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FLOVENT ROTADISK
FLUTICASONE ORAL DISK - INHALATION

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

FLUTICASONE ORAL DISK - INHALATION

(flew-TIC-uh-sone)

COMMON BRAND NAME(S): Flovent Rotadisk

WARNING: Caution is advised if you have previously taken an oral or injectable corticosteroid medication (e.g., prednisone, methylprednisolone) prior to using this medication. Rare but severe (sometimes fatal) reactions have occurred in people transferred from systemic (oral) corticosteroids to inhaled corticosteroids. Your doctor may gradually decrease your dose of the systemic/oral steroid over several months to decrease your risk of serious side effects. See the Precautions section for details.

Uses

Fluticasone is an orally inhaled corticosteroid medication used, as long-term treatment, to prevent or decrease the symptoms of asthma (e.g., wheezing, trouble breathing). It works by decreasing the inflammation and increasing the airway space in the lungs. This medication does not work immediately and should not be used for acute asthma attacks. Use other quick-relief medicines/inhalers (e.g., beta-agonists such as albuterol) for sudden shortness of breath or acute asthma attacks.

How To Use

Learn all preparation and usage instructions in the product package and review the "Patient Instructions for Use" booklet. If any of the information is unclear, consult your doctor or pharmacist. Inhale this medication by mouth usually twice daily; or use as directed by your doctor. Your dosage is based on your medical condition and response to therapy. It may take up to 2 weeks before the full benefit of this drug takes effect. Use this medication exactly as prescribed; do not use it more frequently or use more inhalations than prescribed. Doing so may decrease the effectiveness of the drug and increase the risk of side effects. Do not stop using this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased. Gargle and rinse your mouth after using this medication to help prevent dryness, relieve throat irritation, and to prevent mouth infections (e.g., thrush). Do not swallow the rinse solution. If you need to use 4 or more puffs daily, or use more than 1 inhaler every 8 weeks of a different short-acting inhaler, tell your doctor or pharmacist. Do not breathe into (exhale into) the inhaler device or wash the mouthpiece of the inhaler. Keep the device dry at all times and always use the inhaler in a level (horizontal) position.

Side Effects

Headache, nausea, diarrhea, nervousness, cough, or throat/nasal irritation may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: worsening or increased frequency of asthma symptoms (e.g., coughing, wheezing, trouble breathing), muscle pain/cramps, joint pain. Tell your doctor immediately if any of these unlikely but serious side effects occur: white/patchy spots in the mouth/throat or vagina, vaginal itching or irregular menstrual cycle, hearing problem/ear pain. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: stomach pain, mental/mood changes (depression). Contact your doctor if you experience any of the following signs of low steroid levels: unusual weakness, weight loss, vomiting, fainting, dizziness. An allergic reaction to this product is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, severe trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: kidney or liver problems, recent infections/illnesses, certain eye problems (e.g., glaucoma, cataracts), any allergies (especially to other corticosteroid-like products). If you have switched from an oral corticosteroid (e.g., prednisone tablets) to this inhaler within the past 12 months or have been using this product in higher-than-usual doses and suddenly stop using it, your body may not produce enough natural steroids. You may need to start taking additional corticosteroids, especially if your body is stressed due to a major infection, surgery or injury. Consult your doctor or pharmacist for more details. Avoid contact with people currently infected with the chickenpox or measles. Consult your doctor immediately if you think you have been exposed to the chickenpox or measles virus. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of all prescription and nonprescription medication you may use, especially: azole antifungals (e.g., itraconazole, ketoconazole), cimetidine, HIV protease inhibitors (e.g., indinavir, ritonavir), macrolide antibiotics (e.g., clarithromycin, erythromycin), beta-blockers (e.g., atenolol, propranolol), oral corticosteroids (e.g., dexamethasone, prednisone), mifepristone, other asthma medicine. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: severe tremor, dizziness, rapid breathing.

Notes

Do not share this medication with others. Inform all your doctors you use, or have used this medication and keep regularly scheduled eye appointments to check for rare eye problems that may occur. Laboratory and/or medical tests (e.g., blood glucose) may be performed to monitor your progress.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from moisture.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).