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National Drug Formulary

RESPIRO AEROSOL INHALER 25 MCG/125 MCG PER DOSE [SIN17480P]

Active ingredients: RESPIRO AEROSOL INHALER 25 MCG/125 MCG PER DOSE

View product's general information
Last updated 24 April 2026

Product Info

RESPIRO AEROSOL INHALER 25 MCG/125 MCG PER DOSE

[SIN17480P]

Product information

Active Ingredient and Strength

FLUTICASONE PROPIONATE - 125 MCG/DOSE
SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL - 25 MCG/DOSE

Dosage Form

AEROSOL, METERED

Manufacturer and Country

DEVA HOLDING A.Ş. - TURKEY

Registration Number

SIN17480P

Licence Holder

GOLDPLUS UNIVERSAL PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

R03AK06

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

4.1 Therapeutic indications

Salmeterol/Fluticasone propionate is indicated in the regular treatment of asthma where use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate:

  • patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short- acting β2-agonist
    or

  • patients already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist

Dosing

4.2 Posology and method of administration

Posology
Route of administration: Oral inhalation use.

Patients should be made aware that Salmeterol/Fluticasone propionate metered dose inhaler must be used regularly for optimum benefit, even when asymptomatic.

Patients should be regularly reassessed by a doctor, so that the strength of Salmeterol/Fluticasone propionate metered dose inhaler 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 a salmeterol/fluticasone propionate product containing the appropriate fluticasone propionate dosage for the severity of their disease.

Recommended Doses:
Adults and adolescents 12 years and older:

  • Two inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily.
    or

  • Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.

Paediatric population
Children <12 years:
RESPIRO is not suitable for children under the age of 12 years. For children aged 4 to <12 years, a different inhaled salmeterol/fluticasone product available in lower strength (25/50 microgram) should be used.

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

Contraindications

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.