FLUTICASONE PROPIONATE ALISSA

Fluticasone propionate Alissa is for intranasal use only. Avoid eye contact. Posology Adults and adolescents (aged 12 years and older) The recommended dose is two sprays into each nostril once a day, preferably in the morning. In some cases two sprays into each nostril twice daily may be required.

The maximum daily dose is four sprays per nostril. Paediatric population Children aged 4 to 12 years The recommended dose is one spray into each nostril once a day, preferably in the morning. In some cases one spray into each nostril twice daily may be required.

The maximum daily dose is two sprays per nostril. Children under 4 years of age Fluticasone propionate Alissa should not be used in children aged under 4 years because safety and efficacy have not been established. Elderly population The normal adult dosage is applicable.

For full therapeutic benefit regular usage is essential. The absence of an immediate effect should be explained to the patient, as maximum relief may not be obtained until after 3 to 4 days of treatment. Method of administration Shake before use.

When using a new bottle, prepare it by pumping 5 times in the air. If the bottle has not been used for a week, it should be prepared by pumping once. To use the spray, place the nozzle in one nostril whilst the other is closed, ensuring the nozzle is aimed away from the nasal septum.

Spray into the nostril whilst breathing in and then breathe out through the mouth. After usage, the nose piece and inside of the protector cap should be cleaned with a dry and clean tissue. Once a week the protection cap and the actuator need to be cleaned with water, by immersing them in lukewarm water and leaving to dry at room temperature.

The actuator should not be removed.

The most common side effect experienced after administration is epistaxis; however most cases are non-serious in nature and self-limiting. The most serious events are anaphylactic/anaphylactoid reactions, bronchospasm and nasal septal perforation.

Very common and common events were generally determined from clinical trial data. Very rare events were generally determined from spontaneous post- marketing data. In assigning adverse event frequencies, the background rates in placebo groups were not taken into account.

4) Respiratory, thoracic and mediastinal disorders Epistaxis Nasal dryness, nasal irritation, throat dryness, throat irritation Nasal septum perforation** Nasal ulcer * Adverse events following long-term treatment spontaneously collected in post-marketing experience.

** Class effect: reported following the use of intranasal corticosteroids. 4). 4). 4). 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 Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Maximum relief may not be obtained until after 3 to 4 days of treatment. Local infections: infections of the nasal airways should be appropriately treated but do not constitute a specific contra-indication to treatment with intranasal fluticasone propionate.

Although Fluticasone propionate Alissa will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may in certain instances necessitate appropriate additional therapy. Treatment with higher than recommended doses of nasal corticosteroids may result in clinically significant adrenal suppression.

1 for data on intranasal fluticasone propionate). During post-marketing use, clinically significant drug interactions were described in patients using both fluticasone propionate and ritonavir. Concomitant use resulted in systemic corticosteroid side effects including Cushing’s syndrome and adrenal suppression.

5). effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression and more rarely, cataract, glaucoma, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (especially in children).

Growth retardation has been reported in children receiving some nasal corticosteroids at licensed doses (see paediatric information). 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.

Fluticasone propionate Alissa contains 20 microgram of benzalkonium chloride per dose. Long-term use may cause oedema of the nasal mucosa. Paediatric population Potential systemic effects may include growth retardation in adolescents and depression or aggression.

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