Asthma: This inhaler is indicated for the maintenance treatment of asthma in adults who are not adequately controlled with a combination of a long-acting beta-2 agonist (LABA) and a medium dose inhaled corticosteroid (ICS), and who have experienced one or more exacerbations in the previous year.

COPD: This inhaler is indicated for the maintenance treatment of adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who remain symptomatic despite treatment with either an ICS/LABA combination or a LABA/LAMA combination.

100 HFA Inhaler (per puff):

• Beclometasone Dipropionate BP — 100 mcg
• Formoterol Fumarate Dihydrate BP — 6 mcg
• Glycopyrronium Bromide BP (equivalent to Glycopyrronium) — 10 mcg

200 HFA Inhaler (per puff):

• Beclometasone Dipropionate BP — 200 mcg
• Formoterol Fumarate Dihydrate BP — 6 mcg
• Glycopyrronium Bromide BP (equivalent to Glycopyrronium) — 10 mcg

For Asthma: Recommended doses: Adults (18 years and older): 2 inhalations twice daily (morning and evening, approximately 12 hours apart). The recommended starting dosages are based on patients’ asthma severity.

For COPD: Recommended doses: 2 inhalations twice daily. The maximum dose is two inhalations twice daily. Patients should be advised to take the inhaler every day even when asymptomatic. If symptoms arise in the period between doses, an inhaled, short acting beta-2 agonist should be used for immediate relief. After inhalation, the patient should rinse the mouth with water without swallowing.

Administration

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

• Take off the cap.
• Shake the inhaler (at least six times) vigorously before each use.
• If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
• Breathe out as full as comfortably possible & hold the inhaler upright.
• Place the actuator into mouth between the teeth and close lips around the mouthpiece.
• While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
• Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
• If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations).
• Shake the inhaler well and repeat steps 4 to 7.
• After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
• Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Glycopyrronium is primarily eliminated via the kidneys; therefore, interactions may occur with drugs that affect renal excretion. Beclometasone has minimal dependence on CYP3A metabolism, making interactions less likely; however, caution is advised when used with strong CYP3A inhibitors. Non-selective beta-blockers, quinidine, disopyramide, and other QT-prolonging drugs may increase the risk of ventricular arrhythmias when combined with formoterol. Monoamine oxidase inhibitors (MAOIs) and similar agents may enhance hypertensive responses. The risk of arrhythmias may increase when used with halogenated anesthetics. Xanthine derivatives, corticosteroids, and diuretics may enhance the hypokalemic effect of beta-2 agonists, increasing the risk of arrhythmias, especially in patients taking digitalis glycosides.

This combination is contraindicated in patients with known hypersensitivity to any of the active ingredients or excipients.

Common adverse effects include dysphonia, oral candidiasis, muscle cramps, and dry mouth. In asthma patients, these effects are more likely to occur during the first three months of therapy and tend to decrease with continued use.

There is insufficient data regarding the use of this combination during pregnancy. Corticosteroids may affect early fetal development, and beta-2 agonists like formoterol may inhibit uterine contractions. Therefore, use during pregnancy and labor should be avoided unless clearly necessary. This combination should only be used during pregnancy if the expected benefit outweighs the potential risk to the fetus. Infants born to mothers receiving high doses should be monitored for adrenal suppression.

This inhaler is not intended for acute bronchospasm or sudden worsening of symptoms. It may cause paradoxical bronchospasm, which can be life-threatening. Do not exceed the prescribed dose. Use with caution in patients with cardiac arrhythmias, severe heart disease, myocardial infarction, ischemic heart disease, or heart failure. Caution is also required in patients with pulmonary tuberculosis or fungal and viral infections of the airways. Patients with hyperthyroidism or diabetes should use it carefully. Patients should always keep a rescue inhaler available.

Overdose may produce symptoms related to the individual components, including those seen with beta-2 agonists, anticholinergics, and inhaled corticosteroids. Management is supportive with appropriate monitoring.

Store in a refrigerator (2–8°C) before opening. Do not freeze. During use, keep below 25°C for up to 4 months. Protect from light and moisture. Store with the mouthpiece facing downward and keep out of reach of children.