FORADIL AEROLIZER can cause serious side effects, including:

1. People with asthma who take long-acting beta₂-adrenergic agonist (LABA) medicines, such as formoterol fumarate inhalation powder (FORADIL AEROLIZER), have an increased risk of death from asthma problems.
   • Call your health care provider if breathing problems worsen over time while using FORADIL AEROLIZER. You may need a different treatment
   • Get emergency medical care if:
     • breathing problems worsen quickly, and
     • you use your rescue inhaler medicine, but it does not relieve your breathing problems
2. Do not use FORADIL AEROLIZER as your only asthma medicine. FORADIL AEROLIZER must only be used with a long-term asthma control medicine, such as an inhaled corticosteroid.
3. When your asthma is well controlled, your health care provider may tell you to stop taking FORADIL AEROLIZER. Your health care provider will decide if you can stop FORADIL AEROLIZER without loss of asthma control. You will continue taking your long-term asthma control medicine, such as an inhaled corticosteroid.
4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

FORADIL AEROLIZER is a long-acting beta₂-agonist (LABA). LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. In severe cases, wheezing can stop your breathing and cause death if not treated right away.

FORADIL AEROLIZER is used for asthma, exercise-induced bronchospasm (EIB) and chronic obstructive pulmonary disease (COPD) as follows:

Asthma

FORADIL AEROLIZER is used with a long-term asthma control medicine, such as an inhaled corticosteroid, in adults and children ages 5 and older:

• to control symptoms of asthma, and
• to prevent symptoms such as wheezing

LABA medicines, such as FORADIL AEROLIZER, increase the risk of death from asthma problems. FORADIL AEROLIZER is not for adults and children with asthma who are well controlled with long-term asthma control medicine, such as low to medium dose of an inhaled corticosteroid medicine.

Exercise-Induced Bronchospasm (EIB)

FORADIL AEROLIZER is used to prevent wheezing caused by exercise in adults and children 5 years of age and older.

• If you have EIB only, your health care provider may prescribe only FORADIL AEROLIZER for your condition
• If you have EIB and asthma, your health care provider should also prescribe a long-term asthma control medicine, such as an inhaled corticosteroid

Chronic Obstructive Pulmonary Disease (COPD)

FORADIL AEROLIZER is used long-term, 2 times each day (morning and evening), to control symptoms of COPD and prevent wheezing in adults with COPD.

• Do not take FORADIL AEROLIZER to treat your asthma without a long-term asthma control medicine, such as an inhaled corticosteroid
• If you are allergic to formoterol fumarate or any of the ingredients in FORADIL AEROLIZER. Ask your health care provider if you are not sure. See the end of this Medication Guide for a complete list of ingredients in FORADIL AEROLIZER

Tell your health care provider about all of your health conditions, including if you:

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• are pregnant or planning to become pregnant. It is not known if FORADIL AEROLIZER may harm your unborn baby
• are breastfeeding. It is not known if FORADIL AEROLIZER passes into your milk and if it can harm your baby
• are allergic to FORADIL AEROLIZER, any other medicines, or food products

FORADIL AEROLIZER contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in patients who have a severe milk protein allergy.

Tell your health care provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. FORADIL AEROLIZER and certain other medicines may interact with each other. This may cause serious side effects.

Know the medicines you take. Keep a list and show it to your health care provider and pharmacist each time you get a new medicine.

See the step-by-step instructions for using FORADIL capsules with the AEROLIZER inhaler at the end of this Medication Guide. Do not use FORADIL unless your health care provider has taught you and you understand everything.

Ask your health care provider or pharmacist if you have any questions.

• Children should use FORADIL AEROLIZER with an adult's help, as instructed by the child's health care provider
• Use FORADIL AEROLIZER exactly as prescribed. Do not use FORADIL AEROLIZER more often than prescribed
• For asthma and COPD, the usual dose is 1 FORADIL capsule inhaled through the AEROLIZER inhaler 2 times each day (morning and evening). The 2 doses should be about 12 hours apart
• For preventing exercise-induced bronchospasm, the usual dose is 1 FORADIL capsule inhaled through the AEROLIZER inhaler at least 15 minutes before exercise, as needed. Do not use FORADIL AEROLIZER more often than every 12 hours. Do not use extra FORADIL AEROLIZER before exercise if you already use it 2 times each day
• If you miss a dose of FORADIL AEROLIZER, just skip that dose. Take your next dose at your usual time. Never take 2 doses at one time
• Do not use a spacer device with FORADIL AEROLIZER
• Do not breathe into FORADIL AEROLIZER
• While you are using FORADIL AEROLIZER 2 times each day, do not use other medicines that contain a long-acting beta₂-agonist (LABA) for any reason. Ask your health care provider or pharmacist for a list of these medicines
• Do not stop using FORADIL AEROLIZER or any of your asthma medicines unless told to do so by your health care provider because your symptoms might get worse. Your health care provider will change your medicines as needed
• FORADIL AEROLIZER does not relieve sudden symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have an inhaled, short-acting bronchodilator, contact your health care provider to have one prescribed for you

• Call your health care provider or get medical care right away if:

  • your breathing problems worsen with FORADIL AEROLIZER
  • you need to use your rescue inhaler medicine more often than usual
  • your rescue inhaler medicine does not work as well for you at relieving symptoms
  • you need to use 4 or more inhalations of your rescue inhaler medicine for 2 or more days in a row
  • you use 1 whole canister of your rescue inhaler medicine in 8 weeks' time
  • your peak flow meter results decrease. Your health care provider will tell you the numbers that are right for you
  • you have asthma and your symptoms do not improve after using FORADIL AEROLIZER regularly for 1 week

FORADIL AEROLIZER may cause serious side effects, including:

• See "What is the most important information I should know about FORADIL AEROLIZER?"
• Bronchospasm with wheezing or coughing and difficulty breathing
• Low blood potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm)
• Fast or irregular heartbeat (palpitations)
• Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your health care provider or get emergency medical care if you get any symptoms of a serious allergic reaction

Other possible side effects with FORADIL AEROLIZER include:

• chest pain
• increased blood pressure
• nervousness
• dry mouth
• muscle cramps
• nausea
• dizziness
• tiredness
• high blood sugar
• high blood acid
• trouble sleeping

Common side effects with FORADIL AEROLIZER include:

• headache
• tremor

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 FORADIL AEROLIZER. Ask your health care provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

• Store FORADIL AEROLIZER at room temperature between 68°F and 77°F(20°C to 25°C). Protect FORADIL AEROLIZER from heat and moisture. Do not not remove FORADIL capsules from their foil package until just before use
• Always discard the old AEROLIZER inhaler by the "Use by" date and use the new one provided with each new prescription
• Safely discard FORADIL capsules and the AEROLIZER inhaler if no longer needed or is out-of-date
• Keep FORADIL AEROLIZER and all medicines out of the reach of children

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FORADIL AEROLIZER for a condition for which it was not prescribed. Do not give FORADIL AEROLIZER to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about FORADIL AEROLIZER. If you would like more information, talk with your health care provider. You can ask your health care provider or pharmacist for information about FORADIL AEROLIZER that was written for health care professionals. If you have any questions about the use of FORADIL AEROLIZER, call (toll-free) 1-800-526-4099 or go to www.foradil.us.

Active ingredient: formoterol fumarate

Inactive ingredients: lactose (contains milk proteins), gelatin (capsule shell)