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Important safety information for fluticasone propionate in children

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  • Fluticasone propionate (FP) is contraindicated if hypersensitive to any ingredient of the preparation
  • It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.
  • It is important that the dose of inhaled corticosteroids is titrated to the lowest dose at which effective control is maintained.
  • The possibility of impaired adrenal response should always be considered in emergency situations (including surgery), and in elective situations likely to produce stress, especially in patients taking high doses for an extended duration of time. Additional corticosteroid treatment appropriate to a given clinical situation must be considered.
  • Treatment with FP should not be stopped abruptly. Patients' inhaler technique should be checked to make sure that inhaler actuation is synchronised with inspiration to ensure optimum delivery of the drug to the lungs.
  • Systemic effects may occur with any inhaled corticosteroid (ICS), particularly at high doses prescribed for long periods; these effects are much less likely than with oral corticosteroids.
  • Please refer to the full Flixotide (fluticasone propionate) prescribing information for a complete description of adverse events, special warnings and precautions associated with Flixotide use. Adverse events include:
Frequency Adverse reaction
Very Common (>1/10) Candidiasis of the mouth and throat
Common (>1/100 to <1/10) Hoarseness of voice, Pneumonia (in COPD patients), Contusions
Uncommon (>1/1000 to <1/100) Cutaneous hypersensitivity reactions.
Rare (>1/10,000 to <1/1000) Oesophageal candidiasis
Very Rare (<1/10,000) Angioedema, Respiratory symptoms, Anaphylactic reactions, Cushing's syndrome, Adrenal suppression, Growth retardation, Decreased bone mineral density, Paradoxical bronchospasm

Flixotide is a trademark of GlaxoSmithKline group of companies.
To report an Adverse Event, please contact the toll free line 0800 CALL GSK (0800 2255 475) or send an
email.