Indacaterol 110 µg & Glycopyrronium 50 µg combination is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Combined bronchodilators

This is a once daily fxed dose combination of Glycopyrronium, a long acting muscarinic receptor antagonist (LAMA) and Indacaterol, a long acting β2 receptor agonist (LABA). When Glycopyrronium & Indacaterol are administered together, they provide additive efcacy due to their diferent mode of action targeting diferent receptors and pathways to achieve bronchial smooth muscle relaxation.

Glycopyrronium: Long-acting muscarinic antagonist (LAMA); often referred to as an anticholinergic; produces bronchodilation by inhibiting acetylcholine's effect on muscarinic receptors in the airway smooth muscle Indacaterol: Long-acting β2-agonist (LABA); stimulates intracellular adenyl cyclase, causing conversion of ATP to cyclic AMP; increased cyclic AMP levels cause relaxation of bronchial smooth muscle

The recommended dose is the inhalation of the content of one capsule once daily using this inhaler. This is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day. Patients should be instructed not to take more than one dose in a day.

Method of administration: For inhalation use only. The capsules must not be swallowed. The capsules must be administered only using this inhaler

No specifc interaction studies were conducted for Glycopyrronium and Indacaterol combination. Information on the potential for interactions is based on the potential for each individual component. The concomitant use of Glycopyrronium and Indacaterol with β-adrenergic blockers, anticholinergics or sympathomimetic agents is not recommended. Sympathomimetic agents may potentiate the adverse events of Indacaterol. Caution is required with the concomitant use of hypokalemic treatment.

Hypersensitivity to the active substances or to any of the excipients. This inhalation capsule is not indicated for the treatment of acute episodes of bronchospasm.

• Upper respiratory tract infection: Nasopharyngitis- Common, Sinusitis- Common, Rhinitis- Common
• Immune system disorders: Hypersensitivity- Common, Angioedema- Uncommon
• Metabolism and nutrition disorders: Hyperglycaemia and diabetes mellitus- Common
• Psychiatric disorders: Insomnia- Uncommon
• Nervous system disorders: Dizziness- Common, Headache- Common, Paraesthesia- Rare
• Eye disorders: Glaucoma- Uncommon
• Cardiac disorders: Ischaemic heart disease- Uncommon, Atrial fibrillation- Uncommon, Tachycardia- Uncommon, Palpitations- Uncommon
• Respiratory, thoracic and mediastinal disorders: Cough- Common, Oropharyngeal pain including throat irritation- Common, Paradoxical bronchospasm- Uncommon, Dysphonia -Uncommon
• Gastrointestinal disorders: Dyspepsia- Common, Dental caries- Common, Gastroenteritis- Uncommon, Dry mouth- Uncommon.

There are no data from the use of this inhalation capsule in pregnant women available. Indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. Therefore, this inhalation capsule should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus. It is not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk. The use of this inhalation capsule by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant. Reproduction studies and other data in animals do not indicate a concern regarding fertility in either males or females.

This inhalation capsule should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of this inhalation capsule belong Asthma: This inhalation capsule should not be used for the treatment of asthma due to the absence of data in this indication. Long-acting beta 2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma. Hypersensitivity: Immediate hypersensitivity reactions have been reported after administration of indacaterol or glycopyrronium, which are components of this inhalation capsule. If signs suggesting allergic reactions occur, in particular, angioedema (difficulties in breathing or swallowing, swelling of the tongue, lips and face) urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted. Paradoxical bronchospasm: As with other inhalation therapy, administration of this inhalation capsule may result in paradoxical bronchospasm which can be life-threatening. If this occurs, treatment should be discontinued immediately and alternative therapy instituted. Anticholinergic effects related to glycopyrronium: Narrow-angle glaucoma: No data are available in patients with narrow-angle glaucoma, therefore this inhalation capsule should be used with caution in these patients. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using this inhalation capsule if any of these signs or symptoms develop. Urinary retention: No data are available in patients with urinary retention, therefore this inhalation capsule should be used with caution in these patients. Patients with severe renal impairment: A moderate mean increase in total system exposure to glycopyrronium of up to 1.4-fold was seen in subjects with mild and moderate renal impairment and up to 2.2-fold in subjects with severe renal impairment and end-stage renal disease. In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, this inhalation capsule should be used only if the expected benefit outweighs the potential risk. These patients should be monitored closely for potential adverse reactions. Cardiovascular effects: this inhalation capsule should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension). Beta 2-adrenergic agonists may produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. In case such effects occur with this medicinal product, treatment may need to be discontinued. Patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), This inhalation capsule should be used with caution in these patient groups. Hypokalaemia: Beta 2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment, which may increase the susceptibility to cardiac arrhythmias. Hyperglycaemia: Inhalation of high doses of beta 2-adrenergic agonists may produce increases in plasma glucose. Upon initiation of treatment with this inhalation capsule plasma glucose should be monitored more closely in diabetic patients. General disorders: This inhalation capsule should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta 2-adrenergic agonists. Excipients: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Elderly population: This inhalation capsule can be used at the recommended dose in elderly patients (75 years of age and older). Renal impairment: This inhalation capsule can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis, it should be used only if the expected benefit outweighs the potential risk. Hepatic impairment: This inhalation capsule can be used at the recommended dose in patients with mild and moderate hepatic impairment. There are no data available for the use of this inhalation capsule in patients with severe hepatic impairment, therefore caution should be observed in these patients. Paediatric population: There is no relevant use of this inhalation capsule in the paediatric population (under 18 years) in the indication COPD.

There is no information on clinically relevant overdosing with this inhalation capsule. An overdose could lead to exaggerated effects typical of beta 2 adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia or could induce anticholinergic effects such as increased intraocular pressure, constipation or difficulties in voiding.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.