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This document outlines essential safety information and warnings related to the use of Arnuity Ellipta (fluticasone). Review these details carefully and speak with your healthcare provider if you have any questions or concerns.

• Not for Emergency Use: Arnuity Ellipta (fluticasone) should not be used during an asthma attack or for sudden breathing difficulties, as it does not provide immediate relief. A rescue inhaler, such as albuterol (Ventolin HFA), should be used in such cases.

• Risk of Oral Fungal Infections: Use of this medication may lead to thrush, a fungal infection in the mouth and throat. To reduce this risk, rinse your mouth with water and spit after each use. If symptoms such as white patches, a cotton-like feeling, pain while eating or swallowing, or loss of taste occur, contact your healthcare provider. Those with weakened immune systems may be at higher risk.

• Potential for Bronchospasm: Inhaled medications like Arnuity Ellipta (fluticasone) can occasionally cause bronchospasm, leading to wheezing, cough, and breathing difficulties. If these symptoms occur, use your rescue inhaler and seek medical attention immediately.

• Increased Infection Risk: This medication may weaken the immune system, increasing susceptibility to infections, including respiratory infections and pneumonia. Inform your healthcare provider if you are being treated for serious infections like tuberculosis. Report symptoms such as fever, chills, or body aches immediately.

• Hormonal Changes: Use Arnuity Ellipta (fluticasone) as prescribed. Overuse can lead to excess steroid absorption, potentially causing higher blood sugar or blood pressure. Long-term use increases this risk.

• Growth Delays in Children: Inhaled steroids can affect growth in children. Healthcare providers will prescribe the lowest effective dose and monitor growth regularly. Discuss any concerns with your child's healthcare team.

• Eye and Vision Issues: Long-term users may experience increased eye pressure, glaucoma, or cataracts. If you have a history of these conditions, consult your optometrist for regular eye exams and report any vision changes.

• Allergic Reactions: Some individuals may experience allergic reactions, including facial swelling, shock, or anaphylaxis. Seek immediate medical help if you notice symptoms like hives, rash, red skin, or difficulty breathing.

Contraindications:

• Do not use for treating sudden, severe asthma attacks.
• Avoid if you have an allergy to lactose or milk proteins.

Always consult with your healthcare provider before making any changes to your medication regimen.

When taking this medication, you may experience some common side effects as your body adjusts. These include a dry or irritated throat, hoarseness, coughing, and occasionally, symptoms similar to a common cold, headache, bronchitis, flu, or an upper respiratory infection. These effects are generally mild but should be discussed with your healthcare provider if they persist or worsen.

Other side effects that may occur include oral fungal infections, mouth and throat pain, sinus infections, toothaches, and stomach pain. These are typically manageable, but it is important to consult your healthcare provider if they become bothersome.

While serious side effects are rare, they do require immediate medical attention. Be vigilant for symptoms such as white patches in your mouth or on your tongue, persistent sore throat, fever, chills, mood changes, vision problems, increased thirst or urination, easy bruising or bleeding, and bone pain. In rare cases, the medication may cause severe wheezing or trouble breathing immediately after use, necessitating the use of a quick-relief inhaler.

A serious allergic reaction is also rare but requires urgent medical care if symptoms like rash, itching, swelling (particularly of the face, tongue, or throat), severe dizziness, or trouble breathing occur. Always report any unusual side effects to your healthcare provider for guidance and support.