Active ingredients: Fluticasone (fluticasone propionate)
FLUSPIRAL 50 mcg Pressurized suspension for inhalation
Fluspiral package inserts are available for pack sizes:- FLUSPIRAL 50 mcg Pressurized suspension for inhalation
- Fluspiral 125 mcg Pressurized inhalation suspension, Fluspiral 250 mcg Pressurized inhalation suspension
- Fluspiral 100 mcg Inhalation powder, Fluspiral 250 mcg Inhalation powder, Fluspiral 500 mcg Inhalation powder,
- FLUSPIRAL 500 mcg / 2 ml Suspension to be nebulised - Nebules
Indications Why is Fluspiral used? What is it for?
This medicine contains the active substance fluticasone propionate which belongs to a group of medicines called corticosteroids, medicines used as anti-asthma (to treat asthma, an inflammatory disease characterized by a "reversible obstruction of the lower airways) by inhalation.
Fluticasone propionate reduces swelling and inflammation in the lungs (anti-inflammatory action).
This medicine is indicated in the control of asthma disease and bronchostenosis conditions (reduction in the caliber of a bronchus).
Contraindications When Fluspiral should not be used
Do not use Fluspiral
- if you are allergic to fluticasone propionate or any of the other ingredients of this medicine.
Precautions for use What you need to know before you take Fluspiral
Talk to your doctor or pharmacist before taking Fluspiral.
In particular, contact your doctor if:
- have active or quiescent tuberculosis (TB, contagious disease caused by a bacterium)
- is a diabetic patient
- have a respiratory disease called Chronic Obstructive Pulmonary Disease (COPD)
- switches from oral steroid therapy to inhaled fluticasone. In this case you should be treated with particular care by your doctor who will have to regularly monitor your adrenal function and gradually discontinue oral therapy following the introduction of inhalation therapy. It is therefore advisable to carry a tag indicating that you may need therapy. supplemental with corticosteroids during times of stress.
If your breathing becomes labored (bronchospasm with increased dyspnoea) as a result of using Fluspiral, stop taking the drug and consult your doctor immediately.
Interactions Which drugs or foods can modify the effect of Fluspiral
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- ritonavir, a type of antiviral medicine known as a 'protease inhibitor';
- ketoconazole, a medicine used to treat fungal infections;
Fluspiral with food and drink
You can use Fluspiral at any time of the day, with or without food.
Warnings It is important to know that:
Replacing systemic corticosteroid therapy with inhaled corticosteroids can trigger allergic diseases.
The treatment of asthma must normally be performed within the framework of a therapeutic plan adapted to the severity of the disease; your response to therapy should be verified by your doctor both clinically and by pulmonary function tests.
The need to resort to drugs more frequently to control the symptoms of asthma indicates a worsening of the control of the disease; in this circumstance your treatment plan must be changed by your doctor.
Sudden aggravation of asthma is potentially life-threatening and in this case the physician should consider increasing the dosage of corticosteroids. Do not abruptly stop treatment with fluticasone propionate.
With the use of inhaled glucocorticoids (such as fluticasone propionate), particularly when prescribed in high doses for prolonged periods, systemic (whole organism) effects may occur. These effects are less likely to occur than with oral glucocorticoid treatment.
Possible systemic effects include Cushing's disease (a clinical condition characterized by excess glucocorticoids in the blood leading to obesity, lack of expression on the face, red skin, extensive stretch marks and thick hair, especially on the face), cushingoid appearance (typical of people with Cushing's disease), adrenal suppression (decreased adrenal function), growth retardation in children and adolescents, decreased bone mineral density, cataracts (clouding of the lens inside the eye), glaucoma (severe 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 the inhaled corticosteroid is the lowest possible dose with which it comes man effective control of asthma was maintained.
It is recommended to regularly monitor the height of children receiving prolonged therapy with inhaled corticosteroids.
Some people may be more sensitive to the effects of inhaled corticosteroids than most patients.
There have been very rare cases of acute adrenal crisis in boys exposed to higher than recommended doses (approximately 1,000 micrograms per day) for prolonged periods (several months or years).
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Fluspiral is unlikely to affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Fluspiral: Posology
Fluspiral is available in three different strengths. Your doctor will decide what dosage you need. Always use this medicine exactly as your doctor has told you. If in doubt, consult your doctor, nurse or pharmacist.
Use of this medicine
Adults
The standard dose is 200 micrograms per day, divided into two doses of 100 micrograms each. The dosage can be increased up to 400 micrograms per day.
The starting dose can subsequently be adjusted until control is achieved, or reduced to the lowest effective dose, according to individual response.
In severe forms, a maximum dosage of 2000 micrograms per day can allow adequate disease control by reducing the use of oral steroids.
During exacerbations, dosages of 2000 micrograms per day can replace oral steroid cycles in some cases.
Children (1 to 4 years old)
100 micrograms twice / day administered by means of a spacer device fitted with a face mask (spacer device for pediatric use).
Children over 4 years old
The standard dose is 100 micrograms per day, divided into two doses of 50 micrograms each.
The dosage can 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 their physician.
If you have been using high doses of an inhaled steroid for a long time it may sometimes be necessary to use extra doses of the steroid, for example during stressful circumstances, such as a car accident or before surgery. Your doctor may decide to prescribe a steroid supplement during this time.
Patients who have been treated with high doses of steroids, including Fluspiral pressurized suspension, for a long time, should not stop taking the medicine suddenly without informing their doctor. Suddenly stopping treatment can cause malaise and symptoms such as vomiting, sleepiness, nausea, headache, tiredness, loss of appetite, low blood sugar (hypoglycaemia) and weight changes.
Instructions for Use
Some people find it difficult to spray the medicine right after they start to inhale.
The spacer appliance helps overcome this problem.
Your doctor, nurse or pharmacist should show you how to use the inhaler.
Do not use Fluspiral pressurized suspension other than as prescribed, otherwise the medicine may not relieve asthma.
The medicine is contained in a pressurized can that is placed in a plastic case with a mouthpiece.
Check the functioning of the inhaler
- When using the inhaler for the first time, try that it works. Remove the mouthpiece cover by gently pressing the sides with your thumb and forefinger and pull it out.
- To make sure it works, shake it well, point the mouthpiece away from you and spray a dose into the air. If you do not use the inhaler for a week or more, spray twice into the air.
Using the inhaler
Before using the inhaler it is important to start breathing as slowly as possible.
- When using the inhaler, remain standing or sitting upright.
- Remove the mouthpiece cover (as shown in the first image). Check inside and out that the mouthpiece is clean and free of objects.
- Shake the inhaler 4 or 5 times to make sure that any objects are removed and that the contents of the inhaler are mixed evenly.
- Hold the inhaler upright with your thumb on the base, under the mouthpiece. Exhale until comfortable. Don't inhale yet.
- Place the mouthpiece in your mouth between your teeth. Close your lips around it without biting it.
- Breathe in through your mouth. Immediately after starting to inhale, press on the can lid to release a squirt of medicine. Do this while you are inhaling steadily and deeply.
- Hold your breath; Take the inhaler out of your mouth and your finger from the top of the inhaler. Continue to hold your breath for a few seconds or until comfortable.
- If your doctor has told you to take two inhalations, wait about half a minute before inhaling another dose by repeating steps 3 to 7.
- After use, put the mouthpiece cover back to prevent dust from settling in. Close the cover firmly by pressing it until it clicks into place.
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 pressurized container from the inhaler and remove the mouthpiece cover;
- never remove the metal can from the plastic wrapping;
- clean the inhaler and the protective cap of the mouthpiece with a damp cloth;
- put them to dry in a warm place. Avoid excessive heat;
- put the pressurized canister back into the inhaler and put the mouthpiece cover back on. Do not put the metal canister in water.
If you forget to use Fluspiral
- Take the next dose due to its due date.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Fluspiral
- Do not stop treatment even if you feel better unless you are told to do so by your doctor.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Overdose What to do if you have taken too much Fluspiral
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. You should not increase or decrease the dose without asking your doctor for advice.
Side Effects What are the side effects of Fluspiral
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 see a doctor right away as you may need urgent medical attention:
- allergic reactions (may affect up to 1 in 100 people) - signs include skin rash, redness, itching or blistering like hives 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 rash, feeling faint and lightheaded and collapsing;
- breathing or wheezing gets worse soon 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)
- dry tongue or throat;
- hoarse voice.
Mouth and throat problems can be reduced with certain measures immediately after inhaling the dose.
These are brushing your teeth, rinsing your mouth, or gargle with water and spitting. Tell your doctor if you have these mouth or throat problems, but don't stop the treatment unless they tell you to.
In addition, the following side effects have been reported in patients with chronic obstructive pulmonary disease (COPD):
- pneumonia and bronchitis (lung infection); tell your doctor if you get any of the following symptoms: increased sputum production, change in sputum color, fever, chills, increased cough, increased breathing problems;
- bruises.
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 worried, over-excited, and irritable; these effects are more likely to occur in young people;
- joint pains;
- bad digestion;
- the level of sugar (glucose) in the blood may rise;
- when using Fluspiral the way steroids are produced by the body may be affected. This is more likely to happen if high doses are used over a long period of time (e.g. 400 micrograms per day in children).
This can cause:
- slowdown in 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 eye problems (such as cataracts and glaucoma, which is the increase in pressure in the eye).
Your doctor will help prevent this from happening by making sure you use the lowest dose of the steroid for symptom control.
Although the frequency is unknown, the following side effects may also occur:
- depression, feeling restless or nervous; these effects are more likely to occur in children.
- nose bleeding.
See your doctor as soon as possible if:
- after 7 days of using Fluspiral the shortness of breath or shortness of breath does not improve, or worsens;
- following treatment with high doses of inhaled steroids, malaise occurs with symptoms such as stomach pain, nausea, diarrhea, headache and sleepiness. This can happen during an "infection, such as a" viral infection, or when you have stomach upset. It is important that the steroid dose is not stopped suddenly as this could worsen asthma and could also cause problems with the body's hormones.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
- 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 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, take the metal canister out of the plastic container and warm it in your hands for a few minutes before use. Never use anything else to heat it.
- The metal can is under pressure. Do not pierce, break or burn even when it is apparently empty.
- Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Fluspiral contains
- The active ingredient is fluticasone propionate.
- The other component is HFA 134a.
What Fluspiral pressurized suspension looks like and contents of the pack
- Fluspiral pressurized suspension includes a can, a dispenser and a lid to protect against dust.
- Each can contains 120 doses of 50 micrograms of fluticasone propionate.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
FLUSPIRAL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUSPIRAL 125 mcg- Pressurized suspension for inhalation
A pressurized container of 120 puffs contains:
Active ingredient: fluticasone propionate (125 mcg per actuation) 15.00 mg
FLUSPIRAL 250 mcg - Pressurized suspension for inhalation
A pressurized container of 120 puffs contains:
Active ingredient: fluticasone propionate (250 mcg per supply) 30.00 mg
FLUSPIRAL 50 mcg - Pressurized suspension for inhalation
A pressurized container of 120 puffs contains:
Active ingredient: fluticasone propionate (50 mcg per actuation) 6.00 mg
FLUSPIRAL 250 mcg - Powder for inhalation
in DISKUS inhaler with 60 dose strips
One serving contains:
Active ingredient: fluticasone propionate 250 mcg
Excipients: lactose
FLUSPIRAL 500 mcg - Powder for inhalation
in DISKUS inhaler with 60 dose strips
One serving contains:
Active ingredient: fluticasone propionate 500 mcg
Excipients: lactose
FLUSPIRAL 100 mcg - Powder for inhalation
in DISKUS inhaler with 60 dose strips
One serving contains:
Active ingredient: fluticasone propionate 100 mcg
Excipients: lactose
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Pressurized suspension for inhalation.
Powder for inhalation
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Control of the evolution of asthmatic disease and bronchostenosis conditions.
04.2 Posology and method of administration
Fluticasone propionate should only be administered by oral inhalation.
Patients should be advised of the prophylactic nature of inhaled fluticasone propionate therapy and that it should be used regularly even after symptoms resolve.
Patients must be informed that the drug's effectiveness is not immediate and therefore it must be taken regularly; the onset of the therapeutic effect is between 4 and 7 days, although, in some cases, an improvement may occur as early as within the first 24 hours in patients not previously treated with inhaled steroids.
If the patient notices a decrease in the efficacy of fast-acting beta2-agonists or a greater frequency of their use, medical attention should be sought.
The dosage of fluticasone propionate should be adapted to the individual patient in relation to the severity of the asthma and the phase of therapy.
Once the patient's respiratory function is stabilized, the daily dose should be gradually reduced, according to individual response, until the minimum effective maintenance dose is reached.
Treatment with fluticasone propionate should not be stopped abruptly.
There is no need to reduce the drug dose in elderly patients or patients with hepatic or renal insufficiency.
FLUSPIRAL - Pressurized suspension for inhalation
As with all drugs, administered by inhalation, by means of a dosed aerosol, it is advisable to take the dose in two inhalations.
In patients with poor coordination of movements, appropriate spacer devices can be used.
FLUSPIRAL - Powder for inhalation
The content of each dose is inhaled directly by the special multidose inhaler (DISKUS) which allows the inhalation of the drug even to those patients who are unable to use a pressurized aerosol correctly.
Adults
There standard dose is 200 mcg per day, divided into two doses of 100 mcg each.
The dosage can be increased up to 400 mcg per day.
The starting dose can subsequently be adjusted until control is achieved, or reduced to the lowest effective dose, according to individual response.
The prescribing physician should be aware that fluticasone propionate is as effective as other inhaled steroids at approximately one-half mcg daily dose. For example, 100 mcg of fluticasone propionate is approximately equivalent to a dose of 200 mcg of beclomethasone dipropionate (in CFC-containing formulations) or budesonide.
The efficacy and tolerability profile of fluticasone propionate allow to treat with this inhaled steroid even patients with severe forms who often have to resort to therapy with oral steroids. In these patients fluticasone propionate at a maximum dosage of 2000 mcg per day can allow adequate disease control by drastically reducing the use of oral steroids.
During exacerbations, doses of 2000 mcg per day of fluticasone propionate can replace oral steroid cycles in some cases.
Children over 4 years old
There standard dose is 100 mcg per day, divided into two doses of 50 mcg each.
The dosage can be increased up to 200 mcg per day.
For those patients in whom asthma is not sufficiently controlled, an additional benefit can be obtained by increasing the dose up to 200 micrograms twice daily.
Therapy should be initiated at a dose appropriate to the severity of the disease.
The dose may subsequently be adjusted until control is achieved, or reduced to the lowest effective dose, according to individual response.
It should be noted that only the 50 mcg pressurized inhalation suspension is suitable for administration of this dose.
The pressurized inhalation suspension may not allow the administration of the required pediatric dose; if so, consider administering powdered fluticasone propionate by inhalation via the DISKUS inhaler.
Children from 1 to 4 years
FLUSPIRAL - Pressurized suspension for inhalation
100 mcg twice / day administered by means of a spacer device equipped with a face mask (spacer device for pediatric use).
Administration of fluticasone propionate to younger children is beneficial in the control of frequent and persistent asthma symptoms and is indicated only if symptoms are not adequately controlled by once daily beta agonist therapy.
The maximum authorized dose in children is 200 mcg twice daily.
Clinical studies conducted in children aged 1 to 4 years have shown that optimal control of asthma symptoms is achieved with the administration of 100 micrograms twice daily.
In younger children, higher doses are required than in older children due to the reduced efficiency of drug distribution resulting from the smaller caliber of the airways, the need to use a spacer device and the increase in the amount of nasal inhalation.
Diagnosis and treatment of asthma must be monitored constantly.
FLUSPIRAL - Powder for inhalation
The inhalation powder pharmaceutical form is not suitable for children aged 1 to 4 years; as regards the dosage of the drug in this age group, refer to what is reported for FLUSPIRAL Pressurized suspension for inhalation.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
The treatment of asthma must normally be performed within the framework of a therapeutic plan adapted to the severity of the disease; the patient's response to therapy should be verified both clinically and by pulmonary function tests, when available.
The need for rapid-acting inhaled beta2-agonists more frequently indicates worsening asthma control; in this circumstance the patient's treatment plan must be modified.
Sudden and progressive aggravation of asthma is potentially life-threatening and consideration should be given to increasing the dosage of corticosteroids. In patients considered at risk, daily peak flow monitoring is recommended.
Systemic effects may occur with inhaled corticosteroids, particularly when prescribed in high doses for prolonged periods. These effects are less likely to occur than with oral corticosteroid treatment. Possible systemic effects include Cushing's syndrome, Cushingoid aspect, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, glaucoma and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, disturbances sleep, anxiety, depression or aggression (particularly in children). It is therefore important that the dose of the inhaled corticosteroid is the lowest possible dose with which effective control of asthma is maintained.
There have been very rare cases of acute adrenal crisis in boys exposed to higher than recommended doses (approximately 1000 mcg / day, when administered by inhalation with pressurized suspension, or equivalent doses of other inhaled corticosteroids or other forms of fluticasone propionate) for prolonged periods (several months or years) (see section 4.8).
It is recommended that the height of children receiving prolonged inhaled corticosteroid therapy is regularly monitored.
Due to the possibility of insufficient adrenal response, patients previously treated with oral steroids who are transferred to inhaled fluticasone propionate therapy should be treated with particular care, adrenal function should be monitored regularly, discontinuation of systemic steroid therapy should be gradual and patients should be advised to carry a marker indicating that they may require supplemental corticosteroid therapy during times of stress.
The possibility of an insufficient adrenal response in emergency situations (including surgery) and also in elective surgeries likely to cause stress should always be borne in mind, especially in patients taking high doses for prolonged periods. Additional corticosteroid treatment appropriate to the clinical situation should be considered (see section 4.9).
Replacing systemic corticosteroid therapy with inhalation therapy may reveal allergies such as allergic rhinitis or eczema that were previously masked by systemic drugs.
Treatment with fluticasone propionate should not be stopped abruptly.
There have been very rare reports of increases in blood glucose levels (see section 4.8) and this should be considered when prescribing the drug to patients with a history of diabetes mellitus.
As with all inhaled corticosteroids special attention is needed in patients with active or dormant forms of pulmonary tuberculosis.
Cases of clinically significant drug interactions have been reported during post-marketing use in patients treated with fluticasone propionate and ritonavir resulting in systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects occurring (see section 4.5).
As with other inhaled drugs, paradoxical bronchospasm with increased dyspnoea may occur immediately after taking the drug. In this case, immediately take a fast-acting bronchodilator, discontinue fluticasone propionate therapy immediately, re-evaluate the patient and institute alternative therapy if necessary (see section 4.8).
There was an increase in reports of pneumonia in studies of COPD patients receiving fluticasone propionate 500 mcg (see section 4.8). Physicians should be vigilant for the possible development of pneumonia in COPD patients as the clinical features of pneumonia and exacerbation they often overlap.
FLUSPIRAL - Pressurized suspension for inhalation
If the pressurized suspension is used, the patient's inhalation technique should be verified to ensure that the activation of the inhaler is synchronized with the inspiration to ensure optimal delivery of the drug to the lungs.
Since systemic absorption of the drug occurs through the lung, the use of the spacer may increase the concentration of the drug in the lung and consequently the risk of systemic adverse reactions.
FLUSPIRAL - Powder for inhalation
Fluspiral inhalation powder contains lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product (see also section 4.5).
The lactose excipient contains milk proteins so it is not suitable for people with intolerance to milk proteins.
04.5 Interactions with other medicinal products and other forms of interaction
Under normal circumstances, low plasma concentrations of fluticasone propionate are obtained following inhaled administration due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the intestine and liver. Interactions are therefore unlikely. clinically significant drug mediated by fluticasone propionate.
An interaction study conducted in healthy volunteers has shown that ritonavir (a very potent inhibitor of cytochrome P450 3A4) can significantly increase the plasma concentrations of fluticasone propionate, resulting in significantly lower serum cortisol concentrations.
During post-marketing use, cases of clinically significant drug interactions have been reported in patients treated with intranasal or inhaled fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression. .
Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided unless the potential benefit to the patient outweighs the risks of systemic corticosteroid side effects.
Studies have shown that other cytochrome P450 3A4 inhibitors produce negligible (erythromycin) and minor (ketoconazole) increases in systemic exposure to fluticasone propionate with no notable reductions in serum cortisol concentrations. Nevertheless, caution is advised when potent inhibitors of cytochrome P450 3A4 (eg Ketoconazole) are administered concomitantly as potentially increased systemic exposure to fluticasone propionate could occur.
04.6 Pregnancy and breastfeeding
Fertility
There are no data on human fertility. Studies with fluticasone in animals have shown no effects on male and female fertility. Animal studies to evaluate any interference of fluticasone propionate on reproductive function have shown only those effects characteristic of glucocorticoids at systemic exposure levels far in excess of those observed at the recommended therapeutic inhaled dose.
Pregnancy
There are limited data on pregnant women. Administration of fluticasone propionate during pregnancy should only be considered if the expected benefits to the mother outweigh the possible risks to the fetus.
Results from a retrospective epidemiological study show that the risk of major congenital malformations (MCMs) following exposure to fluticasone propionate alone and in combination with salmeterol is no greater than that found following exposure to other inhaled corticosteroids. , during the first trimester of pregnancy (see section 5.1 Clinical Studies).
Feeding time
It is unknown whether fluticasone propionate is excreted in human breast milk.
Following subcutaneous administration in rats, fluticasone propionate was found to be present in breast milk at measurable plasma concentrations. However, plasma levels are likely to be low in patients receiving fluticasone propionate at recommended inhaled doses.
Administration during lactation should only be considered if the expected benefits to the mother outweigh the possible risks to the fetus.
04.7 Effects on ability to drive and use machines
Fluspiral does not affect the ability to drive and use machines
04.8 Undesirable effects
Adverse reactions are listed below by organ, organ / system and by frequency. Frequencies are defined as: very common (≥1 / 10), common (≥1 / 100,
Infections and infestations
Very common: Candidiasis of the mouth and throat.
Oropharyngeal candidiasis (thrush) may occur in some patients. Such patients may benefit from rinsing their mouth with water after taking the drug. Symptomatic candidiasis can be treated with topical antifungal therapy without stopping the use of fluticasone propionate.
Common: pneumonia (in COPD patients)
Very rare: esophageal candidiasis
Disorders of the immune system
Hypersensitivity reactions manifesting as follows have been reported:
Uncommon: Skin hypersensitivity reactions.
Very rare: Angioedema (mainly edema of the face and oropharynx), respiratory symptoms (dyspnoea and / or bronchospasm) and anaphylactic reactions.
Endocrine pathologies
Possible systemic effects include (see section 4.4):
Very rare: Cushing's syndrome, Cushingoid appearance, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma.
Metabolism and nutrition disorders
Very rare: Hyperglycaemia.
Psychiatric disorders
Very rare: Anxiety, sleep disturbances and behavioral disturbances, including psychomotor hyperactivity and irritability (predominantly in children).
Not known: depression and aggression (predominantly in children).
Respiratory, thoracic and mediastinal disorders
Common: hoarseness.
Hoarseness may occur in some patients; even in these cases it may be advantageous to rinse the mouth with water immediately after inhalation.
Very rare: paradoxical bronchospasm (see section 4.4).
Not known: epistaxis
Skin and subcutaneous tissue disorders
Common: bruises
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Symptoms and signs
Acute inhalation of the drug in higher than recommended doses may lead to temporary suppression of the hypothalamus-pituitary-adrenal axis. This does not normally require the institution of emergency interventions since adrenal function typically returns to normal within a few days.
If doses higher than those approved are used for prolonged periods, significant adrenal suppression may occur. Monitoring of the adrenal reserve may be necessary.
There have been very rare cases of acute adrenal crisis in children exposed to higher than recommended doses (typically 1000 mcg / day and above) for prolonged periods (several months or years); manifestations observed included hypoglycemia and sequelae of decreased consciousness and / or convulsions).
Situations that can potentially trigger an acute adrenal crisis include exposure to trauma, surgery, infection, or any rapid reduction in dosage.
Treatment
Patients treated with doses higher than those approved should be closely monitored and the dose reduced gradually.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for obstructive respiratory tract syndromes - inhaled glucocorticoids.
ATC code: R03BA05
Mechanism of action
Fluticasone propionate, administered by inhalation at recommended doses, exerts a powerful anti-inflammatory activity in the lungs, reducing symptoms and episodes of asthma exacerbation.
Clinical Studies
Medicines containing fluticasone propionate in pregnant women with asthma
An epidemiological observational retrospective cohort study using electronic health records from the UK was conducted to assess the risk of MCMs after exposure to inhaled fluticasone propionate and salmeterol-fluticasone propionate combination versus inhaled corticosteroids not containing fluticasone propionate during the first trimester of pregnancy No comparison with placebo was made in this study.
In the cohort of 5,362 pregnant women with asthma exposed during the first trimester to inhaled corticosteroids, 131 diagnoses of MCMs were identified in one year; 1,612 (30%) were exposed to fluticasone propionate or salmeterol-fluticasone propionate, 42 of which were diagnosed with MCMs. The adjusted odds ratio for diagnoses of MCMs over one year was 1.1 (95% CI: 0.5 - 2.3) for women with moderate asthma exposed to fluticasone propionate vs exposed to corticosteroids not containing fluticasone propionate and 1, 2 (95% CI: 0.7 - 2.0) for women with considerable to severe asthma. No differences were identified in the risk of MCMs after first trimester exposure to fluticasone propionate versus the salmeterol-fluticasone propionate combination. . The absolute risk of MCM across the different asthma severity ranges ranged from 2.0 to 2.9 per 100 pregnancies exposed to fluticasone propionate.
05.2 Pharmacokinetic properties
Absorption
The absolute bioavailability of fluticasone propionate for each type of inhalation regulator was assessed by comparing the pharmacokinetic data of inhaled versus intravenous administration within each individual study and across studies. . In healthy adult subjects, the absolute bioavailability of fluticasone propionate inhaler powder Diskus (7.8%) and fluticasone propionate inhalation pressurized suspension (10.9%), respectively, was evaluated. A lower level of systemic exposure to inhaled fluticasone propionate was observed in subjects with asthma or chronic obstructive pulmonary disease (COPD). Systemic absorption occurs mainly through the lungs and is initially rapid, then prolonged. The remainder of the inhaled dose can be ingested but contributes negligibly to systemic exposure due to low aqueous solubility and pre-systemic metabolism. with an oral availability of less than 1%. There is a linear increase in systemic exposure in relation to the increase in the inhaled dose.
Distribution
Fluticasone propionate has a large steady-state volume of distribution (approximately 300 l). Plasma protein binding is moderately high (91%).
Biotransformation
Fluticasone propionate is cleared very rapidly from the systemic circulation, mainly by metabolism to an inactive carboxylic acid compound, by the cytochrome P450 of the CYP3A4 enzyme system. Care should be taken when administering drugs known to inhibit the CYP3A4 enzyme system as there is a potential for increased systemic exposure to fluticasone propionate.
Elimination
The elimination of fluticasone propionate is characterized by a "high plasma clearance (1150 ml / min) and a" terminal elimination half-life of approximately 8 hours. The renal clearance of fluticasone propionate is negligible (less than 0.2%) and less than 5% is eliminated as a metabolite.
05.3 Preclinical safety data
The toxicological tests have shown, at doses higher than those proposed for therapeutic use, the only class of effects typical of a high potency corticosteroid.
Chronic toxicity studies did not reveal effects of a different nature, as well as studies of reproductive toxicology and teratogenesis.
Fluticasone propionate was found to be non-mutagenic in vitro and in vivo and non-oncogenic in rodents.
In animal models, fluticasone propionate was found to be non-irritating and non-sensitizing.
The propellant HFA 134a, not CFC, has been shown, in numerous animal species, exposed daily to the propellant for periods of two years, not to cause toxic effects at very high vapor concentrations, much higher than those to which patients will be exposed.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Pressurized suspension for inhalation
Propellant HFA 134a.
Powder for inhalation
Lactose (which contains milk proteins).
06.2 Incompatibility
Not relevant
06.3 Period of validity
FLUSPIRAL - Pressurized suspension for inhalation: 2 years.
FLUSPIRAL 100mcg Powder for inhalation: 2 years; FLUSPIRAL 250mcg Powder for inhalation, FLUSPIRAL 500mcg Powder for inhalation: 3 years.
06.4 Special precautions for storage
Pressurized suspension for inhalation
Firmly replace the inhaler lid until you hear a click.
Packages must be kept out of sunlight and protected from freezing.
As with most pressurized dosed aerosol drugs, the therapeutic effect may be less if the pressurized container is cold.
Pressurized containers must not be broken, punctured or burned, even if apparently empty.
Powder for inhalation
Store in a dry place.
Store in the original package to protect from moisture.
The diskus is sealed with a protective laminate cover which only needs to be opened when the medicinal product is used for the first time. Once opened, the protective laminate envelope must be discarded.
06.5 Nature of the immediate packaging and contents of the package
Cartons containing an aluminum pressurized container with metering valve and relative inhaler.
FLUSPIRAL 125 mcg - Pressurized suspension for inhalation
- pressurized container with 120 puffs of 125 mcg each
FLUSPIRAL 250 mcg - Pressurized suspension for inhalation
- pressurized container with 120 puffs of 250 mcg each
FLUSPIRAL 50 mcg - Pressurized suspension for inhalation
- pressurized container with 120 sprays of 50 mcg each
Multidose inhalers in molded plastic material (DISKUS) each containing a strip strip in which individual blisters are arranged, regularly spaced, each of which contains a dose (100 - 250 - 500 mcg) of inhalation powder of dispersed fluticasone in lactose.
FLUSPIRAL 250 mcg - Powder for inhalation
in DISKUS inhaler with 60-dose 250 mcg strips
FLUSPIRAL 500 mcg - Powder for inhalation
in DISKUS inhaler with 60-dose 500 mcg strips
FLUSPIRAL 100 mcg - Powder for inhalation
in DISKUS inhaler with 60-dose 100 mcg strips
06.6 Instructions for use and handling
FLUSPIRAL - Pressurized suspension for inhalation
Check the functioning of the inhaler
Before using the inhaler for the first time, or when it has not been used for a week, remove the protective cap from the mouthpiece by squeezing it lightly at the sides, shake the inhaler vigorously, then spray a dose into the air to make sure it works.
Use of the inhaler.
Important: do not hurriedly carry out the operations indicated in points 5, 6 and 7. The spillage of nebulized material above the inhaler or from the sides of the mouth indicates that the inhalation was not carried out correctly; then repeat the operations from point 2.
If your doctor gives you different information on how to use your inhaler, you should follow them carefully. It is also advisable to inform the doctor of any possible difficulties.
Cleaning the inhaler
The inhaler should be cleaned at least once a week.
1. Remove the pressurized canister from the inhaler and remove the protective cap from the mouthpiece.
2. Clean the inhaler and mouthpiece protective cap with a damp cloth.
3. Place them to dry in a warm place. Avoid excessive heat.
4. Put the pressurized canister back into the inhaler and the protective cap back into the mouthpiece.
DO NOT IMMERSE THE CONTAINER UNDER PRESSURE IN WATER
FLUSPIRAL - Inhalation powder in DISKUS inhaler
DISKUS INFORMATION
The DISKUS, once removed from the box, is in the "closed" position.
DISKUS contains 60 individually protected doses of the drug powder.
Each dose is carefully measured and hygienically protected. The DISKUS requires no maintenance and is not rechargeable.
The dose indicator on the top of the DISKUS shows the number of doses still available.
Numbers from 5 to 0 are in RED to indicate that there are only a few doses left.
The DISKUS is easy to use.
To take a dose of the drug, follow the four simple steps below:
1. Opening
2. Preparing the dose
3. Inhalation
4. Closing
HOW THE DISKUS WORKS
By sliding the lever of the DISKUS, a small hole is opened in the mouthpiece and a dose is prepared ready to be inhaled. When the DISKUS is closed, the lever automatically returns to its original position, ready to prepare the next dose of drug.
The outer cover protects the DISKUS when not in use.
1. Opening
To open the DISKUS, hold the outer part with one hand and place the thumb of the other hand on the recess. Push with your thumb while rotating the inside of the device until you hear a click.
2. Preparing the dose
Hold the DISKUS with the mouthpiece facing the user. Slide the lever forward until it clicks. The DISKUS is now ready for use.
Each time the lever is slid, a dose is made available for inhalation as shown by the dose indicator.
Use the lever only when you have to inhale the drug so as not to waste doses.
3. Inhalation
Read this section carefully before inhaling.
Keep the DISKUS away from your mouth. Breathe out as deeply as possible. Never blow into the DISKUS.
Put the mouthpiece between your lips.
Inhale deeply and regularly through the DISKUS and not through the nose.
Remove the DISKUS from your mouth.
Hold your breath for about 10 seconds or as long as possible.
Breathe out slowly.
4. Closing
To close the DISKUS, place your thumb in the recess and slide it back as far as it will go.
When the DISKUS is closed, it produces a sharp closing sound. This will automatically return the lever to its original position.
The DISKUS is now ready to be used again.
If two inhalations have been prescribed, it is necessary to close the DISKUS after the first inhalation and then repeat steps 1 to 4.
ATTENTION
Keep the DISKUS dry.
Keep the DISKUS closed when not in use.
Never blow into the DISKUS.
Only slide the lever when you are ready to take the drug.
Inhale from the DISKUS with your mouth only.
Do not exceed the recommended dose.
07.0 MARKETING AUTHORIZATION HOLDER
A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi, 1 - Florence
Licensed by GlaxoSmithKline S.p.A. - Verona
Dealer for sale:
Luso Farmaco Institute of Italy S.p.A. - Milanofiori - Road 6 - Building L - Rozzano (MI)
08.0 MARKETING AUTHORIZATION NUMBER
FLUSPIRAL 125 mcg 120 deliveries of 125 mcg A.I.C .: 028675179
FLUSPIRAL 250 mcg 120 deliveries of 250 mcg A.I.C .: 028675181
FLUSPIRAL 50 mcg 120 puffs of 50 mcg A.I.C .: 028675104
FLUSPIRAL 250 mcg Powder for inhalation
in DISKUS inhaler with 60-dose 250 mcg strips A.I.C .: 028675270
FLUSPIRAL 500 mcg Powder for inhalation
in DISKUS inhaler with 60-dose 500 mcg strip A.I.C .: 028675282
FLUSPIRAL 100 mcg Powder for inhalation
in DISKUS inhaler with 60-dose 100 mcg strips A.I.C .: 028675268
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
May 2003 / May 2008
10.0 DATE OF REVISION OF THE TEXT
March 2017
