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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.

Incruse Ellipta is an inhaled medication used to manage chronic obstructive pulmonary disease (COPD). It belongs to a class of drugs known as anticholinergics, which help relax the muscles around the airways to improve breathing.

When taking Incruse Ellipta, it's important to be aware of potential interactions with other medications, especially those that also have anticholinergic properties. Combining Incruse Ellipta with other anticholinergic drugs can increase the risk of side effects such as dry mouth, constipation, urinary retention, and blurred vision. Therefore, it's advisable to avoid using Incruse Ellipta alongside other anticholinergic-containing medications.

Examples of medications with anticholinergic effects include:

• Atropine
• Certain antihistamines (e.g., diphenhydramine, Cetirizine)
• Medications for overactive bladder (e.g., oxybutynin, Tolterodine)
• Drugs for Parkinson's disease (e.g., Benztropine, Trihexyphenidyl)
• Other inhaled anticholinergics (e.g., Tiotropium, Ipratropium)

Additionally, Incruse Ellipta is metabolized in the liver by an enzyme called cytochrome P450 2D6 (CYP2D6) and is a substrate of the P-glycoprotein (P-gp) transporter. While the impact of CYP2D6 variations on Incruse Ellipta is not considered clinically significant, the use of moderate P-gp inhibitors like Verapamil has been shown to increase the systemic exposure of Incruse Ellipta by approximately 1.4 times. This increase is not typically considered clinically significant, but it's important to inform your healthcare provider about all medications you are taking, including prescription drugs, over-the-counter products, vitamins, and herbal supplements.

Always consult your healthcare provider before starting or stopping any medication to ensure that Incruse Ellipta is safe and appropriate for your specific health needs.