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Here are important safety and warning details for Breo Ellipta (fluticasone / vilanterol) that need to be carefully considered before use. Consult your healthcare provider if you have any concerns or questions:

• Not for Acute Asthma or COPD Attacks: Breo Ellipta is not suitable for treating sudden asthma attacks or COPD flare-ups. For immediate relief, use a rescue inhaler like albuterol.

• Fungal Infections: The fluticasone in Breo Ellipta may lead to a fungal infection in your mouth or throat, known as thrush. Rinse your mouth with water and spit after each use to minimize this risk. If symptoms of thrush, such as white patches or pain while swallowing, appear, contact your pulmonologist promptly.

• Bronchospasm Risk: Breo Ellipta can occasionally cause spasms in the lungs, leading to breathing difficulties. Use a rescue inhaler and seek medical attention if you experience these symptoms.

• Increased Infection Risk: This medication can weaken your immune system, making you more susceptible to infections. Notify your healthcare provider if you experience symptoms like fever or chills.

• Hormonal Changes: Overuse of Breo Ellipta can alter stress hormone levels, potentially raising blood sugar or blood pressure. Adhere strictly to the prescribed dosage.

• Growth Delay in Children: Inhaled steroids may slow growth in children. Your child's growth will be monitored, and the lowest effective dose will be prescribed. Discuss any concerns with your child's pulmonologist.

• Eye Problems: Long-term use might increase the risk of glaucoma or cataracts. Regular eye exams are advised if you have a history of these conditions.

• Heart Concerns: Vilanterol may affect heart rate and blood pressure. Regular monitoring may be required for patients with existing heart conditions. Report any symptoms like rapid heartbeat or dizziness to your healthcare provider.

• Low Potassium Levels: Excessive use can lower potassium levels, causing symptoms like muscle cramps or weakness. Inform your provider if such symptoms occur.

• Allergic Reactions: Severe allergic reactions, including anaphylaxis, can occur. Seek immediate medical help if you notice swelling, difficulty breathing, or hives.

Contraindications:

• Do not use this medication for sudden, severe asthma attacks.
• Avoid if you have allergies to fluticasone, vilanterol, or milk proteins.

These guidelines are crucial for safely using Breo Ellipta. Always follow your healthcare provider's instructions and report any adverse effects or concerns promptly.

Common side effects:

• Headaches
• Dry or irritated throat
• Hoarseness
• Runny nose
• Coughing
• Symptoms similar to a common cold
• Upper respiratory tract infection

• Oral thrush

  Serious side effects:

• White patches in the mouth or on the tongue
• Weakness
• Puffy face
• Unusual weight gain
• Slow wound healing
• Thinning skin
• Bone pain
• Changes in menstrual periods
• Mood changes such as depression or nervousness
• Easy bruising or bleeding
• Increased thirst or urination
• Vision problems
• Muscle cramps
• Shaking
• Signs of infection (persistent sore throat, fever, or chills)
• Paradoxical bronchospasm
• Severe allergic reaction (rash, itching, swelling, severe dizziness, or trouble breathing)