This medicine is a combination of a corticosteroid and a long-acting beta-agonist bronchodilator used to treat asthma in certain patients. It may also be used to treat other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. THIS MEDICINE IS FOR ORAL INHALATION ONLY. Do not spray in the eyes. If you get this medicine in the eyes, rinse immediately with cool tap water. YOU WILL NEED TO PRIME THE INHALER before using it for the first time, any time it has not been used for more than 5 days, or if it has been dropped. TO PRIME THE INHALER, point it away from you and others. Spray 4 times, shaking well before each spray. Be sure that the canister is properly placed in the inhaler unit. SHAKE WELL before each use. REMOVE THE MOUTHPIECE COVER. Check the mouthpiece for foreign objects. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches away from the open mouth or to use a special spacing device. As you start to take a slow, deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of this medicine. CONTINUE BREATHING IN SLOWLY AND DEEPLY and hold for as long as comfortable up to 10 seconds, then breathe out slowly through your nose while keeping your lips closed. If more than 1 inhalation is to be used, wait at least 30 seconds and repeat the above steps. Close the mouthpiece cover after each use. RINSE YOUR MOUTH WITH WATER after you finish using the medicine (do not swallow). This will help remove excess medicine and decrease your risk of developing an oral fungal infection. Wipe the mouthpiece clean with a dry cloth at least once a week. Use the new inhaler that comes with each refill. DO NOT REUSE an old inhaler. DO NOT USE this medicine with a different kind of inhaler. Never wash the mouthpiece or any other part of the inhaler with water. Keep it dry and always store in a dry place. Do NOT try to take the inhaler apart. SOME PATIENTS MAY HAVE TROUBLE USING THIS MEDICINE CORRECTLY. Some may also get mouth sores or a bad taste in the mouth after using it. If you have any of these problems, ask your health care provider if a spacing device may help. THIS INHALER CONTAINS 124 SPRAYS. A dose counter shows how many puffs are left in the inhaler. Do not use this inhaler after 124 sprays have been used. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and direct sunlight. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. DO NOT puncture, break, or burn the canister even if it appears to be empty. KEEP THIS MEDICINE out of the reach of children and away from pets. CONTINUE TO USE THIS MEDICINE even if you feel well. DO NOT miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. DO NOT use 2 doses at once.
WARNING: Long-acting beta-agonists such as one of the active ingredients in this medicine (formoterol) have been rarely associated with an increased risk of asthma-related death. They may also increase the risk of asthma-related hospitalizations in CHILDREN and TEENAGERS. This medicine should only be used to treat asthma patients who are not controlled by using other long-term asthma-control medicine. This medicine should not be used in patients whose asthma is well controlled by inhaled corticosteroids. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are using another medicine that has a long-acting beta-agonist (eg, salmeterol) in it. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking azole antifungals (eg, itraconazole, ketoconazole), beta-agonists (eg, albuterol), beta-blockers (eg, propranolol), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), HIV protease inhibitors (eg, atazanavir, indinavir, ritonavir), linezolid, macrolide antibiotics (eg, clarithromycin), nefazodone, telithromycin, xanthines (eg, theophylline), or any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat. TELL YOUR DOCTOR if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these medicines within the last 14 days. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of diabetes, heart problems (eg, fast, slow or irregular heartbeat, heart blood vessel problems), high blood pressure, high blood acid levels (ketoacidosis), low blood potassium levels, seizures, tuberculosis, a weakened immune system, liver problems, thyroid problems, eye problems (eg, glaucoma, cataracts, increased eye pressure), allergies, pregnancy, or breast-feeding. Tell your doctor if you have weakened bones (eg, osteoporosis), a family history of weakened bones, or have other risk factors of weak bones (eg, smoking, poor nutrition, you take certain medicines that weaken bones); diarrhea; a fungal, bacterial, or parasitic infection; a viral infection (eg, chickenpox, measles); herpes infection of the eye; or a lung infection (eg, pneumonia). Tell your doctor if you have recently been to an emergency room for asthma, have a history of frequent hospitalizations for asthma, or have ever had a life-threatening asthma attack; or if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are having an asthma attack (eg, sudden, severe onset or worsening of asthma symptoms such as wheezing, cough, chest tightness, shortness of breath) or if you have asthma that is already well controlled with the use of a long-term asthma-control medicine (eg, inhaled corticosteroid). Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while using this medicine include dizziness; dry mouth; headache; nausea; nervousness; stuffy nose; throat irritation; tiredness; tremor; or trouble sleeping. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bad taste in your mouth; chest pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased mucus production or change in color of mucus; muscle pain, weakness, or cramps; new or worsening asthma symptoms (eg, coughing, increased chest tightness, shortness of breath, wheezing); seizures; severe or persistent dizziness, headache, lightheadedness, nervousness, or tremor; severe or persistent nausea; sluggishness; speech problems; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; flushing; rapid breathing; fruit-like breath odor; weakness); vomiting; white patches or sores in your mouth or throat. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; flushing of the skin; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include chest pain; fainting; fast breathing; fast or irregular heartbeat; muscle pain, weakness, or cramps; seizures; severe or persistent dizziness, dry mouth, fatigue, headache, lightheadedness, nausea, nervousness, trouble sleeping, tremors, or vomiting; severe or unusual drowsiness; shortness of breath; sluggishness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; drowsiness; flushing of the skin; confusion; fruit-like breath odor).
If your symptoms do not get better within 1 to 2 weeks of starting this medicine or if they get worse, contact your doctor right away. TELL YOUR DOCTOR AT ONCE if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often, or if you have a decrease in your peak flow meter results. If you have trouble using this medicine correctly, ask your health care provider if a spacing device may help. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.