Formoterol Fumarate, Inhalation

What are other names for this medicine?

Type of medicine: bronchodilator

Generic and brand names: formoterol fumarate inhalation; Foradil Aerolizer; Foradil Certihaler; Perforomist

What is this medicine used for?

This long-acting medicine is inhaled to:

• prevent asthma attacks (It does not stop asthma attacks that have already started.)
• prevent wheezing caused by exercise in people who have lung problems
• treat chronic obstructive pulmonary (lung) disease such as chronic bronchitis or emphysema

This medicine is not usually used alone. It is usually used with steroids or other medicines to improve breathing.

What should my health care provider know before I take this medicine?

Before taking this medicine, tell your health care provider if you have ever had:

• an allergic reaction to any medicine or to milk products
• a thyroid disorder
• diabetes
• heart disease
• high blood pressure
• long QT syndrome (problems with electrical activity in the heart muscle)
• seizures

Tell your health care provider about all other medicines you are taking or using for your breathing problem.

Females of childbearing age: Tell your health care provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without discussing with your health care provider.

How do I use it?

Check the label on the medicine for directions about your specific dose. Read the information sheet that comes in the medicine package. Ask your health care provider or pharmacist about anything you do not understand.

To prevent exercise-induced asthma, use this medicine 15 minutes before you exercise. Additional doses should not be used for 12 hours. Do not use extra medicine before exercise if you already are taking twice a day.

For other conditions, take this medicine exactly as your health care provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop using this medicine or any other medicine without your health care provider's approval.

If you have the Aerolizer Inhaler:

Do not wash and reuse your old inhaler. Always use the new Aerolizer that comes with each prescription refill. Do not use the Aerolizer with a spacer and do not exhale into the device.

To use the Aerolizer:

1. Remove the capsule containing the medicine from the foil pouch just before using it.
2. Put the capsule in the well of the Aerolizer inhaler. Do not put the capsule in the mouthpiece.
3. Press both side buttons once to puncture the capsule and release the medicine. You will hear a click when you puncture the capsule.
4. Breathe out fully, then put the mouthpiece in your mouth and close your lips around the mouthpiece. Tilt your head back slightly.
5. Breathe in rapidly and deeply through the mouthpiece.
6. Hold your breath for 5 to 10 seconds, or as long as is comfortable (this gives the medicine time to reach the airways).
7. Breathe out slowly.
8. Open the Aerolizer to see if any powder is left. If it is, repeat the inhalation.

Do not swallow the capsules. Use them in the Aerolizer only. If tiny bits of the medicine reach your mouth, they will melt in your saliva.

If you have the Certihaler:

1. Do not shake the Certihaler. Do not try to use a spacer with this medicine. You must keep the Certihaler level in order to use it. Make sure that the dose counter is on top.
2. To open the Certihaler, pull the dark blue cap away from the inhaler until you hear a click. When open, push the cap down until it clicks into place.
3. Turn your head away from the Certihaler and breathe out to the end of a normal breath. Do not breathe into the Certihaler.
4. Hold the Certihaler level and put the mouthpiece between your lips. Close your lips around the mouthpiece. Keep your fingers on the sides and away from the air holes at the back of the inhaler.
5. Breathe in quickly through your mouth as deeply as you can. If you do not breathe in fast enough, you will not hear a click and the medicine will not go into your lungs. Do not breathe through your nose.
6. Hold your breath and remove the mouthpiece from your mouth. Hold your breath for 5 to 10 seconds, or as long as is comfortable before breathing out. This gives the medicine time to settle in your airways and lungs.
7. Turn your head away from the Certihaler and breathe out slowly. Do not breathe into the Certihaler.
8. To close the Certihaler, push the dark blue cap back up. You will hear it click shut. Check the dose counter to make sure that you have 1 less dose than you had when you started.
9. Keep the Certihaler dry. Do not wash it. You may use a dry cloth to wipe it clean.

The Certihaler window shows the number of doses that are left. Refill the prescription before the counter gets to 0 so that you will not run out of medicine.

Rinse your mouth with water and spit out the rinse right after you use this medicine. This may reduce the risk of thrush (a fungus infection) in your mouth. It may also help reduce aftertaste, dry mouth, and hoarseness.

If you are using other inhaled medicines, ask your healthcare provider or pharmacist which you should use first. Use inhaled medicines 10 minutes apart from each other.

What if I miss a dose?

If you miss a dose, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your health care provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: chest pain, nervousness, tremors, chest pain, fast irregular heartbeat, weakness, seizures.

What should I watch out for?

Do not use this medicine for sudden breathing problems or asthma attacks that have already started. Your health care provider will prescribe a short-acting inhaled medicine to use when you have an asthma attack.

Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Talk with your health care provider about this. If you have any of the following signs of worsening asthma, call your health care provider right away:

• You need to use more puffs than usual of your short-acting inhaler or use it more often.
• You have severe breathing trouble that does not improve, such as persistent wheezing, coughing, or shortness of breath.
• You have a bluish color in your lips or fingernails or are unable to speak.

This medicine may increase your heart rate or blood pressure. Talk with your health care provider about this.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your health care provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your health care provider right away. If you are unable to reach your health care provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives, itching, rash, swelling of your tongue or throat, tightness in your chest, increased trouble breathing).

Serious (report these to your health care provider right away): Chest pain, fast or irregular heartbeat, cough.

Other: Nausea, dizziness, tremor, trouble sleeping, headache, muscle cramps, hoarseness, dry mouth, sore throat, runny nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your health care provider if you are taking:

• MAO inhibitor antidepressants such as phenelzine (Nardil), tranylcypromine (Parnate), and isocarboxazid (Marplan) (Do not take an MAO inhibitor and this medicine within 14 days of each other.)
• selegiline (Eldepryl)
• procarbazine (Matulane)

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all health care providers who treat you about all the products you are taking.

How should I store this medicine?

Store the medicine at room temperature. Do not open the blister packs until just before the capsules are needed for use. Do not wash the inhaler. Keep it away from heat and moisture. Handle the medicine with dry hands.

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This advisory includes selected information only and may not include all side effects of this medicine or drug interactions with other medicines. Ask your health care provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.

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