Glycopyrrolate and indacaterol inhalation

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Glycopyrrolate and indacaterol inhalation powder (Utibron Neohaler) is packaged in capsules that come with a special inhaler device. Each time you use the medicine, load a capsule into the device and click the mouthpiece closed. Push the buttons on the side of the device to pierce the capsule and release the medicine into the inhalation chamber. You may need 2 inhalations to get the full dose from 1 capsule.

Do not swallow the Utibron capsule or place it in your mouth. The capsule is for use only with the Neohaler inhalation device.

The usual dose of this medicine is 1 capsule twice daily. Follow your doctor's dosing instructions very carefully.

Use this medicine at the same time each day, even if you feel well.

Glycopyrrolate and indacaterol is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine for a sudden attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your COPD.

Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

Use glycopyrrolate and indacaterol regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Always use the new Neohaler device that comes with this medicine.

You should not stop using glycopyrrolate and indacaterol unless your doctor tells you to. Stopping suddenly may make your condition worse.

Store at room temperature away from moisture and heat. Keep the capsules in the blister pack until it is time for your dose. Remove only one capsule each time you use the medicine. Do not push a capsule through the foil or you may damage the capsule.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: Beta-agonists may potentially interfere with uterine contractility; women should contact their physician if they become pregnant while taking this drug.

Animal studies with glycopyrrolate or indacaterol do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures. There were no effects on peri-natal and post-natal developments in rats at more than the maximum recommended human dose in adults. There are no controlled data with this drug or its individual components in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.