Avamys

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ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 

  



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1. NAME OF THE MEDICINAL PRODUCT 
 

AVAMYS 27.5 micrograms/spray, nasal spray suspension 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Each spray actuation delivers 27.5 micrograms of fluticasone furoate. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Nasal spray, suspension. 

 

White suspension. 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 

 

Avamys is indicated in adults, adolescents and children (6 years and over) 

 

Avamys is indicated for the treatment of the symptoms of allergic rhinitis. 

 

4.2 Posology and method of administration 

 

Posology 

 

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. 

 

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. 



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Children under 6 years of age 

The safety and efficacy of Avamys in children under the age of 6 years has not been established. Currently 

available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made. 

 

Elderly Patients 

No dose adjustment is required in this population (see section 5.2). 

 

Renal Impairment 

No dose adjustment is required in this population (see section 5.2). 

 

Hepatic Impairment 

No dose adjustment is required in patients with hepatic impairment (see section 5.2). 

 

Method of administration 

Avamys nasal spray is for administration by the intranasal route only. 

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 listed in section 6.1. 

 

4.4 Special warnings and precautions for use 

 

Systemic corticosteroid effects 

Systemic effects of nasal corticosteroid may occur, particularly at high doses prescribed for prolonged 

periods. These effects are much less likely to occur than with oral corticosteroids and may vary in 

individual patients and between different corticosteroid preparations. Potential systemic effects may 

include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and 

adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including 

psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). 

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. 

 

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. 

 

Visual disturbance  

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with 

symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral 

to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare 



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diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic 

and topical corticosteroids. 

 

Growth retardation 

Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses. A 

reduction in growth velocity has been observed in children treated with fluticasone furoate 110 

micrograms daily for one year (see section 4.8 and section 5.1). Therefore, children should be maintained 

on the lowest possible efficacious dose which delivers adequate symptom control (see section 4.2). It is 

recommended that the growth 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). 

 

Patients on ritonavir 

Concomitant administration with ritonavir is not recommended because of the risk of increased systemic 

exposure of fluticasone furoate (see section 4.5). 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

Interaction with CYP3A inhibitors 

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, 

coadministration 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 CYP3A inhibitors 

including cobicistat-containing products as an increase in the risk of systemic side effects is expected. Co-

administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid 

side effects, in which case patients should be monitored for systemic corticosteroid side effects. 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. 

 

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 Fertility, pregnancy and lactation 

 

Pregnancy 

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. 

 

Breast-feeding 

It is unknown whether nasal administered fluticasone furoate is excreted in human breast milk. 



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Administration of fluticasone furoate to women who are breast-feeding should only be considered if the 

expected benefit to the mother is greater than any possible risk to the child. 

 

Fertility 

There are no fertility data in humans. 

 

4.7 Effects on ability to drive and use machines 

 

Avamys has no or negligible influence on the ability to drive and use machines. 

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The most commonly reported adverse reactions during treatment with fluticasone furoate are epistaxis, 

nasal ulceration and headache.  The most serious undesirable effects are rare reports of hypersensitivity 

reactions, including anaphylaxis (less than 1 case per 1000 patients). 

 

Tabulated list of adverse reactions 

 

There were over 2700 patients treated with fluticasone furoate in safety and efficacy studies for seasonal 

and perennial allergic rhinitis. Paediatric exposure to fluticasone furoate in safety and efficacy studies in 

seasonal and perennial allergic rhinitis included 243 patients 12 to <18 years, 790 patients 6 to <12 years 

and 241 patients 2 to <6 years. 

 

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; Not known (cannot be estimated from the available data). 
 

Immune system disorders 

Rare Hypersensitivity reactions including anaphylaxis, angioedema, rash, and 

urticaria. 

Nervous system disorders 

Common Headache. 

Eye disorders 

Not known Transient ocular changes (see Clinical experience), vision blurred (see also 

section 4.4) 

Respiratory, thoracic and mediastinal disorders 

Very common *Epistaxis 

Common Nasal ulceration, dyspnoea** 

Uncommon Rhinalgia, nasal discomfort (including nasal burning, nasal irritation, and 

nasal soreness), nasal dryness. 

Very rare Nasal septum perforation 

Not known Bronchospasm 

Musculoskeletal and connective tissue disorders (Children) 

Not known ***Growth retardation (see Clinical experience). 

 

Description of selected adverse reactions 

Epistaxis 

*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). 



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Systemic effects 

Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for 

prolonged periods (see section 4.4). Growth retardation has been reported in children receiving nasal 

corticosteroids. 

 

**Dyspnoea cases were reported in more than 1% of patients during clinical trials with fluticasone 

furoate; similar rates were also observed in placebo groups. 

 

Paediatric population 

The safety in children under 6 years has not been well established.  Frequency, type and severity of 

adverse reactions observed in the paediatric population are similar to those in the adult population.   

 

Epistaxis 

*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.   

 

Growth retardation 

***In a one-year clinical study assessing growth in pre-pubescent children receiving 110 micrograms of 

fluticasone furoate once daily, an average treatment difference of -0.27 cm per year in growth velocity 

was observed compared to placebo (see Clinical efficacy and safety). 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 

continued 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 listed in Appendix V. 

 

 

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 reactions observed (see section 5.2). 

Acute overdose is unlikely to require any therapy other than observation. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Mechanism of action: 

Pharmacotherapeutic group: Nasal preparations, 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 efficacy and safety: 

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. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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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. 

 

In a two-year study designed to assess the ocular safety of fluticasone furoate (110 micrograms once daily 

intranasal spray), adults and adolescents with perennial allergic rhinitis received either fluticasone furoate 

(n=367) or placebo (n=181). The primary outcomes [time to increase in posterior subcapsular opacity 

(0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III grade)) and time to 

increase in intraocular pressure (IOP; 7 mmHg from baseline)] were not statistically significant between 

the two groups. Increases in posterior subscapsular opacity (0.3 from baseline) were more frequent in 

subjects treated with fluticasone furoate 110 micrograms [14 (4%)] versus placebo [4 (2%)] and were 

transient in nature for ten subjects in the fluticasone furoate group and two subjects in the placebo group. 

Increases in IOP (7 mmHg from baseline) were more frequent in subjects treated with fluticasone furoate 

110 micrograms: 7 (2%) for fluticasone furoate 110 micrograms once daily and 1 (<1%) for placebo. 

These events were transient in nature for six subjects in the fluticasone furoate group and one placebo 

subject. At weeks 52 and 104, 95% of subjects in both treatment groups had posterior subcapsular opacity 

values within ± 0.1 of baseline values for each eye and, at week 104, ≤1% of subjects in both treatment 

groups had 0.3 increase from baseline in posterior subcapsular opacity.  At weeks 52 and 104, the 

majority of subjects (>95%) had IOP values of within ± 5mmHg of the baseline value.  Increases in 

posterior subcapsular opacity or IOP were not accompanied by any adverse events of cataracts or 

glaucoma. 

 

Paediatric population: 

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. 

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. 

 

A randomised, double-blind, parallel-group, multicenter, one-year placebo-controlled clinical growth 

study evaluated the effect of fluticasone furoate nasal spray 110 micrograms daily on growth velocity in 

474 prepubescent children (5 to 7.5 years of age for girls and 5 to 8.5 years of age for boys) with 

stadiometry. Mean growth velocity over the 52-week treatment period was lower in the patients receiving 

fluticasone furoate (5.19 cm/year) compared to placebo (5.46 cm/year). The mean treatment difference 

was -0.27 cm per year [95% CI -0.48 to -0.06]. 

 

Seasonal and perennial allergic rhinitis in children (under 6 years): 



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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. 

 

Biotransformation 

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. 

 

Paediatric population 

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 

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. 

 



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Hepatic impairment 

There are no data with intranasal fluticasone furoate in patients with hepatic impairment. Data are 

available following inhaled administration of fluticasone furoate (as fluticasone furoate or fluticasone 

furoate/vilanterol) to subjects with hepatic impairment that are also applicable for intranasal dosing.  A 

study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate 

hepatic impairment (Child-Pugh B) 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. Following 

repeat dosing of orally inhaled fluticasone furoate/vilanterol for 7 days, there was an increase in 

fluticasone furoate systemic exposure (on average two-fold as measured by AUC(0–24)) in subjects with 

moderate or severe hepatic impairment (Child-Pugh B or C) compared with healthy subjects. The increase 

in fluticasone furoate systemic exposure in subjects with moderate hepatic impairment (fluticasone 

furoate/vilanterol 200/25 micrograms) was associated with an average 34% reduction in serum cortisol 

compared with healthy subjects. There was no effect on serum cortisol in subjects with severe hepatic 

impairment (fluticasone furoate/vilanterol 100/12.5 micrograms). Based on these findings the average 

predicted exposure of 110 micrograms of intranasal fluticasone furoate in this patient population would 

not be expected to result in suppression of cortisol.  

 

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. 

Store upright.  

Always keep the cap on. 

 

 



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6.5 Nature and contents of container 

 

14.2 ml Type I or Type III amber bottle (glass) fitted with a metering spray pump. 

 

The medicinal product is available in three pack sizes: 1 bottle of 30, 60 or 120 sprays. 

 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal and other handling 

 

No special requirements for disposal. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

GlaxoSmithKline (Ireland) Limited  

12 Riverwalk, Citywest Business Campus 

Dublin 24, Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 
EU/1/07/434/001 

EU/1/07/434/002 

EU/1/07/434/003 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 11 January 2008 

Date of latest renewal: 17 December 2012 

 

 

10. DATE OF REVISION OF THE TEXT 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency:http://www.ema.europa.eu 
 

  



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ANNEX II 

 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 



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A. MANUFACTURER(S) 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 OR RESTRICTIONS REGARDING SUPPLY AND USE 
 

Medicinal product subject to medical prescription. 

 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

 

• Periodic safety update reports  

 

The requirements for submission of periodic safety update reports for this medicinal product are set out 

in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and any subsequent updates published on the European medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 
USE OF THE MEDICINAL PRODUCT 

 

• Risk Management Plan (RMP) 

 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 

updates of the RMP. 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached.  



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ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



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A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 

PACKAGING 

 

CARTON 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Avamys 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 SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXPIn-use shelf life: 2 months 

 



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9. SPECIAL STORAGE CONDITIONS 

 

Do not refrigerate or freeze 

Store upright.  

Always keep the cap on. 

 

 

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 

 

GlaxoSmithKline (Ireland) Limited  

12 Riverwalk, Citywest Business Campus 

Dublin 24, Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/07/434/001 

EU/1/07/434/002 

EU/1/07/434/003 

 

 

13. BATCH NUMBER 

 

LOT 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Avamys 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 



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PC: 

SN: 

NN: 



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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 

 

Avamys 27.5 micrograms/spray nasal spray suspension 

Fluticasone furoate 

 

 

2. METHOD OF ADMINISTRATION 

 

Read the package leaflet before use 

 

 

3. EXPIRY DATE 

 

EXP  

 

 

4. BATCH NUMBER 

 

LOT 

 

 

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 

 

Avamys 27.5 micrograms per spray nasal spray suspension 

Fluticasone furoate 

 

Read all of this leaflet carefully before you start using this medicine because it contains important 

information for you. 

- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist or nurse. 
- This medicine has been prescribed for you only. Never pass it on to others. It may harm them, even 

if their signs of illness seem the same as yours. 

- If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4 

 

 

What is in this leaflet 

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

Step-by-step guide to using the nasal spray 

 

 

1. What Avamys is and what it is used for 

 

Avamys (fluticasone furoate) belongs to a group of medicines called glucocorticoids. Avamys works to 

decrease inflammation caused by allergy (rhinitis) and therefore reduce symptoms of allergy. 

 

 

Avamys 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 to name some of the most common. 

 

 

2. What you need to know before you use Avamys 

 

Do not use Avamys: 

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

 

Warnings and precautions 

 

Children and adolescents 

Do not use in children under 6 years old. 

 

 



 21 

Taking Avamys: 

• 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 

blurred vision or other visual disturbances while you are taking Avamys.  

 

Other medicines and Avamys 

Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any other 

medicines, including medicines obtained without a prescription. 

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 or cobicistat, used to treat HIV 

• ketoconazole, used to treat fungal infections  
 

Your doctor will assess whether you should take Avamys with these medicines. Your doctor may wish to 

monitor you carefully if you are taking any of these medicines as they may increase the side effects of 

Avamys.  

 

Avamys should not be used at the same time with other nasal sprays containing steroids. 

 

Pregnancy and breast-feeding  

If you are pregnant or breast-feeding, think you may be pregnant or a planning to have a baby, ask your 

doctor for advice before taking this medicine. 

 

Do not use Avamys if you are pregnant, or planning to become pregnant, unless your doctor or 

pharmacist tells you to. 

 

Do not use Avamys if you are breast feeding unless your doctor or pharmacist tells you to. 

 

Driving and using machines 

Avamys is unlikely to affect your ability to drive and use machines. 

 

Avamys contains benzalkonium chloride 

In some patients benzalkonium chloride 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 Avamys 

 

Always use this medicine exactly as your doctor or pharmacist has told you. Don’t exceed the 

recommended dose. Check with your doctor or pharmacist if you’re not sure. 

 

When to use Avamys 

• Use once a day 

• Use at the same time each day. 
This will treat your symptoms throughout the day and night. 

 



 22 

How long Avamys takes to work 

Some people will not feel the full effects until several days after first using Avamys. 

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. 

 

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. 

How to use the nasal spray 

Avamys 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. 

 

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 Avamys 

 See Step-by-step guide to using the nasal spray, after Section 6. 
 

 

If you use more Avamys than you should 

Talk to your doctor or pharmacist. 

 

If you forget to use Avamys 

If 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 medicine, or if you have any discomfort using the 

nasal spray ask your doctor or pharmacist or nurse. 

 

 

4. Possible side effects 

 

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

 

Allergic reactions: get a doctor’s help straight away 

 

Allergic reactions to Avamys 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. 



 23 

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: 

Contact a doctor as soon as possible. 

 

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

• Nosebleeds (generally minor), particularly if you use Avamys for more than 6 weeks continuously. 
 

Common side effects (may affect up to 1 in 10 people) 

• Nasal ulceration – which may cause irritation or discomfort in your nose. You may also get streaks 
of blood when you blow your nose. 

• Headache. 

• Shortness of breath 
 

Uncommon side effects (may affect up to 1 in 100 people) 

• Pain, burning, irritation, soreness or dryness in the inside of the nose. 
 

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

• Small holes (perforations) in the ridge inside the nose that separates the nostrils. 
 

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

• Slowing of growth in children. 

• Blurred vision or temporary changes to vision with long term use. 

• Chest tightness causing difficulty in breathing. 
 

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.  

 

Reporting of side effects 

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system listed in 

Appendix V. By reporting side effects you can help provide more information on the safety of this 

medicine. 

 

 

5. How to store Avamys 

 

Keep this medicine out of the sight and reach of children. 

 

It is best to store your Avamys nasal spray upright. Always keep the cap on. 

 

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date 

refers to the last day of the month. Avamys nasal spray should be used within 2 months after first opening. 

 

Do not refrigerate or freeze. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 

away medicines you no longer use. These measures will help protect the environment. 

 

 

 

 

 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 24 

6. Contents of the pack and other information 

 

What Avamys 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 (see section 2). 

 

What Avamys 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. Avamys is available in pack sizes 30, 60 and 120 sprays. Not all 

pack sizes may be marketed. 

 

 

Marketing authorisation holder 

Marketing authorisation: 

GlaxoSmithKline (Ireland) Limited  

12 Riverwalk, Citywest Business Campus 

Dublin 24, Ireland 

 

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: 

 

België/Belgique/Belgien 

GlaxoSmithKline Pharmaceuticals s.a./n.v. 

Tél/Tel: + 32 (0)10 85 52 00 

Luxembourg/Luxemburg 

GlaxoSmithKline Pharmaceuticals s.a./n.v. 

Belgique/Belgien 

Tél/Tel: + 32 (0)10 85 52 00 

 

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 

cz.info@gsk.com 

 

Malta 

GlaxoSmithKline (Malta) Limited 

Tel: + 356 21 238131 

 



 25 

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 

 

 

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 Services Sp. z o.o. 

Tel.: + 48 (0)22 576 9000 

 

España 

GlaxoSmithKline, S.A. 

Tel: + 34 900 202 700 

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 

 

Hrvatska 

GlaxoSmithKline d.o.o. 

Tel: + 385 1 6051 999 

 

România 

GlaxoSmithKline (GSK) S.R.L. 

Tel: + 4021 3028 208 

 

Slovenija 

GlaxoSmithKline d.o.o. 

Tel: + 386 (0)1 280 25 00 

medical.x.si@gsk.com 

 

Ireland 

GlaxoSmithKline (Ireland) Limited 

Tel: + 353 (0)1 4955000 

 

Slovenská republika 

GlaxoSmithKline Slovakia s. r. o. 

Tel: + 421 (0)2 48 26 11 11 

recepcia.sk@gsk.com 

 

Ísland 

Vistor hf.  

Sími: +354 535 7000 

Suomi/Finland 

GlaxoSmithKline Oy 

Puh/Tel: + 358 (0)10 30 30 30 

Finland.tuoteinfo@gsk.com 

 

Italia 

GlaxoSmithKline S.p.A. 

Tel: + 39 (0)45 9218 111 

 

Sverige 

GlaxoSmithKline AB 

Tel: + 46 (0)8 638 93 00 

info.produkt@gsk.com 

 

Κύπρος 

GlaxoSmithKline (Cyprus) Ltd 

Τηλ: + 357 22 39 70 00 

gskcyprus@gsk.com 

United Kingdom 

GlaxoSmithKline UK Ltd 

Tel: + 44 (0)800 221441 

customercontactuk@gsk.com 

 

mailto:diam@gsk.com
mailto:diam@gsk.com


 26 

Latvija 

GlaxoSmithKline Latvia SIA 

Tel: + 371 67312687 

lv-epasts@gsk.com 

 

 

Lietuva 

GlaxoSmithKline Lietuva UAB 

Tel: + 370 5 264 90 00 

info.lt@gsk.com 

 

 

 

This leaflet was last revised in  

 

Detailed information on this medicine is available on the European Medicines Agency website: 

http://www.ema.europa.eu 



 27 

STEP-BY-STEP GUIDE TO USING THE NASAL SPRAY 

 

 

What the nasal spray looks like 

The nasal spray comes in an amber 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 Avamys 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 

• Avamys comes in an amber glass 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 Avamys is a thick suspension that becomes liquid when you shake 

it well - see picture b. It will only spray when it becomes liquid. 

 



 28 

• 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 for 5 days or the intranasal device has not been used for 30 days or more. 



 29 

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.  



 30 

 

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

7 If your dose is 2 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, don’t 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. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET