Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
AEROSOL, SPRAY
**Dosage and Administration** Seretide Evohaler is for oral inhalation only. Patients should be made aware that Seretide Evohaler must be used regularly for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Seretide they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Patients should be given the strength of Seretide containing the appropriate fluticasone propionate dosage for the severity of their disease. Recommended Doses: **Asthma** Adults and adolescents 12 years and older: - Two inhalations of 25 mcg salmeterol and 50 mcg fluticasone propionate twice daily. or - Two inhalations of 25 mcg salmeterol and 125 mcg fluticasone propionate twice daily. or - Two inhalations of 25 mcg salmeterol and 250 mcg fluticasone propionate twice daily. Children 4 years and older: - Two inhalations of 25 mcg salmeterol and 50 mcg fluticasone propionate twice daily. There are no data available for use of Seretide in children aged under 4 years. Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment.
RESPIRATORY (INHALATION)
Medical Information
**Indications** Pharmaceutical form: Inhalation aerosol. **Asthma** Seretide is indicated in the regular treatment of asthma where use of a combination product (long-acting-beta2-agonist and inhaled corticosteroid) is appropriate: - Patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting-beta2-agonist or - Patients already adequately controlled on both inhaled corticosteroids and long-acting-beta2-agonist Note: Seretide 25/50 mcg strength is not appropriate in adults with severe asthma.
**Contraindications** Seretide is contraindicated in patients with a history of hypersensitivity to any of the ingredients.
R03AK06
salmeterol and fluticasone
Manufacturer Information
GLAXOSMITHKLINE PTE LTD
GLAXO WELLCOME PRODUCTION
Glaxo Wellcome S.A.
Active Ingredients
Documents
Package Inserts
Seretide Evohaler PI.pdf
Approved: June 1, 2021