INDICA-G

Indacaterol Maleate INN & Glycopyrronium Bromide BP

RESPIRATORY

INDICATION

Airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD), Chronic bronchitis and Emphysema.

DOSAGE AND ADMINISTRATION

Route of Administration: Oral inhalation. Indica-G Rotacap must not be swallowed as the intended effects on the lungs will not be obtained. The contents of Indica-G Rotacap are only for oral inhalation and should only be used with ACME’s Easyhaler. Indica-G Rotacap should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use Indica-G Rotacap more than one time in every 24 hours. Indica-G Rotacap must always be stored in the blister and only removed IMMEDIATELY BEFORE USE. No dose adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment or renally impaired patients. No data are available for subjects with severe hepatic impairment. Indica-G Rotacap is not indicated for use in the pediatric population. Safety and efficacy have not been established.

COMPOSITION

Each capsule contains Indacaterol Maleate INN equivalent to Indacaterol 110 mcg & Glycopyrronium Bromide BP equivalent to Glycopyrronium BP 50 mcg.