AZELASTINE HCL/FLUTICASONE PROPIONATE VYGORIS

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.

Instructions 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 reprimed once by pressing down and releasing the pump.

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.

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/Fluticasone. As with all intranasal corticosteroids, the total systemic burden of corticosteroids should be considered whenever other forms of corticosteroid treatment are prescribed concurrently.

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