Assieme mite Turbuhaler 80 mikrogram/4,5 mikrogram/inhalation Inhalationspulver

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

27-10-2017

Produktens egenskaper Produktens egenskaper (SPC)

14-04-2015

Aktiva substanser:
budesonid; formoterolfumaratdihydrat
Tillgänglig från:
Orifarm AB
ATC-kod:
R03AK07
INN (International namn):
budesonide; formoterol
Dos:
80 mikrogram/4,5 mikrogram/inhalation
Läkemedelsform:
Inhalationspulver
Sammansättning:
budesonid 80 mikrog Aktiv substans; formoterolfumaratdihydrat 4,5 mikrog Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagda typ:
Receptbelagt
Terapiområde:
Formoterol och budesonid
Bemyndigande status:
Avregistrerad
Godkännandenummer:
22522
Tillstånd datum:
2005-09-28

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

22-06-2020

Produktens egenskaper Produktens egenskaper - engelska

16-11-2018

Läs hela dokumentet

B. PACKAGE LEAFLET

Package Leaflet: Information for the user

Gardette mite 80 micrograms/4.5 micrograms /inhalation, Inhalation Powder

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 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 Gardette mite is and what it is used for

What you need to know before you use Gardette mite

How to use Gardette mite

Possible side effects

How to store Gardette mite

Contents of the pack and other information

1.

What Gardette mite is and what it is used for

Gardette mite is an inhaler that is used to treat asthma in adults, adolescents and children aged 6 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.

This medicine is not suitable for people with severe asthma. It can be prescribed for asthma in two

different ways.

a) Some people are prescribed two asthma inhalers: Gardette mite and a separate ‘reliever

inhaler’.

They use Gardette mite every day. This helps to prevent asthma symptoms from

happening.

They use their ‘reliever inhaler’ when they get asthma symptoms, to make it easier to

breathe again.

b) Some people are prescribed Gardette mite as their only asthma inhaler.

They use Gardette mite every day. This helps to prevent asthma symptoms from

happening.

They also use Gardette mite when they need extra doses for relief of asthma symptoms,

to make it easier to breathe again. They do not need a separate inhaler for this.

2.

What you need to know before you use Gardette mite

Do not use Gardette mite:

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 Gardette mite 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

heart beat, 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.

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

Other medicines and Gardette mite

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, tell your doctor or pharmacist if you are using 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 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 leva-dopa).

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

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

using Gardette mite.

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

for dental work.

Pregnancy, breast-feeding and fertility

If you are pregnant, or planning to get pregnant, talk to your doctor before using Gardette

mite - do not use Gardette mite unless your doctor tells you to.

If you get pregnant while using Gardette mite, do not stop using Gardette mite but talk to

your doctor immediately.

If you are breast-feeding, talk to your doctor before using Gardette mite.

Driving and using machines

Gardette mite has no or negligible effect on your ability to drive or to use tools or machines.

Gardette mite contains lactose

Gardette mite 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 Gardette mite

Always use this medicine exactly as your doctor has told you. You should check with

your doctor or pharmacist if you are not sure.

It is important to use Gardette mite every day, even if you have no asthma 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 Gardette mite. 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.

You should speak to your doctor if you are concerned as to whether you should continue to use

Gardette mite.

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 symptoms

If you feel you are getting breathless or wheezy while using Gardette mite, you should continue to use

Gardette mite 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 is not being properly controlled and you may need different

or additional treatment immediately.

Asthma

Gardette mite can be prescribed for asthma in two different ways. The amount of Gardette mite to use

and when to use it depends on how it has been prescribed for you.

If you have been prescribed Gardette mite and a separate reliever inhaler, read the section

called ‘a) Using Gardette mite and a separate reliever inhaler’.

If you have been prescribed Gardette mite as your only inhaler, read the section called ‘b)

Using Gardette mite as your only asthma inhaler’.

a) Using Gardette mite and a separate reliever inhaler

Use your Gardette mite every day.

This helps to prevent asthma symptoms from happening.

Adults (18 years and above)

The usual dose is 1 or 2 inhalations, twice a day.

Your doctor may increase this to 4 inhalations, twice a day.

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

once a day.

Adolescents (12 to 17 years)

The usual dose is 1 or 2 inhalations, twice a day.

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

once a day.

Children (6 to 11 years)

The usual dose is 2 inhalations, twice a day.

Gardette mite is not recommended to be used in children who are younger than 6 years.

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

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

talking to your doctor (or asthma nurse) first.

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

Always keep

your ‘reliever inhaler’ with you to use when you need it. Do not use Gardette mite to treat asthma

symptoms - use your reliever inhaler.

b) Using Gardette mite as your only asthma inhaler

Only use Gardette mite in this way if your doctor has told you to and if you are aged 12 or above.

Use your Gardette mite every day.

This helps to prevent asthma symptoms from happening. You

can take:

1 inhalation in the morning

and

1 inhalation in the evening

or

2 inhalations in the morning

or

2 inhalations in the evening.

Also use Gardette mite as a ‘reliever inhaler’ to treat asthma symptoms when they happen.

If you get asthma symptoms, take 1 inhalation and wait a few minutes.

If you do not feel better, take another inhalation.

Do not take more than 6 inhalations at a single time.

Always keep your Gardette mite Inhaler with you, so you can use it when you need it.

A total daily dose of more than 8 inhalations is not normally needed. However, your doctor may allow

you to take up to 12 inhalations a day for a limited period.

If you regularly need to use 8 or more inhalations a day, make an appointment to see your doctor or

nurse. They may need to change your treatment.

Do not use more than 12 inhalations in total in 24 hours.

If you are doing exercise and you get asthma symptoms, use Gardette mite as described here.

However, do not use Gardette mite just before exercise to stop asthma symptoms from happening.

Preparing your new Gardette mite Inhaler

Before using your

new

Gardette mite Inhaler

for the first time

, you need to prepare it for use as

follows:

Unscrew the cover and lift it off. You may hear a rattling sound.

Hold your Gardette mite Inhaler upright with the red grip at the bottom.

Turn the red grip as far as it will go in one direction. Then turn it as far as it will go in

the other direction (it does not matter which way you turn it first). You should hear a

click sound. It does not matter whether the click comes on the first or the second twist.

Do this again, turning the red grip in both directions.

Your Gardette mite Inhaler is now loaded and ready for use.

How to take an inhalation

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

Unscrew the cover and lift it off. You may hear a rattling sound.

Hold your Gardette mite Inhaler upright

with the red grip at the bottom.

Do not

hold the mouthpiece when you load your Gardette mite Inhaler. To load your

Gardette mite Inhaler with a dose, turn the red grip as far as it will go in one direction.

Then turn it as far as it will go in the other direction

(it does not matter which way you

turn it first). You should hear a click sound. It does not matter whether the click comes

on the first or the second twist. Your Gardette mite Inhaler is now loaded and ready to

use. Only load your Gardette mite Inhaler when you need to use it.

Hold your Gardette mite Inhaler away from your mouth. Breathe out gently (as far as is

comfortable). Do not breathe out through your Gardette mite Inhaler.

Place the mouthpiece gently between your teeth. Close your lips. Breathe in as deeply

and as hard as you can through your mouth. Do not chew or bite on the mouthpiece.

Remove your Gardette mite Inhaler from your mouth. Then breathe out gently.

amount of medicine that is inhaled is very small. This means you may not be able to taste

it after inhalation. If you have followed the instructions, you can still be confident that

you have inhaled the dose and the medicine is now in your lungs.

If you are to take a second inhalation, repeat steps 2 to 6.

Replace the cover tightly after use.

Rinse your mouth with water after your daily morning and/or evening doses, and spit it

out.

Do not try to remove or twist the mouthpiece. It is fixed to your Gardette mite Inhaler and must not be

taken off. Do not use your Gardette mite Inhaler if it has been damaged or if the mouthpiece has come

apart from your Gardette mite Inhaler.

As with all inhalers, caregivers should ensure that children prescribed Gardette mite use correct

inhalation technique, as described above.

Cleaning your Gardette mite Inhaler

Wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or liquids.

When to start using a new inhaler

The dose indicator tells you how many doses (inhalations) are left in your Gardette mite

Inhaler, starting with either 60 or 120 doses when it is full.

The dose indicator is marked in intervals of 10 doses. Therefore, it does not show every

dose.

When you first see a red mark at the edge of the indicator window, there are

approximately 20 doses left. For the last 10 doses, the background of the dose indicator is

red. When the ‘0’ on the red background has reached the middle of the window, you

must start using your new Gardette mite Inhaler.

Note:

The grip will still twist and ‘click’ even when your Gardette mite Inhaler is empty.

The sound that you hear as you shake your Gardette mite Inhaler is produced by a drying

agent and not the medicine. Therefore, the sound does not tell you how much medicine is

left in your Gardette mite Inhaler.

If you load your Gardette mite Inhaler more than once by mistake before taking your

dose, you will still only receive one dose. However, the dose indicator will register all

the loaded doses.

If you use more Gardette mite 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 Gardette mite than you should are

trembling, headache or a rapid heart beat.

If you forget to use Gardette mite

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.

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 Gardette mite 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 breathe (angoioedema) and or

sudden feeling if faintness. This may mean that you are having an allergic reaction. This

happens rarely, affecting less than 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 Gardette mite Inhaler straightaway

and use your ‘reliever’ inhaler. Contact your doctor immediately

as you may need

to have your treatment changed.

This happens very rarely, affecting less than 1 in

10,000 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 Gardette mite.

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

with water after using your inhaler.

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 Gardette mite stop using Gardette mite 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 the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety

of this medicine.

5.

How to store Gardette mite

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 or on the label

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

This medicine does not require any special storage conditions.

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 Gardette mite contains

The active substances are budesonide and formoterol. Each inhaled dose contains 80 micrograms of

budesonide and 4.5 micrograms of formoterol fumarate dihydrate.

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

What Gardette mite looks like and contents of the pack

Gardette mite is an inhaler containing your medicine. The inhalation powder is white in colour. Each

Inhaler contains either 60 or 120 doses and has a white body with a red turning grip. The turning grip

contains a Braille code with the number 6 for identification, to differ from other AstraZeneca inhaled

products.

Gardette mite is available in packs of 1, 2, 3, 10 or 18 inhaler(s) containing 60 (or 120) doses.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following

names:

Country

Trade name and strength

Italy

Assieme Mite 80 μg/4.5 μg/inhalation

Portugal

Assieme Turbohaler 80 μg/4.5 μg/inhalation

Spain

Rilast Turbuhaler 80 μg/4.5 μg/inhalation

Sweden

Gardette mite 80 μg/4.5 μg/inhalation

This leaflet was last revised in 2020-06-05

[To be completed nationally]

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Gardette mite, 80 micrograms/4.5 micrograms/inhalation, inhalation powder.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

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

80 micrograms/inhalation and formoterol fumarate dihydrate 4.5 micrograms/inhalation.

Each metered dose contains: budesonide 100 micrograms/inhalation and formoterol fumarate

dihydrate 6 micrograms/inhalation.

Excipient with known effect

Lactose monohydrate 810 micrograms per delivered dose.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Inhalation powder.

White powder.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Gardette mite is indicated in adults, adolescents, and children aged 6 years and older.

Gardette is indicated in the regular treatment of asthma where use of a combination (inhaled

corticosteroid and long-acting β

adrenoceptor agonist) is appropriate:

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

acting β

adrenoceptor agonists.

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

adrenoceptor agonists.

Note:

Gardette mite (80 micrograms/4.5 micrograms/inhalation) is not appropriate in patients with

severe asthma.

4.2

Posology and method of administration

Route of administration: For inhalation use

Posology

Gardette is not intended for the initial management of asthma.

The dosage of the components of Gardette 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.

The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

Patients should be regularly reassessed by their prescriber/health care provider so that the dosage of

Gardette remains optimal. 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.

For Gardette there are two treatment approaches:

A. Gardette maintenance therapy:

Gardette is taken as regular maintenance treatment with a

separate rapid-acting bronchodilator as rescue.

B. Gardette maintenance and reliever therapy:

Gardette is taken as regular maintenance treatment

and as needed in response to symptoms.

A. Gardette maintenance therapy

Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at

all times.

Recommended doses:

Adults (18 years and older):

1-2 inhalations twice daily. Some patients may require up to a maximum

of 4 inhalations twice daily.

Adolescents (12-17 years):

1-2 inhalations twice daily.

Children (6 years and older):

2 inhalations twice daily

.

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

lowest effective dose could include Gardette mite given once daily, when in the opinion of the

prescriber, a long-acting bronchodilator in combination with an inhaled corticosteroid 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.

Children under 6 years

: As only limited data are available, Gardette mite is not recommended for

children younger than 6 years.

B. Gardette maintenance and reliever therapy

Patients take a daily maintenance dose of Gardette and in addition take Gardette as needed in response

to symptoms. Patients should be advised to always have Gardette available for rescue use.

Gardette maintenance and reliever therapy should especially be considered for patients with:

inadequate asthma control and in frequent need of reliever medication

asthma exacerbations in the past requiring medical intervention

Close monitoring for dose-related adverse effects is needed in patients who frequently take high

numbers of Gardette as-needed inhalations.

Recommended doses:

Adults and adolescents (12 years and older):

The recommended maintenance dose is 2 inhalations per

day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning

or evening. Patients should take 1 additional inhalation as needed in response to symptoms. If

symptoms persist after a few minutes, an additional inhalation should be taken. Not more than

6 inhalations should be taken on any single occasion.

A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up

to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily

should be strongly recommended to seek medical advice. They should be reassessed and their

maintenance therapy should be reconsidered.

Children under 12 years:

Gardette maintenance and reliever therapy is not recommended for children.

General information

Special patient groups:

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

Gardette 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

Instructions for correct use of Gardette mite:

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 Gardette mite Inhaler.

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.

to replace the cover of the Gardette mite Inhaler after use.

to rinse their 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.

The patient may not taste or feel any medication when using Gardette mite Inhaler due to the small

amount of drug dispensed.

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 Gardette,

medical attention must be sought (see section 4.2). Sudden and progressive deterioration in control of

asthma 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 Gardette (for

patients using Gardette as maintenance and reliever therapy) or a separate rapid-acting bronchodilator

(for patients using Gardette as maintenance therapy only).

Patients should be reminded to take their Gardette maintenance dose as prescribed, even when

asymptomatic. The prophylactic use of Gardette, e.g. before exercise, has not been studied. The

reliever inhalations of Gardette should be taken in response to asthma symptoms but are not intended

for regular prophylactic use, e.g. before exercise. For such use, a separate rapid-acting bronchodilator

should be considered.

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

Gardette. Regular review of patients as treatment is stepped down is important. The lowest effective

dose of Gardette should be used (see section 4.2).

Patients should not be initiated on Gardette 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 Gardette.

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

uncontrolled or worsen after initiation of Gardette.

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

Gardette 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).

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 of Gardette 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 Gardette 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 Gardette mite, 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. If oropharyngeal

thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations.

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 administration of the

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

maintenance and reliever therapy is not recommended.

Gardette 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 β2 adrenoceptor agonists, additional blood glucose controls should be considered in diabetic

patients.

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.

Gardette contains lactose monohydrate (< 1 mg/inhalation). This amount does not normally cause

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

which may cause allergic reactions.

Paediatric 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 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 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). In patients using potent CYP3A4 inhibitors, Gardette 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

increase 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).

Pharmacodynamic interactions

Beta-adrenergic blockers can weaken or inhibit the effect of formoterol. Gardette 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.

Hypokalaemia may result from beta

-agonist therapy and may be potentiated by concomitant treatment

with xanthine derivatives, corticosteroids and diuretics (see section 4.4).

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

treatment of asthma.

Paediatric population

Interaction studies have only been performed in adults.

4.6

Fertility, pregnancy and lactation

Pregnancy

For Gardette 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, Gardette 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.

Breastfeeding

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 Gardette to women

who are breastfeeding 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

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

4.8

Undesirable effects

Since Gardette 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

adrenoceptor agonist therapy, such as

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

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

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

1/10), common

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

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

1/10 000 to < 1/1000) and very rare

(< 1/10 000).

Table 1

SOC

Frequency

Adverse Drug reaction

Infections and infestations

Common

Candida infections in the oropharynx

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 maintenance dose will minimise the risk. Oropharyngeal Candida infection

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

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

after the as-needed inhalations.

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. Gardette 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

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

acids, glycerol and ketone bodies.

Paediatric population

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

corticosteroids is regularly monitored (see section 4.4).

Reporting of suspected adverse reactions

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

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

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

listed in Appendix V.

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 Gardette 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, Inhalants.

ATC-code: R03AK07

Mechanisms of action and Pharmacodynamic effects

Gardette contains formoterol and budesonide, which have different modes of action and show additive

effects in terms of reduction of asthma exacerbations. The specific properties of budesonide and

formoterol allow the combination to be used either as maintenance and reliever therapy, or as

maintenance treatment of asthma.

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 agonist that when inhaled results in rapid and long-acting

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

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

effect is at least 12 hours after a single dose.

Clinical efficacy and safety

Clinical efficacy for 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.

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

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

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

adrenoceptor agonist as

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

the corresponding dose of budesonide alone.

Clinical efficacy for budesonide/formoterol maintenance and reliever therapy

A total of 12076 asthma patients were included in 5 double-blind efficacy and safety studies (4447

were randomised to budesonide/formoterol maintenance and reliever therapy) for 6 or 12 months.

Patients were required to be symptomatic despite use of inhaled glucocorticosteroids.

Budesonide/formoterol maintenance and reliever therapy provided statistically significant and

clinically meaningful reductions in severe exacerbations for all comparisons in all 5 studies. This

included a comparison with budesonide/formoterol at a higher maintenance dose with terbutaline as

reliever (study 735) and budesonide/formoterol at the same maintenance dose with either formoterol

or terbutaline as reliever (study 734) (Table 2). In study 735, lung function, symptom control, and

reliever use were similar in all treatment groups. In study 734, symptoms and reliever use were

reduced and lung function improved, compared with both comparator treatments. In the 5 studies

combined, patients receiving budesonide/formoterol maintenance and reliever therapy used, on

average, no reliever inhalations on 57% of treatment days. There was no sign of development of

tolerance over time.

Table 2

Overview of severe exacerbations in clinical studies

Severe exacerbations

Study No.

Duration

Treatment groups

n

Events

Events/

patient-year

Budesonide/formoterol 160/4.5 µg bd + as needed

1103

125

0.23

Budesonide/formoterol 320/9 µg bd + terbutaline 0.4 mg as

needed

1099

0.32

Study 735

6 months

Salmeterol/fluticasone 2 x 25/125 µg bd + terbutaline 0.4 mg as

needed

1119

0.38

Budesonide/formoterol 160/4.5 µg bd + as needed

1107

194

0.19

Budesonide/formoterol 160/4.5 µg bd + formoterol 4.5 µg as

needed

1137

0.29

Study 734

12 months

Budesonide/formoterol 160/4.5 µg bd + terbutaline 0.4 mg as

needed

1138

0.37

Hospitalisation/emergency room treatment or treatment with oral steroids

Reduction in exacerbation rate is statistically significant (P value <0.01) for both comparisons

Comparable efficacy and safety in adolescents and adults was demonstrated in 6 double-blind studies,

comprising the 5 studies mentioned above and an additional study using a higher maintenance dose of

160/4.5 micrograms, two inhalations twice daily. These assessments were based on a total of 14385

asthma patients of whom 1847 were adolescents. The number of adolescent patients taking more than

8 inhalations on at least one day as part of budesonide/formoterol maintenance and reliever therapy

was limited, and such use was infrequent.

In 2 other studies with patients seeking medical attention due to acute asthma symptoms,

budesonide/formoterol provided rapid and effective relief of bronchoconstriction similar to salbutamol

and formoterol.

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

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 and 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

3 years.

6.4

Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5

Nature and contents of container

Gardette is an inspiratory flow driven, multidose powder inhaler. The inhaler is white with a red

turning grip. The inhaler is made of different plastic materials (PP, PC, HDPE, LDPE, LLDPE, PBT).

In each secondary package there are 1, 2, 3, 10 or 18 inhaler(s) containing 60 (or 120) doses.

Not all pack-sizes may be marketed.

6.6

Special precautions for disposal

No special requirements.

7.

MARKETING AUTHORISATION HOLDER

[To be completed nationally]

For Sweden (RMS):

AstraZeneca AB

151 85 Södertälje

Sweden

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

[To be completed nationally]

2018-11-16

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