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Indications

• Medication used to prevent and alleviate symptoms (wheezing, difficulty breathing) in asthma and chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
• Inhaler contains two medications: fluticasone (corticosteroid) and vilanterol (long-acting beta agonist).
• Fluticasone reduces airway swelling, facilitating easier breathing.
• Vilanterol relaxes muscles around airways, allowing them to open up for easier breathing.
• Combination of corticosteroid and long-acting beta agonist does not increase the risk of serious asthma-related breathing problems.
• Use when breathing problems are not well controlled with a single asthma-control medication or when combination treatment is needed.
• Learn proper usage before using; must be used regularly for effectiveness.
• Not for immediate relief of sudden asthma attacks, use a quick-relief inhaler (such as albuterol) as prescribed during asthma attacks.

Dosage and administration

• Read the Patient Information Leaflet and Instructions for Use provided by the pharmacist before using; consult doctor or pharmacist for questions.
• Inhale medication once daily as directed by the doctor; do not exceed 1 inhalation daily.
• If you open and close the cover without inhaling, you will lose the dose; load a new dose and inhale if this happens.
• If using a quick-relief inhaler regularly, stop and use as needed for sudden shortness of breath; contact the doctor for details.
• If using other inhalers simultaneously, wait at least 1 minute between each; use this drug last.
• Gargle, rinse mouth with water, and spit after each use to prevent dry mouth, hoarseness, and oral yeast infections; do not swallow the rinse water.
• Use regularly at the same time each day; do not increase, use more often, or stop without consulting the doctor.
• Avoid using other long-acting beta agonists with this medication.
• Seek medical help if this medication stops working well, or if a quick-relief inhaler is needed more often than usual.
• Learn which inhalers to use daily and for sudden breathing issues; consult the doctor for new or worsening symptoms.
• If you regularly take corticosteroids by mouth, follow doctor’s instructions; do not stop suddenly, reduce as per doctor’s guidance.
• Full benefit may take weeks; inform the doctor if the condition does not improve or worsens.

Side effects

• Common side effects may include headache, dry/irritated throat, hoarseness, runny nose, and coughing; inform doctor or pharmacist if persistent or worsening.
• Medication prescribed based on the doctor’s judgment of benefits outweighing risks; many users do not experience serious side effects.
• Report serious side effects promptly to the doctor: white patches in mouth/on tongue, weakness, puffy face, unusual weight gain, slow wound healing, thinning skin, bone pain, menstrual changes, mental/mood changes, easy bruising/bleeding, increased thirst/urination, vision problems, muscle cramps, shaking (tremor), signs of infection.
• Seek medical help for very serious side effects: fast/irregular heartbeat, severe dizziness, fainting, chest pain.
• Rarely, this medication may cause sudden worsening of breathing problems (paradoxical bronchospasm); use a quick-relief inhaler and seek medical help if trouble breathing occurs.
• Very serious allergic reactions are rare; seek immediate medical help for symptoms like rash, itching/swelling (especially face/tongue/throat), severe dizziness, trouble breathing.
• Not a complete list of possible side effects; contact doctor or pharmacist for other observed effects.

Precautions

• Inform doctor or pharmacist of allergies before using fluticasone/vilanterol; may contain inactive ingredients causing allergic reactions.
• Share medical history, especially high blood pressure, bone loss, depression, diabetes, eye problems, heart problems, recent infection, liver problems, overactive thyroid, seizures.
• Fluticasone/vilanterol may affect heart rhythm (QT prolongation); seek medical attention for symptoms like fast/irregular heartbeat, severe dizziness, fainting.
• Increased risk of QT prolongation with certain medical conditions or drugs; inform doctors of all medications and relevant conditions.
• Low levels of potassium/magnesium may increase QT prolongation risk; discuss safety with the doctor, especially if using diuretics or experiencing conditions like severe sweating, diarrhea, vomiting.
• If switched from oral corticosteroid or used higher-than-usual doses in the past 12 months, the body may have difficulty responding to physical stress; inform doctors before surgery or emergency treatment.
• Carry a warning card or medical ID bracelet indicating corticosteroid use.
• Inform doctors about medication use before surgery or dental procedures.
• Fluticasone/vilanterol can increase infection risk or worsen current infections; avoid those with easily spread infections, such as chickenpox, COVID-19, measles, flu.
• Long-term use may temporarily slow a child’s growth; monitor regularly.
• Older adults may be more sensitive to side effects, especially QT prolongation.
• Use during pregnancy only if clearly needed; discuss risks and benefits with the doctor.
• Unknown if medication passes into breast milk; consult a doctor before breastfeeding.