FLIXOTIDE 50 MCG Pressurized inhalation suspension

Зміст інструкції

1. FLIXOTIDE 50 mcg Pressurized suspension for inhalation
   1. What is Flixotide and what is it used for
   2. What you need to know before using Flixotide
   3. How to use Flixotide
   4. Possible side effects
2. Flixotide 125 mcg Pressurized Suspension for Inhalation, 250 mcg Pressurized Suspension for Inhalation
   1. What is Flixotide and what is it used for
   2. What you need to know before using Flixotide
   3. How to use Flixotide
   4. Possible side effects
   5. How to store Flixotide
   6. Content of the pack and other information
3. Flixotide 100 mcg Powder for inhalation, 250 mcg Powder for inhalation, 500 mcg Powder for inhalation
   1. What is Flixotide and what is it used for
   2. What you need to know before using Flixotide
   3. How to use Flixotide
   4. Possible side effects
   5. How to store Flixotide
4. FLIXOTIDE 500 mcg/2 ml Suspension for Nebulisation
   1. What is Flixotide and what is it used for
   2. What you need to know before using Flixotide
   3. How to use Flixotide
   4. Possible side effects
   5. How to store Flixotide

FLIXOTIDE 50 mcg Pressurized suspension for inhalation

fluticasone propionate

Read this leaflet carefully before you start to take this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Flixotide is and what it is used for
• 2. What you need to know before you use Flixotide
• 3. How to use Flixotide
• 4. Possible side effects
• 5. How to store Flixotide
• 6. Contents of the pack and other information

1. What is Flixotide and what is it used for

This medicine contains the active ingredient fluticasone propionate, which belongs to a group of
medicines called corticosteroids, medicines used as antiasmatics (for the treatment of asthma, an inflammatory disease characterized by reversible obstruction of the lower airways) via inhalation.
Fluticasone propionate reduces swelling and inflammation in the lungs (anti-inflammatory action).
This medicine is indicated in the control of asthma and conditions of bronchostenosis
(reduction of the calibre of a bronchus).

2. What you need to know before using Flixotide

Do not use Flixotide

• if you are allergic to fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Flixotide.
In particular, talk to your doctor if:

• you have active or inactive (quiescent) tuberculosis (TB, a contagious disease caused by a bacterium)
• you are a diabetic patient
• you have a respiratory disease called Chronic Obstructive Pulmonary Disease (COPD)
• you are switching from oral steroid therapy to inhaled fluticasone.

In this case, you must be treated with particular attention by the doctor, who will need to monitor
your adrenal function regularly and gradually discontinue oral therapy following
the introduction of inhaled therapy. It is therefore advisable to carry with you a card indicating
that you may require supplementary corticosteroid therapy during periods of stress.
If your breathing becomes difficult (bronchospasm with increased dyspnea) following the use of Flixotide,
stop taking the medicine and consult your doctor immediately.
Replacing systemic corticosteroid therapy with inhaled corticosteroids can trigger
allergic diseases.
Asthma treatment should normally be carried out as part of a therapeutic plan tailored to the
severity of the condition; your response to therapy should be verified by your doctor both clinically and
through lung function tests.
The need to resort more frequently to medications to control asthma symptoms indicates
a worsening of disease control; in this circumstance your therapeutic plan must be
modified by your doctor.
A sudden worsening of asthma is potentially life-threatening and in this case the doctor must
consider the possibility of increasing the dose of corticosteroids.
Do not abruptly stop treatment with fluticasone propionate.
With the use of inhaled glucocorticoids (such as fluticasone propionate), particularly when prescribed at
high doses for prolonged periods, systemic effects (on the whole body) can occur. These effects are
less likely to occur than with treatment with glucocorticoids administered orally.
Possible systemic effects include Cushing's syndrome (a clinical condition characterized by excess
glucocorticoids in the blood leading to obesity, lack of facial expression, red skin, widespread stretch marks
and abundant facial hair, especially on the face), cushingoid appearance (typical of people affected by Cushing's
disease), adrenal suppression (reduced adrenal function), growth retardation in children
and adolescents, reduced bone mineral density, cataracts (clouding of the lens located
inside the eye), glaucoma (serious eye disease) and, more rarely, a number of psychological or behavioral effects including psychomotor hyperactivity, irritability, sleep disturbances, anxiety,
depression or behavioral disorders (particularly in children) (see section 4 “Possible side effects”). It is therefore important that the dose of inhaled corticosteroid is the lowest dose
possible with which effective asthma control is maintained.
It is recommended to regularly check the height of children receiving prolonged therapies with
inhaled corticosteroids.
Some individuals may experience increased sensitivity to the effects of inhaled corticosteroids
compared to most patients.
Very rare cases of acute adrenal crises have been reported in adolescents exposed to doses higher than
those recommended (approximately 1,000 micrograms per day) for prolonged periods (several months or years).
Contact your doctor if you experience blurred vision or other visual disturbances, which may be caused by cataracts or
glaucoma.

Other medicines and Flixotide
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, a medicine used to treat fungal infections.
• Some medicines can increase the effects of Flixotide. Your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Flixotide with food and drink
Flixotide can be used at any time of day, with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
It is unlikely that Flixotide will affect your ability to drive or operate machinery.

3. How to use Flixotide

Flixotide is available in three different dosages. Your doctor will decide which dosage you need. Use this
medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor,
nurse or pharmacist.

Using this medicine
Adults
The standard dose is 200 micrograms per day, divided into two administrations of 100 micrograms
each. The dosage may be increased up to 400 micrograms per day.
The initial dose may then be adjusted until control is achieved, or reduced to the
minimum effective dose, according to individual response.
In severe forms, a maximum dosage of 2000 micrograms per day may allow adequate control
of the disease by reducing the use of oral steroids.
During exacerbations, dosages of 2000 micrograms per day may replace oral steroid cycles in some cases.

Children (from 1 to 4 years)
100 micrograms twice a day administered using a spacer device with a
facial mask (pediatric spacer device).

Children over 4 years
The standard dose is 100 micrograms per day, divided into two administrations of 50 micrograms
each.
The dosage may be increased up to 200 micrograms per day.
It is recommended that the height of children treated with steroids, including Flixotide pressurized suspension,
be regularly monitored by the doctor.

If you are using high doses of an inhaled steroid for a long time, you may sometimes need to use supplementary doses of steroids, for example during stressful circumstances, such as a
car accident or before surgery. Your doctor may decide to prescribe you a
supplement of steroids during that period.
Patients who have been treated with high doses of steroids, including Flixotide pressurized suspension,
for a long period, should not stop taking the medicine suddenly without informing their doctor. Sudden discontinuation of treatment may cause malaise and symptoms such as
vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar levels
(hypoglycemia) and changes in weight.
Instructions for use
Some people find it difficult to spray the medicine immediately after starting to inhale.
The spacer device helps to overcome this problem.
The doctor, nurse or pharmacist must show you how to use the inhaler.
Do not use Flixotide pressurized suspension differently than as prescribed, otherwise it is possible that the
medicine will not provide relief from asthma.
The medicine is contained in a pressurized canister which is inserted into a plastic casing with a
mouthpiece.

Checking the operation of the inhaler When using the inhaler for the first time, check that it works. Remove the mouthpiece cover by gently pressing the sides with your thumb and index finger and pull it out. To make sure it works, shake well, point the mouthpiece away from you and spray one dose into the air. If you do not use the inhaler for a week or more, spray into the air twice.	n a d e l
i Using the inhaler l Before using the inhaler it is important to start a breathing as slowly as possible. 1 When using the inhaler remain standing or t sitting upright. I 2 Remove the mouthpiece cover (as shown in the first image). Check inside a and out that the mouthpiece is clean and free from objects.
i 3 Shake the inhaler 4 or 5 times to ensure that z any objects are removed and that the n contents of the inhaler are mixed evenly. e g

4Hold the inhaler in an upright position with the
thumb on the base, under the mouthpiece. Exhale until
you are comfortable. Do not inhale yet.

5Position the mouthpiece in your mouth between your teeth.
Close your lips around it without biting it.

6Inhale through your mouth. Immediately after
starting to inhale, press down on the canister cover to release a spray of
medicine. Do this while inhaling
steadily and deeply.

7Hold your breath; remove the inhaler from your
mouth and your finger from the top of the inhaler.
Continue to hold your breath for a few seconds
or until you are comfortable.

8If your doctor has told you to take two inhalations, wait about half a minute before inhaling
another dose repeating steps 3 to 7.

9After use, replace the mouthpiece cover to prevent dust from settling on it.
Close the cover tightly by pressing it until you hear the snap click when it is in position.

Cleaning the inhaler
To prevent the inhaler from becoming blocked, it is important to clean it at least once a week.
To clean the inhaler:

• remove the protective cap of the mouthpiece;
• never remove the metal canister from the plastic container;
• clean the inside and outside of the mouthpiece with a dry cloth or tissue;
• replace the protective cap on the mouthpiece. Do not put the pressurized metal container in water.

If you use more Flixotide than you should
If you use more Flixotide than you should, consult your doctor as soon as possible.
It is important to take the dose as prescribed by your doctor. Do not increase or decrease the dose without
asking your doctor for advice.

If you forget to use Flixotide

• Take the next dose at the scheduled time.
• Do not take a double dose to make up for a missed dose.

If you stop using Flixotide

• Do not stop treatmenteven if you feel better unless you are told to do so by your doctor. If you have any doubts about using this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

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

If you notice any of the following serious side effects, stop using this medicine and see a
doctor immediately asyou may need urgent medical attention:

• allergic reactions (can affect up to 1 in 100 people) - signs include skin rashes, redness, itching or nettle rash or hives;
• severe allergic reactions (can affect up to 1 in 10,000 people) - signs include swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling of faintness and dizziness and collapse;
• your breathing or wheezing gets worse immediately after using the inhaler.

Other side effects include:

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

• thrush in the mouth and throat

Common(may affect up to 1 in 10 people)

• dryness of the tongue or throat;
• hoarseness of voice. Problems in the mouth and throat can be reduced with certain precautions immediately after inhaling the dose. These are: brushing your teeth, rinsing your mouth or gargling with water and spitting. Tell your doctor if you have these problems in the mouth or throat, but do not stop treatment unless they tell you to.

In addition, in patients with chronic obstructive pulmonary disease (COPD), the following effects
have been reported:

• pneumonia and bronchitis (lung infection); tell your doctor if you experience any of the following symptoms: increased production of sputum, change in color of sputum, fever, chills, increased cough, increased breathing problems
• bruising.

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

• thrush (candidiasis) in the esophagus.

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

• sleep disturbances or feeling anxious, over-excited and irritable; these effects are more likely to happen in young people;
• joint pain;
• indigestion;
• the level of sugar (glucose) in the blood may increase;
• when using Flixotide, the way steroids are produced by the body may be affected. This is more likely to happen if you use high doses for a long period of time (for example 400 micrograms a day in children). This can cause:
• slowed growth in young people;
• the so-called ‘Cushing’s Syndrome’, a condition characterized by an excess of steroid hormones in the bloodstream, which can cause thinning of the bones and problems with the eyes (such as cataracts and glaucoma, which is an increase in pressure in the eye). The doctor will help to avoid this happening by making sure you use the lowest dose of steroid to control your symptoms.

Despite the frequency is unknown, the following side effects may also occur:

• depression, feeling restless or nervous; these effects are more likely to happen in children;
• blurred vision;
• nosebleeds.

See your doctor as soon as possible if:

• after 7 days of using Flixotide, your shortness of breath or dyspnea does not improve, or gets worse;
• following treatment with high doses of inhaled steroids, you develop a feeling of unwellness with symptoms such as stomach pain, nausea, diarrhea, headache and drowsiness. This can happen during an infection, such as a viral infection, or when you have stomach problems. It is important that the steroid dose is not stopped suddenly as this could worsen your asthma and could also cause problems with your body's hormones.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system located at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5How to store Flixotide

• Keep this medicine out of the sight and reach of children.
• Clean the inhaler weekly as described in the section 'Cleaning'.
• Do not use this medicine after the expiry date which is stated on the label and the carton after 'Exp'. The expiry date refers to the last day of that month.
• Do not store above 30° C. Protect from frost and direct sunlight.
• If the inhaler is very cold, remove the metal canister from the plastic container and warm it between your hands for a few minutes before use. Do not use anything else to warm it.
• Caution: the metal canister is under pressure. Do not expose to temperatures above 50°C. Do not puncture, break or burn even when apparently empty.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.

6Contents of the pack and other information
What Flixotide contains

• The active ingredient is fluticasone propionate.
• The other ingredient is HFA 134a.

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 10.6 g of HFC-134a (also known as norflurane or HFA 134°) which corresponds
to 0.0152 tonnes of CO equivalent (global warming potential GWP = 1 430).

Description of Flixotide pressurized suspension and contents of the pack

• Flixotide pressurized suspension comprises a canister, an actuator and a cap to protect from dust.
• Each canister contains 120 doses of 50 micrograms of fluticasone propionate.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. Viale dell’Agricoltura, 7 – 37135 Verona, Italy.

Manufacturer
Glaxo Wellcome Production - 23 Rue Lavoisier - Zone Industrielle, 2 - Evreux - France
Glaxo Wellcome S.A. - Avenida de Extremadura, 3 - Aranda de Duero (Burgos) – Spain

Flixotide 125 mcg Pressurized Suspension for Inhalation, 250 mcg Pressurized Suspension for Inhalation

fluticasone propionate

Read this leaflet carefully before you start to take this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Flixotide is and what it is used for
• 2. What you need to know before you use Flixotide
• 3. How to use Flixotide
• 4. Possible side effects
• 5. How to store Flixotide
• 6. Contents of the pack and other information

1. What is Flixotide and what is it used for

This medicine contains the active ingredient fluticasone propionate, which belongs to a group of
medicines called corticosteroids, medicines used as antiasmatics (for the treatment of asthma, an inflammatory disease characterized by reversible obstruction of the lower airways) via inhalation.
Fluticasone propionate reduces swelling and inflammation in the lungs (anti-inflammatory action).
This medicine is indicated in the control of asthmatic disease and conditions of bronchostenosis
(reduction of the caliber of a bronchus).

2. What you need to know before using Flixotide

Do not use Flixotide

• if you are allergic to fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Flixotide.
In particular, talk to your doctor if:

• you have active or inactive (latent) tuberculosis (TB, a contagious disease caused by a bacterium).
• you are a diabetic patient
• you have a respiratory disease called Chronic Obstructive Pulmonary Disease (COPD)
• you are switching from oral steroid therapy to inhaled fluticasone. In this case, you must be treated with particular care by your doctor, who will need to regularly monitor your adrenal function and gradually stop oral therapy following the introduction of inhaled therapy. It is therefore advisable to carry with you a card indicating that you may require supplementary corticosteroid therapy during periods of stress. If your breathing becomes wheezy (bronchospasm with increased shortness of breath) after using Flixotide, stop taking the medicine and consult your doctor immediately.

Replacing systemic corticosteroid therapy with inhaled corticosteroids can trigger
allergic diseases.
Asthma treatment should normally be carried out as part of a therapeutic plan tailored to the
severity of the condition; your response to therapy should be verified by your doctor both clinically and
through lung function tests.
The need to resort more frequently to medications to control asthma symptoms indicates
a worsening of disease control; in this circumstance your therapeutic plan must be
modified by your doctor.
A sudden worsening of asthma is potentially life-threatening and in this case the doctor must
consider the possibility of increasing the dose of corticosteroids.
Do not abruptly stop treatment with fluticasone propionate.
With the use of inhaled glucocorticoids (such as fluticasone propionate), particularly when prescribed at
high doses for prolonged periods, systemic effects (on the whole body) can occur. These effects
are less likely to occur than with treatment with glucocorticoids administered orally.
Possible systemic effects include Cushing's syndrome (a clinical condition characterized by an excess of
glucocorticoids in the blood leading to obesity, lack of facial expression, red skin, widespread stretch marks
and abundant facial hair, especially in men), cushingoid appearance (typical of people affected by Cushing's
disease), adrenal suppression (reduced adrenal function), growth retardation in children
and adolescents, reduced bone mineral density, cataracts (clouding of the lens located
inside the eye), glaucoma (a serious eye disease) and, more rarely, a number of psychological or behavioral effects including psychomotor hyperactivity, irritability, sleep disturbances, anxiety,
depression or behavioral disorders (particularly in children) (see section 4 “Possible side effects”). It is therefore important that the dose of inhaled corticosteroid is the lowest dose
with which effective asthma control is maintained.
It is recommended to regularly check the height of children receiving prolonged therapy with
inhaled corticosteroids.
Some individuals may experience greater sensitivity to the effects of inhaled corticosteroids
compared to the majority of patients.
Very rare cases of acute adrenal crises have occurred in children exposed to doses higher than those
recommended (approximately 1,000 micrograms per day) for prolonged periods (several months or years).
Contact your doctor if you experience blurred vision or other visual disturbances, which may be caused by cataracts or
glaucoma.

Other medicines and Flixotide
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, a medicine used to treat fungal infections.
• Some medicines can increase the effects of Flixotide. Your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Flixotide with food and drink
Flixotide can be used at any time of day, with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
It is unlikely that Flixotide will affect your ability to drive or operate machinery.

3. How to use Flixotide

Adults
The standard dose is 200 micrograms per day, divided into two administrations of 100 micrograms
each. The dosage may be increased up to 400 micrograms per day.
The initial dose may subsequently be adjusted until control is achieved, or reduced to the
minimum effective dose, according to individual response.
In severe forms, a maximum dosage of 2,000 micrograms per day may allow adequate control of the
disease by reducing the use of oral steroids.
During exacerbations, dosages of 2,000 micrograms per day may replace oral steroid cycles in some cases.

Children (from 1 to 4 years)
100 micrograms twice a day administered using a spacer device equipped with a
facial mask (spacer device for pediatric use).
The maximum authorized dose in children is 200 micrograms twice a day.

Children over 4 years
The standard dose is 100 micrograms per day, divided into two administrations of 50 micrograms
each.
The dosage may be increased up to 200 micrograms per day.
It is recommended that the height of children treated with steroids, including Flixotide pressurized suspension,
be regularly monitored by the doctor.

If you are using high doses of an inhaled steroid for a long time, you may sometimes need to use
supplementary doses of steroids, for example during stressful circumstances, such as a
car accident or before surgery. The doctor may decide to prescribe you a
supplement of steroids during that period.
Patients who have been treated with high doses of steroids, including Flixotide pressurized suspension,
for a long period, should not suddenly stop taking the medicine without informing their doctor. Sudden
cessation of treatment may cause discomfort and symptoms such as
vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar
(hypoglycemia) and changes in weight.
Instructions for use
Some people find it difficult to spray the medicine immediately after starting to inhale.
The spacer device helps to overcome this problem.
The doctor, nurse or pharmacist must show you how to use the inhaler. Do not use Flixotide
pressurized suspension differently from as prescribed, otherwise the medicine may not provide
relief from asthma.
The medicine is contained in a pressurized canister which is inserted into a plastic casing with a
mouthpiece.

Checking the inhaler's operation When using the inhaler for the first time, check that it is working. Remove the mouthpiece cover by gently pressing the sides with your thumb and index finger and pulling it out. To make sure it works, shake well, point the mouthpiece away from you and spray a dose into the air. If you have not used the inhaler for a week or more, spray into the air for two times.	n a d e l F
a Using the inhaler Before using the inhaler it is important to start i breathing as slowly as possible. l 1 When using the inhaler remain standing or a sitting upright. 2 Remove the mouthpiece cover (as shown in the first image). Check inside and out that the mouthpiece is clean and free from objects.
a 3 Shake the inhaler 4 or 5 times to ensure that any objects are removed and that the i contents of the inhaler are mixed evenly. n e

4 Hold the inhaler in a vertical position with your thumb on the base, under the mouthpiece. Exhale until you are comfortable. Do not inhale yet.	m a c o
5 Position the mouthpiece in your mouth between your teeth. Close your lips around it without biting it.	l F a r
6 Inhale through your mouth. Immediately after starting to inhale, press down on the canister cap to release a spray of medicine. Do this while inhaling steadily and deeply.	n a d e
a 7 Hold your breath; remove the inhaler from your mouth and your finger from the top of the inhaler. l Continue to hold your breath for a few seconds a or longer if you are comfortable. t
I 8 If your doctor has told you to take two inhalations, wait about half a minute before inhaling another dose repeating steps 3 to 7.
a 9 After use, replace the mouthpiece cover to prevent dust from settling on it. Close the cover firmly by pressing it until you hear the click when it is in position. i

Cleaning the inhaler
To prevent the inhaler from becoming blocked, it is important to clean it at least once a week.
To clean the inhaler:

• remove the protective cap of the mouthpiece;
• never remove the metal canister from the plastic container;
• clean the inside and outside of the mouthpiece with a dry cloth or tissue;
• replace the protective cap on the mouthpiece. Do not put the pressurized metal container in water.

If you use more Flixotide than you should
If you use more Flixotide than you should, consult your doctor as soon as possible.
It is important to take the dose as prescribed by your doctor. Do not increase or decrease the dose without
asking your doctor for advice.

If you forget to use Flixotide

• Take the next dose at the scheduled time.
• Do not take a double dose to make up for the missed dose.

If you stop using Flixotide

• Do not stop treatmenteven if you feel better unless you are told to do so by your doctor. If you have any doubts about using this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

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

If you notice any of the following serious side effects, stop using this medicine and tell your doctor immediately,asyou may need urgent medical attention:

• allergic reactions (may affect up to 1 in 100 people) - signs include skin rash, redness, itching or nettle rash or hives;
• severe allergic reactions (may affect up to 1 in 10,000 people) - signs include swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy skin rash, feeling faint and dizzy and collapse;
• your breath or wheezing gets worse immediately after using the inhaler.

Other side effects include:
Very common(may affect more than 1 in 10 people)

• thrush in the mouth and throat.

Common(may affect up to 1 in 10 people)

• dryness of the tongue or throat
• hoarseness. Problems with the mouth and throat can be reduced by some precautions immediately after inhaling the dose. These are: brushing your teeth, rinsing your mouth or gargling with water and spitting. Tell your doctor if you have these problems with your mouth or throat, but do not stop treatment unless they tell you to.

In addition, in patients with Chronic Obstructive Pulmonary Disease (COPD) the following side effects have been reported:

• pneumonia and bronchitis (lung infection). Tell your doctor if you experience any of the following symptoms: increased production of sputum, change in colour of sputum, fever, chills, increased cough, increased breathing problems;
• bruising.

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

• thrush (candidiasis) in the esophagus.

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

• sleep disturbances or feeling worried, over-excited and irritable; these effects are more likely to happen in young people;
• joint pain;
• indigestion;
• the level of sugars (glucose) in the blood may increase;
• when using Flixotide the way steroids are produced by the body can be affected. This is more likely to happen if you use high doses for a long period of time (for example 400 micrograms a day in children). This can cause:
• slowed growth in young people;
• the so-called 'Cushing's Syndrome', a condition characterised by an excess of steroid hormones in the bloodstream, which can cause thinning of the bones and problems with the eyes (such as cataracts and glaucoma, which is an increase in pressure in the eye). Your doctor will help to avoid this happening by making sure you use the lowest dose of steroid for control of your symptoms.

Although the frequency is not known, the following side effects can also occur:

• depression, feeling restless or nervous. These effects are more likely to happen in children;
• blurred vision;
• nosebleeds.

See your doctor as soon as possible if:

• after 7 days of using Flixotide your shortness of breath or dyspnea does not improve, or gets worse;
• following treatment with high doses of inhaled steroids you develop a state of unwellness with symptoms such as stomach pain, nausea, diarrhoea, headache and drowsiness. This can happen during an infection, such as a viral infection, or when you have stomach problems. It is important that the steroid dose is not stopped suddenly as this could worsen your asthma and could also cause problems with your body’s hormones.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system reported at the address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Flixotide

• Keep this medicine out of the sight and reach of children.
• Clean the inhaler weekly as described in the 'Cleaning' section.
• Do not use this medicine after the expiry date which is stated on the label and the packaging after 'Exp'. The expiry date refers to the last day of that month.
• Do not store above 30°C. Protect from frost and direct sunlight.
• If the inhaler is very cold, remove the metal canister from the plastic container and warm it between your hands for a few minutes before use. Never use anything else to heat it.
• Caution: the metal canister is under pressure. Do not expose to temperatures above 50°C. Do not puncture, break or burn even when apparently empty.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Flixotide contains

• The active ingredient is fluticasone propionate.
• The other component is HFA 134a. This medicine contains fluorinated greenhouse gases. Each inhaler contains 12 g of HFC-134a (also known as norflurane or HFA 134°) which corresponds to 0.0172 tonnes of CO equivalent (global warming potential GWP = 1 430).

Description of the appearance of Flixotide pressurised suspension and content of the pack

• Flixotide Pressurised Suspension for inhalation comprises a canister, an actuator and a cap to protect from dust.
• Each canister contains 120 doses of 125 or 250 micrograms of fluticasone propionate.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A., Viale dell’Agricoltura, 7 - 37135 Verona, Italy

Manufacturer
Glaxo Wellcome Production - 23 Rue Lavoisier - Zone Industrielle, 2 - Evreux - France
Glaxo Wellcome S.A. - Avenida de Extremadura, 3 - Aranda de Duero (Burgos) – Spain

Flixotide 100 mcg Powder for inhalation, 250 mcg Powder for inhalation, 500 mcg Powder for inhalation

fluticasone propionate
Read this leaflet carefully before you start to take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Flixotide is and what it is used for
• 2. What you need to know before you use Flixotide
• 3. How to use Flixotide
• 4. Possible side effects
• 5. How to store Flixotide
• 6. Contents of the pack and other information

1. What is Flixotide and what is it used for

This medicine contains the active ingredient fluticasone propionate, which belongs to a group of
medicines called corticosteroids, medicines used as antiasmatics (for the treatment of asthma, a disease
characterized by reversible obstruction of the lower airways) via inhalation.
Fluticasone propionate reduces swelling and inflammation in the lungs (anti-inflammatory action).
This medicine is indicated in the control of asthma and conditions of bronchostenosis
(reduction of the caliber of a bronchus).

2. What you need to know before using Flixotide

Do not use Flixotide

• if you are allergic to fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Flixotide.
In particular, talk to your doctor if:

• you have tuberculosis (TB, a contagious disease caused by a bacterium) that is active or inactive.
• you are a diabetic patient
• you have a respiratory disease called Chronic Obstructive Pulmonary Disease (COPD)
• you are switching from a therapy with oral steroids to inhaled fluticasone. In this case, you must be treated with particular attention by the doctor, who will need to regularly monitor your adrenal function and gradually discontinue oral therapy following the introduction of inhaled therapy. It is therefore advisable to carry with you a card indicating that you may require supplementary corticosteroid therapy during periods of stress. If your breathing becomes difficult (bronchospasm with increased dyspnea) following the use of Flixotide, stop taking the medicine and consult your doctor immediately.

Replacing systemic corticosteroid therapy with inhaled corticosteroids can trigger
allergic diseases.
Asthma treatment should normally be carried out as part of a therapeutic plan tailored to the
severity of the condition; your response to therapy should be verified by the doctor both clinically and
through lung function tests.
The need to resort more frequently to medications to control asthma symptoms indicates
a worsening of disease control; in such circumstances your therapeutic plan must be
modified by the doctor.
Sudden worsening of asthma is potentially life-threatening and in such cases the doctor must
consider the possibility of increasing the dose of corticosteroids.
Do not abruptly stop treatment with fluticasone propionate.
With the use of inhaled glucocorticoids (such as fluticasone propionate), particularly when prescribed at
high doses for prolonged periods, systemic effects (on the whole body) may occur. These effects
are less likely to occur than with treatment with glucocorticoids administered orally.
Possible systemic effects include Cushing's disease (a clinical condition characterized by an excess of
glucocorticoids in the blood leading to obesity, lack of facial expression, red skin, widespread stretch marks
and abundant facial hair, especially on the face), cushingoid appearance (typical of people affected by Cushing's disease), adrenal suppression (reduction of adrenal function), growth retardation in children
and adolescents, reduction of bone mineral density, cataract (clouding of the lens located
inside the eye), glaucoma (severe eye disease) and, more rarely, a series of psychological or behavioral effects including psychomotor hyperactivity, irritability, sleep disturbances, anxiety,
depression or behavioral disorders (particularly in children) (see section 4 “Possible side effects”). It is therefore important that the dose of inhaled corticosteroid is the lowest dose
possible with which effective asthma control is maintained.
It is recommended to regularly check the height of children receiving prolonged therapies with
inhaled corticosteroids.
Some subjects may experience greater sensitivity to the effects of inhaled corticosteroids
compared to the majority of patients.
Very rare cases of acute adrenal crises have been reported in children exposed to doses higher than those
recommended (approximately 1,000 micrograms per day) for prolonged periods (several months or years).
Contact your doctor if you experience blurred vision or other visual disturbances, which may be caused by cataract or
glaucoma.

Other medicines and Flixotide
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines, including medicines obtained without a prescription
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, a medicine used to treat fungal infections.
• Some medicines can increase the effects of Flixotide. Your doctor may want to keep you under close observation if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Flixotide with food and drink
Flixotide can be used at any time of day, with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
It is unlikely that Flixotide will affect your ability to drive vehicles or use machines.

Flixotide contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before using this
medicine.

3. How to use Flixotide

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
It is necessary to wait 4-7 days for this medicine to take effect and it is very important that you use it
regularly.
You must be informed that treatment with this medicine is for preventive purposes and the medicine must be
taken regularly even in the absence of symptoms.
Your doctor will prescribe the dosage suitable for this medicine, following an assessment of the severity
of asthma and your individual response. Your doctor may gradually reduce the dose if your
respiratory function is stabilized.

Adults
The standard dose is 200 micrograms per day, divided into two administrations of 100 micrograms
each. The dosage may be increased up to 400 micrograms per day.
The initial dose may then be adjusted until control is achieved, or reduced to the
minimum effective dose, according to individual response.
In severe forms, a maximum dosage of 2000 micrograms per day may allow adequate control
of the disease by reducing the use of oral steroids.
During exacerbations, dosages of 2000 micrograms per day may replace in some cases cycles of
oral steroid.

Children over 4 years of age
The standard dose is 100 micrograms per day, divided into two administrations of 50 micrograms
each. Flixotide powder for inhalation is not suitable for administering this dose.
The dose may be increased up to 200 micrograms twice a day.
Flixotide Diskus 250 micrograms and Flixotide Diskus 500 micrograms are not recommended for
children aged between 1 and 4 years.
It is recommended that the height of children treated with steroids, including Flixotide powder for inhalation, be
regularly checked by the doctor.

If you are using high doses of an inhaled steroid for a long time, you may sometimes need to use additional doses of steroids, for example during stressful circumstances, such as a
road accident or before surgery. Your doctor may decide to prescribe you a
supplement of steroids during that period.
Patients who have been treated with high doses of steroids, including Flixotide powder for inhalation, for
a long period, must not stop taking the medicine suddenly without informing their doctor. Sudden discontinuation of treatment may cause malaise and symptoms such as
vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar levels
(hypoglycemia) and changes in weight.
Instructions on how to use the inhaler are provided in the form of a step-by-step guide.
Flixotide powder for inhalation must be administered exclusively by inhalation, by means of
a special inhaler called Diskus.
It is made of molded plastic containing a tape strip in which individual blisters are arranged
of 28 or 60.
Each blister contains 100, 250 or 500 micrograms of the active ingredient fluticasone propionate.
Flixotide is available in three different dosages. Your doctor will decide the dosage you need. Use this
medicine following exactly the instructions of your doctor. If you have doubts consult your doctor or
pharmacist.

Instructions for use

• Your doctor or pharmacist should show you how to use the inhaler. Do not use Flixotide Diskus incorrectly or as prescribed, it may result in the medicine not providing relief from asthma as it should.
• The Diskus is supplied in a sealed wrapper. The wrapper protects against moisture and should only be opened when you are ready to use it for the first time. Once the wrapper has been opened, it must be discarded.
• The medicine is contained in a pressurized canister which is inserted into a plastic casing with a mouthpiece.
• The Diskus device contains blisters which are filled with Flixotide in powder form.
• A dose counter on the top of the Diskus shows the number of doses remaining. It counts down to 0. The numbers from 5 to 0 will appear in red to warn when only a few doses remain. Once the counter has shown 0, the inhaler will be empty.

Do not use the inhaler more often than your doctor has told you to. Tell your doctor if the medicine
does not seem to be working as well as usual, as your chest problems may worsen and you
may need a different medicine.
Your doctor may have told you to increase the dosage if your breathlessness and breathing get worse, as
emergency treatment. It is important to carefully follow your doctor’s instructions on how many blisters
to take and how often to use the inhaler.

Using the inhaler

1. In the box, the Diskus is supplied in a sealed wrapper of laminate. To open this wrapper, tear along the serrated edge, then remove the Diskus and discard the wrapper. If you have problems tearing the sheet, do not use scissors or other sharp objects that may damage yourself or the Diskus. Ask someone for help. 2. To open the Diskus, hold the outside with one hand and place your thumb of the other hand on the appropriate recess. Push with the thumb rotating the inner part of the device until you hear a click. A small hole will open in the mouthpiece.	d e l F a r m
3. Hold the Diskus with the mouthpiece towards you. You can hold it in your left or right hand. a Push the lever forward as far as possible. A click is heard. This places a dose of the i medicine in the mouthpiece. l Each time the lever is slid, a a blister is opened inside and the powder made available for inhalation. Use the lever t only when you need to inhale the drug to avoid waste of the medicine.	n a
I 4. Hold the Diskus away from your mouth, exhale until you feel comfortable. i Do not blow into the Diskus. Do not z inhale yet. n
e 5. Put the mouthpiece between your lips; inhale steadily and deeply through the g Diskus with your mouth, not through your nose. Remove the Diskus from the A mouth. Hold your breath for about 10 seconds or until you feel comfortable. Exhale slowly.

If you use more Flixotide than you should
In case of ingestion/accidental intake of an excessive dose of Flixotide, immediately warn your
doctor or go to the nearest hospital.
Acute inhalation of flixotide in doses higher than those recommended may lead to temporary
suppression of adrenal function (for symptoms see “Warnings and precautions”).
Emergency interventions are not necessary as adrenal function returns to normal
within a few days.
However, if doses higher than those recommended are used for prolonged periods, some degree of adrenal suppression may occur. The doctor may request some tests to verify the
degree of functioning of the adrenal gland.

If you forget to use Flixotide

• Do not use a double dose to make up for a missed dose.

If you stop using Flixotide

• Do not stop treatmenteven if you feel better, unless your doctor tells you to. If so, do not stop Flixotide abruptly.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking it and contact your doctor immediately if any of the following symptoms occur
after taking Flixotide:• allergic reactions characterised by skin rashes (cutaneous hypersensitivity);

• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing (angioedema)
• difficulty breathing (dyspnea and/or bronchospasm, paradoxical bronchospasm).

Other side effects include:
Very common(may affect more than 1 in 10 people)

• thrush in the mouth and throat (painful, creamy-yellow raised patches)

Common(may affect up to 1 in 10 people)

• bruising

6. To close the Diskus, position your thumb in the appropriate recess and slide it backwards to the end of its travel. You will hear a click. The lever will return to its original position. The Diskus is now ready for use again.

a c o

• hoarseness of the voice (raucousness). Problems of the mouth and throat can be reduced by taking specific precautions, such as brushing your teeth or rinsing your mouth with water immediately after inhaling the dose. In addition, pneumonia (lung infection) has been reported in patients with chronic obstructive pulmonary disease (COPD).

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

• thrush (candidiasis) in the esophagus;
• anxiety, sleep disorders and behavioural disturbances, including hyperactivity and irritability (predominantly in children)
• increased blood sugar (glucose) levels (hyperglycemia)
• slowed growth in young people
• Cushing's syndrome, a condition characterised by an excess of steroid hormones in the bloodstream, which manifests with a rounded face;
• thinning of the bones
• eye problems such as cataracts (clouding of the eye's lens) and glaucoma (increased pressure inside the eye)
• effects on the adrenal gland (a small gland located next to the kidney).

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

• depression, aggression. These effects are more likely to happen in children;
• blurred vision:
• nosebleeds.

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 through the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Flixotide

• Keep this medicine out of the sight and reach of children.
• Store this medicine in a dry place to protect from humidity.
• Store the Diskus in the laminated wrapper until you are ready to use it for the first time. Once opened, the laminated wrapper must be discarded.
• Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP’. The expiry date refers to the last day of that month.
• Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6Contents of the pack and other information
What Flixotide contains

• The active ingredient is fluticasone propionate.
• The other ingredient is lactose.

Description of the appearance of Flixotide powder for inhalation and contents of the pack
Flixotide powder for inhalation must be administered exclusively by inhalation, by means of
a special inhaler called Diskus. The Diskus is sealed by a protective wrapper. The Diskus contains
stripes with blisters that contain fluticasone propionate and lactose. The blisters protect the powder for
inhalation from the effects of the atmosphere.
Each blister contains 100 micrograms, 250 micrograms or 500 micrograms of fluticasone propionate, and
lactose which acts as a “carrier”.
Packs of Flixotide 100, 250 or 500 micrograms contain 60 blisters.
The Diskus has a counter that shows the number of doses still available. It counts down from 60 to 0.
When the counter shows 0, the inhaler is empty and must be discarded.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A.
Via A.Fleming, 2 - Verona

Manufacturer
Glaxo Operations UK Ltd – Priory Street - Ware - Great Britain
Glaxo Wellcome Production - 23 Rue Lavoisier - Zone Industrielle, 2 - Evreux – France

FLIXOTIDE 500 mcg/2 ml Suspension for Nebulisation

fluticasone propionate
Read this leaflet carefully before you start to use this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Flixotide is and what it is used for
• 2. What you need to know before you use Flixotide
• 3. How to use Flixotide
• 4. Possible side effects
• 5. How to store Flixotide
• 6. Contents of the pack and other information

1. What is Flixotide and what is it used for

This medicine contains the active ingredient fluticasone propionate, which belongs to a group of
medicines called corticosteroids, medicines used as antiasmatics (for the treatment of asthma, a disease
characterized by reversible obstruction of the lower airways) via inhalation.
Fluticasone propionate reduces swelling and inflammation in the lungs (anti-inflammatory action).
This medicine is indicated in the control of asthma and conditions of bronchostenosis
(reduction of the caliber of a bronchus).

2. What you need to know before using Flixotide

Do not use Flixotide

• if you are allergic to fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Flixotide.
In particular, talk to your doctor if:

• you have active or inactive (latent) tuberculosis (TB, a contagious disease caused by a bacterium)
• you are a diabetic patient
• you have a respiratory disease called chronic obstructive pulmonary disease (COPD)
• you are switching from oral steroid therapy to inhaled fluticasone.

In this case, you must be treated with particular attention by the doctor, who will need to monitor
your adrenal function regularly and gradually discontinue oral therapy following
the introduction of inhaled therapy. It is therefore advisable to carry with you a card indicating
that you may require supplementary corticosteroid therapy during periods of stress.
If your breathing becomes wheezy (bronchospasm with increased dyspnea) following the use of Flixotide,
stop taking the medicine and consult your doctor immediately. In fact, fluticasone propionate
administered by nebulization is not indicated alone for treating the symptoms of an acute
bronchospasm attack. Flixotide Nebulizer Suspension does not replace emergency therapy which instead
occurs with corticosteroids administered orally or intravenously.
Replacing systemic corticosteroid therapy with inhaled corticosteroids can trigger
allergic diseases.
Asthma treatment should normally be carried out as part of a therapeutic plan tailored to the
severity of the disease; your response to therapy should be verified by your doctor, both clinically and
through pulmonary function tests.
The need to resort more frequently to medications to control asthma symptoms indicates
a worsening of disease control; in such circumstances, your therapeutic plan must be
modified by your doctor.
A sudden worsening of asthma is potentially life-threatening and, in such cases, the doctor must
consider the possibility of increasing the dose of corticosteroids.
It is important that you take the dose as prescribed by your doctor. Do not increase or decrease the dose
without asking your doctor for advice. Do not abruptly stop treatment with fluticasone propionate.
With the use of inhaled glucocorticoids (such as fluticasone propionate), in particular when prescribed at
high doses for prolonged periods, systemic effects (on the whole body) can occur. These effects are
less likely to occur than with treatment with glucocorticoids administered orally.
Possible systemic effects include Cushing's disease (a clinical condition characterized by excess
glucocorticoids in the blood leading to obesity, lack of facial expression, red skin, extensive stretch marks
and abundant facial hair, especially in men), cushingoid appearance (typical of people affected by Cushing's disease), adrenal suppression (reduced adrenal function), growth retardation in children
and adolescents, reduced bone mineral density, cataract (clouding of the lens located
inside the eye), glaucoma (serious eye disease) and, more rarely, a number of psychological or behavioral effects including psychomotor hyperactivity, irritability, sleep disturbances, anxiety,
depression or behavioral disorders (particularly in children) (see section 4 “Possible side effects”). It is therefore important that the dose of inhaled corticosteroid is the lowest dose
possible with which effective asthma control is maintained.
It is recommended to regularly check the height of children receiving prolonged therapies with
inhaled corticosteroids.
Very rare cases of acute adrenal crises have occurred in children exposed to doses higher than
recommended (approximately 1,000 micrograms per day) for prolonged periods (several months or years).
Contact your doctor if you experience blurred vision or other visual disturbances, which may be caused by cataract or
glaucoma.

Other medicines and Flixotide
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines, including medicines you have bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, medicines used to treat fungal infections.
• Some medicines can increase the effects of Flixotide. Your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Flixotide with food and drink
Flixotide can be used at any time of day, with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
It is unlikely that Flixotide will affect your ability to drive or operate machinery.

3. How to use Flixotide

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor,
nurse or pharmacist.
You should be informed that treatment with this medicine is for preventative purposes and the medicine must
be taken regularly even in the absence of symptoms.
It takes 4-7 days for this medicine to take effect and it is very important that you use it
regularly.

Do not inject or ingest the liquid.
Administer Flixotide Suspension for nebulization only by means of aerosol generated by a nebulizer.
Do not use FLIXOTIDE Suspension for nebulization with ultrasonic nebulizers.

• The nebulizer produces a mist that is inhaled through a mouthpiece or an inhalation mask.
• Each small plastic container (Nebules) contains a liquid.
• The liquid is placed in the nebulizer. This generates a fine mist that is inhaled through a mask or a mouthpiece. Using a mouthpiece prevents the medicine from having effects on the skin of the face, which can happen if you use a mask for a long period of time. If you prefer to use a mask, or if you are using a mask for your child, you must protect the skin of the face with cream or wash your face thoroughly after treatment. If you use a mask, nasal inhalation may occur. Use the nebulizer in a well-ventilated room as the mist released into the air may also be breathed in by others.

The doctor will prescribe the appropriate dosage for this medicine, following an assessment of the severity
of asthma and your individual response. The doctor may gradually reduce the dose if your
respiratory function is stabilized.

Adults and adolescents over 16 years of age

• The normally recommended dose is 250 mcg (½ NEBULES container of 500 mcg) 2 times a day.
• Flixotide Suspension for nebulization 0.5 mg/2 ml provides a dose of 500 micrograms.

Subsequently, the dosage must be adjusted until asthma control is achieved (500-
2000 mcg 2 times a day), or reduced according to individual response, until the
minimum effective maintenance dose is reached.
For the treatment of exacerbation episodes, a high dose is recommended (at
the upper end of the recommended dose range) for a period of 7 days following
the exacerbation itself.
Subsequently, the opportunity to reduce the dosage should be considered.

Children (from 4 to 16 years of age)

• The normally recommended dose is 250 mcg (½ NEBULES container of 500 mcg) 2 times a day. Patients should be treated with an initial dose of fluticasone propionate for nebulization appropriate for the severity of their disease. Subsequently, the dosage must be adjusted until asthma control is achieved, or reduced according to individual response, until the minimum effective maintenance dose is reached. In the treatment of asthma exacerbation episodes, the recommended dosage is 1 mg 2 times a day (2 NEBULES containers of 500 mcg 2 times a day) for up to 7 days of treatment. Subsequently, the dosage must be adjusted according to individual response. It is recommended that the height of children treated with steroids, including Flixotide Suspension for nebulization, be regularly checked by the doctor.

If you are using high doses of an inhaled steroid for a long time, you may sometimes need to use additional doses of steroids, for example during stressful circumstances, such as a
car accident or before surgery. The doctor may decide to prescribe a
supplement of steroids during this period.
Patients who have been treated with high doses of steroids, including Flixotide Suspension for nebulization, for
a long period, should not stop taking the medicine suddenly without first
informing the doctor. Sudden discontinuation of treatment can cause discomfort and symptoms such as
vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar
levels(hypoglycemia) and changes in weight.

Instructions for using Nebules

• 1. The Nebules container is wrapped in a wrapper. Do not open the package until you need it.
• 2.

To open the container, twist off the top.
Insert the suspension into the nebulizer following the manufacturer's instructions for using the nebulizer.
Dilution of Nebules suspension

Do not dilute the contents of the Nebule suspension unless your doctor has told you to
do so

• If your doctor has told you to dilute the solution, empty the contents of the Nebules into the nebulizer ampoule.
• Add the amount of saline solution for injection that your doctor has told you to use.

If you use more Flixotide than you should
In case of ingestion/accidental intake of an excessive dose of Flixotide, immediately inform
your doctor or go to the nearest hospital.
Acute inhalation of Flixotide in doses higher than those recommended can lead to temporary
suppression of adrenal function (for symptoms see “Warnings and precautions”).
Emergency interventions are not necessary as adrenal function returns to normal
within a few days.
However, if doses higher than those recommended are used for prolonged periods, some degree of adrenal suppression may occur. The doctor may request some tests to check
the degree of functioning of the adrenal gland.

If you forget to use Flixotide

• Do not use a double dose to make up for a missed dose.

If you stop using Flixotide

• Do not stop treatmenteven if you feel better unless your doctor tells you to. In this case, do not stop Flixotide abruptly. If you have any doubts about using this medicine, ask your doctor or pharmacist. Make sure the contents of the container are well tap shakemixed before use. Hold the container horizontally by the end with the label, tap the opposite end several times and shake it. Repeat this procedure several times until the entire contents of the container are completely mixed.

4. Possible side effects

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

Stop taking it and contact your doctor immediately if you experience any of the following symptoms
after taking Flixotide:

• allergic reactions characterised by skin rashes (cutaneous hypersensitivity);
• swelling of the face, lips, mouth, tongue or throat that may cause difficulty in swallowing (angioedema);
• difficulty breathing (dyspnoea and/or bronchospasm, paradoxical bronchospasm).

Other side effects include:
Very common(may affect more than 1 in 10 people)

• thrush in the mouth and throat (painful, creamy-yellow raised patches)

Common(may affect up to 1 in 10 people)

• bruising
• hoarseness of voice (raucedine). Problems of the mouth and throat can be reduced with some specific precautions, such as brushing your teeth or rinsing your mouth with water immediately after inhaling the dose. Also, pneumonia (lung infection) has been reported in patients with chronic obstructive pulmonary disease (COPD).

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

• thrush (candidiasis) in the oesophagus;
• anxiety, sleep disorders and behavioural disturbances, including hyperactivity and irritability (mainly in children)
• increased sugar (glucose) levels in the blood (hyperglycaemia)
• slowing of growth in young people;

Cushing's syndrome, a condition characterised by an excess of steroid hormones in the bloodstream, which
manifests with a rounded face;

• thinning of the bones
• problems with the eyes such as cataract (clouding of the lens of the eye) and glaucoma (increased pressure inside the eye)
• effects on the adrenal gland (a small gland located next to the kidney).

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

• depression, aggression. These effects are more likely to happen in children;
• blurred vision;
• nosebleeds.

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 through the national reporting system at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa.
. By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Flixotide

• Keep this medicine out of the sight and reach of children.
• Store Flixotide Nebules in the blister pack, inside the carton.
• Do not store at a temperature above 30°C. Keep the container in the outer packaging to protect it from light and frost. Store in an upright position.
• If the blister pack has not been removed, do not use this medicine after the expiry date stated on the packaging after 'EXP'. The date refers to the last day of that month.
• Nebules vials removed from the blister pack must be protected from light and used within 1 month.
• Opened Nebules vials must be stored in a refrigerator and used within 12 hours of opening. Do not freeze.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6Contents of the pack and other information
What Flixotide contains

• The active ingredient is fluticasone propionate.
• The other ingredients are polysorbate 20, sorbitan monolaurate, disodium phosphate monohydrate, disodium phosphate anhydrous, sodium chloride (salt), water.

Description of the appearance of Flixotide Nebules and contents of the pack
Flixotide Nebules vials are packaged in a strip of 5 Nebules in a blister pack.
Each pack contains 10 Nebules vials of 2 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A.
Via A. Fleming, 2
Verona

Manufacturer
Aspen Bad Oldesloe GmbH - Industriestrasse, 32-36 - Bad Oldesloe – Germany
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) - Harmire Road - Barnard Castle –
County Durham - DL12 8DT - United Kingdom