Adeflo MDI Adverse Reactions

As Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler contains Salmeterol and Fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds.
Adverse events which have been associated with Salmeterol/Fluticasone propionate are given as follows, listed by system organ class and frequency. Frequencies are defined as: very common (1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (<1/10.000) and not known (cannot be estimated from the available data). Frequencies were derived from clinical trial data. The incidence in placebo was not taken into account. (See table.)

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Description of selected adverse reactions: The pharmacological side effects of beta-2-agonist treatment, such as tremor, palpitations and headache, have been reported. but tend to be transient and reduce with regular therapy. Due to the Fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after using the product. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Salmeterol and Fluticasone Propionate Pressurized Inhalation CFC Free inhaler.
Paediatric population: Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression and growth retardation in children and adolescents. Children may also experience anxiety, sleep disorders and behavioural changes, Including hyperactivity and irritability.