Foradil (Formoterol)

FORADIL AEROLIZER may increase the risk of asthma-related death. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using FORADIL AEROLIZER inhalation.

Do not use FORADIL AEROLIZER inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medication.

Asthma is often treated with a combination of different drugs. If you use FORADIL AEROLIZER inhalation to treat asthma, you must use it together with another asthma control medication. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. This device is not to be used with a spacer. Ask your doctor or pharmacist if you have any questions.

FORADIL AEROLIZER capsules are for use only in the Foradil Aerolizer device. Use only one capsule at a time. Do not take the capsules by mouth. Never place a capsule in the mouthpiece of the inhaler.

If you are using FORADIL AEROLIZER inhalation to prevent exercise-induced asthma, use the medicine 15 minutes before exercising, or as directed by your doctor. Allow at least 12 hours to pass before you use the medicine again.

Use FORADIL AEROLIZER inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Store at room temperature, away from moisture, light, and heat. Keep each capsule in the blister pack until you are ready to use one. Be sure your hands are dry when handling a FORADIL AEROLIZER capsule.

Do not try to clean or take apart the Aerolizer device. Throw it away when your capsules run out. Always use the new device provided with the medication when you get your prescription refilled.

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include chest pain, nervousness, dry mouth, nausea, sleep problems (insomnia), tremors, chest pain, fast or irregular heartbeats, feeling weak or light-headed, fainting, or seizure (convulsions).

Use the medication as soon as you remember, then wait 12 hours before using the medication again. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• chest pain, fast or pounding heartbeats, tremors, headache, or restless feeling;

• seizure (convulsions);

• wheezing, choking, or other breathing problems after using this medication;

• increased thirst or hunger, urinating more than usual; or

• worsening asthma symptoms.

Less serious side effects may include:

• dizziness, anxiety, headache;

• sleep problems (insomnia);

• back pain, muscle cramps;

• sore throat, dry mouth, cough, stuffy nose

• skin rash, itching; or

• changes in your voice.

Do not use FORADIL AEROLIZER inhalation to treat an asthma attack that has already begun.

FORADIL AEROLIZER may increase the risk of asthma-related death. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using FORADIL AEROLIZER inhalation.

Asthma is often treated with a combination of different drugs. If you use FORADIL AEROLIZER inhalation to treat asthma, you must use it together with another asthma control medication. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

FORADIL AEROLIZER capsules are for use only in the Foradil Aerolizer device. Use only one capsule at a time. Do not take the capsules by mouth. Never place a capsule in the mouthpiece of the inhaler.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

You should not use this medication if you are allergic to FORADIL AEROLIZER. If you have asthma, FORADIL AEROLIZER inhalation should not be your only asthma medication. You must use it together with at least one other asthma control medication.

To make sure you can safely use FORADIL AEROLIZER, tell your doctor if you have any of these other conditions:

• a food or drug allergy;

• heart disease or high blood pressure;

• epilepsy or other seizure disorder;

• diabetes; or

• a thyroid disorder.

The capsule form of FORADIL AEROLIZER may contain lactose and milk protein. Talk to your doctor before using this form of FORADIL AEROLIZER if you have allergies or severe problems with lactose (milk sugar).

It is not known whether FORADIL AEROLIZER inhalation will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use FORADIL AEROLIZER inhalation without telling your doctor if you are breast-feeding a baby.

FORADIL AEROLIZER should not be given to a child younger than 5 years old.

Do not use a second form of FORADIL AEROLIZER (such as Symbicort) or use a similar other long-acting inhaled bronchodilator such as salmeterol (Advair, Serevent) or FORADIL AEROLIZER (Brovana) unless your doctor has told you to.

Tell your doctor about all other medicines you use, especially:

• cisapride (Propulsid);

• droperidol (Inapsine);

• methadone (Methadose);

• pentamidine (NebuPent, Pentam);

• aminophylline (Phyllocontin, Truphylline) or theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

• a diuretic (water pill);

• caffeine, diet pills, cold medicine, or a stimulant medication;

• an antibiotic such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

• medicines to treat psychiatric disorder, such as pimozide (Orap), haloperidol (Haldol), or thioridazine (Mellaril);

• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);

• a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

• an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others; or

• an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).

This list is not complete and other drugs may interact with FORADIL AEROLIZER inhalation. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.