This medicine is for inhalation use only. It should be inhaled using a dry powder inhaler device (e.g., Rotahaler, Revolizer) as directed by your doctor. The capsule should not be swallowed. Always rinse your mouth with water after inhalation to prevent oral thrush.

Budesonide is a potent glucocorticoid that exerts anti-inflammatory effects in the lungs, reducing airway inflammation and hyperresponsiveness. Formoterol is a selective long-acting beta2-adrenergic agonist that relaxes the smooth muscles of the airways, leading to bronchodilation and improved airflow. The combination provides both anti-inflammatory and bronchodilator effects.

• •Hypersensitivity to budesonide, formoterol, or any excipients.
• •Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.

Store in a cool, dry place, below 30°C. Protect from moisture and light. Keep out of reach of children.

Symptoms of overdose for budesonide are typically limited to systemic corticosteroid effects. Formoterol overdose may lead to exaggerated beta2-agonist effects such as tremor, headache, palpitations, and tachycardia. Treatment is supportive and symptomatic.

Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is excreted in human milk. Formoterol has not been detected in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.