Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Trelegy Ellipta.
Asthma-related death: The safety and effectiveness of using Trelegy Ellipta to treat Asthma symptoms have not been determined. Studies have shown an increase in deaths caused by severe asthma symptoms when LABA medications have been used without a corticosteroid. Trelegy Ellipta should not be used by people with asthma.
Diabetes: Fluticasone - umeclidinium - vilanterol may cause an increase in blood sugar levels and glucose tolerance may change. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Trelegy Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelegy Ellipta, and whether any special monitoring is needed. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Trelegy Ellipta.
Driving: Fluticasone - umeclidinium - vilanterol may cause blurred vision or Headaches, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how Trelegy Ellipta affects you.
Eye problems: Fluticasone may increase the risk of developing Cataracts or Glaucoma. Umeclidinium may cause symptoms of glaucoma (increased pressure in the eyes), such as blurred vision or eye pain or pressure to become worse. If you have glaucoma, discuss with your doctor how Trelegy Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelegy Ellipta, and whether any special monitoring is needed.
Heart conditions: Vilanterol and umeclidinium can cause an increase in blood pressure or heart rate as well as changes to the heart rhythm. If you have any heart conditions, discuss with your doctor how Trelegy Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelegy Ellipta, and whether any special monitoring is needed.
Heart rhythm: Beta-2 agonists, such as vilanterol, can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels), discuss with your doctor how Trelegy Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelegy Ellipta, and whether any special monitoring is needed.
Infections: Trelegy Ellipta, like other medications that contain corticosteroids, may prevent the early signs of a serious infection from being noticed. Try to limit the amount of time you spend around others who have recently had infections such as Chickenpox or Measles. If you do come into contact with someone who has one of these infections, contact your doctor for advice.
Speak to your doctor or pharmacist about the importance of receiving an annual Influenza vaccination.
Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways, which make breathing difficult. If you experience this problem when using fluticasone - umeclidinium - vilanterol stop using Trelegy Ellipta immediately. Speak to your doctor if you experience any problems with breathing while taking this or any other inhaled medication.
Liver function: Liver disease or reduced liver function may cause fluticasone to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Trelegy Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelegy Ellipta, and whether any special monitoring is needed.
Oral hygiene: Fluticasone may cause a thrush infection in the mouth and throat. Adequate oral hygiene is very important in minimizing the overgrowth of microorganisms such as Candidiasis (thrush). To reduce the risk of infection, gargle with water after each use of Trelegy Ellipta.
Osteoporosis: Long-term use of medications like fluticasone may increase your risk of developing osteoporosis. If you have osteoporosis or are at risk for developing osteoporosis, discuss with your doctor how Trelegy Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelegy Ellipta, and whether any special monitoring is needed.
Pneumonia: People using fluticasone - umeclidinium - vilanterol to treat COPD may be at an increased risk of developing pneumonia. If you experience symptoms of pneumonia, such as fever, chills, shortness of breath, cough, or chest pain, get medical attention as soon as possible.
Other medications for COPD: There are several medications, including combination medications, available to treat COPD. Many of these have combinations that include one or more of the ingredients in Trelegy Ellipta or other ingredients that work the same way as the ingredients in Trelegy Ellipta. Taking these other medications may cause dangerous or fatal side effects. With your doctor or pharmacist, review the ingredients of any medications you are prescribed and compare it to the medications you are currently taking.
Thyroid disease: Trelegy Ellipta may increase the symptoms of an overactive thyroid gland. If you have a history of thyroid disease, discuss with your doctor how Trelegy Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelegy Ellipta, and whether any special monitoring is needed.
Urinary tract problems: Trelegy Ellipta can cause the symptoms of some urinary tract problems to become worse. If you have an enlarged prostate or other condition that causes urination to be difficult, discuss with your doctor how Trelegy Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Trelegy Ellipta, and whether any special monitoring is needed.
Worsening symptoms: If you find you need to use your short-acting ("rescue") inhaler more often or if your condition seems to worsen, call your doctor. It is very important that you have your "rescue" medication with you at all times. If you have not been given instructions beforehand, contact your doctor immediately about what to do if any of the following situations occur (they may be signs of seriously worsening COPD):
- decreased effectiveness of short-acting, inhaled bronchodilators such as salbutamol, terbutaline, or fenoterol (less than 4 hours of relief)
- need for more inhalations than usual of short-acting, inhaled bronchodilators
Pregnancy: Trelegy Ellipta should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Trelegy Ellipta, contact your doctor immediately.
Breast-feeding: It is not known whether fluticasone, umeclidinium, or vilanterol pass into breast milk. If you are a breast-feeding mother and are using Trelegy Ellipta, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Trelegy Ellipta have not been established for children or people under the age of 18.
