FORADIL - formoterol fumarate capsule 
Physicians Total Care, Inc.

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Medication Guide

Foradil® [FOR-a-dil] Aerolizer®

(formoterol fumarate inhalation powder)

Important: Do not swallow FORADIL capsules. FORADIL capsules are used only with the Aerolizer inhaler that comes with FORADIL AEROLIZER. Never place a capsule in the mouthpiece of the AEROLIZER Inhaler.

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.

What is the most important information I should know about FORADIL AEROLIZER?

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.

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 healthcare provider may tell you to stop taking FORADIL AEROLIZER. Your healthcare 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.

What is FORADIL AEROLIZER?

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:

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.

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.

Who should not use FORADIL AEROLIZER?

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

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

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.

How do I use FORADIL capsules with the Aerolizer inhaler?

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.

What are the possible side effects with FORADIL AEROLIZER?

FORADIL AEROLIZER may cause serious side effects, including:

Other possible side effects with FORADIL AEROLIZER include:

Common side effects with FORADIL AEROLIZER include:

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.

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

How do I store FORADIL AEROLIZER?

General Information about FORADIL AEROLIZER

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 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, call (toll-free) 1-800-526-4099 or go to www.foradil.us.

     

What are the ingredients in FORADIL AEROLIZER?

Active ingredient: formoterol fumarate

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

     

Instructions for Using FORADIL AEROLIZER

Do not swallow FORADIL capsules.

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

Foil blister cardFoil 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.
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.

Taking a dose of FORADIL AEROLIZER requires the following steps:

1. Do not remove a FORADIL capsule from the blister card until you are ready for a dose.

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

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.

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)

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)

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)

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)

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)

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)

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)

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)

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.)

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.

Remember:

Manufactured by:

Novartis Pharma AG, Basle, Switzerland

Distributed by:

Schering Corporation, a subsidiary of

MERCK & CO., INC.

Whitehouse Station, NJ 08889, USA

Copyright © 2011 Schering Corp.,a subsidiary of MERCK & CO., INC.

All rights reserved.

FORADIL is a registered trademark of Astellas Pharma Inc.

AEROLIZER is a registered trademark of Novartis AG.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

T2011-82

February 2011

Revised: 3/2012
Physicians Total Care, Inc.