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

COPD: This preparation inhaler is indicated for the maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta-2 agonist or a combination of a long-acting beta-2 agonist and a long-acting muscarinic antagonist.

* রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

100 HFA Inhaler: Each puff contains-

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

200 HFA Inhaler: Each puff contains-

• 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.

Glycopyrronium elimination is mainly through the renal route, so there could be potential drug interactions with medications that affect renal excretion. Beclometasone has a low dependence on CYP3A metabolism, so interactions are unlikely. However, caution and monitoring are advised when used with strong CYP3A inhibitors. Non-cardioselective beta-2 blockers, Quinidine, Disopyramide, and other medications can prolong the QT interval and increase the risk of ventricular arrhythmias when used with inhaled Formoterol. Concomitant use of Monoamine oxidase inhibitors or similar medications can precipitate hypertensive reactions. There is an increased risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons. Xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalemic effect of beta-2 agonists, which can increase the risk of arrhythmias, especially in patients treated with digitalis glycosides.

Hypersensitivity to active substances or any of the excipients.

Side effects include dysphonia, oral candidiasis, muscle spasms and dry mouth. In asthma, side effects tend to occur in the first 3 months after the start of treatment and then become less frequent.

There is no adequate data on the use of Beclometasone Dipropionate, Formoterol Fumarate Dihydrate and Glycopyrronium Bromide in pregnant women. Glucocorticoid agents are known to cause effects in the early gestation phase, while beta-2 sympathomimetic agents like formoterol have tocolytic effects. Therefore, as a precautionary measure, it is preferable to avoid the use of Beclometasone Dipropionate, Formoterol Fumarate Dihydrate and Glycopyrronium Bromide during pregnancy and labor. Beclometasone Dipropionate, Formoterol Fumarate Dihydrate and Glycopyrronium Bromide should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus. Infants and neonates born to mothers receiving substantial doses of Beclometasone Dipropionate, Formoterol Fumarate Dihydrate and Glycopyrronium Bromide should be observed for adrenal suppression.

This inhaler is not indicated for the treatment of acute episodes of bronchospasm, or to treat an acute disease exacerbation. This can worsen asthma symptoms and cause paradoxical bronchospasm, which can be life threatening.It should not be used more than the prescribed dose.It should be used with caution in patients with cardiac arrhythmias, especially third-degree atrioventricular block and tachyarrhythmias, severe heart disease (particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure). This should be administered with caution in patients with active or quiescent pulmonary tuberculosis and in patients with fungal and viral infections in the airways. Patients with certain conditions like hyperthyroidism, or diabetes mellitus should use it with caution, Patients should be advised to have their rescue inhaler available at all times.

Before opening store in the refrigerator at 2-8°C temperature. Do not freeze. During use, keep the inhaler below 25°C temperature for a maximum upto 4 months. Keep away from light and wet places. Keep out of reach of children. Store the inhaler with the mouthpiece down.

An overdose may produce signs and symptoms due to the individual component’s actions, including those seen with an overdose of other beta-2 agonists or anticholinergics and consistent with the known inhaled corticosteroid class effects. If overdose occurs, the patient's symptoms should be treated supportively with appropriate monitoring as necessary.