Flonase Allergy Relief

• 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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Flonase Allergy Relief or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Flonase Allergy Relief (fluticasone (nasal)). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Applies to fluticasone nasal: nasal spray

Along with its needed effects, fluticasone nasal (the active ingredient contained in Flonase Allergy Relief) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fluticasone nasal:

• Bloody nose

• Cough
• fever
• headache
• muscle aches
• sore throat
• sores inside the nose
• stuffy or runny nose
• unusual tiredness or weakness

• Difficulty with swallowing
• dizziness
• fast heartbeat
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• skin rash, itching, hives or welts
• tightness in the chest

Some side effects of fluticasone nasal may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain

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 Allergy Relief may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Fluticasone furoate: 2 sprays (27.5 mcg/spray) in each nostril once a day
Fluticasone propionate: 1 or 2 sprays (50 mcg/spray) in each nostril once a day as needed

Comments:
Fluticasone furoate:
-When maximum benefit has been achieved and symptoms have been controlled, reducing the dosage to 55 mcg (1 spray in each nostril) once a day may be effective.

Use: Treatment of symptoms of seasonal and perennial allergic rhinitis

Administration advice:
-This drug should be administered by the intranasal route only.
-The nasal spray should be primed before using for the first time by shaking the contents well and releasing 6 sprays into the air away from the face.
-When the nasal spray has not been used for more than 30 days or if the cap has been left off the bottle for 5 days or longer, the pump should be primed again until a fine mist appears.
-The nasal spray should be shaken well before each use.

Storage requirements:
-The nasal device should be stored in the upright position with the cap in place between 15 and 30 C.
-Do not freeze or refrigerate.

Monitoring:
-Endocrine: HPA-axis suppression (Urinary free-cortisol test, ACTH-stimulation test)