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HSA Product

FLUTIFORM® PRESSURISED INHALATION, SUSPENSION 250 MICROGRAM/10 MICROGRAM PER ACTUATION

Product approved by Health Sciences Authority (SG)

Basic Information

FLUTIFORM® PRESSURISED INHALATION, SUSPENSION 250 MICROGRAM/10 MICROGRAM PER ACTUATION

AEROSOL, METERED

Regulatory Information

SIN14551P

May 19, 2014

Prescription Only

Therapeutic

RESPIRATORY (INHALATION)

August 10, 2023

May 30, 2025

XR03AK07

Company Information

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

Active Ingredients

Fluticasone Propionate

Strength: 250 mcg/actuation

Formoterol Fumarate Dihydrate

Strength: 10 mcg/actuation

Detailed Information

Contraindications

**4.3 Contraindications** Hypersensitivity to any of the active substances or to any of the excipients (see section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

Indication Information

**4.1 Therapeutic indications** This fixed-dose combination of fluticasone propionate and formoterol fumarate ( _**Flutiform**_ ® inhaler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate: - For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β2 agonist. Or - For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist. _**Flutiform**_ ® 50 microgram/5 microgram is indicated in adults, adolescents and children aged 5 years and above. _**Flutiform**_ ® 125 microgram/5 microgram is indicated in adults and adolescents aged 12 years and above. _**Flutiform**_ ® 250 microgram/10 microgram inhaler is indicated in adults only.

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