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The following safety information details important warnings and precautions associated with the use of Breztri. It is crucial to review this information carefully and consult your healthcare provider if you have any concerns.

• Not for Immediate Relief: Breztri is not intended for use during asthma or COPD flare-ups, as it does not provide immediate relief for breathing difficulties. In such cases, a rescue inhaler like albuterol should be used.

• Oral Fungal Infections: Breztri contains budesonide, which can lead to thrush, a fungal infection in the mouth and throat. The risk is higher during the initial three months of treatment. To reduce this risk, rinse your mouth with water and spit after each use. If symptoms of thrush appear, such as white patches, discomfort, or a cotton-like sensation, consult your pulmonologist.

• Bronchospasm Risk: Inhalation of Breztri can occasionally cause bronchospasm, resulting in breathing difficulties. If this occurs, use your rescue inhaler and seek medical attention promptly.

• Allergic Reactions: Potential allergic reactions to Breztri include hives, swelling, and anaphylaxis. Immediate medical attention is necessary if these symptoms develop.

• Increased Infection Risk: Breztri may weaken the immune system, increasing susceptibility to infections. Inform your healthcare provider if you are being treated for any serious infection, such as tuberculosis, or if you experience symptoms like fever or body aches.

• Hormonal Changes: Proper use is essential, as exceeding the recommended dose can alter stress hormone levels, affecting blood sugar and pressure. Discuss any prolonged use with your healthcare provider.

• Eye Health Concerns: Long-term use of Breztri may affect eye pressure, potentially leading to glaucoma or cataracts. Regular eye exams are recommended, particularly for those with pre-existing eye conditions.

• Cardiovascular Effects: The formoterol component in Breztri may impact heart rate and blood pressure. Regular monitoring is advised for individuals with heart conditions. Report any unusual symptoms to your care team.

• Low Potassium Levels: Breztri use can lower blood potassium levels, especially if used excessively. Symptoms include weakness and muscle cramps. Notify your prescriber if these occur.

• Urinary Issues: Individuals with prostate problems or urinary retention should use Breztri cautiously, as it may exacerbate these conditions. Report any urinary difficulties to your healthcare provider.

Contraindications:

• Breztri should not be used for acute breathing difficulties or by individuals allergic to its components: budesonide, glycopyrrolate, or formoterol. Consult your healthcare provider if you have these conditions before using Breztri.

When taking this medication, some individuals may encounter mild side effects such as a dry or irritated throat, hoarseness, or coughing. These are generally not serious, but if they persist or worsen, it is wise to consult your healthcare provider. Common side effects also include upper respiratory tract infections, pneumonia, throat irritation, cough, sinus infections, voice changes, and diarrhea. Occasionally, users might experience back pain, oral thrush, flu-like symptoms, muscle spasms, or urinary tract infections.

Though rare, some side effects are more severe and necessitate immediate medical attention. These include sudden severe wheezing or trouble breathing, which might occur right after usage, and serious allergic reactions characterized by rash, itching, swelling, severe dizziness, or trouble breathing. Furthermore, signs of serious infections, such as persistent sore throat or fever, as well as symptoms like white patches in the mouth, bone pain, mental changes, or increased thirst and urination, require prompt medical consultation.

This medication may also elevate blood pressure, so regular monitoring is advised. If you experience alarming symptoms like chest pain, fast or irregular heartbeat, severe dizziness, fainting, or vision changes, seek urgent care. While very serious allergic reactions are rare, symptoms like hives, swelling of the face, lips, or tongue, and difficulty breathing should be addressed immediately. Always contact your healthcare provider if you notice any other effects not listed here.