FORADIL- formoterol fumarate capsule
Merck Sharp & Dohme Corp.
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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.
It is not known if FORADIL AEROLIZER is safe and effective in children under 5 years of age.
Who should not use FORADIL AEROLIZER?
Do not take 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.
Call your healthcare provider or get medical care right away if:
What are the possible side effects with FORADIL AEROLIZER?
FORADIL AEROLIZER may cause serious side effects, including:
See "What is the most important information I should know about FORADIL AEROLIZER?"
Common side effects with FORADIL AEROLIZER include:
Asthma in Adults and Adolescents:
Asthma in Children 5-12 Years of Age:
COPD:
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?
Keep FORADIL AEROLIZER and all medicines out of the reach of children.
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) 1-800-622-4477 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)
T2012-218
November 2012