AZELASTINE HYDROCHLORIDE/FLUTICASONE PROPIONATE

Posology For full therapeutic benefit regular usage is essential. Contact with the eyes should be avoided. Adults and adolescents (12 years and older) One actuation in each nostril twice daily (morning and evening). Children below 12 years Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray is not recommended for use in children below 12 years of age as safety and efficacy has not been established in this age group.

Elderly No dose adjustment is required in this population. Renal and hepatic impairment There are no data in patients with renal and hepatic impairment. Duration of treatment Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray is suitable for long- term use.

The duration of treatment should correspond to the period of allergenic exposure. Method of administration Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray is for nasal use only.

Instruction for use Preparing the spray:

The bottle should be shaken gently before use for about 5 seconds by tilting it upwards and downwards and the protective cap be removed afterwards. Prior to first use Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray must be primed by pressing down and releasing the pump 6 times.

If Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray has not been used for more than 7 days it must be re-primed once. The bottle should be shaken gently before use for about 5 seconds by tilting it upwards and downwards, the protective cap removed afterwards and the pump has to be pressed down and released once.

Using the spray:

After blowing the nose the suspension is to be sprayed once into each nostril keeping the head tilted downward (see figure). After use the spray tip is to be wiped and the protective cap to be replaced.

Commonly, dysgeusia, a substance-specific unpleasant taste, may be experienced after administration (often due to incorrect method of application, namely tilting the head too far backwards during administration). Adverse reactions are listed below by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000). Not known (cannot be estimated from the available data). 7) * A very small number of spontaneous reports have been identified following prolonged treatment with intranasal fluticasone propionate.

** Nasal septal perforation has been reported following the use of intranasal corticosteroids. 4). Growth retardation has been reported in children receiving nasal corticosteroids. 4). In rare cases osteoporosis was observed, if nasal glucocorticoids were administered long-term.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.

5). Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses 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).

Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray undergoes extensive first-pass metabolism, therefore the systemic exposure of intranasal fluticasone propionate in patients with severe liver disease is likely to be increased.

This may result in a higher frequency of systemic adverse events. Caution is advised when treating these patients. 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. In general the dose of intranasal fluticasone formulations should be reduced to the lowest dose at which effective control of the symptoms of rhinitis is maintained.

2) have not been tested for Azelastine Hydrochloride/Fluticasone Propionate . 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 nasal corticosteroids at licensed doses. Since these medications are also given in adolescents it is recommended that the growth of adolescents receiving prolonged treatment with nasal corticosteroids is regularly monitored, too.

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

Close monitoring is warranted in patients with a change in vision or with a history of increased ocular pressure, glaucoma and/or cataracts. If there is any reason to believe that adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray.

In patients who have tuberculosis, any type of untreated infection, or have had a recent surgical operation or injury to the nose or mouth, the possible benefits of the treatment with Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray should be weighed against possible risk.

Infections of the nasal airways should be treated with antibacterial or antimycotical therapy, but do not constitute a specific contraindication to treatment with Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray. Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray contains benzalkonium chloride.

Long term use may cause oedema of the nasal mucosa.

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