ASMANEX HFA

• Thrush in your mouth and throat. You may develop thrush, a yeast infection (Candida albicans), in your mouth or throat. After each dose (2 puffs) of ASMANEX HFA, rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat.
• Immune system effects and a higher chance for infections. Tell your health care provider about any signs of infection such as:
  • fever
  • feeling tired
  • body aches
  • vomiting
  • pain
  • nausea
  • chills
• Adrenal insufficiency that can lead to death can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines. Adrenal insufficiency can also happen in people who take higher doses of ASMANEX HFA than recommended over a long period of time. When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse. Symptoms of adrenal insufficiency include:
  • feeling tired or exhausted (fatigue)
  • lack of energy
  • low blood pressure (hypotension)
  • weakness
  • nausea and vomiting
  • dizziness or feeling faint
• Increased wheezing right after taking ASMANEX HFA. Always have a rescue inhaler with you to treat sudden wheezing.
• Serious allergic reactions. Stop taking ASMANEX HFA and call your health care provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • hives
  • swelling, including swelling of the face, mouth, and tongue
  • breathing problems
• Lower bone mineral density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
• Slowed growth in children. A child’s growth should be checked often.
• Eye problems including glaucoma, cataracts, and blurred vision. You should have regular eye exams while using ASMANEX HFA.

The most common side effects reported while using ASMANEX HFA include:

• inflammation of the nose and throat (nasopharyngitis)
• headache
• flu infection (influenza)
• inflammation of the sinuses (sinusitis)
• bronchitis

Other side effects: Worsening asthma or sudden asthma symptoms have been reported with the use of inhaled mometasone furoate.

Tell your health care provider about any side effect that bothers you or that does not go away. These are not all the side effects with ASMANEX HFA. Ask your health care provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

ASMANEX HFA is an inhaled corticosteroid (ICS) prescription medicine used as maintenance treatment for the prevention and control of asthma symptoms in people 5 years of age and older. ASMANEX HFA is not used to treat sudden severe symptoms of asthma. ASMANEX HFA should not be used as a rescue inhaler.

It is not known if ASMANEX HFA is safe and effective in children less than 5 years of age.

Yes, ASMANEX HFA contains mometasone furoate, which is a corticosteroid.

ASMANEX HFA does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of ASMANEX HFA. If you do not have a rescue inhaler, call your health care provider to have a rescue inhaler prescribed for you.

Thrush is a yeast infection of the mouth and throat. Rinse your mouth with water after using ASMANEX HFA to help prevent an infection in your mouth or throat.

Rinse your mouth with water after each dose (2 puffs) of ASMANEX HFA. Spit out the water. Do not swallow it. This will help to lessen the chance of getting a yeast infection (thrush) in the mouth and throat.

Slowed growth in children is a possible serious side effect of ASMANEX HFA. A child's growth should be checked often.

ASMANEX HFA comes in 3 strengths. Your health care provider will prescribe the strength that is best for you or your child.

Use ASMANEX HFA exactly as prescribed. Do not use ASMANEX HFA more often than prescribed. Read the step-by-step instructions for using ASMANEX HFA in the Instructions for Use.

The mouthpiece should be cleaned using a dry wipe after every 7 days of use.

Routine cleaning instructions:

• Remove the cap off the mouthpiece. Wipe the inside and outside surfaces of the actuator mouthpiece with a clean, dry, lint-free tissue or cloth. Do not wash or put any parts of your inhaler in water. Put the cap back on the mouthpiece after cleaning.
• Do not remove the canister from the actuator.
• Do not attempt to unblock the actuator with a sharp object, such as a pin.

• Store ASMANEX HFA at room temperature between 68°F to 77°F (20°C to 25°C).
• The contents of your ASMANEX HFA are under pressure. Do not puncture. Do not use or store near heat or open flame. Storage above 120°F may cause the canister to burst.
• Do not throw container into fire or incinerator.
• Keep ASMANEX HFA and all medicines out of the reach of children.