than 6 years.

Patients should be regularly reassessed by their prescriber/healthcare provider, so that the dosage of

Respimix Easyhaler remains optimal. The dose should be titrated to the lowest dose at which effective

control of symptoms is maintained. When long-term control of symptoms is maintained with the

lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.

In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the

lowest effective dose could include Respimix Easyhaler given once daily, when in the opinion of the

prescriber, a long-acting bronchodilator would be required to maintain control.

Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying

condition and warrants a reassessment of the asthma therapy.

Respimix Easyhaler 320 micrograms/9 micrograms/inhalation should be used as maintenance therapy

only. Lower strengths (160 micrograms/4.5 micrograms/ inhalation and 80 micrograms/4.5

micrograms/inhalation) are available for the maintenance and reliever therapy regimen.


Recommended doses:


1 inhalation twice daily.

General information

Special patient groups:

There are no special dosing requirements for elderly patients. There are no data available for use of

Respimix Easyhaler in patients with hepatic or renal impairment. As budesonide and formoterol are

primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with

severe liver cirrhosis.

Method of administration

For inhalation use

Instructions for correct use of Respimix Easyhaler:

The inhaler is inspiratory flow-driven, which means that when the patient inhales through the

mouthpiece, the substance will follow the inspired air into the airways.



It is important to instruct the patient

To carefully read the instructions for use in the patient information leaflet which is packed

together with each Respimix Easyhaler.

To shake and actuate the inhaler prior to each inhalation.

To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is

delivered to the lungs.

Never to breathe out through the mouthpiece as this will result in a reduction in the delivered

dose. Should this happen the patient is instructed to tap the mouthpiece onto a table top or the

palm of a hand to empty the powder, and then to repeat the dosing procedure.

Never to actuate the device more than once without inhalation of the powder. Should this happen

the patient is instructed to tap the mouthpiece onto a table top or the palm of a hand to empty the

powder, and then to repeat the dosing procedure.

To always replace the dust cap (and, if in use, close the protective cover) after use to prevent

accidental actuation of the device (which could result in either overdosing or under dosing the

patient when subsequently used).

To rinse the mouth out with water after inhaling the maintenance dose to minimise the risk of

oropharyngeal thrush. If oropharyngeal thrush occurs, patients should also rinse their mouth with

water after the as-needed inhalations.

To clean the mouthpiece with a dry cloth at regular intervals. Water should never be used for

cleaning because the powder is sensitive to moisture.

To replace Respimix Easyhaler when the counter reaches zero even though powder can still be

observed within the inhaler.



Hypersensitivity to the active substances or to the excipient listed in section 6.1 (lactose,which

contains small amounts of milk protein).


Special warnings and precautions for use

It is recommended that the dose is tapered when the treatment is discontinued and should not be

stopped abruptly.

If patients find the treatment ineffective, or exceed the highest recommended dose of Respimix

Easyhaler, medical attention must be sought (see section 4.2). Increasing use of rescue

bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the

asthma therapy. Sudden and progressive deterioration in control of asthma or COPD is potentially life

threatening and the patient should undergo urgent medical assessment. In this situation, consideration

should be given to the need for increased therapy with corticosteroids, e.g. a course of oral

corticosteroids, or antibiotic treatment if an infection is present.

Patients should be advised to have rescue inhaler available at all times.

Patients should be reminded to take their Respimix Easyhaler maintenance dose as prescribed, even

when asymptomatic.

Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of

Respimix Easyhaler. Regular review of patients as treatment is stepped down is important. The lowest

effective dose of Respimix Easyhaler should be used (see section 4.2).

Patients should not be initiated on Respimix Easyhaler during an exacerbation, or if they have

significantly worsening or acutely deteriorating asthma.

Serious asthma-related adverse events and exacerbations may occur during treatment with Respimix

Easyhaler. Patients should be asked to continue treatment but to seek medical advice if asthma

symptoms remain uncontrolled or worsen after initiation of Respimix Easyhaler.

There are no clinical study data on budesonide/formoterol combination products available in COPD

patients with a pre-bronchodilator FEV

>50% predicted normal and with a post-bronchodilator FEV

<70% predicted normal (see section 5.1).

As with other inhalation therapy, paradoxical bronchospasm may occur, with an immediate increase

in wheezing and shortness of breath after dosing. If the patient experiences paradoxical bronchospasm

Respimix Easyhaler should be discontinued immediately, the patient should be assessed and an

alternative therapy instituted, if necessary. Paradoxical bronchospasm responds to a rapid-acting

inhaled bronchodilator and should be treated straightaway (see section 4.8).

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for

long periods. These effects are much less likely to occur with inhalation treatment than with oral

corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal

suppression, growth retardation in children and adolescents, decrease in bone mineral density,

cataract and glaucoma, and more rarely, a range of psychological or behavioural effects including

psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in

children) (see section 4.8).

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents

with symptoms such as blurred vision or other visual disturbances, the patient should be considered

for referral to an ophthalmologist for evaluation of possible causes which may include cataract,

glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported

after use of systemic and topical corticosteroids.

Potential effects on bone density should be considered, particularly in patients on high doses for

prolonged periods that have coexisting risk factors for osteoporosis. Long-term studies with inhaled

budesonide in children at mean daily doses of 400 micrograms (metered dose) or in adults at daily

doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral

density. No information regarding the effect at higher doses is available.

If there is any reason to suppose that adrenal function is impaired from previous systemic steroid

therapy, care should be taken when transferring patients to Respimix Easyhaler therapy.

The benefits of inhaled budesonide therapy would normally minimise the need for oral steroids, but

patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a

considerable time. Recovery may take a considerable amount of time after cessation of oral steroid

therapy and hence oral steroid-dependent patients transferred to inhaled budesonide may remain at

risk from impaired adrenal function for some considerable time. In such circumstances HPA axis

function should be monitored regularly.

Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended

doses, may also result in clinically significant adrenal suppression. Therefore additional systemic

corticosteroid cover should be considered during periods of stress such as severe infections or elective

surgery. Rapid reduction in the dose of steroids can induce acute adrenal crisis. Symptoms and signs

which might be seen in acute adrenal crisis may be somewhat vague but may include anorexia,

abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness,

seizures, hypotension and hypoglycaemia.

Treatment with supplementary systemic steroids or inhaled budesonide should not be stopped


During transfer from oral therapy to Respimix Easyhaler a generally lower systemic steroid action

will be experienced which may result in the appearance of allergic or arthritic symptoms such as

rhinitis, eczema and muscle and joint pain. Specific treatment should be initiated for these conditions.

A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such

as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the

dose of oral glucocorticosteroids is sometimes necessary.

To minimise the risk of oropharyngeal candida infection (see section 4.8), the patient should be

instructed to rinse their mouth out with water after inhaling the maintenance dose.

Concomitant treatment with itraconazole, ritonavir or other potent CYP3A inhibitors should be

avoided (see section 4.5). If this is not possible the time interval between administration of the

interacting drugs should be as long as possible.

Respimix Easyhaler should be administered with caution in patients with thyrotoxicosis,

phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive

cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe

cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

Caution should be observed when treating patients with prolongation of the QTc-interval. Formoterol

itself may induce prolongation of the QTc-interval.

The need for, and dose of inhaled corticosteroids should be re-evaluated in patients with active or

quiescent pulmonary tuberculosis, fungal and viral infections in the airways.

Potentially serious hypokalaemia may result from high doses of β

-adrenoceptor agonists.

Concomitant treatment of β

-adrenoceptor agonists with drugs which can induce hypokalaemia or

potentiate a hypokalaemic effect, e.g xanthine-derivatives, steroids and diuretics, may add to a

possible hypokalaemic effect of the β

-adrenoceptor agonist. Particular caution is recommended in

unstable asthma with variable use of rescue bronchodilators, in acute severe asthma as the associated

risk may be augmented by hypoxia and in other conditions when the likelihood for hypokalaemia is

increased. It is recommended that serum potassium levels are monitored during these circumstances.

As for all β

-adrenoceptor agonists, additional blood glucose controls should be considered in diabetic


Pneumonia in patients with COPD

An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been

observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an

increased risk of pneumonia with increasing steroid dose but this has not been demonstrated

conclusively across all studies.

There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia

risk among inhaled corticosteroid products.

Physicians should remain vigilant for the possible development of pneumonia in patients with COPD

as the clinical features of such infections overlap with the symptoms of COPD exacerbations.

Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass

index (BMI) and severe COPD.

Respimix Easyhaler contains approx. 8 mg of lactose per inhalation. This amount does not normally

cause problems in lactose intolerant people. The excipient lactose contains small amounts of milk

proteins, which may cause allergic reactions.

Paediatric populations

It is recommended that the height of children receiving prolonged treatment with inhaled

corticosteroids is regularly monitored. If growth is slowed, therapy should be re-evaluated with the

aim of reducing the dose of inhaled corticosteroid to the lowest dose at which effective control of

asthma is maintained, if possible. The benefits of the corticosteroid therapy and the possible risks of

growth suppression must be carefully weighed. In addition consideration should be given to referring

the patient to a paediatric respiratory specialist.

Limited data from long-term studies suggest that most children and adolescents treated with inhaled

budesonide will ultimately achieve their adult target height. However, an initial small but transient

reduction in growth (approximately 1 cm) has been observed. This generally occurs within the first

year of treatment.


Interaction with other medicinal products and other forms of interaction

Pharmacokinetic interactions

Potent inhibitors of CYP3A (e.g. ketoconazole, itraconazole, voriconazole, posaconazole,

clarithromycin, telithromycin, nefazodone, cobicistat and HIV protease inhibitors) are likely to

markedly increase plasma levels of budesonide and concomitant use should be avoided. If this is not

possible the time interval between administration of the inhibitor and budesonide should be as long as

possible (see section 4.4). In patients using potent CYP3A inhibitors, maintenance and reliever

therapy is not recommended.

The potent CYP3A4 inhibitor ketoconazole, 200 mg once daily, increased plasma levels of

concomitantly orally administered budesonide (single dose of 3 mg) on average six-fold. When

ketoconazole was administered 12 hours after budesonide the concentration was on average increased

only three-fold showing that separation of the administration times can reduce the increase in plasma

levels. Limited data about this interaction for high-dose inhaled budesonide indicates that marked

increases in plasma levels (on average four fold) may occur if itraconazole, 200 mg once daily, is

administered concomitantly with inhaled budesonide (single dose of 1000 µg).

Co-treatment with cobicistat-containing products, is expected to increase the risk of systemic side-

effects. The combination should be avoided unless the benefit outweighs the increased risk of

systemic corticosteroid side-effects, in which case patients should be monitored for systemic

corticosteroid side-effects.

Pharmacodynamic interactions

Beta-adrenergic blockers can weaken or inhibit the effect of formoterol. Respimix Easyhaler should

therefore not be given together with beta-adrenergic blockers (including eye drops) unless there are

compelling reasons.

Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines

(terfenadine) and tricyclic antidepressants can prolong the QTc-interval and increase the risk of

ventricular arrhythmias.

In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards


Concomitant treatment with monoamine oxidase inhibitors including agents with similar properties

such as furazolidone and procarbazine may precipitate hypertensive reactions.

There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with

halogenated hydrocarbons.

Concomitant use of other beta-adrenergic drugs or anticholinergic drugs can have a potentially

additive bronchodilating effect.

Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with

digitalis glycosides.

Budesonide and formoterol have not been observed to interact with any other drugs used in the

treatment of asthma.

Paediatric populations

Interaction studies have only been performed in adults


Fertility, pregnancy and lactation


For Respimix Easyhaler or the concomitant treatment with formoterol and budesonide, no clinical

data on exposed pregnancies are available. Data from an embryo-fetal development study in the rat

showed no evidence of any additional effect from the combination.

There are no adequate data from use of formoterol in pregnant women. In animal studies formoterol

has caused adverse effects in reproduction studies at very high systemic exposure levels (see

section 5.3).

Data on approximately 2000 exposed pregnancies indicate no increased teratogenic risk associated

with the use of inhaled budesonide. In animal studies glucocorticosteroids have been shown to induce

malformations (see section 5.3). This is not likely to be relevant for humans given recommended


Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased

risks for intrauterine growth retardation, adult cardiovascular disease and permanent changes in

glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the

teratogenic dose range.

During pregnancy, Respimix Easyhaler should only be used when the benefits outweigh the potential

risks. The lowest effective dose of budesonide needed to maintain adequate asthma control should be



Budesonide is excreted in breast milk. However, at therapeutic doses no effects on the suckling child

are anticipated. It is not known whether formoterol passes into human breast milk. In rats, small

amounts of formoterol have been detected in maternal milk. Administration of Respimix Easyhaler to

women who are breast-feeding should only be considered if the expected benefit to the mother is

greater than any possible risk to the child.


There is no data available on the potential effect of budesonide on fertility. Animal reproduction

studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic

exposure (see section 5.3).


Effects on ability to drive and use machines

Respimix Easyhaler has no or negligible influence on the ability to drive and use machines.


Undesirable effects

Since Respimix Easyhaler contains both budesonide and formoterol, the same pattern of undesirable

effects as reported for these substances may occur. No increased incidence of adverse reactions has

been seen following concurrent administration of the two compounds. The most common drug related

adverse reactions are pharmacologically predictable side-effects of β

agonist therapy, such as tremor

and palpitations. These tend to be mild and usually disappear within a few days of treatment.

Adverse reactions, which have been associated with budesonide or formoterol, are given below, listed

by system organ class and frequency. Frequencies are defined as: very common (

1/10), common

1/100 to < 1/10), uncommon (

1/1 000 to < 1/100), rare (

1/10 000 to < 1/1 000) and very rare

(< 1/10 000).

Table 1



Adverse Drug Reaction

Infections and infestations


Candida infections in the oropharynx, pneumonia

(in COPD patients)

Immune system disorders


Immediate and delayed hypersensitivity reactions,

e.g. exanthema, urticaria, pruritus, dermatitis,

angioedema and anaphylactic reaction

Endocrine disorders

Very rare

Cushing’s syndrome, adrenal suppression, growth

retardation, decrease in bone mineral density



Metabolism and nutrition


Very rare



Aggression, psychomotor hyperactivity, anxiety,

sleep disorders

Psychiatric disorders

Very rare

Depression, behavioural changes (predominantly

in children)


Headache, tremor



Nervous system disorders

Very rare

Taste disturbances


Vision, blurred (see also section 4.4)

Eye disorders

Very rare

Cataract and glaucoma






Cardiac arrhythmias, e.g. atrial fibrillation,

supraventricular tachycardia, extrasystoles

Cardiac disorders

Very rare

Angina pectoris. Prolongation of QTc- interval

Vascular disorders

Very rare

Variations in blood pressure


Mild irritation in the throat, coughing, hoarseness

Respiratory, thoracic and

mediastinal disorders



Gastrointestinal disorders



Skin and subcutaneous

tissue disorders



Musculoskeletal and

connective tissue disorders


Muscle cramps

Candida infection in the oropharynx is due to drug deposition. Advising the patient to rinse the mouth

out with water after each dose will minimise the risk. Oropharyngeal Candida infection usually

responds to topical anti-fungal treatment without the need to discontinue the inhaled corticosteroid.

As with other inhalation therapy, paradoxical bronchospasm may occur very rarely, affecting less than

1 in 10,000 people, with an immediate increase in wheezing and shortness of breath after dosing.

Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated

straightaway. Respimix Easyhaler should be discontinued immediately, the patient should be assessed

and an alternative therapy instituted if necessary (see section 4.4).

Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for

prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible

systemic effects include Cushing’s Syndrome, Cushingoid features, adrenal suppression, growth

retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.

Increased susceptibility to infections and impairment of the ability to adapt to stress may also occur.

Effects are probably dependent on dose, exposure time, concomitant and previous steroid exposure

and individual sensitivity.

Treatment with β

agonists may result in an increase in blood levels of insulin, free fatty acids,

glycerol and ketone bodies.

Paediatric populations

It is recommended that the height of children receiving prolonged treatment with inhaled

corticosteroids is regularly monitored (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the national reporting system

listed in Appendix V.



An overdose of formoterol would likely lead to effects that are typical for β

-adrenoceptor agonists:

tremor, headache, palpitations. Symptoms reported from isolated cases are tachycardia,

hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting. Supportive

and symptomatic treatment may be indicated. A dose of 90 micrograms administered during three

hours in patients with acute bronchial obstruction raised no safety concerns.

Acute overdosage with budesonide, even in excessive doses, is not expected to be a clinical problem.

When used chronically in excessive doses, systemic glucocorticosteroid effects, such as

hypercorticism and adrenal suppression, may appear.

If Respimix Easyhaler therapy has to be withdrawn due to overdose of the formoterol component of

the drug, provision of appropriate inhaled corticosteroid therapy must be considered.




Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for obstructive airway diseases: Adrenergics in combination with

corticosteroids or other drugs, excl. anticholinergics.

ATC-code: R03AK07

Mechanisms of action and Pharmacodynamic effects

Respimix Easyhaler contains formoterol and budesonide, which have different modes of action and

show additive effects in terms of reduction of asthma exacerbations. The mechanisms of action of the

two substances respectively are discussed below.


Budesonide is a glucocorticosteroid which when inhaled has a dose-dependent anti-inflammatory

action in the airways, resulting in reduced symptoms and fewer asthma exacerbations. Inhaled

budesonide has less severe adverse effects than systemic corticosteroids. The exact mechanism

responsible for the anti-inflammatory effect of glucocorticosteroids is unknown.


Formoterol is a selective β

-adrenoceptor adrenergic agonist that when inhaled results in rapid and

long-acting relaxation of bronchial smooth muscle in patients with reversible airways obstruction. The

bronchodilating effect is dose-dependant, with an onset of effect within 1-3 minutes. The duration of

effect is at least 12 hours after a single dose.

Clinical efficacy and safety (Clinical trials were not conducted with Respimix Easyhaler unless



Clinical studies in adults have shown that the addition of formoterol to budesonide improved asthma

symptoms and lung function, and reduced exacerbations. In two 12-week studies the effect on lung

function of budesonide/formoterol was equal to that of the free combination of budesonide and

formoterol, and exceeded that of budesonide alone. All treatment arms used a short-acting β

adrenoceptor agonist as needed. There was no sign of attenuation of the anti-asthmatic effect over


A randomised, double-blind study in 72 adult asthmatics (aged 18-70 years) was performed to

evaluate efficacy of Respimix Easyhaler compared to Symbicort Turbuhaler after a single dose. The

enrolled patients had stable but less than optimally controlled asthma and their FEV1 was on average

1.92 L (62% of the predicted value). Two dose levels of formoterol were tested for both products, 9

μg and 36 μg (one or four inhalations of the 320/9 μg/inhalation strength). The difference in the

primary parameter, average FEV1 over 12 hours, was negligible between the treatments at both doses.

At the lower dose the difference between the treatments (Easyhaler-Turbuhaler) was 0.013 L (95% CI

from -0.047 to 0.073 L) and at the higher dose -0.028 L (95% CI from -0.087 to 0.032 L).The study

results confirmed equivalent bronchodilator efficacy between Respimix Easyhaler and Symbicort


Two 12-week paediatric studies have been performed in which 265 children aged 6–11 years were

treated with a maintenance dose of budesonide/formoterol (2 inhalations of

80 micrograms/4.5 micrograms/inhalation twice daily), and a short acting β

-adrenoceptor agonist as

needed. In both studies, lung function was improved and the treatment was well tolerated compared to

the corresponding dose of budesonide alone.


In two 12-month studies, the effect on lung function and the rate of exacerbation (defined as courses

of oral steroids and/or course of antibiotics and/or hospitalisations) in patients with moderate to

severe COPD was evaluated. The inclusion criteria for both studies was pre-bronchodilator FEV

<50% predicted normal. Median post-bronchodilator FEV

at inclusion in the trials was 42%

predicted normal. The mean number of exacerbations per year (as defined above) was significantly

reduced with budesonide/formoterol as compared with treatment with formoterol alone or placebo

(mean rate 1.4 compared with 1.8-1.9 in the placebo/formoterol group). The mean number of days on

oral corticosteroids/patient during the 12 months was slightly reduced in the budesonide/formoterol

group (7-8 days/patient/year compared with 11-12 and 9-12 days in the placebo and formoterol

groups, respectively). For changes in lung-function parameters, such as FEV

, budesonide/formoterol

was not superior to treatment with formoterol alone.


Pharmacokinetic properties


Respimix Easyhaler and Symbicort Turbuhaler fixed-dose combination of budesonide and formoterol

have been shown to be bioequivalent with regard to total systemic exposure and exposure via the


Symbicort Turbuhaler fixed-dose combination of budesonide and formoterol, and the corresponding

monoproducts have been shown to be bioequivalent with regard to systemic exposure of budesonide

and formoterol, respectively. In spite of this, a small increase in cortisol suppression was seen after

administration of the fixed-dose combination compared to the monoproducts. The difference is

considered not to have an impact on clinical safety.

There was no evidence of pharmacokinetic interactions between budesonide and formoterol.

Pharmacokinetic parameters for the respective substances were comparable after the administration of

budesonide and formoterol as monoproducts or as the fixed-dose combination. For budesonide, AUC

was slightly higher, rate of absorption more rapid and maximal plasma concentration higher after

administration of the fixed combination. For formoterol, maximal plasma concentration was similar

after administration of the fixed combination. Inhaled budesonide is rapidly absorbed and the

maximum plasma concentration is reached within 30 minutes after inhalation. In studies, mean lung

deposition of budesonide after inhalation via the powder inhaler ranged from 32% to 44% of the

delivered dose. The systemic bioavailability is approximately 49% of the delivered dose. In children

6-16 years of age the lung deposition falls in the same range as in adults for the same given dose. The

resulting plasma concentrations were not determined.

Inhaled formoterol is rapidly absorbed and the maximum plasma concentration is reached within

10 minutes after inhalation. In studies the mean lung deposition of formoterol after inhalation via the

powder inhaler ranged from 28% to 49% of the delivered dose. The systemic bioavailability is about

61% of the delivered dose.

Distribution and biotransformation

Plasma protein binding is approximately 50% for formoterol and 90% for budesonide. Volume of

distribution is about 4 l/kg for formoterol and 3 l/kg for budesonide. Formoterol is inactivated via

conjugation reactions (active O-demethylated and deformylated metabolites are formed, but they are

seen mainly as inactivated conjugates). Budesonide undergoes an extensive degree (approximately

90%) of biotransformation on first passage through the liver to metabolites of low glucocorticosteroid

activity. The glucocorticosteroid activity of the major metabolites, 6-beta-hydroxy-budesonide and

16-alfa-hydroxy-prednisolone, is less than 1% of that of budesonide. There are no indications of any

metabolic interactions or any displacement reactions between formoterol and budesonide.


The major part of a dose of formoterol is transformed by liver metabolism followed by renal

elimination. After inhalation, 8% to 13% of the delivered dose of formoterol is excreted

unmetabolised in the urine. Formoterol has a high systemic clearance (approximately 1.4 l/min) and

the terminal elimination half-life averages 17 hours.

Budesonide is eliminated via metabolism mainly catalysed by the enzyme CYP3A4. The metabolites

of budesonide are eliminated in urine as such or in conjugated form. Only negligible amounts of

unchanged budesonide have been detected in the urine. Budesonide has a high systemic clearance

(approximately 1.2 l/min) and the plasma elimination half-life after i.v. dosing averages 4 hours.

The pharmacokinetics of formoterol in children have not been studied. The pharmacokinetics of

budesonide or formoterol in patients with renal failure are unknown. The exposure of budesonide and

formoterol may be increased in patients with liver disease.


Systemic exposure for both budesonide and formoterol correlates in a linear fashion to administered


Respimix Easyhaler pharmacokinetic profile

In pharmacokinetic studies with and without a charcoal blockage, Respimix Easyhaler was evaluated

by comparing it with an alternative authorised fixed-dose combination inhaled product containing the

same active substances, budesonide and formoterol and has been shown to be equivalent in both

systemic exposure (safety) and pulmonary deposition (efficacy).


Preclinical safety data

The toxicity observed in animal studies with budesonide and formoterol, given in combination or

separately, were effects associated with exaggerated pharmacological activity.

In animal reproduction studies, corticosteroids such as budesonide have been shown to induce

malformations (cleft palate, skeletal malformations). However, these animal experimental results do

not seem to be relevant in humans at the recommended doses. Animal reproduction studies with

formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure and

implantation losses as well as decreased early postnatal survival and birth weight at considerably

higher systemic exposures than those reached during clinical use. However, these animal

experimental results do not seem to be relevant in humans.




List of excipients

Lactose monohydrate (which contains milk proteins).



Not applicable.


Shelf life

As packaged for sale: 2 years.

After first opening the laminate bag: 4 months. Do not store above 25°C and protect from moisture.


Special precautions for storage

This medicinal product does not require any special storage conditions.

For storage conditions after first opening of the medicinal product, see section 6.3.


Nature and contents of container

The multidose powder inhaler consists of seven plastic parts and a stainless steel spring. The plastic

materials of the inhaler are: polybutylene terepthalate, low density polyethylene, polycarbonate,

styrene butadiene, polypropylene. The inhaler is sealed in a laminate bag and packed with or without

a protective cover (polypropylene and thermoplastic elastomer) in a cardboard box.


Respimix Easyhaler 320/9 micrograms/inhalation, inhalation powder:

60 doses

60 doses + protective cover

180 doses (3 x 60 doses)

Not all packs may be marketed.


Special precautions for disposal

No special requirements



Orion Corporation

Orionintie 1

FI-02200 Espoo




[To be completed nationally]



[To be completed nationally]



14 July 2017

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