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The safety information and warnings for Breo Ellipta (fluticasone / vilanterol) are crucial for ensuring safe usage of this medication. Please review the following points carefully and consult with your healthcare provider if you have any questions or concerns.

• Not for Immediate Relief: Breo Ellipta is not suitable for treating asthma attacks, COPD flare-ups, or breathing difficulties requiring quick relief. Use a rescue inhaler like albuterol for immediate assistance.

• Fungal Infection Risk: The steroid component, fluticasone, may lead to oral thrush. To minimize this risk, rinse your mouth with water and spit after inhalation. If symptoms such as white patches, pain, or a cotton-like feeling in your mouth occur, contact your pulmonologist.

• Bronchospasm Alert: Breo Ellipta may cause bronchospasm, leading to breathing difficulties. If this occurs, use a rescue inhaler and seek medical help immediately.

• Infection Vulnerability: Corticosteroid use may reduce immune function, increasing infection risks. Notify your healthcare provider if you experience symptoms like fever or body aches.

• Hormonal Changes: Excessive use can lead to altered stress hormone levels, potentially raising blood sugar or blood pressure. Follow dosage instructions carefully.

• Growth Concerns in Children: Inhaled steroids may impact growth in children. Use the lowest effective dose and monitor growth regularly with your healthcare provider.

• Eye Health Considerations: Long-term use may impact eye health, potentially causing glaucoma or cataracts. Regular eye exams are recommended, especially for those with a history of eye conditions.

• Cardiac Monitoring: Vilanterol may affect heart function. Regular monitoring of blood pressure and heart rate is advised for those with existing heart conditions.

• Low Potassium Levels: Overuse can lead to a drop in potassium levels, causing symptoms like fatigue or muscle cramps. Report these to your provider if they occur.

• Allergic Reactions: Be aware of possible severe allergic reactions, including swelling and difficulty breathing. Seek immediate medical attention if these symptoms occur.

Contraindications: Breo Ellipta should not be used for sudden asthma attacks, if allergic to fluticasone, vilanterol, or lactose.

For any adverse effects or if you need to use the medication more frequently, consult your healthcare provider to adjust your treatment plan accordingly.

When taking this medication, some individuals may experience mild side effects as their body adjusts. These can include headaches, dry or irritated throat, hoarseness, runny nose, coughing, common cold symptoms, and upper respiratory tract infections. Oral thrush, a fungal infection in the mouth, may also occur. While these effects are usually mild and temporary, consult your healthcare provider if they persist or worsen to ensure your comfort and safety.

More serious side effects, though rare, demand immediate medical attention. These include white patches in the mouth or on the tongue, significant weakness, facial puffiness, unusual weight gain, slow wound healing, thinning skin, bone pain, changes in menstrual periods, mood or mental changes such as depression or mood swings, easy bruising or bleeding, increased thirst or urination, vision problems, muscle cramps, and tremors. Additionally, any signs of infection like a persistent sore throat, fever, chills, or cough should be reported promptly.

Certain very serious side effects, though extremely uncommon, require urgent medical help. These include a fast or irregular heartbeat, severe dizziness, fainting, and chest pain. Paradoxical bronchospasm, a sudden and severe worsening of breathing problems, can occur and needs immediate intervention with a quick-relief inhaler followed by emergency medical care. Lastly, though exceedingly rare, an allergic reaction featuring a rash, itching, swelling, severe dizziness, or trouble breathing necessitates prompt medical attention. Always be vigilant about your symptoms and seek advice from your healthcare provider if needed.