Formoterol Fumarate Inhalation powder, capsule

What is this medicine?

FORMOTEROL (for MOH te rol) is a slow-acting bronchodilator. It helps keep open the airways in your lungs to make it easier to breathe. This medicine is used to treat asthma and chronic obstructive pulmonary disease (COPD). It is also used to prevent exercise-induced bronchospasm. Do not use in an acute asthma or COPD attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

They need to know if you have any of the following conditions:

• diabetes
• heart disease or irregular heartbeat
• high blood pressure
• pheochromocytoma
• seizures
• thyroid disease
• an unusual or allergic reaction to formoterol, milk, other medicines, food, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

The capsules are only for inhalation through an inhaler device. Do NOT swallow the capsules. Follow the directions on your prescription label. Do not use a spacer device. Do not use more often than directed. Make sure that you are using your inhaler correctly. Ask you doctor or health care provider if you have any questions.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 5 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

• caffeine
• cisapride
• diuretics
• furazolidone
• medicines for blood pressure
• medicines for depression, anxiety, or psychotic disturbances
• other medicines for breathing problems
• pimozide
• procarbazine
• risperidone
• sertindole
• some antibiotics like clarithromycin, erythromycin, levofloxacin, and linezolid
• some heart medicines
• steroid hormones like dexamethasone, cortisone, hydrocortisone
• stimulant medicines for attention disorders, weight loss, or to stay awake

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Tell your doctor or health care professional if your symptoms do not get better. If your symptoms get worse or if you need your short-acting inhalers more often, call your doctor right away. Do not use this medicine more than every 12 hours.

If you have asthma, be aware that using this medicine may increase your risk of dying from asthma related problems. Talk to your doctor about the risks and benefits of taking this medicine. NEVER use this medicine for an acute asthma attack.

If you are going to have surgery tell your doctor or health care professional that you are using this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions such as skin rash or itching, hives, swelling of the face, lips or tongue
• chest pain
• difficulty breathing or wheezing that increases or does not go away
• dizziness or fainting
• fever
• irregular heartbeat
• nervousness
• tremors

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough
• headache
• sore throat
• stuffy nose
• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 to 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date. Protect from heat and moisture. Remove capsules from the blister pack immediately before using them.

Special rules describing how to store and how long you should keep your medicine may apply. Be sure to read the MedGuide that came with your prescription carefully and follow the directions for storing and using your medicine.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.