When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to mometasone or milk proteins. Do not use this medicine to treat bronchospasm or an asthma attack that has already started.

How to Use This Medicine:
Powder Under Pressure

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• For patients using Asmanex®:
  
  • You will use this medicine with a device called a Twisthaler®. The Twisthaler® holds the powdered medicine and measures out each dose for you. Your caregiver will show you how to use your inhaler.
  • The Twisthaler® has a small window on the side with numbers showing. This is the dose counter. The dose counter should change to a lower number when you take off the cap.
  • Breathe out fully to get as much air out of your lungs as possible.
  • Put the mouthpiece in your mouth and close your lips around it. The Twisthaler® will be sideways.
  • Take a fast, deep breath.
  • Take the Twisthaler® out of your mouth. Hold your breath for about 10 seconds, then breathe out slowly. Do not breathe out into the Twisthaler®.
  • Wipe the mouthpiece dry with a cloth or tissue. Put the cap back on right away. You should hear a click when the cap is fully closed.
  • Rinse your mouth out with water after each dose.
  • Throw away the inhaler when the dose counter is at "00" or 45 days after you opened the package.
• For patients using Asmanex® HFA:
  
  • When you use the inhaler for the first time, or if you have not used it in a while, test or prime it by releasing 4 test sprays into the air, away from the face.
  • Shake well before each spray.
  • Breathe out fully to get as much air out of your lungs as possible. Put the mouthpiece into your mouth.
  • Breathe in through your mouth as deeply as you can until you have taken a full deep breath.
  • Do not use the Asmanex® HFA canister or actuator with any other medicines. Do not remove the canister from the actuator.
  • Rinse your mouth with water after each dose. Do not swallow the water after rinsing.
  • Do not wash the inhaler in water. The mouthpiece should be cleaned using a dry wipe after every 7 days of use.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not use extra medicine to make up for a missed dose.
• Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty. Keep the Twisthaler® in the foil pouch until you are ready to use it the first time. Store the medicine at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how mometasone works. Tell your doctor if you are using atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or other steroids (including dexamethasone, methylprednisolone, prednisolone, prednisone).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver problems, cataracts, glaucoma, osteoporosis, tuberculosis, or any type of infection.
• This should not be the first and only medicine you use for asthma. This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma attack.
• This medicine may cause the following problems:
  
  • Adrenal gland problems
  • Fungus infection of the mouth or throat (thrush)
  • Decrease in bone mineral density, which can lead to weak bones
  • Higher risk of infection (tell your doctor if you are exposed to chickenpox or measles)
  • Slow growth in children
  • Glaucoma or cataracts
• This medicine helps prevent asthma attacks for most people, but some people may have more severe asthma attacks when they use it. Talk to your doctor about what you should do if this happens.
• If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
• You may need to use this medicine for 1 to 2 weeks before your asthma starts to improve. Call your doctor if your symptoms do not improve or if they get worse.
• Make sure any doctor or dentist who treats you knows that you are using this medicine.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Breathing problems get worse
• Change in how much or how often you urinate, difficult or painful urination
• Dark freckles, skin color changes, coldness, weakness, tiredness, nausea, vomiting, weight loss
• Eye pain or trouble seeing
• Fever, chills, cough, stuffy or runny nose, sneezing, sore throat, and body aches
• White patches inside your mouth or throat, pain when eating or swallowing

If you notice these less serious side effects, talk with your doctor:

• Change in menstrual periods, or heavy bleeding
• Headache
• Joint or muscle pain
• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088