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Indacaterol + Glycopyrronium is used for the treatment of chronic obstructive pulmonary disorder (a lung disorder in which the flow of air to the lungs is blocked). It helps in relaxing the muscles of the air passages and making it easier to breathe. It relieves coughing, wheezing and feeling short of breath. Your doctor will tell you how often you need to use your inhaler. The effect of this medicine may be noticeable after a few days but will only reach its maximum after a few weeks. This medicine must be used regularly to be effective, so go on taking it even if you don't have any symptoms. That means it's doing its job. If you stop taking it your COPD may get worse. This medicine should not be used to relieve sudden shortness of breath. To get the benefit from this medicine you need to make sure you get your inhaler technique right, otherwise, it Does not work as well. The most common side effects are indigestion, high blood pressure, nasopharyngitis (inflammation of the throat and nasal passages), chest pain, fever, sore throat, cough, headache, dizziness, inflammation of the nose, and sinus inflammation. If you get there, don't stop taking it but do talk to your doctor. You can prevent some of these symptoms by rinsing your mouth and throat with water or brushing your teeth after using your inhaler. There are other, rarer side effects which can be serious. Talk to your doctor if you're worried about them. Indacaterol + Glycopyrronium is a combination of two medicines: Indacaterol and Glycopyrrolate which treat chronic obstructive pulmonary disease (COPD). Indacaterol is a bronchodilator which works by relaxing the muscles in the airways and widens the airways. Glycopyrrolate is an anticholinergic which works by decreasing the secretions in the airways. Together, they make breathing easier.

• Chronic obstructive pulmonary disease (COPD)

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 beta2-agonist (LABA); stimulates intracellular adenyl cyclase, causing conversion of ATP to cyclic AMP; increased cyclic AMP levels cause relaxation of bronchial smooth muscle

Adult Dose: Adult Chronic Obstructive Pulmonary Disease (COPD) Inhale 1 cap with inhaler once daily. Hepatic Impairment: This can be used at the recommended dose in patients with mild and moderate hepatic impairment. There are no data available for the use of Indacaterol + Glycopyrronium Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients. Child Dose: Safety and efficacy not established Renal Dose: Renal Impairment: This 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.

Take this medicine in the dose and duration as advised by your doctor. Check the label before use.

Common: • Indigestion • High blood pressure • Nasopharyngitis (inflammation of the throat and nasal passages) • Chest pain • Fever • Urinary retention • Sore throat • Cough • Headache • Dizziness • Allergic reaction • Increased glucose level in blood • Inflammation of the nose • Sinus inflammation • Urinary tract infection

No interaction found/established Indacaterol + Glycopyrronium is a combination of two medicines that makes breathing easier for patients with chronic obstructive pulmonary disease (COPD). This medicine is for inhalation only. The tablet should not be swallowed. It should be taken at the same time each day. It does not work right away and should not be used to relieve sudden breathing problems. Take the first dose of this medicine under medical supervision as it may cause wheezing or tightening of the airways (bronchospasm) immediately after using. Dry mouth may occur as a side effect. Frequent mouth rinses, good oral hygiene, increased water intake and sugarless candy may help. Your doctor may regularly monitor your blood potassium levels as low oxygen levels in the blood (hypoxia) and COPD medicines such as Indacaterol + Glycopyrronium can lower potassium levels in blood.

Hypersensitivity to indacaterol, glycopyrronium or to any of the excipients of Indacaterol + Glycopyrronium. All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication Indacaterol/glycopyrrolate is not indicated for the treatment of asthma Use in children: This should not be used in patients <18 years.

Decreases levodopa effects. Effects may be enhanced by using drugs with antimuscarinic properties or MAOIs concurrently. May antagonise the GI effects of cisapride, metoclopramide and dompeidone. Potentially Fatal: IV admin in the presence of cyclopropane anesth can result in ventricular arrhythmias.

[UNSAFE] It is unsafe to consume alcohol with Indacaterol + Glycopyrronium.

[CONSULT YOUR DOCTOR] Indacaterol + Glycopyrronium may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[SAFE IF PRESCRIBED] Indacaterol + Glycopyrronium is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby. Long-term use of Indacaterol + Glycopyrronium might reduce milk production.

No interaction found/established No interaction found/established

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