Alisade

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1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
ALISADE 27.5 micrograms/spray  
nasal spray suspension 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each spray actuation delivers 27.5 micrograms of fluticasone furoate. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Nasal spray, suspension. 
 
White suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Adults, adolescents (12 years and over) and children (6 – 11 years)  
 
Alisade is indicated for the treatment of: 
• the symptoms of allergic rhinitis 
 
4.2 Posology and method of administration 
 
Fluticasone furoate nasal spray is for administration by the intranasal route only.  
 
For full therapeutic benefit regular, scheduled usage is recommended. Onset of action has been 
observed as early as 8 hours after initial administration. However, it may take several days of 
treatment to achieve maximum benefit, and the patient should be informed that their symptoms will 
improve with continuous regular use (see section 5.1). The duration of treatment should be restricted 
to the period that corresponds to allergenic exposure. 
 
Adults and Adolescents (12 years and over) 
The recommended starting dose is two spray actuations (27.5 micrograms of fluticasone furoate per 
spray actuation) in each nostril once daily (total daily dose, 110 micrograms).  
 
Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril 
(total daily dose 55 micrograms) may be effective for maintenance. 
 The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. 
 
Children (6 to 11 years of age) 
The recommended starting dose is one spray actuation (27.5 micrograms of fluticasone furoate per 
spray actuation) in each nostril once daily (total daily dose, 55 micrograms).  
 
Patients not adequately responding to one spray actuation in each nostril once daily (total daily dose, 
55 micrograms) may use two spray actuations in each nostril once daily (total daily dose, 
110 micrograms). Once adequate control of symptoms is achieved, dose reduction to one spray 
actuation in each nostril once daily (total daily dose, 55 micrograms) is recommended. 
 



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Children under 6 years of age: The experience in children under the age of 6 years is limited (see 
section 5.1 and 5.2). Safety and efficacy in this group has not been well established. 
 
Elderly Patients: No dose adjustment is required in this population (see section 5.2). 
 
Renal Impaired Patients: No dose adjustment is required in this population (see section 5.2). 
 
Hepatic Impaired Patients: No dose adjustment is required in mild to moderate hepatic impairment. 
There are no data in patients with severe hepatic impairment (see section 4.4 and 5.2). 
 
The intranasal device should be shaken before use. The device is primed by pressing the mist release 
button for at least six spray actuations (until a fine mist is seen), whilst holding the device upright. Re-
priming (approximately 6 sprays until a fine mist is seen) is only necessary if the cap is left off for 5 
days or the intranasal device has not been used for 30 days or more. 
The device should be cleaned after each use and the cap replaced. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients of Alisade. 
 
4.4 Special warnings and precautions for use 
 
Fluticasone furoate undergoes extensive first-pass metabolism, therefore the systemic exposure of 
intranasal fluticasone furoate in patients with severe liver disease is likely to be increased. This may 
result in a higher frequency of systemic adverse events (see section 4.2 and 5.2). Caution is advised 
when treating these patients. 
 
Ritonavir 
Concomitant administration with ritonavir is not recommended because of the risk of increased 
systemic exposure of fluticasone furoate (see section 4.5). 
 
Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged 
periods. These effects vary between patients and different corticosteroids (see section 5.2). 
 
Treatment with higher than recommended doses of nasal corticosteroids may result in clinically 
significant adrenal suppression. If there is evidence for higher than recommended doses being used, 
then additional systemic corticosteroid cover should be considered during periods of stress or elective 
surgery.  Fluticasone furoate 110 micrograms once daily was not associated with hypothalamic-
pituitary-adrenal (HPA) axis suppression in adult, adolescent or paediatric subjects. However the dose 
of intranasal fluticasone furoate should be reduced to the lowest dose at which effective control of the 
symptoms of rhinitis is maintained. As with all intranasal corticosteroids, the total systemic burden of 
corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed 
concurrently. 
 
Growth retardation has been reported in children receiving some nasal corticosteroids at licensed 
doses. It is recommended that the height of children receiving prolonged treatment with nasal 
corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of 
reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of 
symptoms is maintained. In addition, consideration should be given to referring the patient to a 
paediatric specialist (see section 5.1). 
 
If there is any reason to believe that adrenal function is impaired, care must be taken when transferring 
patients from systemic steroid treatment to fluticasone furoate. 
 
Nasal and inhaled corticosteriods may result in the development of glaucoma and/or cataracts. 
Therefore close monitoring is warranted in patients with a change in vision or with a history if 
increased pressure, glaucoma and/or cataracts. 



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Alisade contains benzalkonium chloride. It may cause irritation of the nasal mucosa. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Fluticasone furoate is rapidly cleared by extensive first pass metabolism mediated by the cytochrome 
P450 3A4.  
 
Based on data with another glucocorticoid (fluticasone propionate), that is metabolised by CYP3A4, 
co-administration with ritonavir is not recommended because of the risk of increased systemic 
exposure of fluticasone furoate. 
 
Caution is recommended when co-administering fluticasone furoate with potent CYP3A4 inhibitors as 
an increase in systemic exposure cannot be ruled out. In a drug interaction study of intranasal 
fluticasone furoate with the potent CYP3A4 inhibitor ketoconazole there were more subjects with 
measurable fluticasone furoate concentrations in the ketoconazole group (6 of the 20 subjects) 
compared to placebo (1 out of 20 subjects). This small increase in exposure did not result in a 
statistically significant difference in 24 hour serum cortisol levels between the two groups (see section 
4.4). 
 
The enzyme induction and inhibition data suggest that there is no theoretical basis for anticipating 
metabolic interactions between fluticasone furoate and the cytochrome P450 mediated metabolism of 
other compounds at clinically relevant intranasal doses. Therefore, no clinical studies have been 
conducted to investigate interactions of fluticasone furoate on other drugs. 
 
4.6 Pregnancy and lactation 
 
There are no adequate data from the use of fluticasone furoate in pregnant women. In animal studies 
glucocorticoids have been shown to induce malformations including cleft palate and intra-uterine 
growth retardation. This is not likely to be relevant for humans given recommended nasal doses which 
results in minimal systemic exposure (see section 5.2). Fluticasone furoate should be used in 
pregnancy only if the benefits to the mother outweigh the potential risks to the foetus or child. 
 
It is unknown whether nasal administered fluticasone furoate is excreted in human breast milk. 
Administration of fluticasone furoate to women who are breastfeeding should only be considered if the 
expected benefit to the mother is greater than any possible risk to the child.  
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed as fluticasone 
furoate is not expected to affect this ability. 
 
4.8 Undesirable effects 
 
Data from large clinical trials were used to determine the frequency of adverse reactions.  
The following convention has been used for the classification of frequencies: Very common >1/10; 
Common >1/100 to <1/10; Uncommon >1/1000 to <1/100; Rare >1/10,000 to <1/1000; Very rare 
<1/10,000. 
 

Immune system disorders 
Rare Hypersensitivity reactions including anaphylaxis, angioedema, rash, and 

urticaria. 
Respiratory, thoracic and mediastinal disorders 
Very common *Epistaxis 
Common Nasal ulceration 



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*Epistaxis was generally mild to moderate in intensity. In adults and adolescents, the incidence of 
epistaxis was higher in longer-term use (more than 6 weeks) than in short-term use (up to 6 weeks).  In 
paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between 
patients receiving fluticasone furoate and patients receiving placebo. 
 
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for 
prolonged periods. 
 
4.9 Overdose 
 
In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over 
three days with no adverse systemic effects observed (see section 5.2). 
Acute overdose is unlikely to require any therapy other than observation. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Corticosteroids. ATC code: R01AD12 
 
Fluticasone furoate is a synthetic trifluorinated corticosteroid that possesses a very high affinity for the 
glucocorticoid receptor and has a potent anti-inflammatory action. 
 
Clinical experience: 
Seasonal Allergic Rhinitis in adults and adolescents 
Compared with placebo, fluticasone furoate nasal spray 110 micrograms once daily significantly 
improved nasal symptoms (comprising rhinorrhoea, nasal congestion, sneezing and nasal itching) and 
ocular symptoms (comprising itching/burning, tearing/watering and redness of the eyes) in all 4 
studies. Efficacy was maintained over the full 24-hours dosing period with once daily administration. 
 
Onset of therapeutic benefit was observed as early as 8 hours after initial administration, with further 
improvement observed for several days afterwards.   
Fluticasone furoate nasal spray significantly improved the patients’ perception of overall response to 
therapy, and the patients’ disease-related quality of life (Rhinoconjunctivitis Quality of Life 
Questionnaire – RQLQ), in all 4 studies. 
 
Perennial Allergic Rhinitis in adults and adolescents: 
Fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms as 
well as patients’ perception of overall response to therapy compared to placebo in three studies.  
Fluticasone furoate nasal spray 110 micrograms once daily significantly improved ocular symptoms as 
well as improving patients’ disease-related quality of life (RQLQ) compared to placebo in one study. 
Efficacy was maintained over the full 24-hour dosing period with once daily administration.  
 
Seasonal and perennial allergic rhinitis in children: 
The paediatric posology is based on assessment of the efficacy data across the allergic rhinitis 
population in children. 
In seasonal allergic rhinitis, fluticasone furoate nasal spray 110 micrograms once daily was effective 
but no significant differences were observed between fluticasone furoate nasal spray 55 micrograms 
once daily and placebo on any endpoint. 
In perennial allergic rhinitis, fluticasone furoate nasal spray 55 micrograms once daily exhibited a 
more consistent efficacy profile than fluticasone furoate nasal spray 110 micrograms once daily over 4 
weeks’ treatment. Post-hoc analysis over 6 and 12 weeks in the same study, as well as 6-week HPA 
axis safety study, supported the efficacy of fluticasone furoate nasal spray 110 micrograms once daily. 



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A 6-week study that assessed the effect of fluticasone furoate nasal spray 110 micrograms once daily 
on adrenal function in children aged 2 to 11 years showed that there was no significant effect on 24-
hour serum cortisol profiles, compared with placebo. 
Results from a placebo-controlled knemometry study of fluticasone furoate nasal spray 
110 micrograms once daily revealed no clinically relevant effects on short-term lower leg growth rate 
in children (6 to 11 years). 
 
Seasonal and perennial allergic rhinitis in children (under 6 years): 
Safety and efficacy studies were performed in a total of 271 patients from 2 to 5 years of age in both 
seasonal and perennial allergic rhinitis, of whom 176 were exposed to fluticasone furoate. 
 Safety and efficacy in this group has not been well established. 
 
5.2 Pharmacokinetic properties 
 
Absorption: Fluticasone furoate undergoes incomplete absorption and extensive first-pass metabolism 
in the liver and gut resulting in negligible systemic exposure. The intranasal dosing of 110 micrograms 
once daily does not typically result in measurable plasma concentrations (<10 pg/ml). The absolute 
bioavailability for intranasal fluticasone furoate is 0.50 %, such that less than 1 microgram of 
fluticasone furoate would be systemically available after administration of 110 micrograms (see 
section 4.9). 
 
Distribution: The plasma protein binding of fluticasone furoate is greater than 99 %. Fluticasone 
furoate is widely distributed with volume of distribution at steady-state of, on average, 608 l.  
 
Metabolism: Fluticasone furoate is rapidly cleared (total plasma clearance of 58.7 l/h) from systemic 
circulation principally by hepatic metabolism to an inactive 17β-carboxylic metabolite (GW694301X), 
by the cytochrome P450 enzyme CYP3A4. The principal route of metabolism was hydrolysis of the S-
fluoromethyl carbothioate function to form the 17β-carboxylic acid metabolite. In vivo studies have 
revealed no evidence of cleavage of the furoate moiety to form fluticasone. 
 
Elimination: Elimination was primarily via the faecal route following oral and intravenous 
administration indicative of excretion of fluticasone furoate and its metabolites via the bile. Following 
intravenous administration, the elimination phase half-life averaged 15.1 hours. Urinary excretion 
accounted for approximately 1 % and 2 % of the orally and intravenously administered dose, 
respectively. 
 
Children:  
In the majority of patients fluticasone furoate is not quantifiable (< 10 pg/ml) following intranasal 
dosing of 110 micrograms once daily. Quantifiable levels were observed in 15.1 % of paediatric 
patients following intranasal dosing of 110 micrograms once daily and only 6.8 % of paediatric 
patients following 55 micrograms once daily.  There was no evidence for higher quantifiable levels of 
fluticasone furoate in younger children (less than 6 years of age). Median fluticasone furoate 
concentrations in those subjects with quantifiable levels at 55 micrograms were 18.4 pg/ml and 
18.9 pg/ml for 2-5 yrs and 6-11 yrs, respectively. At 110 micrograms, median concentrations in those 
subjects with quantifiable levels were 14.3 pg/ml and 14.4 pg/ml for 2-5 yrs and 6-11 yrs, respectively. 
The values are similar to those seen in adults (12+) where median concentrations in those subjects 
with quantifiable levels were 15.4 pg/ml and 21.8 pg/ml at 55 micrograms and 110 micrograms, 
respectively. 
 
Elderly: 
Only a small number of elderly patients (≥ 65 years, n=23/872; 2.6 %) provided pharmacokinetic data. 
There was no evidence for a higher incidence of patients with quantifiable fluticasone furoate 
concentrations in the elderly, when compared with the younger patients. 
 
Renal Impairment:  



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Fluticasone furoate is not detectable in urine from healthy volunteers after intranasal dosing. Less than 
1 % of dose-related material is excreted in urine and therefore renal impairment would not be expected 
to affect the pharmacokinetics of fluticasone furoate. 
 
Hepatic Impairment:  
There are no data with intranasal fluticasone furoate in patients with hepatic impairment. A study of a 
single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic 
impairment resulted in increased Cmax (42 %) and AUC(0-∞) (172 %) and a modest (on average 
23 %) decrease in cortisol levels in patients compared to healthy subjects. From this study the average 
predicted exposure of 110 micrograms of intranasal fluticasone furoate in patients with moderate 
hepatic impairment would not be expected to result in suppression of cortisol. Therefore moderate 
hepatic impairment is not predicted to result in a clinically relevant effect for the normal adult dose. 
There are no data in patients with severe hepatic impairment. The exposure of fluticasone furoate is 
likely to be further increased in such patients. 
 
5.3 Preclinical safety data 
 
Findings in general toxicology studies were similar to those observed with other glucocorticoids and 
are associated with exaggerated pharmacological activity. These findings are not likely to be relevant 
for humans given recommended nasal doses which results in minimal systemic exposure. No 
genotoxic effects of fluticasone furoate have been observed in conventional genotoxicity tests. Further, 
there were no treatment-related increases in the incidence of tumours in two year inhalation studies in 
rats and mice. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Glucose anhydrous 
Dispersible cellulose 
Polysorbate 80 
Benzalkonium chloride 
Disodium edetate 
Purified water 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years 
In-use shelf life: 2 months 
 
6.4 Special precautions for storage 
 
Do not refrigerate or freeze. 
 
6.5 Nature and contents of container 
 
Alisade nasal spray is a predominantly off-white plastic device with a dose indicator window, light 
blue side actuated lever and lid which contains a stopper. The plastic device contains the nasal spray 
suspension within a Type I amber bottle (glass) fitted with a metering spray pump.  
 
The medicinal product is available in three pack sizes: 30, 60 and 120 sprays. 



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Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford, Middlesex, UB6 0NN 
United Kingdom 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/474/001 
EU/1/08/474/002 
EU/1/08/474/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
06/10/2008 
 
 
10. DATE OF REVISION OF THE TEXT 
 
{MM/YYYY} 
 
Detailed information on this medicine is available on the European Medicines Agency (EMEA) 
website: 
http://www.emea.europa.eu/ 
 
 



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9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURING AUTHORISATION HOLDER 
RESPONSIBLE FOR BATCH RELEASE 

 
B. CONDITIONS OF THE MARKETING AUTHORISATION 

 



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A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE 

 
 
Name and address of the manufacturer responsible for batch release 
 
Glaxo Operations UK, Ltd,(trading as Glaxo Wellcome Operations) 
Harmire Road 
Barnard Castle 
County Durham 
DL12 8DT 
 
Glaxo Wellcome S.A. 
Avenida de Extremadura 3 
09400 Aranda de Duero 
Burgos 
Spain 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
Medicinal product subject to medical prescription. 
 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 
• OTHER CONDITIONS 
 
Pharmacovigilance system 
 
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the 
Marketing Authorisation, is in place and functioning before and whilst the product is on the market. 
 
Risk Management plan 
 
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in 
the Pharmacovigilance Plan, as agreed in version GM2006/00247/05 of the Risk Management Plan 
(RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent 
updates of the RMP agreed by the CHMP. 
 
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the 
updated RMP should be submitted at the same time as the next Periodic Safety Update Report 
(PSUR). 
 
In addition, an updated RMP should be submitted 

• When new information is received that may impact on the current Safety Specification, 
Pharmacovigilance Plan or risk minimisation activities 

• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being 
reached 



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• At the request of the EMEA  
 

PSURs 
The PSUR cycle of Alisade will correspond to the one attributed to the cross-referred product, 
Avamys, until otherwise specified. 



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12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



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13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING THE IMMEDIATE 
PACKAGING> 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Alisade 27.5 micrograms/spray nasal spray suspension  
Fluticasone furoate 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each spray delivers 27.5 micrograms of fluticasone furoate 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: Glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, 
disodium edetate, purified water 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Nasal spray, suspension 
1 bottle - 30 sprays 
1 bottle - 60 sprays 
1 bottle - 120 sprays 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Shake well before use 
Read the package leaflet before use. 
Nasal use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP {MM/YYYY] 
In-use shelf life: 2 months 
 
 



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9. SPECIAL STORAGE CONDITIONS 
 
Do not refrigerate or freeze 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Glaxo Group Ltd 
Greenford, Middlesex, UB6 0NN 
United Kingdom 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/474/001 
EU/1/08/474/002 
EU/1/08/474/003 
 
 
13. BATCH NUMBER 
 
LOT {Number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
alisade  



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
INTRANASAL SPRAY/DEVICE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Alisade 27.5 micrograms/spray nasal spray suspension 
Fluticasone fuorate 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use 
 
 
3. EXPIRY DATE 
 
EXP {MM/YYYY] 
 
 
4. BATCH NUMBER 
 
LOT {Number} 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
30 sprays 
60 sprays 
120 sprays 
 
6. OTHER 
 



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B. PACKAGE LEAFLET 



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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Alisade 27.5 micrograms per spray nasal spray suspension 
Fluticasone furoate 

 
Read all of this leaflet carefully before you start taking this medicine. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you. Never pass it on to others. It may harm them, even if 

their symptoms seem the same as yours. 
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 

tell your doctor or pharmacist. 
 
 
In this leaflet:  
1. What Alisade is and what it is used for 
2. Before you use Alisade  
3. How to use Alisade  
4. Possible side effects 
5. How to store Alisade  
6. Further information 

Step-by-step guide to using the nasal spray 
 
 
1. WHAT ALISADE IS AND WHAT IT IS USED FOR 
 
Alisade nasal spray is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, 
sneezing and watery, itchy or red eyes, in adults and children aged 6 years and over. 
 
Allergy symptoms can occur at specific times of the year and be caused by allergy to pollen from grass 
or trees (hayfever), or they can occur all year round and be caused by allergy to animals, house-dust 
mites or moulds.  
 
Alisade belongs to a group of medicines called glucocorticoids. 
Alisade works to decrease inflammation caused by allergy (rhinitis).  
 
 
2. BEFORE YOU USE ALISADE 
 
Do not use Alisade: 
If you are allergic (hypersensitive) to fluticasone furoate or any of the other ingredients of Alisade. 
 
Take special care with Alisade: 
If you have any liver problems, tell your doctor or pharmacist. Your doctor may adjust your dose of 
Alisade. 
 
Taking nasal glucocorticoids (such as Alisade): 
• may when taken for a long time cause children to grow more slowly. The doctor will check your 

child’s height regularly, and make sure he or she is taking the lowest possible effective dose. 
• may cause eye conditions such as glaucoma (increase in pressure in the eye) or cataracts 

(clouding of the lens of the eye).  Tell your doctor if you had these conditions in the past, or if 
you notice any change in your vision while you are taking Alisade 

 
Taking other medicines 
Tell your doctor if you are taking, or have recently taken, any other medicines, including those bought 
without a prescription.  



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It is especially important to tell your doctor if you are taking, or have recently taken any of the 
following medicines: 
• steroid tablets or injected steroids 
• steroid creams 
• medicines for asthma 
• ritonavir, used to treat HIV  
• ketoconazole, used to treat fungal infections  
 
Your doctor will assess whether you should take Alisade with these medicines. 
 
Pregnancy and breast-feeding 
Ask your doctor for advice before taking any medicine. 
 
Do not use Alisade if you are pregnant, or planning to become pregnant, unless your doctor or 
pharmacist tells you to. 
 
Do not use Alisade if you are breast feeding unless your doctor or pharmacist tells you to. 
 
Driving and using machines 
Alisade is unlikely to affect your ability to drive and use machines. 
 
Important information about some of the ingredients of Alisade 
Alisade contains benzalkonium chloride. In some patients this can cause irritation in the inside of the 
nose. Tell your doctor or pharmacist if you feel discomfort when using the spray. 
 
 
3. HOW TO USE ALISADE  
 
Always use Alisade exactly as your doctor has told you. You should check with your doctor if you are 
not sure. 
 
Alisade has virtually no taste or smell. It is sprayed into the nose as a fine mist. Be careful not to get 
any spray into your eyes. If you do, rinse your eyes with water. 
 
When to use Alisade 
• Use once a day 
• Use at the same time each day. 
This will treat your symptoms throughout the day and night. 
 
How long Alisade takes to work 
Some people will not feel the full effects until several days after first using Alisade. However, it is 
usually effective within 8 to 24 hours of use. 
 
How much to use 

Adults and children 12 years and over 
• The usual starting dose is 2 sprays in each nostril once every day.  
• Once symptoms are controlled you may be able to decrease your dose to 1 spray in each nostril, 

once every day. 
 



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Children 6 to 11 years  
• The usual starting dose is 1 spray in each nostril once a day.  
• If symptoms are very bad your doctor may increase the dose to 2 sprays in each nostril once 

every day until the symptoms are under control. It may then be possible for the dose to be 
reduced to 1 spray in each nostril once every day. 

• Do not use in children under 6 years old. 

How to use the nasal spray 
There is a step-by-step guide to using the nasal spray after Section 6 of this leaflet. Follow the guide 
carefully to get full benefit from using Alisade 

See Step-by-step guide to using the nasal spray, after Section 6. 
 
 
If you use more Alisade than you should 
Talk to your doctor or pharmacist. 
 
If you forget to use AlisadeIf you miss a dose, take it when you remember. 
 
If it is nearly the time for your next dose, wait until then. Do not take a double dose to make up for a 
forgotten dose. 
 
If you have any further questions on the use of this product, or if you have any discomfort using the 
nasal spray ask your doctor or pharmacist. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Alisade can cause side effects, although not everybody gets them.  
 
Allergic reactions: get a doctor’s help straight away 
 
Allergic reactions to Alisade are rare and affect less than 1 person in 1,000. In a small number of 
people, allergic reactions can develop into a more serious, even life-threatening problem if not treated. 
Symptoms include: 

- becoming very wheezy, coughing or having difficulty with breathing 
- suddenly feeling weak or light-headed (which may lead to collapse or loss of consciousness) 
- swelling around the face 
- skin rashes or redness. 

In many cases, these symptoms will be signs of less serious side effects. But you must be aware that 
they are potentially serious — so, if you notice any of these symptoms: 

See a doctor as soon as possible. 
 
Very common side effects (These can affect more than 1 person in 10)  
• Nosebleeds (generally minor), particularly if you use Alisade for more than 6 weeks continuously. 
 
Common side effects (These can affect less than 1 person in 10 and more than 1 person in 100) 
• Irritation or discomfort in the inside of the nose – you may also get streaks of blood when you blow 

your nose. This may be due to nasal ulceration. 
 
Nasal corticosteroids can affect the normal production of hormones in your body, particularly if you 
use high doses for a long time. In children this side effect can cause them to grow more slowly than 
others.  
 



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If you get side effects 
If any of the side effects gets serious or troublesome, or if you notice any side effects not 

listed in this leaflet: Tell your doctor or pharmacist. 
 
 
5. HOW TO STORE ALISADE 
 
Keep out of the reach and sight of children. 
 
It is best to store your Alisade nasal spray upright. Always keep the cap on. 
 
Do not use Alisade after the expiry date which is stated on the label and carton. The expiry date refers 
to the last day of the month. Alisade nasal spray should be used within 2 months after first opening. 
 
Do not refrigerate or freeze. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. FURTHER INFORMATION 
 
What Alisade contains 
The active substance is fluticasone furoate. Each spray delivers 27.5 micrograms of fluticasone 
furoate. 
The other ingredients are glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium 
chloride, disodium edetate, purified water. 
 
What Alisade looks like and contents of the pack 
The medicine is a white nasal spray suspension contained in an amber glass bottle, fitted with a pump.  
The bottle is in an off-white plastic casing with a light blue cap and side-actuated lever. The casing has 
a window for viewing the bottle contents. Alisade is available in pack sizes 30, 60 and 120 sprays. 
 
Marketing authorisation holder 
Marketing authorisation: 
Glaxo Group Ltd 
Greenford, Middlesex, UB6 0NN 
United Kingdom 
 
Manufacturer: 
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) 
Harmire Road 
Barnard Castle 
County Durham 
DL12 8DT 
United Kingdom 
 
Glaxo Wellcome S.A. 
Avenida de Extremadura 3 
09400 Aranda de Duero 
Burgos 
Spain 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 



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België/Belgique/Belgien 
GlaxoSmithKline s.a./n.v. 
Tél/Tel: + 32 (0)2 656 21 11 

Luxembourg/Luxemburg 
GlaxoSmithKline s.a./n.v. 
Belgique/Belgien 
Tél/Tel: + 32 (0)2 656 21 11 
 

България 
ГлаксоСмитКлайн ЕООД 
Teл.: + 359 2 953 10 34 
 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36 1 225 5300 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 222 001 111 
gsk.czmail@gsk.com 
 

Malta 
GlaxoSmithKline Malta 
Tel: + 356 21 238131 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
dk-info@gsk.com 
 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 6938100 
nlinfo@gsk.com 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel.: + 49 (0)89 36044 8701 
produkt.info@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 

Eesti 
GlaxoSmithKline Eesti OÜ 
Tel: + 372 6676 900 
estonia@gsk.com 
 

Österreich 
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com 
 

Ελλάδα 
GlaxoSmithKline A.E.B.E. 
Τηλ: + 30 210 68 82 100 
 

Polska 
GSK Commercial Sp. z o.o. 
Tel.: + 48 (0)22 576 9000 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 902 202 700 
es-ci@gsk.com 
 

Portugal 
GlaxoSmithKline – Produtos Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com  
 

France 
Laboratoire GlaxoSmithKline 
Tél.: + 33 (0)1 39 17 84 44 
diam@gsk.com 
 

România 
GlaxoSmithKline (GSK) S.R.L.  
Tel: + 4021 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0)1 4955000 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0)1 280 25 00 
medical.x.si@gsk.com 
 
 

Ísland 
GlaxoSmithKline ehf. 
Sími: + 354 530 3700 

Slovenská republika 
GlaxoSmithKline Slovakia s. r. o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 



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Italia 
GlaxoSmithKline S.p.A. 
Tel: + 39 (0)45 9218 111 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 (0)10 30 30 30 
Finland.tuoteinfo@gsk.com 
 

Κύπρος 
GlaxoSmithKline Cyprus Ltd 
Τηλ: + 357 22 39 70 00 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com 
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 67312687 
lv-epasts@gsk.com 

United Kingdom 
GlaxoSmithKline UK 
Tel: + 44 (0)800 221441 
customercontactuk@gsk.com  
  

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com 
 

 

 
This leaflet was last approved in {MM/YYYY}. 
Detailed information on this medicine is available on the European Medicines Agency (EMEA) 
website: 
http://www.emea.europa.eu/ 



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STEP-BY-STEP GUIDE TO USING THE NASAL SPRAY 
 
 
What the nasal spray looks like 

The nasal spray comes in a brown glass bottle inside a plastic casing - see picture a. It will contain 
either 30, 60 or 120 sprays, depending on the pack size that has been prescribed for you. 
 

 
 
The window in the plastic casing lets you see how much Alisade is left in the bottle. You will be able 
to see the liquid level for a new 30 or 60 spray bottle, but not in a new 120 spray bottle because the 
liquid level is above the window.  

Six important things you need to know about using the nasal spray 

• Alisade comes in a brown bottle. If you need to check how much is left hold the nasal spray 
upright against a bright light. You will then be able to see the level through the window.   

• When you first use the nasal spray you will need to shake it vigorously with the cap on for 
about 10 seconds. This is important as Alisade is a thick suspension that becomes liquid when 
you shake it well - see picture b. It will only spray when it becomes liquid. 

 

 



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• The mist-release button must be pressed firmly all the way in, to release the mist through the 
nozzle - see picture c.  

 

 
• If you have difficulty pressing the button with your thumb, you can use two hands – see picture 

d 
 

 
 

• Always keep the cap on the nasal spray when you are not using it. The cap keeps the dust out, 
seals in the pressure and stops the nozzle from blocking up. When the cap is in place the mist-
release button cannot be pressed accidentally. 

• Never use a pin or anything sharp to clear the nozzle. It will damage the nasal spray. 

 

Preparing the nasal spray for use 
 
You must prepare the nasal spray: 
 
• before you use it for the first time 

• if you have left the cap off 



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Preparing the nasal spray helps to make sure you always get the full dose of medicine. Follow these 
steps: 

1 Shake the nasal spray vigorously with the cap on for about 10 seconds.   

2 Remove the cap by squeezing firmly on the sides of the cap with your thumb and forefinger– 
see picture e.  

 
 
3 Hold the nasal spray upright, then tilt and point the nozzle away from you.  

4 Press the button firmly all the way in. Do this at least 6 times until it releases a fine mist of 
spray into the air  – see picture f. 

 
 
The nasal spray is now ready for use. 

 
Using the nasal spray 

1 Shake the nasal spray vigorously.  

2 Remove the cap.  

3 Blow your nose to clear your nostrils, then tilt your head forward a little bit. 

4 Place the nozzle in one of your nostrils – see picture g.  Point the end of the nozzle slightly 
outwards, away from the centre ridge of your nose. This helps to get the medicine to the correct part of 
your nose. 

5 Press the button firmly all the way in, while you breathe in through your nose – see picture 
h.  

 

 

 



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6 Take the nozzle out and breathe out through your mouth. 

7 If your dose is two sprays in each nostril repeat steps 4 to 6. 

8 Repeat steps 4 to 7 to treat the other nostril. 

9 Replace the cap on the nasal spray. 

 
Cleaning the nasal spray 

After each use: 

1 Wipe the nozzle and inside of the cap with a clean, dry tissue – see pictures i and j.  

 
2 Do not use water to clean it.  

3 Never use a pin or anything sharp on the nozzle.  

4 Always replace the cap once you have finished. 

 If the nasal spray does not seem to be working: 

• Check you still have medicine left. Look at the level through the window. If the level is very 
low there may not be enough left to work the nasal spray. 

• Check the nasal spray for damage  

• If you think the nozzle may be blocked, do not use a pin or anything sharp to clear it.  

• Try to reset it by following the instructions under ‘Preparing the nasal spray for use’.  

If it is still not working, or if it produces a jet of liquid, take the nasal spray back to the 
pharmacy to get advice. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OF THE MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET