DUORESP® SPIROMAX® DRY POWDER FOR INHALATION 320 MCG9 MCG

Singapore - English - HSA (Health Sciences Authority)

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Active ingredient:
Budesonide (micronised); Formoterol fumarate dihydrate (micronised)
Available from:
DRUG HOUSES OF AUSTRALIA PTE. LTD.
ATC code:
R03AK07
Pharmaceutical form:
POWDER, METERED
Composition:
Budesonide (micronised) 320 mcg / inhalation; Formoterol fumarate dihydrate (micronised) 9 mcg / inhalation
Administration route:
RESPIRATORY (INHALATION)
Prescription type:
Prescription Only
Manufactured by:
Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland
Authorization status:
ACTIVE
Authorization number:
SIN16057P
Authorization date:
2020-12-07

Read the complete document

Dry powder for inhalation

budesonide/formoterol fumarate dihydrate

320 mcg/9 mcg

Dry powder for inhalation

budesonide/formoterol fumarate dihydrate

Read all of this leaflet carefully before you start using 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, pharmacist or

nurse.

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, pharmacist or

nurse. This includes any possible side effects not listed in this

leaflet. See section 4.

What is in this leaflet

1. What DuoResp Spiromax is and what it is used for

2. What you need to know before you use DuoResp

Spiromax

3. How to use DuoResp Spiromax

4. Possible side effects

5.How to store DuoResp Spiromax

6.Contents of the pack and other information

1.

What DuoResp Spiromax is and what

it is used for

DuoResp Spiromax contains two different active substances:

budesonide and formoterol fumarate dihydrate.

Budesonide belongs to a group of medicines called ‘corticosteroids’

also known as ‘steroids’. It works by reducing and preventing

swelling and inflammation in your lungs and helps you to breathe

more easily.

Formoterol fumarate dihydrate belongs to a group of medicines

called ‘long-acting β

adrenoceptor agonists’ or ‘bronchodilators’.

It works by relaxing the muscles in your airways. This will help to

open the airways and help you to breathe more easily.

Your doctor has prescribed this medicine to treat asthma or chronic

obstructive pulmonary disease (COPD).

Asthma

When used for asthma, your doctor will prescribe DuoResp Spiromax

together with a separate ‘reliever inhaler’ such as salbutamol.

Use DuoResp Spiromax every day. This helps to prevent asthma

symptoms such as breathlessness and wheezing from occurring.

Use the ‘reliever inhaler’ when you get asthma symptoms, to make

it easier to breathe again.

Do not use DuoResp Spiromax 320/9 micrograms as a ‘reliever inhaler’.

Chronic obstructive pulmonary disease (COPD)

COPD is a long-term lung disease of the airways in the lungs, which is

often caused by cigarette smoking. Symptoms include shortness of

breath, cough, chest discomfort and coughing up mucus. DuoResp

Spiromax can also be used to treat the symptoms of COPD in

adults only.

2.

What you need to know before you

use DuoResp Spiromax

Do not use DuoResp Spiromax if

You are allergic to budesonide, formoterol fumarate dihydrate, or the

other ingredient in this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor,pharmacist or nurse before taking DuoResp

Spiromax if

you are diabetic.

you have a lung infection.

you have high blood pressure or you have ever had a heart problem

(including an uneven heartbeat, a very fast pulse, narrowing of the

arteries or heart failure).

you have problems with your thyroid or adrenal glands.

you have low levels of potassium in your blood.

you have severe liver problems.

you regularly drink alcohol.

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 DuoResp Spiromax. If you have been taking steroid tablets for

a long time, your doctor may want you to have regular blood tests.

When reducing 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 medicines if you develop allergic or

arthritic symptoms. You should speak to your doctor if you are

concerned as to whether you should continue to use DuoResp

Spiromax.

Your doctor may consider adding steroid tablets to your usual

treatment if you have an illness such as a chest infection or before an

operation.

Contact your doctor if you experience blurred vision or other visual

disturbances.

This medicine should not be used in children under the age of

12 years.

Other medicines and DuoResp Spiromax

Tell your doctor or pharmacist if you are taking, have recently taken or

might take any other medicines.

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

following medicines:

β blockers (such as atenolol or propranolol for high blood pressure

or a heart condition), including eyedrops (such as timolol for

glaucoma).

Oxytocin which is given to pregnant women to induce labour.

Medicines for a fast or uneven heartbeat (such as quinidine,

disopyramide, procinamide and terfanidine).

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 tablets 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 antidepressants (such as amitriptyline) and the

antidepressant nefazodone.

Antidpressant medicines such as monoamine oxidase inhibitors and

those with similar properties (such as the antibiotic furazolidine

and the chemotherapy medicine procarbazine).

Antipsychotic phenothiazine medicines (such as chlorpromazine

and prochlorperazine).

Medicines called ‘HIV protease inhibitors’ (such as ritonavir) to treat

HIV infection.

Medicines to treat infections (such as ketoconazole, itraconazole,

voriconazole, posaconazole, clarithromycin and telithromycin).

Medicines for Parkinson’s disease (such as levodopa).

Medicines for thyroid problems (such as levothyroxine).

Some medicines may increase the effects of DuoResp Spiromax and

your doctor may wish to monitor you carefully if you are taking these

medicines (including some medicines for HIV: ritonavir, cobicistat).

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

doctor,pharmacist or nurse before using DuoResp Spiromax.

Also tell your doctor,pharmacist or nurse if you are going to have a

general anaesthetic for an operation or for dental work to help lower

any risk of interaction with the anesthetic you receive.

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, pharmacist or nurse

for advice before taking DuoResp Spiromax - do NOT use this

medicine unless your doctor tells you to.

If you get pregnant while using DuoResp Spiromax, do NOT stop

using DuoResp Spiromax but talk to your doctor immediately.

Driving and using machines

DuoResp Spiromax is not likely to affect your ability to drive or to use

tools or machines.

DuoResp Spiromax contains lactose

Lactose is a type of sugar found in milk. If you have been told by your

doctor that you have an intolerance to some sugars, talk to your

doctor before using this medicine.

3.

How to use DuoResp Spiromax

Always use this medicine exactly as your doctor or pharmacist has

told you. Check with your doctor pharmacist, or nurse if you are

not sure.

It is important to use DuoResp Spiromax every day, even if you

have no asthma or COPD symptoms at the time.

If you are using DuoResp Spiromax for asthma, your doctor will

want to regularly check your symptoms.

Asthma

Use your DuoResp Spiromax every day. This helps to prevent

asthma symptoms from occurring.

Recommended dose:

Adults (18 years and older)

1 inhalation (actuation), twice a day, taken in the morning and in the

evening

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.

Adolescents (12 – 17 years)

1 inhalation twice daily.

Your doctor will help you to manage your asthma and will adjust the

dose of this medicine to the lowest dose that controls your asthma. If

your doctor feels that you need a lower dose than is available from

your DuoResp Spiromax, your doctor may prescribe an alternative

inhaler containing the same active substances as your DuoResp

Spiromax but with a lower dose of the corticosteroid. However, do not

adjust the number of inhalations your doctor has prescribed without

talking to your doctor first.

Use your separate ‘reliever inhaler’ to treat asthma symptoms

when they happen.

Always keep your ‘reliever inhaler’ with you and use it to relieve

sudden attacks of breathlessness and wheezing. Do not use DuoResp

Spiromax to treat these asthma symptoms.

Chronic Obstructive Pulmonary Disease (COPD)

Recommended dose:

Adults:

1 inhalation twice a day, taken in the morning and in the evening.

Preparing your new DuoResp Spiromax

Before using your DuoResp Spiromax for the first time, you need to

prepare it for use as follows:

Open the foil pouch by tearing at the notch at the top of the foil

pouch and take out the inhaler

Check the dose indicator to see that there are 60 inhalations in the

inhaler.

Write the date you opened the foil pouch on the label of the

inhaler.

Do not shake your inhaler before use.

How to take an inhalation

Every time you need to take an inhalation, follow the instructions

below.

Hold your inhaler with the semi-transparent wine red

mouthpiece cover at the bottom.

Open the mouthpiece cover by folding it down until one loud click

is heard. Your medicine is actively metered. Your inhaler is now

ready for use.

OPEN

AIR VENT

Do not

block

Breathe out gently (as far as is comfortable). Do not breathe out

through your inhaler.

Place the mouthpiece between your teeth. Do not bite the

mouthpiece. Close your lips around the mouthpiece. Take care not

to block the air vents.

Breathe in through your mouth as deeply and as hard as you can.

BREATHE

Remove your inhaler from your mouth. You may notice a taste

when you take your inhalation

Hold your breath for 10 seconds or as long as you comfortably

can.

Then breathe out gently (do not breathe out through the

inhaler). Close the mouthpiece cover.

CLOSE

If you are to take a second inhalation, repeat steps 1 to 7.

Rinse your mouth with water after every dose and spit it out.

Do not try to take your inhaler apart, remove or twist the mouthpiece

cover, it is fixed to your inhaler and must not be taken off. Do not use

your Spiromax if it has been damaged or if the mouthpiece has come

apart from your Spiromax. Do not open and close the mouthpiece

cover unless you are about to use your inhaler.

Cleaning your Spiromax

Keep your Spiromax dry and clean.

If necessary you may wipe the mouthpiece of your Spiromax after use

with a dry cloth or tissue.

When to start using a new Spiromax

The dose indicator tells you how many doses (inhalations) are left

in your inhaler, starting with 60 inhalations when it is full and

ending with 0 (zero) inhalations when it is empty.

The dose indicator, on the rear of the device, shows the number of

inhalations remaining as even numbers. The spaces between the

even numbers represent the odd number of remaining inhalations.

For inhalations remaining from 20 downwards to ‘8’, ‘6’, ‘4’, ‘2’ the

numbers are displayed in red on a white background. When the

numbers become red in the window, you should consult your doctor

and obtain a new inhaler.

Note:

The mouthpiece will still ‘click’ even when your Spiromax is empty.

If you open and close the mouthpiece without taking an inhalation,

the dose indicator will still register it as a count. This dose will be

securely held inside the inhaler for when the next inhalation is due. It

is impossible to accidentally take extra medicine or a double dose in

one inhalation.

Keep the mouthpiece closed all the time unless you are about to

use your inhaler.

Important information about your asthma or COPD symptoms

If you feel you are getting breathless or wheezy while using DuoResp

Spiromax, you should continue to use DuoResp Spiromax 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

breathlessness and wheezing.

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.

Once your asthma is well controlled your doctor may consider it

appropriate to gradually reduce the dose of DuoResp Spiromax.

If you use more DuoResp Spiromax than you should

It is important that you take your dose as advised by your doctor. You

should not exceed your prescribed dose without seeking medical

advice.

If you use more DuoResp Spiromax than you should, contact your

doctor, pharmacist or nurse for advice.

The most common symptoms that may occur after when you use more

DuoResp Spiromax than you should are trembling, headache or a rapid

heartbeat.

If you forget to use DuoResp Spiromax

If you forget to take a dose, take it as soon as you remember.

However, do not take a double dose to make up for a forgotten dose.

If it is nearly time for your next dose just take your next dose at the

usual time.

If you become wheezy or breathless, or develop any other symptoms

of an asthma attack, use your ‘reliever inhaler’, then seek medical

advice.

If you stop using DuoResp Spiromax

Do not stop using your inhaler without telling your doctor first.

If you have any further questions on the use of this medicine, ask

your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not

everybody gets them.

If any of the following happen to you, stop using DuoResp

Spiromax and talk to your doctor immediately:

Rare side effects: may affect up to 1 in 1,000 people

Swelling of your face, particularly around your mouth (tongue and/

or throat and/or difficulty to swallow) or hives together with

difficulties to breathe (angioedema) and/or sudden feeling of

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

which may also include rash and itching.

Bronchospasm (tightening of the muscles in the airways which causes

wheezing and shortness of breath). If the wheezing comes on

suddenly after using this medicine stop using it and talk to your doctor

immediately (see below).

Very rare side effects: may affect up to 1 in 10,000 people

Sudden, unexpected and acute wheezing and/or shortness of

breath immediately after using your inhaler (also referred to as

‘paradoxical bronchospasm’. If either of these symptoms occur,

stop using DuoResp Spiromax straightaway and use your

’reliever inhaler’ if you have one. Contact your doctor immediately

as you may need to have your treatment changed.

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 DuoResp Spiromax.

Thrush (a fungal infection) in the mouth. This is less likely to occur

if you rinse your mouth out with water after using your medicine.

Mild sore throat, coughing and a hoarse voice.

Headache.

Pneumonia (infection to the lung) in COPD patients.

Tell your doctor if you have any of the following while taking DuoResp

Spiromax they could be symptoms of a lung infection:

Fever or chills

Increased mucus production, change in mucus colour

Increased cough or increased breathing difficulties

Uncommon: may affect up to 1 in 100 people

Feeling restless, nervous, agitated, anxious or angry.

Disturbed sleep.

Feeling dizzy.

Nausea (feeling sick).

Fast heartbeat.

Bruising of the skin.

Muscle cramps

Blurred vision.

Rare:

Low levels of potassium in your blood.

Uneven heartbeat.

Very rare:

Depression.

Changes in behaviour, especially in children.

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

Disturbance of the heart’s electrical system which does not cause

symptoms (prolongation of the QTc-interval).

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

you have a blood test.

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).

Symptoms of adrenal gland suppression could be tiredness,

weakness, stomach problems, including nausea, vomiting, pain and

diarrhoea, darkening of the skin and weight loss.

These effects happen very rarely and 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, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet.

5.

How to store DuoResp Spiromax

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

Do not use this medicine after the expiry date which is stated on

the carton or on the label of your inhaler after EXP. The expiry date

refers to the last day of that month.

Do not store above 30

C. Keep the mouthpiece cover closed

after removal of the foil wrapping.

Use within 3 months of removing from the foil wrapping.

Use the label on the inhaler to write down the date you open the

foil pouch.

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 protect the environment.

6.

Contents of the pack and other

information

What DuoResp Spiromax contains

— The active substances are budesonide and formoterol fumarate

dihydrate. Each delivered (inhaled) dose contains

320 micrograms of budesonide and 9 micrograms of formoterol

fumarate dihydrate. This is equivalent to a metered dose of

400 micrograms of budesonide and 12 micrograms of formoterol

fumarate dihydrate.

— The other ingredient is lactose monohydrate (see section 2

under ‘DuoResp Spiromax contains lactose’).

What DuoResp Spiromax looks like and contents of the pack

DuoResp Spiromax is an inhalation powder.

Each DuoResp Spiromax inhaler contains 60 inhalations and has a

white body with a semi-transparent wine red mouthpiece cover.

Packs of 1, 2, and 3 inhalers. Not all pack sizes may be marketed in

your country.

Manufacturer

Norton (Waterford) Limited T/A Teva

Pharmaceuticals Ireland

Unit 27/35, IDA Industrial Park, Cork Road,

Waterford, Ireland

This leaflet was last revised in September 2020.

Package leaflet: Information for the patient

320 mcg/9 mcg

Read the complete document

NAME OF THE MEDICINAL PRODUCT

DuoResp

Spiromax

Dry powder for inhalation 320 mcg/9 mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each delivered dose (the dose that leaves the mouthpiece of the Spiromax)

contains 320 micrograms of budesonide and 9 micrograms of formoterol

fumarate dihydrate.

This is equivalent to a metered dose of 400 micrograms budesonide and

12 micrograms of formoterol fumarate dihydrate.

Excipient(s) with known effect:

Each dose contains approximately 10 milligrams of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Inhalation powder.

White powder.

White inhaler with a semi-transparent wine red mouthpiece cover.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Asthma

DuoResp Spiromax is indicated in the regular treatment of asthma, where

use of a combination (inhaled corticosteroid and long-acting β

adrenoceptor

agonist) is appropriate:

− in patients not adequately controlled with inhaled corticosteroids and “as

needed” inhaled short-acting β

adrenoceptor agonists.

− in patients already adequately controlled on both inhaled corticosteroids

and long-acting β

adrenoceptor agonists.

Chronic Obstructive Pulmonary Disease (COPD)

Symptomatic treatment of patients with COPD with FEV1 <70% predicted

normal (post-bronchodilator) and a history of repeated exacerbations,

despite regular long-acting bronchodilator therapy (see section Special

warnings and precautions for use).

4.2

Posology and method of administration

Posology

Asthma

DuoResp Spiromax is not intended for the initial management of asthma.

The dosage of the components of DuoResp Spiromax 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

-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.

Adolescents (12-17 years): 1 inhalation twice daily.

Patients should be regularly reassessed by their prescriber/healthcare

provider, so that the dosage of DuoResp Spiromax remains optimal. The dose

should be titrated to the lowest dose at which effective control of symptoms

is maintained. When 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 DuoResp

Spiromax given once daily, when in the opinion of the prescriber, a

long-acting bronchodilator would be required to maintain control.

DuoResp Spiromax 320 micrograms/9 micrograms should be used as

maintenance therapy only. A lower strength of DuoResp Spiromax is

available for the maintenance and reliever therapy regimen.

COPD

Recommended doses:

Adults: 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 DuoResp Spiromax 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

Inhalation use.

Spiromax is a breath actuated, inspiratory flow-driven inhaler, which means

that the active substances are delivered into the airways when the patient

inhales through the mouthpiece.

Moderate and severe asthmatic patients were shown to be able to generate

sufficient inspiratory flow rate for Spiromax to deliver the therapeutic dose

(see section 5.1).

DuoResp Spiromax should be used correctly in order to achieve effective

treatment. As such, the patients should be advised to read the patient

information leaflet carefully and follow the instructions for use as detailed in

the leaflet.

The use of DuoResp Spiromax follows three simple steps: open, breathe and

close which are outlined below.

Open: Hold the Spiromax with the mouthpiece cover at the bottom and open

the mouthpiece cover by folding it down until it is fully opened when one

click is heard.

Breathe: Place the mouthpiece between the teeth with the lips closed

around the mouthpiece, do not bite the mouthpiece of the inhaler. Breathe in

forcefully and deeply through the mouthpiece. Remove the Spiromax from

mouth and hold the breath for 10 seconds or as long as comfortable for the

patients.

Close: Breathe out gently and close the mouthpiece cover

It is also important to advise patients not to shake the inhaler before use and

not to breathe out through the Spiromax and not to block the air vents when

they are preparing the “Breathe” step.

Patients should also be advised to rinse their mouth with water after

inhaling (see section 4.4)

The patient may notice a taste when using DuoResp Spiromax due to the

lactose excipient.

4.3

Contraindications

Hypersensitivity to the active substances or the excipient listed in section 6.1.

4.4

Special warnings and precautions for use

General

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 DuoResp Spiromax, medical attention must be sought

(see section 4.2). 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 their rescue inhaler available at all times,

either DuoResp Spiromax (for asthma patients using DuoResp Spiromax as

maintenance and reliever therapy) or a separate rapid-acting bronchodilator

(for asthma patients using DuoResp Spiromax as maintenance therapy only).

Patients should be reminded to take their DuoResp Spiromax maintenance

dose as prescribed, even when asymptomatic. The prophylactic use of

DuoResp Spiromax, e.g. before exercise, has not been studied. The reliever

inhalations of DuoResp Spiromax should be taken in response to symptoms

but are not intended for regular prophylactic use, e.g. before exercise. For

such, a separate rapid-acting bronchodilator should be considered.

Asthma symptoms

Patients should be reassessed regularly by their prescriber/healthcare

provider so that the dose of DuoResp Spiromax remains optimal. The dose

should be titrated to the lowest dose at which effective control of symptoms

is maintained. Once asthma symptoms are controlled, consideration may be

given to gradually reducing the dose of DuoResp Spiromax. When it is

appropriate to titrate down to a lower strength than is available for DuoResp

Spiromax, a change to an alternative fixed-dose combination of budesonide

and formoterol fumarate containing a lower dose of the inhaled

corticosteroid is required.

Regular review of patients as treatment is stepped down is important.

Patients should not be initiated on DuoResp Spiromax during an

exacerbation, or if they have significantly worsening or acutely deteriorating

asthma.

Serious asthma-related adverse reactions and exacerbations may occur

during treatment with DuoResp Spiromax. Patients should be asked to

continue treatment but to seek medical advice if asthma symptoms remain

uncontrolled or worsen after initiation with DuoResp Spiromax.

There are no clinical study data on DuoResp Spiromax available in COPD

patients with a pre-bronchodilator FEV1 >50% predicted normal and with a

post-bronchodilator FEV1 <70% predicted normal (see section 5.1)

Paradoxical bronchospasm may occur, with an immediate increase in

wheezing and shortness of breath, after dosing. If the patient experiences

paradoxical bronchopasm DuoResp Spiromax should be discontinued

immediately, the patient should be assessed and an alternative therapy

instituted, if necessary. Paradoxical bronchopasm responds to a rapid-acting

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

Systemic effects

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.

Paediatric population

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. 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.

Effects on bone density

Potential effects on bone density should be considered, particularly in

patients on high doses for prolonged periods that have co-existing risk

factors for osteoporosis.

Long-term studies with inhaled budesonide 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 of a budesonide/

formoterol fumarate dihydrate fixed-dose combination at higher doses is

available.

Adrenal function

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 a budesonide/formoterol fumarate fixed- dose combination

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 hypothalamic pituitary adrenocortical (HPA) axis function

should be monitored regularly.

High dose corticosteroids

The 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 systematic steroids or inhaled budesonide

should not be stopped abruptly.

Transfer from oral therapy

During transfer from oral therapy to a budesonide/formoterol fumarate

fixed-dose combination therapy, 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.

Oral infections

To minimise the risk of oropharyngeal candida infection, the patient should

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

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

water after the as-needed inhalations.

COPD population

There are no clinical study data on Budesonide/Formoterol available in COPD

patients with a pre-bronchodilator FEV1 >50% predicted normal and with a

post-bronchodilator FEV1 <70% predicted normal (see section

Pharmacodynamic properties).

Clinical studies and meta-analyses indicate that treatment of COPD with

inhaled corticosteroids may lead to an increased risk of pneumonia. However,

the absolute risk for budesonide is small. A meta-analysis of 11 COPD double

blind trials including 10,570 patients did not demonstrate a statistically

significant increased risk of pneumonia in patients treated with budesonide

(with or without formoterol) compared to non-budesonide containing

treatments (placebo or formoterol). The incidence rate of pneumonia

reported as a serious adverse event was 1.9% per year on budesonide

containing treatments and 1.5% per year on non-budesonide containing

treatments. The pooled hazard ratio comparing all budesonide-containing

versus non-budesonide containing treatments was 1.15 (95% CI: 0.83, 1.57).

The pooled hazard ratio comparing budesonide/formoterol versus formoterol

or placebo was 1.00 (95% CI: 0.69, 1.44). A causal relationship with

budesonide-containing products has not been established.

Interaction with other medicinal products

Concomitant treatment with itraconazole, ritonavir or other potent CYP3A4

inhibitors should be avoided (see section 4.5). If this is not possible the time

interval between administrations of the interacting medicinal products

should be as long as possible. In patients using potent CYP3A4 inhibitors,

a budesonide/formoterol fumarate fixed-dose combination is not

recommended.

Caution with special diseases

A fixed-dose combination of budesonide and formoterol fumarate dihydrate

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.

Additional blood glucose controls should be considered in diabetic patients.

adrenoreceptor agonists

Potentially serious hypokalaemia may result from high doses of β

adrenoceptor agonists. Concomitant treatment of β

adrenoceptor agonists

with medicinal products 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.

Treatment with β

adrenoceptor agonists may result in an increase in blood

levels of insulin, free fatty acids, glycerol and ketone bodies.

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.

Excipients

This medicinal product contains lactose. Patients with rare hereditary

problems of galactose intolerance, the Lapp lactase deficiency or

glucose-galactose malabsorption should not take this medicine. The

excipient lactose contains small amounts of milk proteins which may cause

allergic reactions.

4.5

Interaction with other medicinal products and other forms of

interaction

Pharmacokinetic interactions

Potent inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, voriconazole,

posaconazole, clarithromycin, telithromycin, nefazodone 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).

The potent CYP3A4 inhibitor ketoconazole, 200 mg once daily, increased

plasma levels of concomitantly orally administered budesonide (single dose

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 micrograms).

Co-treatment with CYP3A inhibitors, including 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

β adrenergic blockers can weaken or inhibit the effect of formoterol. A

fixed-dose combination therapy of budesonide and formoterol fumarate

dihydrate should therefore not be given together with β 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 β

sympathomimetics.

Concomitant treatment with monoamine oxidase inhibitors including

medicinal products 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 β adrenergic medicinal products and anticholinergic

medicinal products 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 medicinal products used in the treatment of asthma.

Paediatric population

Interaction studies have only been performed in adults.

4.6

Fertility, pregnancy and lactation

Pregnancy

For a fixed-dose combination therapy of budesonide and formoterol

fumarate dihydrate 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 reactions 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, a fixed-dose combination therapy of budesonide and

formoterol fumarate dihydrate 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 a

fixed-dose combination therapy of budesonide and formoterol fumarate

dihydrate 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

DuoResp Spiromax has no or negligible influence on the ability to drive and

use machines.

4.8

Undesirable effects

Summary of safety profile

Since DuoResp Spiromax contains both budesonide and formoterol, the same

pattern of adverse reactions 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 adverse reactions

are pharmacologically predictable adverse reactions of β

adrenoceptor

agonist therapy, such as tremor and palpitations. These tend to be mild and

usually disappear within a few days of treatment. In a 3-year clinical trial

with budesonide in COPD, skin bruises and pneumonia occurred at a

frequency of 10% and 6%, respectively, compared with 4% and 3% in the

placebo group (p<0.001 and p<0.01, respectively).

Tabulated list of adverse reactions

Adverse reactions, which have been associated with budesonide or

formoterol, are given below and listed by system organ class and frequency.

Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10),

uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare

(<1/10,000) and not known (cannot be estimated from the available data).

System Organ Class

Frequency

Adverse 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

Metabolism and nutrition

disorders

Rare

Hypokalaemia

Very rare

Hyperglycaemia

Psychiatric disorders

Uncommon

Agitation, psychomotor

hyperactivity, anxiety, sleep

disorders

Very rare

Depression, behavioural

changes (predominantly in

children)

Nervous system disorders

Common

Headache, tremor

Uncommon

Dizziness

Very rare

Taste disturbances

Eye disorders

Very rare

Cataract and glaucoma

Uncommon

Vision, blurred (see also

section 4.4)

Cardiac disorders

Common

Palpitations

Uncommon

Tachycardia

Rare

Cardiac arrhythmias, e.g.

atrial fibrillation,

supraventricular tachycardia,

extrasystoles

Very rare

Angina pectoris. Prolongation

of QTc-interval

Vascular disorders

Very rare

Variations in blood pressure

Respiratory, thoracic and

mediastinal disorders

Common

Mild irritation in the throat,

coughing, hoarseness

Rare

Bronchospasm

Very rare

Paradoxical bronchospasm

Gastrointestinal disorders

Uncommon

Nausea

Skin and subcutaneous tissue

disorders

Uncommon

Bruises

Musculoskeletal and connective

tissue disorders

Uncommon

Muscle cramps

Description of selected adverse reactions

Candida infection in the oropharynx is due to active substance 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.

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 bronchopasm responds to a rapid-acting

inhaled bronchodilator and should be treated straightaway. DuoResp

Spiromax should be discontinued immediately, the patient should be

assessed and an alternative therapy is instituted if necessary

(see section 4.4).

Systemic effects of inhaled corticosteroids may occur, particularly at high

doses prescribed for long 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

adrenoceptor 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.

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 overdose 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 DuoResp Spiromax therapy has to be withdrawn due to overdose of the

formoterol component of the medicinal product, provision of appropriate

inhaled corticosteroid therapy must be considered.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Mechanism of action and pharmacodynamic effects

DuoResp Spiromax 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 reactions than systemic corticosteroids. The exact

mechanism responsible for the anti-inflammatory effect of

glucocorticosteroids is unknown.

Formoterol

Formoterol is a selective β

adrenoceptor 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

Budesonide/formoterol maintenance therapy

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.

In a 12-week paediatric study, 85 children aged 6-11 years were treated

with a maintenance dose of Budesonide/Formoterol (2 inhalations of

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

-agonist as

needed. Lung function was improved, and the treatment was well tolerated

compared to the corresponding dose of Budesonide 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

FEV1<50% predicted normal. Median post-bronchodilator FEV1 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

The 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 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 (see paediatric

population sub-heading in section 4.2).

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 metabolism

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.

Pharmacokinetic/pharmacodynamic relationship(s)

The pharmacokinetics of budesonide or formoterol in children and 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.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose monohydrate (which contains milk proteins).

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

Please refer to expiry date on the outer carton.

After opening the foil wrap: 3 months.

6.4

Special precautions for storage

Do not store above 30 °C.

Keep the mouthpiece cover closed after removal of the foil wrap.

6.5

Nature and contents of container

The inhaler is white with a semi-transparent wine red mouthpiece cover.

The drug/mucosal contact parts of the inhaler are made of acrylonitrile

butadiene styrene (ABS), polyethylene (PE), and polypropylene (PP). Each

inhaler contains 60 doses and is foil-wrapped.

Pack sizes of 1, 2 or 3 inhalers.

Not all pack-sizes may be marketed.

6.6

Special precautions for disposal and other handling

No special requirements.

MANUFACTURER

Norton (Waterford) Limited T/A

Teva Pharmaceuticals Ireland

Unit 27/35, IDA Industrial Park,

Cork Road, Waterford, Ireland.

DATE OF REVISION OF THE TEXT

09-2020

H63960

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