Patients should be instructed to read the accompanying Medication Guide with each new prescription and refill. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be given the following information:

1. Patients should be informed that long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death.

2. FORADIL AEROLIZER is not indicated to relieve acute asthma symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting, beta₂-agonist (the health-care provider should prescribe the patient with such medication and instruct the patient in how it should be used). Patients should be instructed to seek medical attention if their symptoms worsen, if FORADIL AEROLIZER treatment becomes less effective, or if they need more inhalations of a short-acting beta₂-agonist than usual. Patients should not inhale more than the contents of one capsule at any one time. The daily dosage of FORADIL AEROLIZER should not exceed one capsule twice daily (24 mcg total daily dose).

3. FORADIL AEROLIZER should not be used as a substitute for oral or inhaled corticosteroids. The dosage of these medications should not be changed and they should not be stopped without consulting the physician, even if the patient feels better after initiating treatment with FORADIL AEROLIZER.

4. The active ingredient of FORADIL (formoterol fumarate) is a long-acting, bronchodilator used for the treatment of asthma, including nocturnal asthma, and for the prevention of exercise-induced bronchospasm. FORADIL AEROLIZER provides bronchodilation for up to 12 hours. Patients should be advised not to increase the dose or frequency of FORADIL AEROLIZER without consulting the prescribing physician. Patients should be warned not to stop or reduce concomitant asthma therapy without medical advice.

5. When FORADIL AEROLIZER is used for the prevention of EIB, the contents of one capsule should be taken at least 15 minutes prior to exercise. Additional doses of FORADIL AEROLIZER should not be used for 12 hours. Prevention of EIB has not been studied in patients who are receiving chronic FORADIL AEROLIZER administration twice daily and these patients should not use additional FORADIL AEROLIZER for prevention of EIB.

6. Patients should be informed that treatment with beta₂-agonists may lead to adverse events which include palpitations, chest pain, rapid heart rate, tremor or nervousness.

7. Patients should be informed never to use FORADIL AEROLIZER with a spacer and never to exhale into the device.

8. Patients should avoid exposing the FORADIL capsules to moisture and should handle the capsules with dry hands. The AEROLIZER Inhaler should never be washed and should be kept dry. The patient should always use the new AEROLIZER Inhaler that comes with each refill.

9. Women should be advised to contact their physician if they become pregnant or if they are nursing.

10. Patients should be told that in rare cases, the gelatin capsule might break into small pieces. These pieces should be retained by the screen built into the AEROLIZER Inhaler. However, it remains possible that rarely, tiny pieces of gelatin might reach the mouth or throat after inhalation. The capsule is less likely to shatter when pierced if: storage conditions are strictly followed, capsules are removed from the blister immediately before use, and the capsules are only pierced once.

11. It is important that patients understand how to use the AEROLIZER Inhaler appropriately and how it should be used in relation to other asthma medications they are taking (see the accompanying Medication Guide).

Foradil® [FOR-a-dil] Aerolizer®(formoterol fumarate inhalation powder)

Read the Medication Guide that comes with FORADIL AEROLIZER before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your health care provider about your medical condition or treatment.

FORADIL AEROLIZER is a medicine called a long-acting beta₂-agonist or LABA. LABA medicines are used in patients with asthma, exercise-induced bronchospasm (EIB), and chronic obstructive pulmonary disease (COPD). LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent 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.

· In patients with asthma, LABA medicines such as FORADIL AEROLIZER, may increase the chance of death from asthma problems. In a large asthma study, more patients who used another LABA medicine died from asthma problems compared with patients who did not use that LABA medicine. Talk to your healthcare provider about this risk and the benefits of treating your asthma with FORADIL AEROLIZER.

· FORADIL AEROLIZER does not relieve sudden symptoms. Always have a short-acting beta₂-agonist medicine with you to treat sudden symptoms. If you do not have an inhaled, short-acting bronchodilator, contact your healthcare provider to have one prescribed for you.

· Do not stop using FORADIL AEROLIZER unless told to do so by your healthcare provider because your symptoms might get worse.

· FORADIL AEROLIZER

• should not be the only medicine prescribed for your asthma
  · should only be used if your healthcare provider decides that another asthma-controller medicine alone does not control your asthma or that you need 2 asthma-controller medicines
• Call your healthcare provider if breathing problems worsen over time while using FORADIL AEROLIZER. You may need different treatment.
• Get emergency medical care if:
• breathing problems worsen quickly, and
• you use your short-acting beta₂-agonist medicine, but it does not relieve your breathing problems

FORADIL AEROLIZER is a long-acting beta₂-agonist (LABA). FORADIL AEROLIZER is used for asthma, exercise-induced bronchospasm (EIB) and chronic obstructive pulmonary disease (COPD) as follows:

FORADIL AEROLIZER is used long-term, twice-a-day, to control symptoms of asthma, and prevent symptoms such as wheezing in adults and children ages 5 and older.

· are well controlled with another asthma-controller medicine, such as a low to medium dose of an inhaled corticosteroid
· only need short-acting beta₂-agonist medicines once in awhile

FORADIL AEROLIZER is used for the prevention of wheezing caused by exercise in adults and children 5 years of age and older.

FORADIL AEROLIZER is used long-term, twice-a-day, in controlling symptoms of COPD and preventing wheezing in adults with COPD.

What should I tell my healthcare provider before using FORADIL AEROLIZER?

Tell your healthcare 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 healthcare 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 healthcare 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 healthcare provider has taught you and you understand everything. Ask your healthcare provider or pharmacist if you have any questions.

· Children should use FORADIL AEROLIZER with an adult's help, as instructed by the child's healthcare 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 twice a 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 twice-a-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 twice a day, do not use other medicines that contain a long-acting beta₂-agonist (LABA) for any reason. Other LABA medicines include SEREVENT® DISKUS® (salmeterol xinofoate inhalation powder) and ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder).

· Do not change or stop any of your medicines to control or treat your breathing problems. Your healthcare provider will adjust your medicines as needed.

· Make sure you always have a short-acting beta₂-agonist medicine with you. Use your short-acting beta₂-agonist medicine if you have breathing problems between doses of FORADIL AEROLIZER.

· Call your healthcare provider or get medical care right away if:

• your breathing problems worsen with FORADIL AEROLIZER
• you need to use your short-acting beta₂-agonist medicine more often than usual
• your short-acting beta₂-agonist medicine does not work as well for you at relieving symptoms
you need to use 4 or more inhalations of your short-acting beta₂-agonist medicine for 2 or more days in a row
• you use 1 whole canister of your short-acting beta₂-agonist medicine in 8 weeks time
• your peak flow meter results decrease. Your healthcare 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.

· In patients with asthma, LABA medicines such as FORADIL AEROLIZER may increase the chance of death from asthma problems. See "What is the most important information I should know about FORADIL AEROLIZER?"

· serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.

Tell your healthcare 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 healthcare provider or pharmacist for more information.

• Store FORADIL AEROLIZER at room temperature between 68 and 77° F (20 to 25° C). Protect FORADIL AEROLIZER from heat and moisture. Do 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 not mentioned 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 healthcare provider. You can ask your healthcare provider or pharmacist for information about FORADIL AEROLIZER that was written for healthcare professionals. If you have any questions about the use of FORADIL AEROLIZER, go to www.foradil.us.

Follow the instructions below for using your FORADIL AEROLIZER. You will breathe-in (inhale) the medicine in the FORADIL capsules from the FORADIL AEROLIZER. If you have any questions, ask your healthcare provider or pharmacist.

· FORADIL AEROLIZER consists of FORADIL capsules and a AEROLIZER Inhaler.

· FORADIL capsules come on blister cards and are wrapped in foil pouches. Do not open a foil pouch until you are ready to use FORADIL AEROLIZER.

· Keep your FORADIL and AEROLIZER Inhaler dry. Handle with DRY hands.

	Aluminum pouch covering the foil blister cards
	Foil blister card

The Aerolizer consists of the following parts: 1. A cap to protect the mouthpiece of the base 2. A base that allows the proper release of medicine from the capsule The base consists of: 3. A mouth piece 4. A capsule chamber 5. A button with "winglets" (projecting side pieces) and pins on each side 6. An air inlet channel.

With each new prescription of FORADIL AEROLIZER or refill, your pharmacist should have written the "Use by" date on the sticker on the outside of the FORADIL AEROLIZER box. Remove the "Use by" sticker on the box and place it on the AEROLIZER Inhaler cover that comes with FORADIL. If the sticker is blank, count 4 months from the date you got your FORADIL AEROLIZER from the pharmacy and write this date on the sticker. Also, check the expiration date stamped on the box. If this date is less than 4 months from your purchase date, write this date on the sticker.

Do not use FORADIL capsules with any other capsule inhaler, and do not use the AEROLIZER inhaler to take any other capsule medicine.

1. Open the foil pouch containing a blister card of FORADIL capsules. Do not remove a FORADIL capsule until you are ready for a dose.

2. Pull off the AEROLIZER Inhaler cover. (Figure 1)

Figure 1

3. Hold the base of the AEROLIZER Inhaler firmly and twist the mouthpiece in the direction of the arrow to open. (Figure 2) Push the buttons in on each side to make sure that you can see 4 pins in the capsule well of the AEROLIZER Inhaler.

Figure 2

4. Separate one FORADIL capsule blister by tearing at the pre-cut lines. (Figure 3)

Figure 3

5. Peel the paper backing that covers one FORADIL capsule on the blister card. Push the FORADIL capsule through the foil. (Figure 4)

Figure 4

6. Place the FORADIL capsule in the capsule-chamber in the base of the AEROLIZER Inhaler. Never place a capsule directly into the mouthpiece. (Figure 5)

Figure 5

7. Twist the mouthpiece back to the closed position. (Figure 6)

Figure 6

8. Hold the mouthpiece of the AEROLIZER Inhaler upright and press both buttons at the same time. Only press the buttons ONCE. You should hear a click as the FORADIL capsule is being pierced. (Figure 7)

Figure 7

9. Release the buttons. If the buttons stay stuck, grasp the wings on the buttons and pull them out of the stuck position before the next step. Do not push the buttons a second time. This may cause the FORADIL capsule to break into small pieces. There is a screen built into the AEROLIZER Inhaler to hold these small pieces. It is possible that tiny pieces of a FORADIL capsule might reach your mouth or throat when you inhale the medicine. This will not harm you, but to avoid this, only pierce the capsule once. The FORADIL capsules are also less likely to break into small pieces if you store them the right way (See "How do I store FORADIL AEROLIZER?").

10. Breathe out (exhale) fully. Do not exhale into the AEROLIZER mouthpiece. (Figure 8)

Figure 8

11. Tilt your head back slightly. Keep the AEROLIZER Inhaler level, with the blue buttons to the left and right (not up and down). Place the mouthpiece in your mouth and close your lips around the mouthpiece. (Figures 9 and 10)

Figure 9	Figure 10

12. Breathe in quickly and deeply (Figure 11). This will cause the FORADIL capsule to spin around in the chamber and deliver your dose of medicine. You should hear a whirring noise and experience a sweet taste in your mouth. If you do not hear the whirring noise, the capsule may be stuck. If this occurs, open the AEROLIZER Inhaler and loosen the capsule allowing it to spin freely. Do not try to loosen the capsule by pressing the buttons again. (You will have to repeat steps 10 to 12 again to get your dose.)

Figure 11

13. Remove the AEROLIZER Inhaler from your mouth. Continue to hold your breath as long as you can and then exhale.

14. Open the AEROLIZER Inhaler to see if any powder is still in the capsule. If any powder remains in the capsule repeat steps 10 to 13. Most people are able to empty the capsule in one or two inhalations.

15. After use, open the AEROLIZER Inhaler, remove and discard the empty capsule. Do not leave a used capsule in the chamber.

16. Close the mouthpiece and replace the cover.

• Never breathe into the AEROLIZER Inhaler.
• Never take the AEROLIZER Inhaler apart.
• Never place a FORADIL capsule directly into the mouthpiece of the AEROLIZER Inhaler.
• Never leave a used FORADIL capsule in the AEROLIZER Inhaler chamber.
• Always use the AEROLIZER Inhaler in a level position.
• Never wash the AEROLIZER Inhaler. Keep it dry.
• Always keep the AEROLIZER Inhaler and FORADIL capsules in a dry place.
• Always use the new AEROLIZER Inhaler that comes with your refill.

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