Possible increase in asthma-related deaths in patients receiving long-acting β2-adrenergic bronchodilators (e.g., salmeterol) in addition to usual asthma therapy.
Reserve use of long-acting β2-adrenergic agonists in patients with asthma for those whose disease is inadequately controlled with other anti-asthma therapy (e.g., low-to-medium dosage of inhaled corticosteroids) or whose disease severity warrants treatment with 2 maintenance therapies. (See Increased Risk of Asthma-related Death under Cautions.)
FORMOTEROL (for MOH te rol) is a slow-acting bronchodilator. It helps to open up the airways in your lungs and to make it easier to breathe. This medicine is used to treat chronic obstructive pulmonary disease (COPD). 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 these conditions:
This medicine is used in a nebulizer. Nebulizers make a liquid into an aerosol that you breathe in through your mouth or your mouth and nose into your lungs. You will be taught how to use your nebulizer. Follow the directions on your prescription label. Take your medicine at regular intervals. Do not use more often than directed.
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. Special care may be needed.
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, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
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:
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 between 2 and 25 degrees C (36 and 77 degrees F). Protect from heat and moisture. Keep this medicine in the foil pouch until ready to use. Throw away any unused medicine after the expiration date.
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.
