AZELAIR

Posology Adults and adolescents 12 years and older: 2 sprays in each nostril once a day. In some cases, 2 sprays in each nostril twice a day may be required. The maximum daily dose is 2 sprays in each nostril twice daily. Children 6 to 11 years: 1 spray in each nostril twice daily.

Clinical experience of up to 4 weeks duration showed good efficacy and safety in children. Longer experiences in children have not been available; however, clinical trials of up to one year duration using a double higher daily dose showed good safety in adults and adolescents.

Azelair is not recommended for use in children below 6 years of age due to a lack of data on safety and/or efficacy. Duration of treatment Azelair is suitable for long-term use. The duration of treatment should be a clinical decision considering the severity of allergic symptoms, safety and should correspond to the period of allergenic exposure.

Use longer than 4 weeks is not recommended in children 6-11 years due to lack of clinical data. Method of administration Nasal use (topical – nasal mucosa) Precautions to be taken before handling or administering the medicinal product: Spray with head held upright.

Before the first use, the pump must be primed by pressing down and releasing the pump six times. When Azelair has not been used for 3 or more days, the pump must be reprimed by pressing down and releasing the pump a sufficient number of times until a fine mist emerges.

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) which, in rare cases, may lead to nausea.

Adverse events 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) 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).

Nothing relevant

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