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This document provides essential safety and warning information for users of Incruse Ellipta (umeclidinium). Please review this information carefully and consult your healthcare provider with any concerns.

• Not for Immediate Relief: Incruse Ellipta (umeclidinium) is not a substitute for a rescue inhaler. If you experience difficulty breathing, use a rescue inhaler like albuterol (Ventolin HFA) for immediate relief.

• Risk of Bronchospasm: This medication may cause bronchospasm, a condition where the muscles of the lungs tighten, leading to breathing difficulties, wheezing, cough, and chest discomfort. If you experience these symptoms after using Incruse Ellipta, use your rescue inhaler and seek medical assistance immediately.

• Serious Allergic Reactions: Be aware of the potential for severe allergic reactions, including facial swelling, shock, and anaphylaxis. If you experience hives, rash, swelling of the lips or tongue, or difficulty breathing, seek emergency medical attention. Individuals allergic to milk proteins (lactose) are at increased risk.

• Glaucoma Concerns: Incruse Ellipta may increase eye pressure and exacerbate glaucoma symptoms. If you have glaucoma, consult your optometrist before using this medication and report any vision changes promptly. This is particularly important for those with a history of glaucoma or high eye pressure.

• Urinary Difficulties: Use with caution if you have prostate issues or urinary retention, as Incruse Ellipta can exacerbate these conditions, leading to difficulty urinating. Contact your healthcare provider if you experience any urinary problems.

Contraindications: Do not use Incruse Ellipta if you have an allergy to lactose or milk proteins, as it may pose serious health risks. Always consult your healthcare provider before starting this medication if you have any concerns regarding these contraindications.

Ensure you follow these guidelines and seek medical advice when necessary to use Incruse Ellipta safely and effectively.

When taking this medication, some individuals may experience mild side effects such as a common cold, upper respiratory tract infection, cough, or joint pain. These are typically not severe and often resolve on their own, but if they persist or worsen, it's advisable to consult your healthcare provider for guidance.

In addition to these, some users have reported a sore throat, muscle pain, or a fast heartbeat. While these are generally not alarming, it's important to monitor your symptoms and reach out to a healthcare provider if they become bothersome or severe.

There are also rare but serious side effects that warrant immediate medical attention. These include sudden and severe wheezing or trouble breathing, which may occur right after using the medication. Should this happen, use your quick-relief inhaler and seek urgent medical help. Additionally, be vigilant for signs of severe allergic reactions, such as a rash, itching, swelling of the face, tongue, or throat, severe dizziness, or breathing difficulties. In rare instances, serious eye issues like pain, swelling, redness, or vision changes, such as seeing rainbows around lights, may occur and require prompt medical evaluation.

It is important to contact your healthcare provider if you notice any other side effects not mentioned here. Your safety is a priority, and professional advice will help manage any adverse effects effectively.