Fobumix Easyhaler 320 mikrogram/9 mikrogram/inhalation Inhalationspulver

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

21-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

21-04-2018

Aktiva substanser:
budesonid; formoterolfumaratdihydrat
Tillgänglig från:
Orion Corporation
ATC-kod:
R03AK07
INN (International namn):
budesonide; formoterol
Dos:
320 mikrogram/9 mikrogram/inhalation
Läkemedelsform:
Inhalationspulver
Sammansättning:
budesonid 320 mikrog Aktiv substans; formoterolfumaratdihydrat 9 mikrog Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Inhalator, 60 doser; Inhalator, 60 doser med fodral; Inhalator, 180 (3 x 60) doser
Bemyndigande status:
Godkänd
Godkännandenummer:
54363
Tillstånd datum:
2017-01-13

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

08-05-2020

Produktens egenskaper Produktens egenskaper - engelska

09-06-2017

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

13-01-2017

Läs hela dokumentet

QR code to www.oeh.fi/ xxxx [to be completed nationally].

Scan this code or visit www.oeh.fi/ xxxx [to be completed nationally] to see instructions on how to use

Easyhaler

Package leaflet: Information for the patient

Fobumix 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 Fobumix Easyhaler 320/9 is and what it is used for

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

How to use Fobumix Easyhaler 320/9

Possible side effects

How to store Fobumix Easyhaler 320/9

Contents of the pack and other information

1.

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

Fobumix Easyhaler is an inhaler that is used to treat asthma in adults aged 18 years and older. 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

beta

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

airways. This helps you to breathe more easily.

Fobumix Easyhaler is indicated for use in adults 18 years of age and older only.

Fobumix Easyhaler is NOT indicated for use in children 12 years of age and younger or adolescents

13 to 17 years of age.

2.

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

Do not use Fobumix 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 Fobumix 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.

Children and adolescents

This medicine should not be used in children or adolescents under the age of 18 years.

Other medicines and Fobumix 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 Fobumix Easyhaler and your doctor may wish to monitor

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

cobicistat).

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

pressure.

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

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

asthma.

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).

Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as phenelzine).

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

Fobumix 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 Fobumix Easyhaler unless your doctor tells you to.

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

talk to your doctor immediately.

Driving and using machines

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

Fobumix 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

intolerant.

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

3.

How to use Fobumix Easyhaler 320/9

Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of

formoterol fumarate dihydrate. This dose corresponds to that received from other

budesonide/formoterol combination products which have a metered dose of 400 micrograms of

budesonide and 12 micrograms of formoterol fumarate dihydrate but similar delivered doses to

Fobumix Easyhaler.

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 Fobumix 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 Fobumix 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 Fobumix

Easyhaler.

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 Fobumix Easyhaler, you should continue

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

treatment.

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.

ASTHMA

Use your Fobumix 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

day.

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 Fobumix 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 Fobumix 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 Fobumix Easyhaler 320/9 than you

should are trembling, headache or a rapid heart beat.

If you forget to use Fobumix 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.

not

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.

4.

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 Fobumix Easyhaler and talk to your doctor

immediately:

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 Fobumix 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 Fobumix 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 people).

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 Fobumix Easyhaler.

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

water after using your Fobumix Easyhaler.

Mild sore throat, coughing and a hoarse voice.

Headache.

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 Fobumix Easyhaler stop using Fobumix 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)

Depression.

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

tablets.

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.

5.

How to store Fobumix 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 Fobumix Easyhaler gets damp you need to replace it with a new one.

Replace Fobumix 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.

6.

Contents of the pack and other information

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

Fobumix 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.

Fobumix 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

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

This leaflet was last revised on 2020-05-04

Detailed and updated information on how to use this product is available by scanning this QR code

(included also on the outer carton and inhaler label) with a smartphone. The same information is also

available on the following URL: www.oeh.fi/ xxxx [to be completed nationally].

QR code to www.oeh.fi/ xxxx [to be completed nationally].

How to use the Easyhaler inhaler

About your Easyhaler

Fobumix 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 Fobumix Easyhaler

use correct inhalation technique, as described below. You can also use the instruction video at

www.oeh.fi/ xxxx [to be completed nationally].

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.

HOW TO USE CORRECTLY

Step 1:

SHAKE

Remove the dustcap

Shake the inhaler

3

5

times

holding it in the

upright

position

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

CLICK

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

CLICK x 1

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

upright

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

INHALE

Keep holding the inhaler

upright

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

normally.

INHALE

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

mouthpiece

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

mouthpiece.

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.

Inhale.

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.

Remember

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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SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE MEDICINAL PRODUCT

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

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

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

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

With the Fobumix Easyhaler device the delivered dose (the dose that leaves the mouthpiece) contains a

similar quantity of active substance as the metered dose. Excipients with known effect: Lactose

monohydrate 7600 micrograms per delivered dose.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Inhalation powder in a device metered inhaler (Easyhaler) which is white with a red cap.

White to yellowish powder.

4.

Clinical particulars

4.1

Therapeutic indications

Fobumix Easyhaler is indicated in adults 18 years of age and older only.

Asthma

Fobumix Easyhaler 320 micrograms/9 micrograms/inhalation is indicated 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

-adrenoceptor agonists.

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

-adrenoceptor

agonists.

Chronic Obstructive Pulmonary Disease (COPD)

Fobumix 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).

4.2

Posology and method of administration

Posology

Fobumix Easyhaler is indicated in adults 18 years of age and older only.

Fobumix Easyhaler is not indicated for use in children, 12 years of age and younger or adolescents, 13 to

17 years of age.

Asthma

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

Fobumix 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.

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

Fobumix 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 Fobumix 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.

Fobumix 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.

Paediatric population

This medicinal product is not recommended for use in children and adolescents under the age of 18 years.

COPD

Recommended doses:

Adults (18 years and older):

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

Fobumix 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

The delivered dose corresponds to that received from other budesonide/formoterol combination products

which have a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate

dihydrate but similar delivered doses to Fobumix Easyhaler.

Instructions for correct use of Fobumix 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.

Note

:

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 Fobumix Easyhaler.

To hold the inhaler upright, gripping it between finger and thumb

To vigorously shake the inhaler up and down 3 to 5 times before actuation

To actuate (click) the inhaler before 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 Fobumix Easyhaler when the counter reaches zero even though powder can still be observed

within the inhaler.

4.3

Contraindications

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

small amounts of milk protein).

4.4

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 Fobumix 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 Fobumix Easyhaler maintenance dose as prescribed, even when

asymptomatic.

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

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

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

Patients should not be initiated on Fobumix 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 Fobumix

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

remain uncontrolled or worsen after initiation of Fobumix 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

Fobumix 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 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 Fobumix 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 abruptly.

During transfer from oral therapy to Fobumix 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.

Fobumix 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

patients.

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.

Fobumix 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.

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.

4.5

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. Fobumix 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

-sympathomimetics.

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

4.6

Fertility, pregnancy and lactation

Pregnancy

For Fobumix 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 doses.

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, Fobumix 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 used.

Breast-feeding

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 Fobumix 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.

Fertility

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).

4.7

Effects on ability to drive and use machines

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

4.8

Undesirable effects

Since Fobumix 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.

Fobumix Easyhaler is not indicated in children and adolescents under the age of 18 years (see section 4.2).

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

SOC

Frequency

Adverse Drug Reaction

Infections and infestations

Common

Candida infections in the oropharynx, pneumonia

(in COPD patients)

Immune system disorders

Rare

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

Rare

Hypokalaemia

Metabolism and nutrition

disorders

Very rare

Hyperglycaemia

Uncommon

Aggression, psychomotor hyperactivity, anxiety,

sleep disorders

Psychiatric disorders

Very rare

Depression, behavioural changes (predominantly

in children)

Common

Headache, tremor

Uncommon

Dizziness

Nervous system disorders

Very rare

Taste disturbances

Uncommon

Vision, blurred (see also section 4.4)

Eye disorders

Very rare

Cataract and glaucoma

Common

Palpitations

Uncommon

Tachycardia

Rare

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

Common

Mild irritation in the throat, coughing, hoarseness

Respiratory, thoracic and

mediastinal disorders

Rare

Bronchospasm

Gastrointestinal disorders

Uncommon

Nausea

Skin and subcutaneous

tissue disorders

Uncommon

Bruises

Musculoskeletal and

connective tissue disorders

Uncommon

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.

Fobumix 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.

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.

4.9

Overdose

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 Fobumix 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.

5.

PHARMACOLOGICAL PROPERTIES

5.1

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

Fobumix 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

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

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

Asthma

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 time.

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

efficacy of Fobumix 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. 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 Fobumix Easyhaler and Symbicort

Turbuhaler.

COPD

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.

5.2

Pharmacokinetic properties

Absorption

Fobumix 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 lungs.

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.

Elimination

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.

Linearity/non-linearity

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

5.3

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.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose monohydrate (which contains milk proteins).

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

As packaged for sale: 2 years.

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

6.4

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.

6.5

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 foil wrapping and packed with or without a protective

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

Packages:

Fobumix 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.

6.6

Special precautions for disposal

No special requirements

7.

MARKETING AUTHORISATION HOLDER

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

8.

MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

[To be completed nationally]

10.

DATE OF REVISION OF THE TEXT

9 June 2017

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