Breo Ellipta

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Breo Ellipta. If you are concerned about side effects, discuss the risks and benefits of Breo Ellipta with your doctor.

The following side effects have been reported by at least 1% of people taking Breo Ellipta. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• anxiety
• back pain
• cough
• dizziness
• Fever
• headache
• itchy, runny, or blocked nose
• joint pain
• nausea
• muscle spasms
• pain and irritation in the back of the mouth
• tremor
• voice hoarseness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• bone pain or fractures (Osteoporosis)
• flu-like symptoms (sudden lack of energy, fever, cough, sore throat) that includes rash, pins and needles sensation, worsening breathing problems
• increased blood pressure
• increased or irregular heartbeat
• signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat)
• signs of pneumonia (e.g., fever, chills, shortness of breath, cough)
• signs of too much corticosteroid (e.g., rapid weight gain, sweating, thinning skin, dry skin, muscle weakness)
• sinus or throat infections
• symptoms of Cataracts (e.g., clouding in the eye, blurry vision, eye pain)
• symptoms of a common cold (e.g., sinus congestion, runny nose, sore throat, general feeling of being unwell)
• symptoms of COPD (e.g., shortness of breath, cough, chest discomfort, coughing up mucus)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of Glaucoma (increased pressure in the eye; e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
• symptoms of thrush (sore, raised patches in the mouth)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• sudden worsening or shortness of breath and wheezing immediately after using the medication

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Breo Ellipta.

100 µg/25 µg
Breo Ellipta is provided in two strips of foil blisters. On one strip, each blister contains a white dry powder mixture of micronized fluticasone furoate equivalent to 100 µg and lactose monohydrate for inhalation. On the other strip, each blister contains a white dry powder mixture of micronized vilanterol trifenatate equivalent to 25 µg of vilanterol, magnesium stearate, and lactose monohydrate for inhalation administration.

200 µg/25 µg
Breo Ellipta is provided in two strips of foil blisters. On one strip, each blister contains a white dry powder mixture of micronized fluticasone furoate equivalent to 200 µg and lactose monohydrate for inhalation. On the other strip, each blister contains a white dry powder mixture of micronized vilanterol trifenatate equivalent to 25 µg of vilanterol, magnesium stearate, and lactose monohydrate for inhalation administration.

Do not use Breo Ellipta if you:

• are allergic to fluticasone, vilanterol, or any ingredients of the medication
• are allergic to lactose or milk protein
• are having an asthma attack with sudden shortness of breath or wheezing

There may be an interaction between fluticasone - vilanterol and any of the following:

• Aldesleukin
• Amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• amphotericin B
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Aprepitant
• Atomoxetine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• BCG vaccine
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Betahistine
• caffeine
• cannabis
• chloroquine
• Cobicistat
• conivaptan
• Cyclosporine
• decongestant cold medications (e.g., phenylephrine, Pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• Deferasirox
• Denosumab
• Desmopressin
• diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Metformin, Rosiglitazone)
• Diltiazem
• dipivefrin
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• dofetilide
• Domperidone
• Dronedarone
• echinacea
• Epinephrine
• fast-acting beta-2 agonists (e.g., salbutamol, fenoterol, terbutaline)
• Fingolimod
• Flecainide
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
• hyaluronidase
• Leflunomide
• Linezolid
• Lomitapide
• other long-acting beta-2 agonists (e.g., formoterol, Indacaterol, salmeterol)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• Methylphenidate
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Nabilone
• Natalizumab
• Nivolumab
• pentamidine
• Pimecrolimus
• Primaquine
• procainamide
• protein kinase inhibitors (e.g., Ceritinib, Crizotinib, Dasatinib, Idelalisib, Nilotinib, imatinib, Sunitinib, )
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Tacrolimus
• Tetrabenazine
• Tetracycline
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• Tofacitinib
• Trastuzumab
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• vaccines
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Breo Ellipta. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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 Breo Ellipta.

Asthma-related deaths: When used for asthma treatment, another medication in the same class as vilanterol (LABAs) has been linked to an increase in asthma-related deaths. The use of inhaled corticosteroids, such as fluticasone, with LABAs appears to reduce the risk of serious asthma-related events. If you experience worsening symptoms or your "rescue" medications are not as effective as usual, contact your doctor or seek medical attention immediately.

Diabetes: Breo Ellipta may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Breo Ellipta.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Eye problems: Fluticasone may increase the risk of developing cataracts or glaucoma. If you are at risk of developing either of these conditions, have your eyes checked by your doctor before starting long-term treatment with Breo Ellipta. You should have your eyes monitored at regular intervals while using Breo Ellipta.

Heart conditions: Vilanterol may cause increased blood pressure, rapid heart rate or irregular heart rhythms, 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), high blood pressure or other heart disease, discuss with your doctor how Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Infections: Breo Ellipta, like other 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.

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 Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Oral hygiene: Fluticasone may cause 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 Breo 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 Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Pneumonia: People using fluticasone-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.

Seizures: People with seizure disorders may be more likely to experience side effects of vilanterol. If you have a seizure disorder, discuss with your doctor how Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Steroid medication use: If you have taken or are still taking oral steroid medications over the last several months, consult with your doctor before using Breo Ellipta. In times of stress or during a severe asthma attack, your doctor may want you to start your oral steroid medication again.

Thyroid problems: People with thyroid conditions may be more likely to experience side effects of vilanterol. If you have an overactive thyroid gland, discuss with your doctor how Breo Ellipta may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Breo Ellipta, and whether any special monitoring is needed.

Wheezing: Breo Ellipta may cause the airways to spasm immediately after using the inhaler. If this happens, use your rescue inhaler as soon as possible to relieve the symptoms, then call your doctor as soon as possible.

Pregnancy: Breo Ellipta should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Breo Ellipta, contact your doctor immediately.

Breast-feeding: It is not known if fluticasone - vilanterol passes into breast milk. If you are a breast-feeding mother and are taking Breo Ellipta, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Breo Ellipta is not intended for use by children. The safety and effectiveness of using Breo Ellipta have not been established for children or people under the age of eighteen.