Fluspiral

Patient Information Leaflet: Information for the User

Fluspiral 100 mcg Powder for Inhalation, 250 mcg Powder for Inhalation, 500 mcg Powder for Inhalation

fluticasone propionate
Please read this leaflet carefully before using 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Fluspiral is and what it is used for

This medicinal product contains the active substance fluticasone propionate, which belongs to a group of medicines called corticosteroids. These medicines are used as anti-asthma agents (for the treatment of asthma, an inflammatory disease characterized by reversible obstruction of the lower airways) administered by inhalation.
Fluticasone propionate reduces swelling and inflammation in the lungs (anti-inflammatory action).
This medicine is indicated for the control of asthma and conditions involving bronchoconstriction (reduction in the diameter of a bronchus).

2. What you need to know before using Fluspiral

Do not use Fluspiral

• if you are allergic to fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic or suspect you may be allergic to cow's milk, you should not use this medicine as it may contain traces of cow's milk proteins. Severe allergic reactions have occurred in patients allergic to cow's milk.

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

• you have active or inactive tuberculosis (TB, a contagious disease caused by bacteria)
• you are a diabetic patient
• you suffer from 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 carefully managed by your doctor, who will need to regularly monitor your adrenal function and gradually discontinue oral therapy following the initiation of inhaled treatment.
  It is therefore advisable to carry an identification tag indicating that you might require additional corticosteroid therapy during periods of stress.
  If you experience shortness of breath (bronchospasm with increased dyspnea) after using Fluspiral, stop taking the medicine immediately and consult your doctor.
  Switching from systemic corticosteroid therapy to inhaled corticosteroids may trigger allergic disorders.
  Asthma treatment should normally be managed within a therapeutic plan tailored to the severity of the condition; your response to treatment must be assessed by your doctor both clinically and through lung function tests.
  The need to use rescue medication more frequently indicates worsening asthma control; in such cases, your therapeutic plan should be revised by your doctor.
  Sudden worsening of asthma may be potentially life-threatening, and in such cases your doctor should consider increasing the dose of corticosteroids.
  Do not stop treatment with fluticasone propionate abruptly.
  When inhaled glucocorticoids (such as fluticasone propionate) are used, particularly at high doses for prolonged periods, systemic effects (on the whole body) may occur. These are less likely than with orally administered glucocorticoids.
  Possible systemic effects include Cushing's syndrome (a clinical condition characterized by excess glucocorticoids in the blood, leading to obesity, expressionless facial features, red skin, widespread stretch marks, and excessive hair growth, especially on the face), Cushingoid appearance (typical of patients with Cushing's syndrome), adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataract (clouding of the lens inside the eye), glaucoma (a serious eye disease), and, less commonly, a range 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 be the lowest possible dose that maintains effective asthma control.
  Regular monitoring of height is recommended in children receiving long-term inhaled corticosteroid therapy.
  Some individuals may be more sensitive to the effects of inhaled corticosteroids than the majority of patients.
  Very rare cases of acute adrenal crisis have been reported 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 Fluspiral
Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, a medicine used to treat fungal infections;
• certain medicines may increase the effects of Fluspiral, and your doctor may wish to monitor you closely if you are taking these medicines (including some medicines used to treat HIV: ritonavir, cobicistat).

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
Fluspiral is unlikely to affect your ability to drive or operate machinery.

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

3. How to use Fluspiral

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It takes 4–7 days for this medicine to take effect, and it is very important that you use it regularly.
You should be aware that treatment with this medicine is preventive in purpose, and the medicine must be taken regularly even in the absence of symptoms.
Your doctor will prescribe the dose appropriate for you after assessing the severity of your asthma and your individual response. Your doctor may gradually reduce your dose if your respiratory function has stabilized.

Adults
The standard dose is 200 micrograms per day, divided into two doses of 100 micrograms each. The dose may be increased up to 400 micrograms per day.
The initial dose may subsequently be adjusted until control is achieved, or reduced to the lowest effective dose, depending on individual response.
In severe cases, a maximum dose of 2000 micrograms per day may allow adequate disease control, reducing the need for oral steroids.
During exacerbations, doses of 2000 micrograms per day may in some cases replace courses of oral steroids.

Children over 4 years of age
The standard dose is 100 micrograms per day, divided into two doses of 50 micrograms each. Fluspiral powder for inhalation is not suitable for administering this dose.
The dose may be increased up to 200 micrograms twice daily.
Fluspiral Diskus 250 micrograms and Fluspiral 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 Fluspiral powder for inhalation, be regularly monitored by a doctor.

If you have been using high doses of an inhaled steroid for a long time, it may sometimes be necessary to use additional steroid doses, for example during stressful situations such as a road accident or before surgery. Your doctor may decide to prescribe additional steroids during such periods.
Patients who have been treated with high doses of steroids, including Fluspiral powder for inhalation, over a long period should not stop taking the medicine suddenly without informing their doctor. Abruptly stopping treatment may cause discomfort and symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar (hypoglycaemia), and changes in weight.

Instructions on how to use the inhaler are provided as a step-by-step guide.
Fluspiral powder for inhalation must be administered exclusively by inhalation using a special inhaler called the Diskus.
The Diskus is a molded plastic device containing a strip with 28 or 60 individual blisters (pouches).
Each blister contains 100, 250, or 500 micrograms of the active substance fluticasone propionate.
Fluspiral is available in three different strengths. Your doctor will decide which strength you need. Always use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor, nurse, or pharmacist.

Instructions for use

• Your doctor or pharmacist should show you how to use the inhaler. Not using Fluspiral Diskus correctly or as prescribed may mean the medicine does not relieve your asthma as it should.
• The Diskus is supplied in a sealed package. This package protects the device from moisture and should only be opened when you are ready to use it for the first time. Once the package is opened, it should be discarded.
• The Diskus device contains blisters filled with Fluspiral as a powder.
• A dose counter on the top of the Diskus shows the number of doses remaining. It counts down to zero. The numbers from 5 to 0 appear in red to warn you when only a few doses remain. Once the counter shows 0, the inhaler is empty.
• You may not be able to taste or feel the powder on your tongue, even if the Diskus has been used correctly.

Do not use the inhaler more often than your doctor has instructed. Inform your doctor if the medicine does not seem to work as well as before, since your chest problems may be worsening and you may need a different medicine.
Your doctor may have advised you to increase the dose if breathlessness and breathing worsen, as an emergency treatment. It is important to follow your doctor’s instructions carefully regarding how many blisters to take and how often to use the inhaler.

Using the inhaler

After use, rinse your mouth and spit.
If you have been prescribed two inhalations, close the Diskus after the first inhalation and then repeat steps 2 to 6.

If you use more Fluspiral than you should
In case of accidental ingestion or overdose of Fluspiral, contact your doctor immediately or go to the nearest hospital.
Acute inhalation of Fluspiral in doses higher than recommended may lead to temporary suppression of adrenal function (for symptoms, see “Warnings and precautions”).
Emergency interventions are not required, as adrenal function returns to normal within a few days.
However, if doses higher than recommended are used for prolonged periods, some degree of adrenal suppression may occur. Your doctor may carry out tests to assess the functioning of your adrenal gland.

If you forget to use Fluspiral

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

If you stop using Fluspiral

• Do not stop treatment, even if you feel better, unless your doctor tells you to. In such a case, do not stop Fluspiral abruptly. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms after taking Fluspiral:

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

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

• oral and throat thrush (raised, painful, cream-yellow patches).

Common (may affect up to 1 in 10 people)

• bruising;
• hoarseness (dysphonia). Mouth and throat problems may be reduced by taking certain 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)

• oesophageal thrush (candidiasis);
• anxiety, sleep disorders and behavioural disturbances, including hyperactivity and irritability (mainly in children);
• increased blood sugar (glucose) levels (hyperglycaemia);
• slowed growth in children;
• Cushing's syndrome, a condition characterised by an excess of steroid hormones in the bloodstream, manifesting as a rounded facial appearance;
• thinning of the bones;
• eye problems such as cataract (clouding of the eye's lens) and glaucoma (increased internal pressure in the eye);
• effects on the adrenal gland (a small gland located next to the kidney).

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website. By reporting side effects, you can help provide more information on the safety of this medicine.

5 How to store Fluspiral

• Keep this medicine out of the sight and reach of children.
• Store this medicine in a dry place to protect it from moisture.
• Keep the Diskus in its foil pouch until you are ready to use it for the first time. After opening, the foil pouch must be discarded.
• Do not use this medicine after the expiry date 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6 Contents of the pack and other information
What Fluspiral contains

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

Description of the appearance of Fluspiral powder for inhalation and contents of the pack
Fluspiral powder for inhalation must be administered only by inhalation, using a special inhaler called a Diskus. The Diskus is sealed within a protective foil pouch. The Diskus contains a strip with blisters containing fluticasone propionate and lactose. The blisters protect the inhalation powder from atmospheric effects.
Each blister contains 100 micrograms, 250 micrograms or 500 micrograms of fluticasone propionate, and lactose which acts as a "carrier".
Fluspiral packs of 100, 250 or 500 micrograms contain 60 blisters.
The Diskus has a dose counter which shows the number of doses remaining. 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
A. Menarini Industrie Farmaceutiche Riunite s.r.l. – Via Sette Santi 3 - Florence
Trademark owned by companies of the GSK group or by licensors
© 2020 Companies of the GSK group or licensor
Sales licensee:
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Edificio L - Rozzano (MI)
Manufacturer
Glaxo Operations UK Ltd – Priory Street - Ware - United Kingdom
Glaxo Wellcome Production - 23 Rue Lavoisier - Zone Industrielle, 2 - Evreux – France
A. Menarini Manufacturing Logistics and Services srl – Via Sette Santi 3, Florence - Italy

Package leaflet: information for the user

Fluspiral 50 mcg Pressurized Inhalation Suspension

fluticasone propionate
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

7. What Fluspiral is and what it is used for

This medicinal product contains the active substance fluticasone propionate, which belongs to a group of medicines called corticosteroids. These medicines are used as anti-asthma agents (for the treatment of asthma, an inflammatory disease characterised by reversible obstruction of the lower airways) administered by inhalation.
Fluticasone propionate reduces swelling and inflammation in the lungs (anti-inflammatory action).
This medicine is indicated for the control of asthma and conditions of bronchoconstriction (reduction in the diameter of a bronchus).

8. What you need to know before using Fluspiral

Do not use Fluspiral

• 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 Fluspiral. In particular, consult your doctor if:

• you have active or quiescent tuberculosis (TB, an infectious disease caused by a bacterium).
• you are a diabetic patient.
• you suffer from 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 carefully monitored by your doctor, who will regularly check your adrenal function and gradually discontinue the oral therapy after initiating inhaled treatment. It is therefore advisable to carry identification indicating that you might require additional corticosteroid therapy during periods of stress. If you experience shortness of breath (bronchospasm with increased dyspnea) after using Fluspiral, stop taking the medicine and consult your doctor immediately.

Switching from systemic corticosteroid therapy to inhaled corticosteroids may trigger allergic conditions.
Asthma treatment should normally be managed within a therapeutic plan tailored to the severity of the disease; your response to treatment must be assessed by your doctor both clinically and through lung function tests.
The need to use rescue medication more frequently indicates worsening asthma control; in such cases, your treatment plan should be revised by your doctor.
Sudden worsening of asthma may be life-threatening, and in such cases your doctor may consider increasing the dose of corticosteroids.
Do not abruptly stop treatment with fluticasone propionate.
When inhaled glucocorticoids (such as fluticasone propionate) are used, particularly at high doses over prolonged periods, systemic effects (affecting the whole body) may occur. These are less likely than with orally administered glucocorticoids.
Possible systemic effects include Cushing's syndrome (a clinical condition characterized by excess glucocorticoids in the blood, leading to obesity, expressionless facial appearance, red skin, widespread stretch marks, and excessive hair growth, especially on the face), Cushingoid appearance (typical of people with Cushing's syndrome), adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataract (clouding of the lens inside the eye), glaucoma (a serious eye disease), and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, irritability, sleep disturbances, anxiety, depression, or behavioral disturbances (particularly in children) (see section 4 “Possible side effects”). It is therefore important that the dose of inhaled corticosteroid be the lowest possible dose at which effective asthma control is maintained.
Regular monitoring of height is recommended in children receiving long-term inhaled corticosteroid therapy.
Some individuals may be more sensitive to the effects of inhaled corticosteroids than the majority of patients.
Very rare cases of acute adrenal crisis have been reported in adolescents exposed to doses higher than recommended (approximately 1,000 micrograms daily) 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 Fluspiral

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

• ketoconazole, a medicine used to treat fungal infections;
• certain medicines may increase the effects of Fluspiral, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).

Fluspiral with food and drink

Fluspiral can be used at any time of day, with or without food.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Fluspiral is unlikely to affect your ability to drive or operate machinery.

3. How to use Fluspiral

Fluspiral is available in three different strengths. Your doctor will decide which strength you need. Always use this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor, nurse, or pharmacist.

Use of 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 subsequently be adjusted until disease control is achieved, or reduced to the lowest effective dose, depending on individual response.
In severe cases, a maximum dosage of 2000 micrograms per day may provide adequate disease control while reducing the need for oral steroids.
During exacerbations, dosages of 2000 micrograms per day may in some cases replace courses of oral steroids.

Children (1 to 4 years of age)
100 micrograms twice daily administered via a spacer device equipped with a facial mask (spacer device for pediatric use).

Children over 4 years of age
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 Fluspiral pressurized suspension, be regularly monitored by a physician.

If you have been using high doses of an inhaled steroid for a long time, it may sometimes be necessary to use additional steroid doses, for example during stressful situations such as a traffic accident or before surgery. Your doctor may decide to prescribe you supplemental steroids during such periods.

Patients who have been treated with high doses of steroids, including Fluspiral pressurized suspension, for a prolonged period should not stop taking the medicine suddenly without informing their doctor. Sudden discontinuation of treatment may cause discomfort and symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar (hypoglycaemia), and weight changes.

Instructions for use
Some people find it difficult to coordinate spraying the medicine with the beginning of inhalation.
A spacer device can help overcome this problem.
Your doctor, nurse, or pharmacist should demonstrate how to use the inhaler.
Do not use Fluspiral pressurized suspension differently from how it has been prescribed, otherwise the medicine may not provide relief from asthma.
The medicine is contained in a pressurized canister that fits into a plastic holder with a mouthpiece.

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

If you use more Fluspiral than you should
If you use more Fluspiral than prescribed, 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
consulting your doctor.

If you forget to use Fluspiral

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

If you stop using Fluspiral

• Do not stop treatment even if you feel better, unless your doctor tells you to do so. If you have any doubts about using this medicine, speak to your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you notice any of the following serious side effects, stop using this medicine and contact a doctor immediately,
as you may need urgent medical treatment:

• allergic reactions (may affect up to 1 in 100 people) – signs include rash, redness, itching or blistering, hives or urticaria;
• 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 rash, feeling faint, dizziness or collapse;
• breathing difficulties or wheezing immediately after using the inhaler.

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

• oral thrush (fungal infection in the mouth and throat)

Common (may affect up to 1 in 10 people)

• dryness of the tongue or throat;
• hoarseness. Mouth and throat problems can be reduced by taking certain precautions immediately after inhaling the dose. These include brushing your teeth, rinsing your mouth or gargling with water and then spitting it out. Inform your doctor if you experience these mouth or throat problems, but do not stop treatment unless instructed to do so.

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

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

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

• oesophageal candidiasis (thrush in the oesophagus)

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

• sleep disturbances or feeling anxious, over-excited or irritable; these effects are more likely to occur in younger individuals;
• joint pain;
• indigestion;
• blood sugar (glucose) levels may increase;
• when using Fluspiral, the way steroids are produced by the body may be affected. This is more likely to occur if high doses are used for a prolonged period (e.g. 400 micrograms daily in children). This may cause:
  • slowed growth in children;
  • Cushing's syndrome, a condition characterised by excess steroid hormones in the bloodstream, which may lead to thinning of the bones and eye problems (such as cataracts and glaucoma, which is increased pressure in the eye). Your doctor will help prevent this by ensuring the lowest effective steroid dose is used to control symptoms.

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

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

Contact your doctor as soon as possible if:

• after 7 days of using Fluspiral, shortness of breath or breathlessness does not improve or worsens;
• after treatment with high doses of inhaled steroids, you feel unwell with symptoms such as stomach pain, nausea, diarrhoea, headache and drowsiness. This may occur during an infection, such as a viral infection, or when you have stomach upset. It is important not to stop the steroid dose suddenly, as this could worsen asthma and may also cause problems with the body's hormones.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps provide more information on the safety of this medicine.

5 How to store Fluspiral

• 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 carton after 'Exp'. The expiry date refers to the last day of that month.
• Do not store above 30°C. Protect from freezing and direct sunlight.
• If the inhaler is very cold, remove the metal canister from the plastic holder and warm it in your hands for a few minutes before use. Never use any other method to warm it.
• The metal canister contains a pressurised liquid. Do not expose to temperatures above 50°C. Do not pierce, break or burn the container, even if it appears empty.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6 Contents of the pack and other information
What Fluspiral contains

• The active substance is fluticasone propionate.
• The other component is HFA 134a.

This medicine contains fluorinated greenhouse gases.
Each inhaler contains 10.6 g of HFC-134a (also known as norflurane or HFA 134a), equivalent to 0.0152 tonnes of CO₂e (global warming potential GWP = 1,430).

Description of the appearance of Fluspiral pressurised suspension and contents of the pack

• Fluspiral pressurised suspension includes a canister, a dispenser and a dust cap.
• Each canister contains 120 doses of 50 micrograms of fluticasone propionate.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l. – Via Sette Santi 3 - Florence
Sales Licence Holder:
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Edificio L - Rozzano (MI)
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

Package leaflet: information for the user

Fluspiral 125 mcg Pressurized suspension for inhalation, 250 mcg Pressurized suspension for inhalation

fluticasone propionate
Please read this leaflet carefully before using 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

9. What Fluspiral is and what it is used for

This medicinal product contains the active substance fluticasone propionate, which belongs to a group of
medicines called corticosteroids, medicines used as anti-asthma agents (for the treatment of asthma, an
inflammatory disease characterised by reversible obstruction of the lower airways) administered by inhalation.
Fluticasone propionate reduces swelling and inflammation in the lungs (anti-inflammatory action).
This medicine is indicated for the control of asthma and conditions of bronchoconstriction (reduction in the diameter of a bronchus).

10. What you should know before using Fluspiral

Do not use Fluspiral

• 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 taking Fluspiral.
In particular, speak to your doctor if:

• you have active or quiescent tuberculosis (TB, an infectious disease caused by bacteria).
• you are diabetic.
• you suffer from 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 carefully managed by your doctor, who will regularly monitor your adrenal function and gradually discontinue oral therapy following the initiation of inhaled treatment. It is therefore recommended that you carry a medical alert card indicating that you may require additional corticosteroid therapy during periods of stress.
  If you experience shortness of breath (bronchospasm with increased dyspnea) after using Fluspiral, stop taking the medicine and consult your doctor immediately.
  Switching from systemic corticosteroid therapy to inhaled corticosteroids may trigger allergic disorders.
  Asthma treatment should normally be carried out within a therapeutic plan tailored to the severity of the condition; your response to treatment must be assessed by your doctor both clinically and through lung function tests.
  The need to use asthma control medications more frequently indicates worsening disease control; in such cases, your treatment plan should be revised by your doctor.
  Sudden worsening of asthma may be life-threatening, and in such cases your doctor must consider increasing the dose of corticosteroids.
  Do not stop treatment with fluticasone propionate abruptly.
  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 are less likely than with oral glucocorticoid therapy.
  Possible systemic effects include Cushing's syndrome (a clinical condition characterized by excess glucocorticoids in the blood, leading to obesity, a blank facial expression, red skin, widespread stretch marks, and excessive hair growth, especially on the face), Cushingoid appearance (typical of people with Cushing's syndrome), adrenal suppression, growth retardation in children and adolescents, reduced bone mineral density, cataract (clouding of the lens inside the eye), glaucoma (a serious eye disease), and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, irritability, sleep disturbances, anxiety, depression, or behavioral disturbances (particularly in children) (see section 4 “Possible side effects”). It is therefore important that the dose of inhaled corticosteroid be the lowest possible dose at which effective asthma control is maintained.
  Regular monitoring of height is recommended in children receiving long-term inhaled corticosteroid therapy.
  Some individuals may be more sensitive to the effects of inhaled corticosteroids than the majority of patients.
  Very rare cases of acute adrenal crisis have been reported in adolescents 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 Fluspiral
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, inform your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, a medicine used to treat fungal infections;
• certain medicines may increase the effects of Fluspiral, and your doctor may wish to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

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

3. How to use Fluspiral

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 lowest effective dose, according to individual response.
In severe cases, a maximum dosage of 2000 micrograms per day may provide adequate disease control while reducing the need for oral steroids.
During exacerbations, dosages of 2000 micrograms per day may in some cases replace courses of oral steroids.

Children (1 to 4 years of age)
100 micrograms twice daily administered via a spacer device equipped with a facial mask (paediatric spacer device).
The maximum authorised dose in children is 200 micrograms twice daily.

Children over 4 years of age
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 corticosteroids, including Fluspiral pressurised suspension, be regularly monitored by the physician.

If you have been using high doses of an inhaled corticosteroid for a prolonged period, it may sometimes be necessary to take additional steroid doses, for example during stressful situations such as a road accident or prior to surgery. Your doctor may decide to prescribe you additional steroids during such periods.

Patients who have been treated with high doses of corticosteroids, including Fluspiral pressurised suspension, for a prolonged period should not stop taking the medicine suddenly without consulting 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 (hypoglycaemia), and weight changes.

Instructions for use
Some people find it difficult to spray the medicine just after starting to inhale.
The spacer device helps overcome this problem.
Your doctor, nurse, or pharmacist should show you how to use the inhaler. Do not use Fluspiral pressurised suspension differently from how it has been prescribed, otherwise the medicine may not provide relief from asthma.
The medicine is contained in a pressurised canister that fits into a plastic holder with a mouthpiece.

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

If you use more Fluspiral than you should
If you use more Fluspiral 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
consulting your doctor.
If you forget to use Fluspiral

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

If you stop treatment with Fluspiral

• Do not stop treatment, even if you feel better, unless your doctor tells you to do so. If you have any doubts about using this medicine, consult 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 experience any of the following serious side effects, stop using this medicine and seek immediate medical advice, as you may need urgent medical treatment:

• allergic reactions (may affect up to 1 in 100 people) – signs include skin rash, redness, itching, or blistering similar to hives or urticaria;
• 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 rash, feeling faint, dizziness and collapse;
• breathing difficulties or wheezing immediately after using the inhaler.

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

• oral and throat thrush (fungal infection).

Common (may affect up to 1 in 10 people)

• dryness of the tongue or throat;
• hoarseness of voice.

Problems in the mouth and throat may be reduced by taking certain precautions immediately after inhaling the dose. These include brushing your teeth, rinsing your mouth or gargling with water and then spitting it out. Inform your doctor if you experience these mouth or throat problems, but do not stop treatment unless instructed to do so.
Additionally, in patients with chronic obstructive pulmonary disease (COPD), the following side effects have been reported:

• pneumonia and bronchitis (lung infections). Inform your doctor if you experience any of the following symptoms: increased sputum production, change in sputum colour, fever, chills, increased coughing, or worsening breathing difficulties;
• bruising.

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

• thrush (candidiasis) in the oesophagus.

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 occur in younger individuals;
• joint pain;
• indigestion;
• blood sugar (glucose) levels may increase;
• when using Fluspiral, the way steroids are produced by the body may be affected. This is more likely if high doses are used for a prolonged period (e.g. 400 micrograms per day in children). This may cause:
  • slowed growth in children;
  • so-called 'Cushing's syndrome', a condition characterised by excess steroid hormones in the bloodstream, which may lead to bone thinning and eye problems (such as cataract and glaucoma, which is increased pressure in the eye). Your doctor will help prevent this by ensuring the lowest effective steroid dose is used to control symptoms.

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

• depression, restlessness or nervousness. These effects are more likely in children;
• nosebleeds;
• blurred vision.

Consult your doctor as soon as possible if:

• after 7 days of using Fluspiral, shortness of breath or breathlessness does not improve or worsens;
• after treatment with high doses of inhaled steroids, you feel unwell with symptoms such as stomach pain, nausea, diarrhoea, headache and drowsiness. This may occur during an infection, such as a viral infection, or when you have stomach problems. It is important that

the steroid dose should not be stopped abruptly, as this could worsen asthma and may also cause problems with the body's hormones.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system 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.

5 How to store Fluspiral

• 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 stated on the label and box after 'Exp'. The expiry date refers to the last day of that month.
• Do not store above 30°C. Protect from freezing and direct sunlight.
• If the inhaler is very cold, remove the metal canister from the plastic holder and warm it in your hands for a few minutes before use. Never use any other method to heat it.
• The metal canister contains a pressurised liquid. Do not expose to temperatures above 50°C. Do not pierce, break or burn the container, even if it appears empty.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6 Contents of the pack and other information
What Fluspiral contains

• The active substance 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 134a), equivalent to 0.0172 tonnes of CO₂ equivalent (global warming potential GWP = 1,430).

Description of the appearance of Fluspiral pressurised suspension and contents of the pack

• Fluspiral Pressurised Suspension for Inhalation consists of a canister, an inhaler device and a dust cap.
• Each canister contains 120 doses of 125 or 250 micrograms of fluticasone propionate.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l. – Via Sette Santi 3 - Florence
Sales Licence Holder:
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori - Strada 6 - Edificio L - Rozzano (MI)
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