Fluticasone

Relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient.

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.

1.

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion itchy, watery eyes itchy nose runny nose sneezing

Directions read the Quick Start Guide for how to: prime the bottle use the spray clean the spray nozzle shake gently before each use use this product only once a day do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER Week 1- use 2 sprays in each nostril once daily Week 2 through 6 months- use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms After 6 months of daily use – ask your doctor if you can keep using CHILDREN 4 TO 11 YEARS OF AGE the growth rate of some children may be slower while using this product.

Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. an adult should supervise use use 1 spray in each nostril once daily CHILDREN UNDER 4 YEARS OF AGE do not use

Warnings Only for use in the nose. Do not spray into your eyes or mouth.

Do not use in children under 4 years of age to treat asthma if you have an injury or surgery to your nose that is not fully healed if you have ever had an allergic reaction to this product or any of the ingredients