Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
POWDER, METERED
**Dosage and Administration** The preparation is intended for oral inhalation only. This preparation is particularly useful for patients who are unable to use metered dose inhaler properly and for patients to whom the use of inhalation aerosol causes irritation of airways. For optimum results, Beclomet Easyhaler™ inhalation powder should be used regularly. Patients who have received systemic corticosteroids should continue them for a week after having started to use Beclomet Easyhaler™ inhalation powder. Thereafter, the systemic treatment can be reduced gradually under careful monitoring. Adults: The usual maintenance dose is one to two inhalations (200 – 400 mcg) twice daily. If needed, the dose can be increased up to 1600 mcg/day divided in two to four doses and subsequently reduced when asthma has stabilized. Children 6 – 12 years: One inhalation (200 mcg) two times daily according to the clinical response. In more severe cases, the dose can be increased up to 800 mcg/day divided in two to four doses and subsequently reduced when asthma has stabilized. **Instructions for Use/ handling:** Patients have to be instructed to perform a strong and deep inhalation through the Easyhaler device. Patients have to be instructed not to exhale into the device. Illustrated user’s instructions for use accompany each package.
RESPIRATORY (INHALATION)
Medical Information
**Indications** Treatment of bronchial asthma
**Contraindications** Hypersensitivity to the components of Beclomet Easyhaler™ inhalation powder. Special care is necessary in patients with pulmonary tuberculosis.
R03BA01
beclometasone
Manufacturer Information
ORION PHARMA (SG) PTE. LTD.
ORION CORPORATION (ESPOO PLANT)
Active Ingredients
Documents
Package Inserts
Beclomet PI.pdf
Approved: December 10, 2020