This combination is indicated for the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), helping to improve breathing and reduce symptoms.

Aclidinium Bromide: Aclidinium bromide is a long-acting antimuscarinic (anticholinergic) agent that blocks muscarinic receptors (especially M3) in the airway smooth muscles. This action leads to relaxation of airway muscles and results in bronchodilation. Its effects are dose-dependent and can last for more than 24 hours, primarily acting locally in the lungs.

Formoterol Fumarate: Formoterol fumarate is a long-acting selective beta-2 adrenergic receptor agonist (LABA). When inhaled, it acts directly on the lungs to relax bronchial smooth muscles. It works by stimulating adenyl cyclase, increasing cyclic AMP levels, which leads to bronchodilation and reduces the release of inflammatory mediators from cells such as mast cells.

For oral inhalation only. Should be taken by inhaler device. 400 mcg/12 meg, twice daily (One inhalation capsule in the morning and one in the evening ). Do not take more than one inhalation twice daily.

Concomitant use of other adrenergic drugs may enhance the effects of this combination and should be used cautiously.

• Xanthine derivatives, corticosteroids, and diuretics (especially non–potassium-sparing) may increase the risk of hypokalemia and ECG changes.
• Non–potassium-sparing diuretics may further worsen potassium loss when used with beta₂-agonists.
• Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants may intensify the cardiovascular effects of formoterol and should be used with extreme caution.
• Beta-blockers may reduce the effectiveness of this combination and should only be used when necessary.
• Concomitant use with other anticholinergic drugs may increase additive effects and should generally be avoided.

• This combination is contraindicated in patients with asthma when used without an inhaled corticosteroid.
• It should not be used in individuals with known hypersensitivity to aclidinium bromide, formoterol fumarate, or any of its components.

The most common side effects include upper respiratory tract infections and headache.

There is insufficient data regarding the safety of this combination or its individual components during pregnancy. Similarly, there is no adequate information about its effects on breastfeeding infants or milk production.

• Long-acting beta₂-agonists used alone in asthma may increase the risk of serious asthma-related events.
• Not suitable for acute COPD attacks or sudden worsening symptoms.
• Avoid using with other LABA-containing medications to prevent overdose.
• Discontinue immediately if paradoxical bronchospasm occurs.
• Use cautiously in patients with seizure disorders, hyperthyroidism, diabetes, or ketoacidosis.
• Monitor for hypokalemia and hyperglycemia.
• Use with caution in narrow-angle glaucoma and advise immediate medical attention if symptoms appear.
• May worsen urinary retention; caution is needed in patients with prostate enlargement or bladder obstruction.

Combined bronchodilators

Store below 25°C, protected from light and moisture. Keep out of reach of children.