Fluticasone and vilanterol Inhalation

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fluticasone and vilanterol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fluticasone and vilanterol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of fluticasone and vilanterol combination is not recommended in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone and vilanterol combination in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fluticasone and vilanterol, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fluticasone and vilanterol with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Desmopressin
• Dronedarone
• Fluconazole
• Ketoconazole
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using fluticasone and vilanterol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Aripiprazole
• Aripiprazole Lauroxil
• Atazanavir
• Bemiparin
• Boceprevir
• Bupropion
• Buserelin
• Butriptyline
• Ceritinib
• Clarithromycin
• Clomipramine
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Dabrafenib
• Darunavir
• Dasabuvir
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dibenzepin
• Donepezil
• Dothiepin
• Doxepin
• Efavirenz
• Escitalopram
• Foscarnet
• Gonadorelin
• Goserelin
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Idelalisib
• Imipramine
• Indinavir
• Iprindole
• Itraconazole
• Ivabradine
• Ketoconazole
• Leuprolide
• Levofloxacin
• Lofepramine
• Lopinavir
• Lumacaftor
• Melitracen
• Methadone
• Metronidazole
• Nadroparin
• Nafarelin
• Nefazodone
• Nelfinavir
• Nilotinib
• Nortriptyline
• Opipramol
• Panobinostat
• Pasireotide
• Pimavanserin
• Pitolisant
• Pixantrone
• Posaconazole
• Propizepine
• Protriptyline
• Quetiapine
• Ribociclib
• Ritonavir
• Saquinavir
• Sotalol
• Sulpiride
• Tacrolimus
• Telaprevir
• Telithromycin
• Tianeptine
• Tipranavir
• Trimipramine
• Triptorelin
• Troleandomycin
• Vemurafenib
• Vinflunine
• Voriconazole
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fluticasone and vilanterol with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use fluticasone and vilanterol, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of fluticasone and vilanterol. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute or
• Bronchospasm (difficulty with breathing), acute or
• Milk protein allergy, severe—Should not be used in patients with these conditions.

• Bone problems (eg, osteoporosis) or
• Cataracts, history of or
• Diabetes or
• Glaucoma, history of or
• Heart or blood vessel disease (eg, coronary insufficiency) or
• Heart rhythm problems (eg, arrhythmia, prolonged QT interval) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (high ketones in the blood) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Chickenpox (including recent exposure) or
• Herpes simplex (virus) infection of the eye or
• Infections (virus, bacteria, or fungus) or
• Measles or
• Tuberculosis, active or history of—Inhaled fluticasone can reduce the body's ability to fight off these infections.

• Infection or
• Stress or
• Surgery or
• Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.

• Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.