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National Drug Formulary

SERETIDE 50/500 ACCUHALER 50 MCG/500 MCG [SIN11032P]

Active ingredients: FLUTICASONE PROPIONATE | SALMETEROL XINAFOATE EQV SALMETEROL

View product's general information
Last updated on 9 October 2026

Product Info

SERETIDE 50/500 ACCUHALER 50 MCG/500 MCG

[SIN11032P]

Product information

Active Ingredient and Strength

FLUTICASONE PROPIONATE - 500 MCG/INHALATION
SALMETEROL XINAFOATE EQV SALMETEROL - 50 MCG/INHALATION

Dosage Form

POWDER, METERED

Manufacturer and Country

GLAXOSMITHKLINE LLC - UNITED STATES
GLAXO WELLCOME PRODUCTION - FRANCE

Registration Number

SIN11032P

Licence Holder

GLAXOSMITHKLINE PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

R03AK06

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

Indications

Pharmaceutical form: Inhalation powder.

Seretide is indicated in the regular treatment of asthma where use of a combination (bronchodilator and inhaled corticosteroid) has been found to be appropriate.

Seretide is indicated for the symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Dosing

Dosage and Administration

Seretide Accuhaler is for oral inhalation only.

Patients should be made aware that Seretide Accuhaler 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.

Asthma

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.

If a patient is inadequately controlled on inhaled corticosteroid therapy alone, substitution with Seretide at a therapeutically equivalent corticosteroid dose may result in an improvement in asthma control.

Recommended Doses:

Adults and adolescents 12 years and older:

One inhalation (50 mcg salmeterol and 100 mcg fluticasone propionate) twice daily.

or

One inhalation (50 mcg salmeterol and 250 mcg fluticasone propionate) twice daily.

or

One inhalation (50 mcg salmeterol and 500 mcg fluticasone propionate) twice daily.

Children 4 years and older:

One inhalation (50 mcg salmeterol and 100 mcg fluticasone propionate) twice daily.

There are no data available for use of Seretide in children aged under 4 years.

Chronic Obstructive Pulmonary Disease (COPD)

For adult patients, the recommended dose is one inhalation (50 mcg salmeterol and 500 mcg fluticasone propionate) twice daily.

Special patient groups

There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment.

Contraindications

Contraindications

Seretide is contraindicated in patients with a history of hypersensitivity to any of the ingredients.

Seretide Accuhaler is contraindicated in patients with severe milk protein allergy.