Active ingredients: Fluticasone (Fluticasone propionate)
Flixonase 50 micrograms / actuation Nasal Spray, Suspension
Why is Flixonase used? What is it for?
Flixonase 50 micrograms / actuation Nasal Spray, Suspension (called Flixonase in this leaflet) belongs to a group of medicines called corticosteroids. Flixonase reduces inflammation of the nose which is accompanied by the following symptoms: swelling and irritation of the nose, stuffy or runny nose, sneezing and itchy nose.
Flixonase is used for prophylaxis and treatment of:
- Inflammation of the lining of the nose (allergic rhinitis) due to seasonal allergies such as hay fever
- Inflammation of the mucous membrane of the nose (allergic rhinitis) due to allergies throughout the year (chronic) such as allergies to animals, house dust mites or mold
- Vasomotor rhinitis
Contraindications When Flixonase should not be used
Do not use Flixonase:
- if you are allergic (hypersensitive) to fluticasone propionate or any of the other ingredients of Flixonase (listed in section 6)
- if you have local viral or tuberculous infections
Precautions for use What you need to know before taking Flixonase
Before you use Flixonase your doctor needs to know:
- if you have a "nose infection."
- if you have ever been told that you have an underactive adrenal gland (Addison's disease)
- if you are taking a medicine called ritonavir.
Check with your doctor if you think this applies to you.
Systemic effects of nasal corticosteroids may occur particularly when administered at high prescribed doses for prolonged periods of time. These effects vary between patients and for different corticosteroids.
Growth retardation has been reported in children treated with certain nasal corticosteroids at authorized doses. It is recommended to regularly monitor the height of children treated for long periods with nasal corticosteroids. If growth is slowed, therapy should be reconsidered in order to reduce the dose of the nasal corticosteroid, if possible, to the lowest dose at which it is maintained. effective symptom control Consideration should also be given to referring the patient to a specialist pediatric visit.
Interactions Which drugs or foods can modify the effect of Flixonase
Tell your doctor or pharmacist if you are taking or have recently taken or are about to take any other medicines. This includes medicines bought without a prescription.
Some medications can affect how Flixonase works or make it more likely that you will have side effects. These drugs include:
- ritonavir (used to treat HIV)
- ketoconazole (used to treat fungal infections)
- steroids administered for long periods, taken both by injection and orally.
Tell your doctor or pharmacist if you are taking any of these medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant, or think you may be pregnant or are planning to become pregnant, do not use Flixonase without first checking with your doctor. Your doctor will assess the benefit to you and the risk to your baby of taking Flixonase while you are pregnant.
It is not known whether the active substance and the excipients of Flixonase can pass into breast milk. If you are breastfeeding, you should consult your doctor before using Flixonase.
Important information about some of the ingredients of Flixonase
The medicine contains benzalkonium chloride which may be irritating to the mucous membranes.
Dose, Method and Time of Administration How to use Flixonase: Posology
Always use Flixonase exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
It is important to take the drug dose as directed in the package leaflet or as prescribed by your doctor. Only the dose recommended by your doctor should be used; use of higher or lower doses may cause worsening of symptoms.
Use of the medicine
Adults and children aged 12 and over
- The usual starting dose is 2 applications per nostril once a day, preferably in the morning.
- If necessary, your doctor may increase the dose to a maximum of 2 applications in each nostril twice a day (morning and evening) until the symptoms are under control.
The maximum dose should not exceed 4 applications per nostril per day.
Senior citizens
- The dosage is that of the adult patient.
Children between the ages of 4 and 11
- The usual starting dose is 1 application per nostril once a day, preferably in the morning.
- If necessary, your doctor may increase the dose to 1 application in each nostril twice a day (morning and evening) until symptoms are under control. The maximum allowable dose should not exceed 2 applications in each nostril.
How to use the nasal spray
Flixonase is administered nasally as a fine mist.
The first time you use the nebulizer, you must check that it is working correctly.
Carefully follow the step-by-step instructions in section 7. Avoid contact with eyes
STEP BY STEP INSTRUCTIONS
Nasal spray
The nasal spray has a dust cap that fixes the nasal applicator and keeps it clean. Remember to remove it before using the nasal spray. A new nasal spray (or one that has not been used for a few days) may not work the first time , so you need to prepare the nasal spray following the instructions in the "Preparing the nasal spray" section.
Preparation of the nasal spray
Prepare the nasal spray:
- Before using it for the first time
- If you haven't used it for a few days
- If you have just cleaned it by following the instructions in the section "Cleaning the nasal spray"
Preparing the nasal spray helps ensure that you always take the full dose of the medicine. Follow these steps:
- Shake the nasal spray and remove the dust cap by gently pressing the knurled sides with your index finger and thumb and pulling the cap up. Do not unscrew. (Figure 1)
- Hold the nasal spray upright and aim the spray away from you.
- Place your index and middle fingers on the collar on the sides of the nasal applicator and place your thumb under the bottle. (Figure 2)
- Keeping your thumb still, press firmly on the collar with your fingers until a fine mist is released into the air. (Figure 2)
- The nasal spray is now ready for use.
- If you think the nasal applicator is blocked, do not use a needle or anything sharp to clear it.
- You can clean the nasal applicator by following the instructions in the "Cleaning the nasal spray" section.
Using the nasal spray
- Shake the nasal spray and remove the dust cap.
- Blow your nose to clear your nostrils.
- Close one nostril with a finger and carefully insert the nasal applicator into the other nostril. Tilt your head slightly forward and hold the nasal spray vertical. (Figures 3a and 3b)
- While inhaling through the nose, press firmly on the collar with your fingers. (Figures 3a and 3b)
- Breathe out through your mouth.
- Repeat steps 3 through 4 for the other nostril.
- After using the nasal spray, clean the nasal applicator carefully using a tissue or tissue.
- Put the dust cap back on (Figure 4)
Cleaning the nasal spray
Clean the nasal spray at least once a week to prevent the nasal applicator from clogging. Follow the steps:
- Remove the dust cap.
- Remove the nasal applicator by pressing under the collar and pulling slightly upwards. (Figure 5)
- Soak the nasal applicator and dust cap in warm water for a few minutes.
- Rinse under running water.
- Remove excess water and allow to dry well.
- Put the nasal applicator back on the spray.
- Prepare the nasal spray following the instructions in the "Preparing the nasal spray" section so that it is ready for use.
Overdose What to do if you have taken too much Flixonase
If you forget to use Flixonase
Do not take an additional dose to make up for a forgotten dose. Take the next dose when scheduled.
If you use more Flixonase than you should
If you use more Flixonase, contact your doctor or pharmacist for advice. If possible, show the Flixonase pack.
If you have any further questions on the use of Flixonase, ask your doctor or pharmacist.
Do not stop taking Flixonase without your doctor's advice
It takes 3 to 4 days for Flixonase to work well and it is important that you take Flixonase on a regular basis.
Take Flixonase for the period your doctor has prescribed for you. Do not stop treatment unless your doctor tells you to.
Side Effects What are the side effects of Flixonase
Like all medicines, Flixonase can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Conditions to which attention must be paid
Allergic reactions: These are very rare in people taking Flixonase. The signs include:
- skin rash (hives) or redness
- swelling around the face, mouth and tongue which may cause difficulty in swallowing
- very wheezing, coughing or difficulty breathing
- sudden feeling of weakness or lightheadedness (can lead to fainting and loss of consciousness)
Contact your doctor immediately if you get any of these symptoms. Stop taking Flixonase.
Very common (affects more than 1 in 10 people)
- nosebleeds
Common (affects up to 1 in 10 people)
- a dry or sore throat or nose - you may see streaks of blood when you blow your nose
- headache, unpleasant taste and smell.
Very rare (affects up to 1 in 10,000 people)
- allergic reactions
- clouded lens of the eye (cataract), increased pressure in the eye causing vision problems (glaucoma). These eye problems occur in people who use Flixonase for long periods
- small holes (perforations) in the nasal septum that separates the nostrils
Tell your doctor immediately if you get any of these symptoms.
Tell your doctor or pharmacist if any of the side effects listed become serious or troubling, or if you notice any side effects not listed in this leaflet.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena.
Systemic effects may occur with intranasal corticosteroids, particularly when prescribed in high doses for prolonged periods. These can include growth retardation in children and adolescents.
Expiry and Retention
Keep Flixonase out of the reach and sight of children.
Do not use Flixonase after the expiry date which is stated on the package. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Flixonase contains
- The active ingredient is fluticasone propionate.
- The other ingredients are: anhydrous glucose, microcrystalline cellulose-sodium carmellose, 2-phenylethyl alcohol, benzalkonium chloride, polysorbate 80, purified water. See also section 2.
What Flixonase looks like and contents of the pack
- Flixonase is a 0.050% w / w aqueous suspension of micronized fluticasone propionate for topical administration to the nasal mucosa using a nasal spray dosed with a nebulizer.
- The nebulizer contains 6 or 12 g of suspension and delivers 60 or 120 puffs. Each puff of 100 mg administered via the nasal adapter contains 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
FLIXONASE 50 MCG / NASAL SPRAY DISPENSING, SUSPENSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of suspension contain:
active ingredient: fluticasone propionate 0.050 g.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Nasal spray, 0.050% w / w aqueous suspension of micronized fluticasone propionate for topical administration on the nasal mucosa using a nasal spray dosed with a nebulizer.
The nebulizer contains 6 or 12 g of suspension and delivers 60 or 120 puffs. Each puff of 100 mg administered via the nasal adapter contains 50 mcg of fluticasone propionate.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Prophylaxis and treatment of seasonal and chronic allergic rhinitis, including pollinosis ("hay fever") and vasomotor rhinitis.
04.2 Posology and method of administration
FLIXONASE should only be administered via the nose.
Adults and children over 12 years of age
Two applications per nostril, once a day, preferably in the morning. If necessary, the dosage can be increased to two applications per nostril twice a day. The maximum dosage should not exceed 4 applications per nostril per day.
Senior citizens
The dosage is that of the adult patient.
Children between the ages of 4 and 11
1 application per nostril, once a day, preferably in the morning. If necessary, the dosage can be increased to 1 application per nostril, twice a day.
The maximum dosage should not exceed 2 applications per nostril per day.
To obtain the complete therapeutic response, FLIXONASE must be taken regularly. It should be explained to the patient that FLIXONASE does not have an immediate therapeutic effect, but that 3 or 4 days of treatment are required to achieve maximum therapeutic activity.
Avoid contact with eyes.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Local viral or tuberculous infections.
04.4 Special warnings and appropriate precautions for use
General informations
Infections of the nasal passages and sinuses must be treated appropriately, however they are not a specific contraindication to the use of intranasal fluticasone propionate.
The replacement of general corticosteroid therapy with topical therapy requires caution, especially where there is reason to believe that some degree of adrenal function impairment is present.
Systemic effects may occur with intranasal corticosteroids, particularly when prescribed in high doses for prolonged periods. These effects are less likely to occur than with oral corticosteroid treatment and may vary in individual patients and between different corticosteroid preparations. 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).
Growth retardation has been observed in children treated with intranasal corticosteroids at authorized doses. Regular monitoring of the height of children receiving prolonged intranasal corticosteroid treatment is recommended (see section 4.8). If growth is slowed, therapy should be reconsidered in order to reduce the nasal corticosteroid dose, if possible, to the lowest dose. in which effective symptom control is maintained, and consideration should be given to referring the patient to a specialist pediatric visit.
During post-marketing use, cases of clinically significant drug interactions have been reported in patients treated with fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression. 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 (see section 4.5).
Benzalkonium chloride (BAC) contained as a preservative in FLIXONASE, especially when used for long periods, can cause swelling of the nasal mucosa. If such a reaction (persistent nasal congestion) is suspected, a BAC-free nasal medicine should be used if possible. If such nasal medications without BAC are not available, another pharmaceutical form should be considered. May cause bronchospasm.
Nasal spray
It may take several days of treatment to achieve a complete response to treatment with FLIXONASE.
Although FLIXONASE controls seasonal allergic rhinitis in most cases, an abnormally high presence of summer allergens may, in particular cases, require appropriate additional therapy.
04.5 Interactions with other medicinal products and other forms of interaction
Under normal circumstances, very low plasma concentrations of fluticasone propionate are obtained following inhaled intranasal administration due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the intestine and liver. clinically significant drug interactions unlikely, 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 fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression. 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.
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 there is a potential for increased systemic exposure to fluticasone propionate.
04.6 Pregnancy and lactation
Direct nasal administration results in minimal systemic exposure.
However, as with other drugs, the expected benefits of using fluticasone propionate aqueous nasal spray during pregnancy and lactation should be weighed taking into account the possible risks associated with the use of the product or any alternative therapy.
Pregnancy: Information on the tolerability of FLIXONASE in pregnancy is still limited.
In animal reproduction studies, typical adverse reactions of potent corticosteroids were observed only at high levels of systemic exposure; direct intranasal application ensures minimal systemic exposure.
Feeding time: The excretion of fluticasone propionate in human breast milk has not been investigated.
When measurable plasma levels were obtained in lactating laboratory mice following subcutaneous administration, fluticasone propionate was found in milk. However, plasma levels in patients after cutaneous application of fluticasone propionate at recommended doses are likely to be low.
04.7 Effects on ability to drive and use machines
Not reported.
04.8 Undesirable effects
Adverse events are listed below by organ, organ / system and by frequency. Frequencies are defined as: very common (≥1 / 10), common (≥1 / 100,
In assigning the frequencies of adverse events, the background incidences of the placebo groups were not taken into account since these incidences are generally comparable to those of the groups treated with the active substance.
Alterations of the immune system
Very rare: hypersensitivity reactions, anaphylaxis / anaphylactic reactions, bronchospasm, rash, edema of the face or tongue
Alterations of the nervous system
Common: headache, unpleasant taste, unpleasant smell
As with other nasal sprays, unpleasant sensations of taste, smell and headache have been reported.
Eye disorders
Very rare: glaucoma, increased intraocular pressure, cataracts
Very few spontaneous reports have been identified following prolonged treatment. However, clinical studies up to one year in duration have shown that the use of intranasal fluticasone propionate is not associated with the increased incidence of ocular events including cataracts, increased intraocular pressure or glaucoma.
Respiratory, thoracic and mediastinal disorders
Very common: epistaxis
Common: nasal dryness, nasal irritation, dry throat, throat irritation
As with other nasal sprays, dryness and irritation of the nose and throat, and epistaxis have been reported.
Very rare: perforation of the nasal septum
Cases of nasal septal perforation have been reported following the use of nasal corticosteroids.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena.
Systemic effects may occur with intranasal corticosteroids, particularly when prescribed in high doses for prolonged periods. These can include growth retardation in children and adolescents.
04.9 Overdose
No information is yet available on cases of acute and chronic overdose of FLIXONASE. Nasal administration of 2 mg (equal to 40 actuations) of fluticasone propionate twice a day for seven days, conducted on the volunteer, had no effect on the function of the hypothalamic-pituitary-adrenal axis.
Treatment
Administration of higher than recommended doses over a long period of time may lead to temporary suppression of adrenal function.
In these patients, fluticasone propionate treatment should continue with a dose sufficient to control.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: decongestants and other nasal preparations for topical use - corticosteroids.
ATC code: R01AD08.
Fluticasone propionate causes little or no suppression of the hypothalamic-pituitary-adrenal axis following nasal administration.
Obvious suppression of the hypothalamic-pituitary-adrenal axis occurs only after high oral doses (10 mg four times a day - for example 40 mg a day or more).
A one-year, randomized, double-blind, placebo-controlled growth study in pre-pubescent children aged 3 to 9 years was conducted (56 patients received intranasal fluticasone propionate and 52 received placebo): There was no statistically significant difference in growth rate in patients receiving nasal fluticasone propionate (200 mcg per day nasal spray) compared to those taking placebo.
The estimated growth rate over one year of treatment was 6.20cm / year (SE = 0.23) in the placebo group and 5.99cm / year (SE = 0.23) in the fluticasone propionate group; the mean difference between treatments in growth rate after one year was 0.20cm / year (SE = 0.28; 95% CI = -0.35; 0.76). There was no evidence of clinically relevant changes in hypothalamic-pituitary-adrenal axis function or bone mineral density, as verified by 12-hour urinary cortisol excretion assessment and dual-energy X-ray absorption spectrometry, respectively.
05.2 "Pharmacokinetic properties
Following nasal administration of fluticasone propionate (200 mcg / day) there was no significant change in the 24-hour AUC of serum cortisol compared to placebo (ratio 1.01; I C 90% 0.9 - 1.14).
Absorption: Following nasal administration of fluticasone propionate (200 mcg / day), steady-state maximum plasma concentrations were not quantifiable in most subjects (swallowed. When administered orally, systemic exposure is orally is negligible.
Distribution: Fluticasone propionate has a large steady-state volume of distribution (approximately 318 l). Plasma protein binding is moderately high (91%).
Metabolism: Fluticasone propionate is cleared rapidly from the systemic circulation, primarily by hepatic metabolism to an inactive carboxylic acid metabolite, by the cytochrome P450 enzyme CYP3A4. Swallowed fluticasone propionate also undergoes extensive first pass metabolism. Caution should be exercised when concomitantly administered drugs known to be strong inhibitors of the CYP3A4 enzyme system, such as ritonavir and ketoconazole, as there is a potential for increased systemic exposure to fluticasone propionate.
Elimination: The elimination rate of intravenously administered fluticasone propionate is linear over the dose range of 250 to 1000 micrograms and is characterized by high plasma clearance (CL = 1.1 L / min). Peak plasma concentrations are reduced by approximately 98% within 3-4 hours and only low plasma concentrations are associated with a terminal half-life of 7.8 hours. Renal clearance of fluticasone propionate is negligible (bile.
05.3 Preclinical safety data
The toxicological tests have shown, at doses far higher than those proposed for therapeutic use, the only class of effects typical of a high potency corticosteroid.
Chronic toxicity studies did not highlight effects of a different nature, as did reproductive toxicology and teratogenesis studies. Fluticasone propionate was found to be devoid of mutagenic activity in vitro and in vivo.
Carcinogenicity studies have shown that fluticasone propionate has no oncogenic potential in rodents. In animal models it was found to have no irritating and sensitizing effect.
However, in animal studies to evaluate possible interference of fluticasone propionate on reproductive function, FLIXONASE showed only the adverse reactions typical of exposure to high levels of potent corticosteroids.
Following subcutaneous administration in rats, the presence of fluticasone propionate was found in breast milk in the presence of measurable plasma concentrations.
Preclinical data suggest that benzalkonium chloride is capable of producing a toxic effect - concentration and time dependent - on the vibrating cilia of the epithelium of the nasal mucosa, including irreversible immobility and can induce histopathological changes of the nasal mucosa.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Anhydrous glucose, microcrystalline cellulose-sodium carmellose, 2-phenylethyl alcohol, benzalkonium chloride, polysorbate 80, purified water.
06.2 Incompatibility
Not reported.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicinal product does not require any storage conditions.
06.5 Nature of the immediate packaging and contents of the package
12 g bottle of suspension sufficient for 120 disbursements of 50 mcg of active ingredient
Type III amber glass bottle, equipped with a special dispenser with nasal applicator.
6 g bottle of suspension sufficient for 60 disbursements of 50 mcg of active ingredient
Type I amber glass bottle, equipped with a special dispenser with nasal applicator.
06.6 Instructions for use and handling
Shake gently before use.
Patients should follow the step-by-step instructions at the end of the package leaflet.
Instructions for cleaning the nasal applicator
To clean the nasal applicator, remove the plastic cap, press under the collar and pull slightly upwards, thus releasing the nasal applicator. Wash the applicator and dust cap in warm water. Dry thoroughly and put the dust cap back on.
If the applicator is clogged, remove the dust cap, remove the applicator and leave it in lukewarm water for a few minutes. Dry it well and put it back on the bottle. Do not use sharp points or objects.
07.0 MARKETING AUTHORIZATION HOLDER
GlaxoSmithKline S.p.A. - Via A. Fleming, 2 - Verona
08.0 MARKETING AUTHORIZATION NUMBER
FLIXONASE 50 mcg / supply Nasal Spray, Suspension: 1 bottle of 120 doses - AIC: 027657016
FLIXONASE 50 mcg / supply Nasal Spray, Suspension: 1 bottle of 60 doses - AIC: 027657042
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
29 November 1994 / April 2008
10.0 DATE OF REVISION OF THE TEXT
January 2014
