Floebb 125 mikrogram per puff Inhalationsspray, suspension

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

18-10-2018

Produktens egenskaper Produktens egenskaper (SPC)

20-04-2018

Aktiva substanser:
flutikasonpropionat
Tillgänglig från:
Mylan AB
ATC-kod:
R03BA05
INN (International namn):
fluticasone propionate
Dos:
125 mikrogram per puff
Läkemedelsform:
Inhalationsspray, suspension
Sammansättning:
flutikasonpropionat 125 mikrog Aktiv substans
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Spraybehållare, 120 doser
Bemyndigande status:
Godkänd
Godkännandenummer:
51551
Tillstånd datum:
2016-03-17

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

18-10-2018

Produktens egenskaper Produktens egenskaper - engelska

18-10-2018

Läs hela dokumentet

PACKAGE LEAFLET

Package leaflet: Information for the patient

Floebb 50 micrograms per actuation pressurised inhalation, suspension

Floebb 125 micrograms per actuation pressurised inhalation, suspension

Floebb 250 micrograms per actuation pressurised inhalation, suspension

fluticasone propionate

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 asthma 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 asthma nurse. This

includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Floebb is and what it is used for

2. What you need to know before you use Floebb

3. How to use Floebb

4. Possible side effects

5. How to store Floebb

6. Contents of the pack and other information

1.

What Floebb is and what it is used for

Floebb contains the active substance fluticasone propionate. Fluticasone is a corticosteroid

(often just called steroid). It has an anti-inflammatory action which reduces asthma-related

swelling and irritation in the lungs. Only a very small dose of steroid is needed because it is

inhaled straight into your lungs.

Your doctor has prescribed this medicine to help prevent breathing problems such as asthma.

Fluticasone propionate is sometimes called a ‘preventer’.

Floebb is not used to treat Chronic Obstructive Pulmonary Disease (COPD).

You must use Floebb every day as directed by your doctor, even if you are not currently

experiencing any breathing problems. This will make sure that it works properly in

controlling your asthma. It takes 4-7 days for this medicine to work fully.

Floebb

helps to prevent breathlessness and wheezing. It does not relieve sudden

attacks of breathlessness or wheezing. If this happens you need to use a rapid-acting

'reliever' (‘rescue’) inhaler, such as salbutamol. You should have your rapid-acting

‘rescue’ inhaler with you at all times.

Floebb 50 micrograms is used to treat asthma in adults and children and adolescents aged

4 to 18 years. Floebb 50 micrograms is not recommended for children less than 4 years of

age.

Floebb 125 micrograms and Floebb 250 micrograms are used to treat asthma in adults and

adolescents over 16 years of age. Floebb 125 micrograms and Floebb 250 micrograms

are not recommended for adolescents and children 16 years of age and younger.

2.

What you need to know before you use Floebb

Do not use Floebb:

If you are allergic to fluticasone propionate or the other ingredient in this medicine

(listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or asthma nurse before using Floebb

if you have ever had:

Tuberculosis (TB).

Diabetes mellitus (because fluticasone may increase your blood sugar level).

Thinning of the bones.

Eye problems (cataract and glaucoma).

Growth problems (in children and adolescents).

Cushing’s Syndrome (associated with upper body weight gain, rounding of the face,

thinning of the skin and bones, depression, and various non-specific effects such as

headache and fatigue).

Adrenal suppression or an adrenal crisis.

Treatment with steroid tablets/injections or high dose inhalers for a long period of

time.

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

asthma nurse before using Floebb.

If you develop a chest (lung) infection during treatment (e.g. viral, fungal, or bacterial),

make sure that you tell your doctor, or nurse, that you are taking this medicine and have

asthma.

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

If you use high doses of Floebb for a long period of time, it may affect the way your body

produces its own steroid hormones. This can lead to symptoms of increased steroid

hormones in the body (a condition known as Cushing’s syndrome), or reduce the amount

of steroid hormones produced by the adrenal gland (adrenal suppression). Other effects

include thinning of the bones, eye problems (such as cataracts or glaucoma), possible

behaviour changes (for example depression or aggression) and slowing of growth in

children and adolescents. For more information on these possible side effects see ‘

If you

stop using Floebb

’ (in Section 3) and ‘

Possible side effects’

(Section 4).

Children and adolescents

Floebb should not be used in children less than 4 years of age.

Floebb 50 micrograms can be used to treat asthma in children and adolescents aged 4 to 18

years.

Floebb 125 micrograms and Floebb 250 micrograms can be used to treat asthma in

adolescents over 16 years of age.

Floebb 125 micrograms and Floebb 250 micrograms are

not recommended for use in adolescents and children 16 years of age and younger.

Other medicines and Floebb

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

might take any other medicines, including medicines used for asthma and other inhalers

and any non-prescription medicines. This is because Floebb may not be suitable to be

taken with some other medicines as some medicines may increase the amount of

fluticasone propionate in your body and this can increase the risk of you developing side

effects or may make side effects worse.

Tell your doctor if you are taking any of the following medicines

before

starting to use

Floebb:

Antibiotics such as erythromycin or clarithromycin (called macrolide antibiotics).

Antifungal tablets such as ketoconazole or itraconazole.

Steroid tablets or steroid injections, even if you have just finished taking these. Your

doctor might have given you a steroid warning card, as there is a possibility of

impaired adrenal function, especially at times when your asthma is worse, or you have

a chest infection or another illness, after a serious accident or if you have surgery.

Your doctor may decide to give you extra steroids during this time.

Some medicines may increase the effects of Floebb and your doctor may wish to

monitor you carefully if you are taking these medicines (including some medicines

for HIV: ritonavir, cobicistat).

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

before using Floebb.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have

a baby, ask your doctor, pharmacist or asthma nurse for advice before using this medicine.

Driving and using machines

Floebb is unlikely to affect your ability to drive or use machines.

3.

How to use Floebb

Floebb is available in three different strengths. Your doctor will have decided which

strength you need. Always use this medicine exactly as your doctor, pharmacist or asthma

nurse has told you to, or as described in this leaflet. Check with your doctor, pharmacist

or asthma nurse if you are not sure.

Use Floebb every day until your doctor advises you to stop. Do not take more than the

dose your doctor or asthma nurse has told you to take. If you are not sure how much

Floebb you should be taking, check with your doctor, pharmacist or asthma nurse.

Do not stop taking Floebb or reduce the dose that you take without talking to your

doctor first.

Floebb should be inhaled through the mouth into the lungs.

Your doctor will decide what dose you need to take. The starting dose needs to be

appropriate for the severity of your disease. Your doctor will work with you to decrease

your dose to the lowest dose that effectively controls your asthma. Your doctor will want

to check your symptoms regularly and do some lung function tests.

Dosage

Adults and adolescents over 16 years of age

If you have mild asthma, the recommended starting dose of Floebb is 100 micrograms

(two puffs of Floebb 50 micrograms) twice daily.

If you have moderate or severe asthma, the recommended starting dose of Floebb is 250

micrograms (two puffs of Floebb 125 micrograms or one puff of Floebb 250 micrograms)

to 500 micrograms (four puffs of Floebb 125 micrograms or two puffs of Floebb 250

micrograms) twice daily.

In some cases, your doctor or asthma specialist may prescribe a higher dose.

The

maximum dose is 1,000 micrograms

(eight puffs of Floebb 125 micrograms or four

puffs of Floebb 250 micrograms)

twice daily.

Children 4 to 12 years of age and adolescents 13 to 16 years of age

Only Floebb 50 micrograms can be used in children 4 to 12 years of age and adolescents

13 to 16 years of age.

Floebb 125 micrograms and Floebb 250 micrograms are NOT recommended for use

by children 4 to 12 years of age and adolescents 13 to 16 years of age.

The recommended starting dose of Floebb is 50 micrograms (one puff of Floebb 50

micrograms) to 100 micrograms (two puffs of Floebb 50 micrograms) twice daily.

In some cases, your doctor may prescribe a higher dose.

The maximum dose in children

4 to 12 years of age and adolescents 13 to 16 years of age is 200 micrograms (four

puffs

of Floebb 50 micrograms) twice daily.

Whilst your child is taking this medicine, your doctor will also check your child’s height

regularly.

Children under 4 years

Floebb is not recommended for children less than 4 years of age.

Please make sure you know how many actuations (puffs) you need to take and how and

when to take them. This information should be on the pharmacist’s label on the carton in

which you received your inhaler. If it is not, or you are not sure, ask your doctor,

pharmacist or asthma nurse.

If your asthma or breathing gets worse, tell your doctor straight away.

You may find

that you feel more wheezy, your chest feels tight more often or you may need to use

more of your rapid-acting 'reliever' medicine or you may feel that your medicine is

working less well than usual. If any of these happen, you should continue to take Floebb

but do not increase the number of puffs that you take

unless advised by your doctor

Talk to your doctor immediately as your chest condition may be getting worse and you

could become seriously ill. You may need additional treatment. If required, your doctor

may recommend that you use more of this medicine or may prescribe corticosteroids in

tablet form.

If you have been using high doses of an inhaled steroid for a long time, your doctor

may decide to give you extra steroids, either by increasing the dose of your inhaler or

by prescribing steroid tablets for you to take during stressful times such as after a

car accident or before surgery.

Also, patients who have been on high doses of steroids, including Floebb, for a long

time, must not stop taking their medicine without talking to their doctor. Suddenly

stopping treatment can make you feel unwell. For more information, see ‘If you stop

using Floebb’ later in the leaflet.

Instructions for use

Your doctor, asthma nurse or pharmacist should show you how to use your

inhaler. They should check how you use your inhaler from time to time. If you do

not use your Floebb properly, or if you do not use it as prescribed, the medicine

will not help your asthma as it should.

The medicine is contained in a pressurised canister in a plastic casing with a

mouthpiece.

Floebb produces a fine mist, which must be inhaled through your mouth into your

lungs.

Make sure that you know how to use this inhaler properly by reading this section. If you

have any problems ask your doctor, pharmacist or asthma nurse.

Testing your inhaler

(also known as ‘priming’ the inhaler)

When using your inhaler

for the first time, test that it is working. Remove the

mouthpiece cover by gently squeezing the sides with your thumb and forefinger and

pull apart (figure A).

To make sure that the inhaler works, shake it well (figure B), point the mouthpiece

away from you and press the canister firmly to release a puff into the air. Repeat these

steps at least two times, shaking the inhaler before releasing each puff. If you have not

used your inhaler for one day or more you should release two puffs of medicine into the

air.

If the inhaler gets very cold, the metal canister should be taken out of the plastic

actuator and warmed in your hands for a few minutes before use. Do not use

anything else to warm it up.

Using your inhaler

You should either stand up or sit upright when using your inhaler.

Remove the mouthpiece cover. Check that the inside and outside of the mouthpiece

are clean and free of loose objects (figure A). If it needs cleaning, read the

instructions under “

Cleaning your inhaler

” later in this leaflet.

Shake the inhaler well prior to use to make sure that any loose objects are removed

and that the contents of the inhaler are evenly mixed (figure B).

Hold the inhaler upright with your thumb on the base, below the mouthpiece.

Breathe out as far as is comfortable (figure C).

Immediately

place the mouthpiece in your mouth between your teeth, and close

your lips around it. Be careful not to bite the mouthpiece.

Breathe in slowly and deeply through your mouth

. Just after starting to breathe

in, press down firmly on the top of the inhaler to release a puff of medicine while

still breathing in steadily and deeply (figure D).

Hold your breath, take the inhaler from your mouth, and take your finger from the

top of the inhaler. Continue holding your breath for a few seconds, or as long as is

comfortable (figure E). Then breathe out slowly.

Breathing Technique

Do not rush steps 4, 5, 6 and 7.

It is important that you breathe in as slowly as possible just before using your

inhaler. You should use your inhaler whilst standing in front of a mirror for the first

few times. If you see a ‘mist’ or spray coming from the top of your inhaler or the

sides of your mouth, you should start again from step 3.

If your doctor has told you to take another puff, keep the inhaler upright, and wait

about half a minute before repeating steps 3 to 7.

After using Floebb, you should rinse your mouth out with water and spit out, and/or

brush your teeth. This should reduce the risk of infections in the mouth (e.g.

thrush) and hoarseness of the voice.

Once you have finished using the inhaler, always replace the mouthpiece cover to

keep out dust. Replace the cover by firmly clicking it into position.

If you find it difficult to use your inhaler and you have difficulty breathing in immediately

before you press down on the top of your inhaler to release a puff of medicine while you are

still breathing in

or

if you are taking high doses of this medicine, either your doctor or your

asthma nurse may recommend that you use a spacer device, such as a Volumatic spacer

device, with your inhaler.

A spacer device should always be used by children taking this medicine. A spacer device with

a face mask may be more suitable for younger children.

Only the Volumatic spacer device should be used with Floebb. Other spacing devices

should not be used with Floebb and you should not switch from one spacer device to

another.

Your doctor, asthma nurse or pharmacist should show you how to use the spacer device with

your inhaler and how to care for your spacer device and will answer any questions you may

have.

It is important that if you or your child are using a spacer device with Floebb that you do not

stop using it without talking to your doctor or asthma nurse first.

If you stop using a spacer device your doctor may need to change the dose of medicine

required to control your asthma. Always talk to your doctor before making any changes to

your asthma treatment.

People with weak hands, or children, may find it easier to operate the inhaler with both

hands, by putting both forefingers on the top of the inhaler, and both thumbs on the

bottom below the mouthpiece. Younger children may need help from a parent or carer

when using the inhaler.

Cleaning your inhaler:

Your inhaler should be cleaned at least once a week, to prevent it from blocking.

Remove the mouthpiece cover.

Do not remove the canister from the plastic casing.

Wipe the inside and outside of the mouthpiece and the plastic casing with a dry

cloth or tissue.

Do not put the metal canister in water.

Discharge one actuation (puff) to waste before next use.

Replace the mouthpiece cover.

If you use more Floebb than you should

It is important to use Floebb as stated on the pharmacist’s label or as advised by your

doctor. If you accidentally take a larger dose than recommended, talk to your doctor as

soon as possible. Do not change your dose without seeking medical advice.

If you have used high doses for a long period of time, you should talk to your doctor for

advice. This is because high doses of this medicine may reduce the amount of steroid

hormones produced by the adrenal gland (adrenal suppression).

If you forget to use Floebb

If you forget to use Floebb, take your next dose when it is due.

Do not take a double dose to make up for a forgotten dose.

If you stop using Floebb

It is very important that you take Floebb every day as directed.

Keep taking it until your

doctor tells you to stop. Do not stop or suddenly reduce your dose of Floebb

. This

could make your asthma worse.

If you do suddenly stop taking Floebb or reduce your dose, particularly if you have been

using high doses for a long period of time, this may reduce the amount of steroid

hormones produced by the adrenal gland (adrenal suppression), which can cause side

effects.

These side effects may include any of the following:

Stomach pain

Tiredness and loss of appetite, feeling sick

Sickness

Weight loss

Headache or drowsiness

Low levels of sugar in your blood

Low blood pressure and seizures (fits).

When your body is under stress, for example from fever, trauma (such as a car accident),

infection, or surgery, adrenal suppression can get worse and you may experience any of the

side effects listed above.

If you get any side effects, or you are unwell or need to go into hospital, talk to your

doctor or pharmacist and tell them that you are taking this medicine. Your doctor or

pharmacist may also give you a ‘steroid warning card’, which you should carry with you

at all times. To prevent these side effects occurring, your doctor may prescribe extra

corticosteroids in tablet form.

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

or asthma nurse.

4.

Possible side effects

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

them. To reduce the chance of side effects, your doctor will prescribe the lowest dose of

this medicine to control your asthma.

If you get any of the following symptoms after using this medicine,

talk to your doctor

or, if serious, go to the nearest hospital emergency department immediately:

Very rare

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

Signs of an allergic reaction:

you may notice itching, a rash (hives) and swelling,

usually of the face, lips, mouth, tongue or throat, which may cause difficulty in

swallowing or breathing, or you may suddenly feel your heart beating very fast or

you feel faint and light headed (which may lead to collapse or loss of consciousness).

If this happens

stop using this inhaler and contact your doctor straightaway

Breathing difficulties or wheezing that gets worse immediately after inhaling

Floebb

. If this happens

stop using this inhaler and contact your doctor

straightaway

. Use your

rapid-acting 'reliever' inhaler

to help your breathing.

Other side effects have also been reported.

If any of these trouble you, talk to your

doctor, pharmacist or asthma nurse:

Very common (may affect more than 1 in 10 people):

Thrush (sore, creamy-yellow, raised patches) in the mouth or throat, also known as

oral candidiasis.

Your doctor may prescribe an antifungal medication to treat the thrush.

Common (may affect up to 1 in 10 people):

Sore tongue, throat and hoarse voice.

Bruising.

Problems with your mouth and throat can be reduced by doing certain things straight after

taking your medicine. These are brushing your teeth, rinsing your mouth or gargling with

water and spitting it out. Tell your doctor or pharmacist if you have these problems, but

do not stop using this medicine unless you are told to.

Uncommon (may affect up to 1 in 100 people):

Allergic skin rash.

Rare

may affect up to 1 in 1,000 people

A fungal infection of the oesophagus (the tube that connects the mouth and stomach).

You may have a dry mouth and have pain or difficulty on swallowing.

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

Sleeping problems or feeling worried (anxious), changes in behaviour such as being

over-excited, restless or irritable (these effects are more likely to occur in children),

Increased level of sugar (glucose) in your blood,

Aching, swollen joints and muscle pain,

Heartburn/indigestion (dyspepsia).

Using high doses of fluticasone propionate for a long period of time can cause:

A reduction in the amount of steroid hormones produced by the adrenal gland

(adrenal suppression), which if severe or if your body is stressed (fever, infection,

trauma, surgery) can lead to adrenal crisis and you may become very ill. You may

feel tired, you may feel sick or actually be sick, have pain in the stomach or a

headache, notice weight loss or you may not want to eat, or you may have very low

blood sugar which could lead to loss of consciousness or fits,

Symptoms of increased amounts of steroid hormones in the body (Cushing’s

syndrome). You may notice upper body weight gain, rounding of the face, thinning

of the skin (which may bruise very easily or you may have stretch marks on the

thighs, stomach, legs etc.),

Thinning of your bones,

Eye problems such as cataracts (clouding of the eye lens) and glaucoma (raised

pressure in the eye) which may cause blurred vision,

Slowing of growth in children and adolescents.

Your doctor will help stop these side effects from happening by making sure that you use

the lowest dose of this medicine which controls your symptoms.

A serious lung infection (pneumonia) has been reported in people with chronic obstructive

pulmonary disease (COPD) using fluticasone propionate. COPD is a long-term lung

disease that causes shortness of breath, coughing and frequent chest infections. The term

COPD includes conditions known as chronic bronchitis and emphysema. If you have

difficulty breathing, have a fever, and/or have a cough which produces thick mucus which

may be yellow, green or brownish or have blood in it, talk to your doctor straight away.

Not known (frequency cannot be estimated from the available data):

Depression, restlessness, nervousness or aggression (mainly in children),

Nose bleeds,

Blurred vision

Reporting of side effects

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

any possible side effects not listed in this leaflet. You can also report side effects directly

via [To be completed nationally]. By reporting side effects you can help provide more

information on the safety of this medicine.

5.

How to store Floebb

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 and canister

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

Store below 25°C. Do not refrigerate or freeze. Protect from frost and direct sunlight.

As with most inhaled medicines in pressurised canisters, the effect of this medicine may

decrease when the canister is cold (see section 3 ‘Using your inhaler’).

The canister contains a pressurised liquid. Do not expose to temperatures higher than

50°C. Do not pierce, break or burn the canister, even if apparently empty.

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 Floebb

contains

The active substance in Floebb is fluticasone propionate. Each metered dose (ex-valve)

contains 50, 125 or 250 micrograms of fluticasone propionate. This is equivalent to a

delivered dose (ex-actuator) of 44, 110 or 220 micrograms of fluticasone propionate

respectively.

The other ingredient is the propellant: norflurane (HFA 134a).

What Floebb

looks like and the contents of the pack

Floebb 50 micrograms consists of a white to off-white suspension in an aluminium

canister sealed with a metering valve, inside a light orange actuator with a white dust cap.

Floebb 125 micrograms consists of a white to off-white suspension in an aluminium

canister sealed with a metering valve, inside an orange actuator with a white dust cap.

Floebb 250 micrograms consists of a white to off-white suspension in an aluminium

canister sealed with a metering valve, inside a dark brown actuator with a white dust cap.

Each canister contains 120 metered actuations (puffs).

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

Pharmaserve North West Limited, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn,

Cheshire, WA7 1NU, UK

McDermott Laboratories Limited T/A as Gerard Laboratories T/A Mylan Dublin, Unit

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

McDermott Laboratories T/A Mylan Dublin Respiratory, Unit 25 Baldoyle Industrial

Estate, Grange Road, Baldoyle, Dublin 13, Ireland

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

following names:

Sweden: Floebb 50 mikrogram, 125 mikrogram, 250 mikrogram

United Kingdom: Floebb Inhaler 50 micrograms, 125 micrograms, 250 micrograms

This leaflet was last revised in

2018-10-18

VOLUMATIC is a registered trade mark of Glaxo Group Limited.

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SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Floebb 50 micrograms per actuation pressurised inhalation, suspension.

Floebb 125 micrograms per actuation pressurised inhalation, suspension.

Floebb 250 micrograms per actuation pressurised inhalation, suspension.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each metered dose (ex-valve) contains 50 micrograms of fluticasone propionate.

This is equivalent to a delivered dose (ex-actuator) of 44 micrograms of fluticasone

propionate.

Each metered dose (ex-valve) contains 125 micrograms of fluticasone propionate.

This is equivalent to a delivered dose (ex-actuator) of 110 micrograms of fluticasone

propionate.

Each metered dose (ex-valve) contains 250 micrograms fluticasone propionate. This

is equivalent to a delivered dose (ex-actuator) of 220 micrograms fluticasone

propionate.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Pressurised inhalation, suspension.

Floebb is supplied in a pressurised aluminium multidose canister, fitted with a

metering valve.

The canister contains a white to off-white suspension.

The canisters are fitted into light orange plastic actuators fitted with white dust caps.

The canisters are fitted into orange plastic actuators fitted with white dust caps.

The canisters are fitted into dark brown plastic actuators fitted with white dust caps.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Fluticasone propionate given by inhalation offers prophylactic treatment for mild,

moderate and severe asthma.

Adults and adolescents over 16 years:

Floebb 50/125/250 micrograms is indicated in adults and adolescents over 16 years of

age for the prophylactic treatment of asthma.

Children aged over 4 years up to 12 years and adolescents aged 13 to 16 years:

Only the lowest strength of this inhaled corticosteroid, Floebb 50 micrograms, is

authorised for use in these young age groups.

Floebb 50 micrograms is indicated in any child (aged over 4 years up to 12 years) and

adolescents (aged 13 to 16 years) with asthma and requiring prophylactic treatment,

including those not controlled currently on other available prophylactic treatments.

Floebb 125 micrograms and Floebb 250 micrograms are NOT authorised for use in

these young age groups.

Asthma severity

Mild asthma: Patients requiring intermittent symptomatic rapid-acting

bronchodilators (β

agonists) on a regular daily basis.

Moderate persistent asthma: Patients with daily symptoms, daily use of ‘rescue’

rapid-acting bronchodilators (β

agonists) and moderate to severe airflow limitation

and for whom rapid control of asthma is essential.

Severe asthma: Patients with severe chronic asthma and those who are dependent on

systemic corticosteroids for adequate control of symptoms. Introduction of inhaled

fluticasone propionate may allow for significant reduction, or elimination, of oral

corticosteroid use (see section 4.4).

4.2

Posology and method of administration

Route of administration: Inhalation use.

Patients should be made aware of the prophylactic nature of therapy with inhaled

fluticasone propionate and that it should be used regularly, even when asymptomatic.

The onset of therapeutic effect is within 4 to 7 days.

If patients find that relief with rapid-acting bronchodilator treatment becomes less

effective, or they need more inhalations than usual, medical attention must be sought

(see section 4.4).

Patients should be given a starting dose of inhaled fluticasone propionate which is

appropriate to the severity of their disease.

Dose titration

The dose may be increased until control is achieved. The dose should then be titrated

down to the lowest dose at which effective control of asthma is maintained, according

to the individual response.

Posology

Adults and adolescents over 16 years

Patients should be given a starting dose of inhaled fluticasone propionate which is

appropriate for the severity of their disease. The dose should then be individually

adjusted until control is achieved; the dose may be increased to achieve control of

asthma but should then be titrated downwards to the lowest dose at which effective

control of asthma is maintained.

Usual doses are between 100 micrograms to a maximum of 1,000 micrograms, twice

daily.

Typical starting doses for adults and adolescents over 16 years

Mild asthma: Typical starting dose is 100 micrograms twice daily.

Moderate and more severe asthma: Starting doses may need to be 250 to 500

micrograms twice daily.

However due to the risk of systemic effects, doses above 500 micrograms twice daily

should be prescribed only for adult patients with severe asthma where additional

clinical benefit is expected, demonstrated by either an improvement in pulmonary

function and/or symptom control, or by a reduction in oral corticosteroid therapy (see

sections 4.4 and 4.8).

Therefore in severe asthma where additional clinical benefit is expected: Doses of up

to 1,000 micrograms twice daily may be used. Initiation of such doses should be

prescribed only by a specialist in the management of asthma (such as a consultant

physician or general practitioner with appropriate experience).

Paediatric population - children aged over 4 years up to 12 years and adolescents

aged 13 to 16 years:

Only the lowest strength of this inhaled corticosteroid, Floebb 50 micrograms, is

authorised for use in these young age groups.

Floebb 125 micrograms and Floebb 250 micrograms are NOT authorised for use in

these age groups; the maximum dose authorised for use in children aged over 4 years

up to 12 years and adolescents aged 13 to 16 years is 200 micrograms twice daily (4 x

50 micrograms twice daily, a dose which CANNOT be prescribed using the two

higher strengths of this inhaled corticosteroid).

Typical starting doses for children aged over 4 years up to 12 years and adolescents

aged 13 to 16 years

Floebb 50 microgram: 50 to 100 micrograms twice daily.

Many children with asthma will be well controlled using a 50 to 100 microgram twice

daily dosing regimen.

For those children and younger adolescents aged (13 to 16 years) whose asthma is not

sufficiently controlled, additional benefit may be obtained by increasing the dose up

to 200 micrograms twice daily.

The maximum dose for use in these age groups is

200 micrograms twice daily.

Should Floebb 50 microgram not offer the exact paediatric dose prescribed by the

physician, alternative fluticasone propionate-containing products are available.

As in adults and the older adolescents the starting dose should be appropriate for the

severity of asthma. The dose should be individually adjusted until control is achieved

and then be titrated downwards to the lowest dose at which effective control of

asthma is maintained.

Special patient groups

There is no need to adjust the dose in elderly patients or in those with hepatic or renal

impairment.

Use of spacer device

Volumatic

spacer device should always be available for use with a pressurised

metered dose inhaler and should always be considered for use when a pressurised

metered dose inhaler is prescribed for use by a child, and may need to be used with a

face mask.

Floebb may also be used with a

Volumatic

spacer device by patients who find it

difficult to synchronise aerosol actuation with inspiration of breath, or those

administering doses above 1,000 micrograms (500 micrograms twice daily) to help

reduce side effects in the mouth and throat (see section 4.4).

The spacer device must be appropriate for the age groups of intended use.

Only the Volumatic

spacer device should be used with Floebb. Other spacing

devices should not be used with Floebb and patients should not switch from one

spacer device to another.

Patients should be instructed in the proper use and care of their inhaler and spacer

device. Technique when using the inhaler both without and with the spacer device

should be checked regularly to ensure that actuation of the inhaler and inspiration of

breath are synchronised and to ensure optimum delivery of the inhaled drug to the

lungs.

Patients should always use the recommended Volumatic spacer device as

switching to an alternative spacer device can result in changes in the dose of

fluticasone propionate delivered to the lungs. Patients should also be told not to

discontinue their use of a spacer device without consulting their doctor or

asthma nurse, as a reduction in the dose delivered to the lungs may be expected

(see section 4.4).

Re-titration to the lowest dose at which effective control of asthma is maintained

should always be carried out when patients who have not used a spacer device

previously are prescribed the Volumatic spacer device and when patients who have

been using an alternative product without or with a spacer device are transferred to

Floebb, used either without or with the Volumatic spacer device.

Method of administration

Instructions for use

Patients should be instructed in the proper use of their inhaler (see package leaflet).

During inhalation, the patient should preferably sit or stand.

The inhaler has been designed for use in a vertical position.

Testing the inhaler

Before using the inhaler for the first time patients should test that it is working.

Patients should remove the mouthpiece cover by gently squeezing the sides of the

cover (figure A) and hold the inhaler between the fingers and thumb with their thumb

on the base, below the mouthpiece (figure B). To make sure that the inhaler works,

the patient should shake it well, point the mouthpiece away from them and press the

canister firmly to release an actuation (puff) into the air. These steps should be

repeated at least two times, shaking the inhaler before releasing each puff.

If the inhaler has not been used for one day (24 hours) or more, the mouthpiece cover

should be removed, the patient should shake the inhaler well and two puffs should be

released into the air to prime the inhaler.

If the inhaler is cold, the canister should be removed from the actuator and warmed in

the hands. No other form of external heat should be applied.

Use of the inhaler

Patients should remove the mouthpiece cover by gently squeezing the sides of

the cover (figure A).

Patients should check inside and outside of the inhaler including the mouthpiece

for the presence of loose objects (figure A).

Patients should shake the inhaler well prior to use to ensure that any loose

objects are removed and that the contents of the inhaler are evenly mixed

(figure B).

Patients should hold the inhaler upright between the fingers and thumb with their

thumb on the base, below the mouthpiece (figure C).

Patients should breathe out as far as is comfortable and then place the

mouthpiece in their mouth between their teeth and close their lips around it.

Patients should be instructed not to bite the mouthpiece (figure D).

Just after starting to breathe in through their mouth, patients should press firmly

down on the top of the inhaler to release the medicine whilst still breathing in

steadily and deeply (figure D).

While holding their breath, patients should take the inhaler from their mouth and

take their finger from the top of the inhaler. Patients should continue holding

their breath for as long as is comfortable (figure E).

To take a second inhalation, patients should keep the inhaler upright and wait

about half a minute before repeating steps 3 to 7.

Patients should immediately replace the mouthpiece cover by firmly pushing

and snapping the cap into position. This does not require excessive force, the

cover should click into position.

IMPORTANT

Patients should not rush stages 5, 6 and 7. It is important that patients start to

breathe in as slowly as possible just before operating their inhaler. Patients

should practise in front of a mirror for the first few times. If they see "mist"

coming from the top of their inhaler or the sides of their mouth they should start

again from stage 3.

Patients should rinse their mouth out with water and spit out, and/or brush their teeth

after each dose of medicine, in order to minimise the risk of oropharyngeal

candidiasis and hoarseness.

Patients with weak hands, or children, may find it easier to operate the inhaler with

both hands, by putting both forefingers on the top of the inhaler, and both thumbs on

the bottom below the mouthpiece. Younger children may need help from a parent or

carer when using the inhaler.

Cleaning the inhaler (also detailed in package leaflet)

The inhaler should be cleaned at least once a week. The mouthpiece cover should be

removed and then replaced when cleaning is complete. The inside and outside of the

mouthpiece and plastic casing should be wiped with a dry cloth. The canister should

not be removed, nor placed in water. Before use, one puff should be released into the

air (see package leaflet).

THE METAL CANISTER SHOULD NOT BE PUT IN WATER.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section

6.1.

4.4

Special warnings and precautions for use

Management of asthma

The management of asthma should follow a stepwise programme, and patient

response should be monitored clinically and by lung function tests.

Once asthma symptoms are controlled, consideration may be given to gradually

reducing the dose of fluticasone propionate. Regular review of patients as treatment is

stepped down is important. The lowest dose at which effective control of asthma is

maintained should be used (see section 4.2).

Fluticasone propionate should not be used to treat acute asthma symptoms for which

an inhaled rapid-acting bronchodilator (e.g. β

agonist) is required. Patients should be

advised to have their inhaler to be used for relief in an acute asthma attack available

at all times.

Severe asthma requires regular medical assessment, including lung function testing,

as patients are at risk of severe attacks and even death. Increasing symptoms may

indicate deterioration of asthma control and medical assessment may be required.

Treatment with fluticasone propionate should not be stopped abruptly due to the risk

of exacerbation. Therapy should be down-titrated under medical supervision.

Paradoxical bronchospasm

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

immediate increase in wheezing and shortness of breath after dosing. Paradoxical

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

straightaway. Fluticasone propionate should be discontinued immediately, the patient

assessed and alternative therapy instituted if necessary.

Deterioration of asthma control

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

with fluticasone propionate. Patients should be asked to continue treatment but to

seek medical advice if symptoms remain uncontrolled or worsen on initiation on

Floebb.

Increased requirements for use of reliever medication (rapid-acting bronchodilators),

or decreased response to reliever medication, indicate deterioration of asthma control

and patients should be reviewed by a physician.

Sudden and progressive deterioration, or lack of response, in asthma control is

potentially life-threatening and the patient should undergo urgent medical assessment.

Consideration should be given to increasing corticosteroid therapy (e.g. higher doses

of inhaled corticosteroids or a course of oral corticosteroids). In patients considered at

risk, daily peak flow monitoring may be instituted.

Severe exacerbations of asthma must be treated in the normal way.

If necessary, an antibiotic should be considered if there is a concomitant bacterial

infection.

Inhaler technique

Patients’ inhaler technique should be checked regularly to make sure that inhaler

actuation is synchronised with inspiration to ensure optimum delivery to the lungs

(see section 4.2 ‘

Use of the inhaler

’).

Blood glucose/patients with diabetes mellitus

There have been very rare reports of increases in blood glucose levels, in patients

with or without a history of diabetes mellitus (see section 4.8). This should be

considered in particular when prescribing to patients with a history of diabetes

mellitus.

Hypothalamic-pituitary-adrenal (HPA) axis suppression

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

prescribed for long periods. These effects are much less likely to occur than with oral

corticosteroids. Certain individuals, however, can show greater susceptibility to the

effects of inhaled corticosteroids.

Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal

suppression, acute adrenal crisis, 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

Paediatric population

sub-heading below for

information on the systemic effects of inhaled corticosteroids in children and

adolescents).

It is important therefore, that the patient is reviewed regularly and the dose of

inhaled corticosteroid is reduced to the lowest dose at which effective control of

asthma is maintained.

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.

Prolonged treatment of patients with high doses of inhaled corticosteroids may result

in adrenal suppression and acute adrenal crisis. Very rare cases of adrenal

suppression and acute adrenal crisis have also been described with doses of

fluticasone propionate between 500 and less than 1,000 micrograms. Situations,

which could potentially trigger acute adrenal crisis, include trauma, surgery, infection

or any rapid reduction in dosage.

Presenting symptoms are typically vague and may include anorexia, abdominal pain,

weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of

consciousness, hypoglycaemia, and seizures.

Additional systemic corticosteroid cover should be considered during periods of

stress or elective surgery.

Oral corticosteroid therapy

The benefits of inhaled fluticasone propionate therapy should minimise the need for

oral corticosteroids, but patients transferring from oral corticosteroids, particularly

after prolonged or high dose treatment, may remain at risk of impaired adrenal

reserve and associated adverse effects for a considerable time. Therefore these

patients should be treated with special care and adrenocortical function regularly

monitored. Patients who have required high dose emergency corticosteroid therapy in

the past may also be at risk.

Where impaired adrenal reserve is identified, patients should carry a steroid warning

card or notify the Doctor that they are taking fluticasone propionate as they may

require appropriate supplementary systemic corticosteroid treatment during periods of

stress e.g. worsening asthma attacks, chest infections, major concurrent illness,

surgery and trauma.

The possibility of residual impairment should always be borne in mind in emergency

and elective situations also likely to produce stress for all patients, and appropriate

corticosteroid treatment must be considered. The extent of the adrenal impairment

may require specialist advice before elective procedures.

Gradual and cautious withdrawal of the oral corticosteroid should commence with

decreases in dose appropriate to the level of maintenance oral corticosteroid (

for more

information, refer to the SmPC of the oral corticosteroid

Some patients feel unwell in a non-specific way during the withdrawal phase despite

maintenance or even improvement of respiratory function. They should be

encouraged to persevere with inhaled fluticasone propionate and to continue

withdrawal of the oral corticosteroid, unless there are objective signs of adrenal

insufficiency.

Use of a spacer device

Administration of high doses, above 1,000 micrograms daily is recommended through

Volumatic

spacer device to reduce side effects in the mouth and throat.

However, as systemic absorption of fluticasone propionate is largely through the

lungs, the use of a spacer device with a metered dose inhaler may increase drug

delivery to the lungs. It should be noted that this could potentially lead to an increase

in the risk of systemic adverse effects. A lower dose may be required (see section

4.2).

Exacerbation of underlying conditions

Replacement of systemic corticosteroid treatment with inhaled therapy sometimes

unmasks allergies such as allergic rhinitis or eczema previously controlled by the

systemic drug. These allergies should be symptomatically treated with antihistamine

and/or topical preparations, including topical corticosteroids.

Concomitant infections

As with all inhaled corticosteroids, fluticasone propionate should be administered

with caution in patients with active or quiescent pulmonary tuberculosis and fungal,

viral or other infections of the airway. Appropriate treatment should be instituted

promptly, if indicated and patients observed closely.

Ritonavir

Ritonavir can greatly increase the concentration of fluticasone propionate in plasma.

Therefore, concomitant use should be avoided, unless the potential benefit to the

patient outweighs the risk of systemic corticosteroid side effects. There is also an

increased risk of systemic side effects when combining fluticasone propionate with

other potent CYP3A inhibitors (see section 4.5).

Paediatric population

Children and adolescents 16 years of age and younger inhaling high doses of

fluticasone propionate (typically ≥ 1,000 micrograms/day) may be at particular risk of

systemic effects. Systemic effects may occur, particularly at high doses prescribed

for long periods. Possible systemic effects include Cushing's syndrome, Cushingoid

features, adrenal suppression, acute adrenal crisis and growth retardation in

children and adolescents and more rarely, a range of psychological or behavioural

effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or

aggression. Consideration should be given to referring the child or adolescent to a

paediatric respiratory specialist.

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

inhaled corticosteroid is regularly monitored.

If growth is slowed, therapy should

be reviewed and the dose of inhaled corticosteroid should be reduced, if

possible, to the lowest dose at which effective control of asthma is maintained.

Volumatic

spacer device should always be considered for use when a pressurised

metered dose inhaler is prescribed for use in this population, and may need to be used

with a face mask for younger children (see section 4.2).

4.5

Interaction with other medicinal products and other forms of interaction

Under normal circumstances, low plasma concentrations of fluticasone propionate are

achieved after inhaled dosing, due to extensive first pass metabolism and high

systemic clearance mediated by cytochrome P450 3A4 in the gut and liver. Hence,

clinically significant drug interactions mediated by fluticasone propionate are

unlikely.

In an interaction study in healthy subjects with intranasal fluticasone propionate,

ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg b.i.d. increased the

fluticasone propionate plasma concentrations several hundred fold, resulting in

markedly reduced serum cortisol concentrations. Information about this interaction is

lacking for inhaled fluticasone propionate, but a marked increase in fluticasone

propionate plasma levels is expected. Cases of Cushing's syndrome and adrenal

suppression have been reported. The combination should be avoided unless the

benefit outweighs the increased risk of systemic glucocorticoid side effects.

In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor

ketoconazole increased the exposure of fluticasone propionate after a single

inhalation by 150%. This resulted in a greater reduction of plasma cortisol as

compared with fluticasone propionate alone. 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.

4.6

Fertility, pregnancy and lactation

Fertility

There are no data in humans. No evidence of impairment of fertility was observed in

reproductive studies conducted in male and female rats (see section 5.3).

Pregnancy

There is inadequate evidence of safety of fluticasone propionate in human pregnancy.

Data on a limited number (between 300 and 1000 pregnancy outcomes) of exposed

pregnancies indicate no adverse effects of fluticasone propionate on pregnancy or the

health of the fetus/new born child. To date no other relevant epidemiological data are

available.

Administration of corticosteroids to pregnant animals have shown reproductive

toxicity (see section 5.3). There may therefore be a very small risk of such effects in

the human fetus. It should be noted, however, that the fetal changes in animals occur

after relatively high systemic exposure. Floebb delivers fluticasone propionate

directly to the lungs by the inhaled route and therefore, the high level of exposure that

occurs when corticosteroids are given by systemic routes is avoided.

Administration of fluticasone propionate during pregnancy should only be considered

if the expected benefit to the mother is greater than any possible risk to the fetus.

The lowest effective dose of fluticasone propionate needed to maintain adequate

asthma control should be used in the treatment of pregnant women.

Breastfeeding

The secretion of fluticasone propionate in human breast milk has not been

investigated.

Subcutaneous administration of fluticasone propionate to lactating laboratory rats

produced measurable plasma levels and evidence of fluticasone propionate in the

milk. However, plasma levels in humans after inhalation at recommended doses are

likely to be low.

A risk to breastfed newborns/infants cannot be excluded. A decision must be made

whether to discontinue breastfeeding or to discontinue treatment with fluticasone

propionate taking into account the benefit of breastfeeding for the child and the

benefit of fluticasone propionate for the woman.

4.7

Effects on ability to drive and use machines

Fluticasone propionate has no or negligible influence on the ability to drive and use

machines.

4.8

Undesirable effects

Adverse events are listed below by system organ class and frequency. Frequencies are

defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon

(≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000), very rare (<1/10,000) and not

known (cannot be estimated from the available data) including isolated reports.

Very common, common and uncommon events were generally determined from

clinical trial data. Rare and very rare events were generally determined from

spontaneous data.

System Organ Class

Adverse Event

Frequency

Candidiasis of the mouth and throat*

Very common

Pneumonia (in COPD patients)****

Common

Infections and infestations

Oesophageal candidiasis*

Rare

Hypersensitivity reactions with the

following manifestations:

Cutaneous hypersensitivity reactions

Uncommon

Angioedema (mainly facial and

oropharyngeal oedema)

Very rare

Respiratory symptoms (dyspnoea

and/or bronchospasm)

Very rare

Immune system disorders

Anaphylactic reactions

Very rare

Endocrine disorders

Cushing's syndrome, Cushingoid

features, adrenal suppression, growth

retardation in children and

adolescents, decreased bone mineral

density, cataract, glaucoma**

Very rare

Metabolism and nutrition

disorders

Hyperglycaemia (see section 4.4)

Very rare

Anxiety, sleep disorders, behavioural

changes, including hyperactivity and

irritability (predominantly in

children)**

Very rare

Psychiatric disorders

Depression, aggression

(predominantly in children)**

Not known

Eye disorders

Blurred vision (see section 4.4)

Not known

Hoarseness/dysphonia*

Common

Respiratory, thoracic and

mediastinal disorders

Paradoxical bronchospasm***

Very rare

Epistaxis

Not known

Gastrointestinal disorders

Dyspepsia

Very rare

Skin and subcutaneous tissue

disorders

Contusions

Common

Musculoskeletal and

connective tissue disorders

Arthralgia

Very rare

*Hoarseness and candidiasis (thrush) of the mouth and throat and, rarely, of the

oesophagus can occur in some patients. Both hoarseness and candidiasis of the mouth

and throat may be relieved, or their incidence may be reduced, by rinsing the mouth

with water and/or brushing the teeth after using Floebb. Symptomatic mouth and

throat candidiasis can be treated with topical anti-fungal therapy whilst still

continuing with Floebb.

**Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal

suppression, growth retardation, decreased bone mineral density, cataract, glaucoma,

anxiety, sleep disorders, behavioural changes, including hyperactivity, irritability and

depression and aggression (predominantly in children) (see section 4.4).

***As with other inhalation therapy, paradoxical bronchospasm may occur (see

section 4.4) with an immediate increase in wheezing and shortness of breath after

dosing. Paradoxical bronchospasm responds to a rapid-acting bronchodilator and

should be treated straightaway. Fluticasone propionate should be discontinued

immediately, the patient assessed, and if necessary alternative therapy instituted.

****There was an increased reporting of pneumonia in studies of patients with

Chronic Obstructive Pulmonary Disease (COPD) receiving 500 micrograms

fluticasone propionate. Physicians should remain vigilant for the possible

development of pneumonia in patients being treated with fluticasone propionate as

the clinical features of pneumonia and exacerbation frequently overlap.

Paediatric population

Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal

suppression and growth retardation in children and adolescents (see section 4.4).

Children may also experience anxiety, sleep disorders and behavioural changes,

including hyperactivity, irritability, depression and aggression.

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 [To be completed nationally].

4.9

Overdose

Acute

: Inhalation of fluticasone propionate in doses in excess of those recommended

may lead to temporary suppression of adrenal function. This does not necessitate

emergency action being taken. Adrenal function recovers in a few days and can be

verified by measuring plasma cortisol.

Chronic overdose of inhaled fluticasone propionate

: If higher than approved doses

are continued over prolonged periods, significant adrenocortical suppression is

possible.

There have been very rare reports of acute adrenal crisis occurring in adults and in

children. Observed features include hypoglycaemia, decreased consciousness and/or

convulsions. Situations which could potentially trigger acute adrenal crisis include

exposure to trauma, surgery, infection or any rapid reduction in dose of the inhaled

corticosteroid.

Adrenal reserve should be monitored and treatment with a systemic corticosteroid

may be necessary. When stabilised, treatment should be continued with an inhaled

corticosteroid at the recommended dose (see section 4.4 ‘

Hypothalamic-pituitary-

adrenal (HPA) axis suppression

’ and ‘

Paediatric population

’).

Treatment

Patients receiving higher than approved doses should be managed closely and the

dose reduced gradually.

In cases of both acute and chronic fluticasone propionate overdose, fluticasone

propionate therapy should be continued at a suitable dosage for symptom control.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Other drugs for obstructive airway diseases, inhalants,

glucocorticoids, ATC code: R03BA05

Fluticasone propionate given by inhalation at recommended doses has a potent

glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of

both symptoms and exacerbations of asthma, with a lower incidence and severity of

adverse effects than those observed when corticosteroids are administered

systemically.

5.2

Pharmacokinetic properties

Absorption

The absolute bioavailability of a single dose of inhaled fluticasone propionate in

healthy subjects varies between approximately 5 to 11% of the nominal dose

depending on the inhalation device used. In patients with asthma a lesser degree of

systemic exposure to inhaled fluticasone propionate has been observed.

Systemic absorption occurs mainly through the lungs and is initially rapid then

prolonged. The remainder of the inhaled dose may be swallowed but contributes

minimally to systemic exposure due to the low aqueous solubility and pre-systemic

metabolism, resulting in oral availability of less than 1%. There is a linear increase in

systemic exposure with increasing inhaled dose.

Distribution

The disposition of fluticasone propionate is characterised by high plasma clearance

(1150 mL/min), a large volume of distribution at steady-state (approximately 300 L)

and a terminal half-life of approximately 8 hours.

Plasma protein binding is 91%.

Biotransformation

Fluticasone propionate is cleared very rapidly from the systemic circulation. The

main pathway is metabolism to an inactive carboxylic acid metabolite, by the

cytochrome P450 enzyme CYP3A4. Other unidentified metabolites are also found in

the faeces.

Elimination

The renal clearance of fluticasone propionate is negligible. Less than 5% of the dose

is excreted in urine, mainly as metabolites. The main part of the dose is excreted in

faeces as metabolites and unchanged drug.

5.3

Preclinical safety data

The only safety concerns for human use derived from animal studies of fluticasone

propionate were effects associated with exaggerated pharmacological actions, and

these only occurred at doses greatly in excess of that proposed for therapeutic use.

In animal reproduction studies, glucocorticosteroids have been shown to induce

malformations (including growth retardation, cleft palate and skeletal malformations).

These animal experimental results do not seem to be relevant for (adult) man given

recommended doses; however, very rarely growth retardation may occur in children

inhaling fluticasone propionate (see section 4.8). No novel effects were identified in

repeat dose toxicity tests, reproductive studies or teratology studies. Fluticasone

propionate is devoid of mutagenic activity

in vitro

in vivo

and showed no

tumorigenic potential in rodents. It is both non-irritant and non-sensitising in animal

models.

The non-CFC propellant, norflurane (HFA 134a), has been shown to have no toxic

effect at very high vapour concentrations, far in excess of those likely to be

experienced by patients, in a wide range of animal species exposed daily for periods

of two years.

The use of norflurane (HFA 134a) as a propellant has not altered the toxicity profile

of fluticasone propionate compared to that using the conventional CFC propellant.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Propellant: norflurane (HFA 134a).

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

24 months.

6.4

Special precautions for storage

Store below 25°C. Do not refrigerate or freeze. Protect from frost and direct sunlight.

As with most inhaled medicinal products in pressurised canisters, the therapeutic

effect of this medicinal product may decrease when the canister is cold.

The multidose canister contains a pressurised liquid. Do not expose to temperatures

higher than 50°C. Do not pierce, break or burn the canister, even if apparently empty.

Replace the mouthpiece cover firmly and snap into position after use.

6.5

Nature and contents of container

Pressurised aluminium multidose canister sealed with a metering valve, with a

polypropylene actuator and a polypropylene dust cap.

Floebb 50 micrograms has a light orange actuator and a white dust cap.

Each canister contains 120 metered actuations of 50 micrograms of fluticasone

propionate.

Floebb 125 micrograms has an orange actuator and a white dust cap.

Each canister contains 120 metered actuations of 125 micrograms of fluticasone

propionate.

Floebb 250 micrograms has a dark brown actuator and a white dust cap.

Each canister contains 120 metered actuations of 250 micrograms of fluticasone

propionate.

6.6

Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance

with local requirements.

7.

MARKETING AUTHORISATION HOLDER

[To be completed nationally]

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

2018-10-18

VOLUMATIC is a registered trade mark of Glaxo Group Limited.

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