Flonase Sensimist

Tell your doctor if you are pregnant or plan to become pregnant.

There are no adequate and well-controlled studies with Flonase Sensimist in pregnant women. Flonase Sensimist should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn baby.

It is not known whether fluticasone furoate (the active ingredient in Flonase Sensimist) is excreted in human breast milk. However, other corticosteroids have been detected in human milk. Since there are no data from controlled trials on the use of this medication by nursing mothers, caution should be exercised when Flonase Sensimist is administered to a nursing woman.

• This medicine is for use in the nose only. Do not spray it in your eyes or mouth.
• An adult should help a young child use this medicine.
• Do not take extra doses or stop taking Flonase Sensimist without telling your healthcare provider.
• Flonase Sensimist may begin to work within 24 hours after you take your first dose. It may take several days before it has its greatest effect.
• You will get the best results if you keep using Flonase Sensimist regularly each day without missing a dose. If you miss a dose by several hours, just take your next dose at the usual time. DO NOT take an extra dose.

• Store the device in the upright position with the cap in place between 15° and 30°C (59° and 86°F).
• Do not freeze or refrigerate.
• Keep this and all medicines out of the reach of children.

• It is used to ease allergy signs.

• If you have an allergy to fluticasone or any other part of Flonase Sensimist (fluticasone (nasal)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking any of these drugs: Atazanavir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Flonase Sensimist with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Store at room temperature. Throw away any part not used after labeled number of doses are used.
• Store upright with the cap on.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to fluticasone nasal: nasal spray

Endocrine

Frequency not reported: Hypothalamic-pituitary-adrenal (HPA) axis effects (including growth reduction)[Ref]

Nervous system

Common (1% to 10%): Headache, unpleasant taste, unpleasant smell[Ref]

Gastrointestinal

Common (1% to 10%): Toothache, nausea, diarrhea, abdominal distension, vomiting, gastrointestinal gaseous symptoms
Frequency not reported: Gum signs and symptoms[Ref]

Hypersensitivity

Very rare (less than 0.01%): Hypersensitivity reactions (including anaphylaxis, angioedema, rash, urticaria, bronchospasm)[Ref]

Ocular

Common (1% to 10%): Conjunctivitis
Very rare (less than 0.01%): Cataracts, glaucoma, raised intraocular pressure
Frequency not reported: Transient ocular changes[Ref]

Immunologic

Frequency not reported: Candida albicans infection, immunosuppression[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (26%), epistaxis (20%)
Common (1% to 10%): Pharyngolaryngeal pain, nasal ulceration, cough, pharyngitis, bronchitis, nasal dryness, throat irritation, throat dryness, blood in nasal mucosa, nasal irritation
Uncommon (0.1% to 1%): Rhinalgia, nasal discomfort (including nasal burning, nasal soreness)
Postmarketing reports: Nasal septal perforation[Ref]

General

The most commonly reported side effects were nasopharyngitis, epistaxis, and pyrexia.[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Other

Very common (10% or more): Pyrexia
Frequency not reported: Impaired wound healing[Ref]

Some side effects of Flonase Sensimist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.