IMPORTANT SAFETY INFORMATION
What is the most important information I should know about budesonide and formoterol fumarate dihydrate inhalation aerosol?

• Do not use budesonide and formoterol fumarate dihydrate inhalation aerosol to treat sudden severe symptoms of asthma or COPD.
• Do not use if you are allergic to any of the ingredients in budesonide and formoterol fumarate dihydrate inhalation aerosol.
• Do not use budesonide and formoterol fumarate dihydrate inhalation aerosol for a condition for which it was not prescribed.
• Do not give budesonide and formoterol fumarate dihydrate inhalation aerosol to other people, even if they have the same symptoms that you have. It may harm them.

What should I tell my healthcare provider before using budesonide and formoterol fumarate dihydrate inhalation aerosol?
Before using budesonide and formoterol fumarate dihydrate inhalation aerosol, tell your healthcare provider if you:

• have heart problems.
• have high blood pressure.
• have seizures.
• have thyroid problems.
• have diabetes.
• have liver problems.
• have osteoporosis.
• have an immune system problem.
• have eye problems such as increased pressure in the eye, glaucoma, or cataracts.
• are allergic to any medicines.
• have any type of viral, bacterial, fungal, or parasitic infection.
• are exposed to chicken pox or measles.
• are pregnant or plan to become pregnant. It is not known if budesonide and formoterol fumarate dihydrate inhalation aerosol may harm your unborn baby.
• are breastfeeding. Budesonide, one of the active ingredients in budesonide and formoterol fumarate dihydrate, passes into breast milk. You and your healthcare provider should decide if you will take budesonide and formoterol fumarate dihydrate inhalation aerosol while breast-feeding.

Tell your healthcare provider about all the medicines you take. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Budesonide and formoterol fumarate dihydrate inhalation aerosol and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take antifungal or anti-HIV medicines.
Know all the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.

What are the possible side effects of budesonide and formoterol fumarate dihydrate inhalation aerosol?
Budesonide and formoterol fumarate dihydrate inhalation aerosol may cause serious side effects including:

Using too much of a LABA medicine may cause:

• chest pain
• increased blood pressure
• a fast and irregular heartbeat
• headache
• tremor
• nervousness

Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using budesonide and formoterol fumarate dihydrate inhalation aerosol to help reduce your chance of getting thrush.
Pneumonia and other lower respiratory tract infections. People with COPD have a higher chance of getting pneumonia and other lung infections. Inhaled corticosteroids may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of these symptoms:

• increase in mucus (sputum) production
• change in mucus color
• fever
• chills
• increased cough
• increased breathing problems

Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs of infection such as:

• fever
• pain
• body aches
• chills
• feeling tired
• nausea
• vomiting

Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine.
Increased wheezing right after taking budesonide and formoterol fumarate dihydrate inhalation aerosol. Always have a rescue inhaler with you to treat sudden wheezing.
Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
Lower bone mineral density. This can happen in people who have a high chance for low bone mineral density (osteoporosis). Your healthcare provider should check you for this during treatment with budesonide and formoterol fumarate dihydrate inhalation aerosol.
Slowed growth in children. A child’s growth should be checked regularly while using budesonide and formoterol fumarate dihydrate inhalation aerosol.
Eye problems including glaucoma and cataracts. You should have regular eye exams while using budesonide and formoterol fumarate dihydrate inhalation aerosol.

Swelling of your blood vessels. This can happen in people with asthma. Tell your healthcare provider right away if you have:

• a feeling of pins and needles or numbness of your arms or legs
• flu like symptoms
• pain and swelling of the sinuses
• rash

Decreases in blood potassium levels (hypokalemia).
Increases in blood sugar levels (hyperglycemia).

The most common side effects of budesonide and formoterol fumarate dihydrate inhalation aerosol include:
People with asthma:

• throat irritation
• headache
• upper respiratory tract infection
• throat pain
• inflammation of mucous membranes of the sinuses (sinusitis)
• flu
• nasal congestion
• back pain
• vomiting
• stomach discomfort
• thrush in the mouth and throat. Rinse your mouth with water without swallowing after use to help prevent thrush

People with COPD:

• throat irritation.
• thrush in the mouth and throat. Rinse your mouth with water without swallowing after use to help prevent thrush.
• infection and inflammation of the mucous membranes of the bronchial tubes (bronchitis).
• inflammation of mucous membranes in the sinuses (sinusitis).
• upper respiratory tract infection.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of budesonide and formoterol fumarate dihydrate inhalation aerosol. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use budesonide and formoterol fumarate dihydrate inhalation aerosol for a condition for which it was not prescribed. Do not give budesonide and formoterol fumarate dihydrate inhalation aerosol to other people, even if they have the same symptoms that you have. It may harm them.

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
You may also report side effects to Teva at 1-888-838-2872.
Please read the Patient Leaflet in the full Prescribing Information.

What is budesonide and formoterol fumarate dihydrate inhalation aerosol?
Budesonide and formoterol fumarate dihydrate inhalation aerosol combines an inhaled corticosteroid medicine (ICS), budesonide and a long-acting beta₂-adrenergic agonist (LABA) medicine, formoterol.

• Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
• LABA medicines are used in people with chronic obstructive pulmonary disease (COPD) and asthma. LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, 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 may lead to death if not treated right away.

Budesonide and formoterol fumarate dihydrate inhalation aerosol is not used to relieve sudden breathing problems and will not replace a rescue inhaler.
Budesonide and formoterol fumarate dihydrate inhalation aerosol is used for asthma and COPD as follows:

• Asthma: Budesonide and formoterol fumarate dihydrate inhalation aerosol is used to control symptoms of asthma and prevent symptoms such as wheezing in adults and children ages 6 and older.

Budesonide and formoterol fumarate dihydrate inhalation aerosol contains formoterol. LABA medicines such as formoterol when used alone increase the risk of death and hospitalizations from asthma problems. Budesonide and formoterol fumarate dihydrate inhalation aerosol contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems. Budesonide and formoterol fumarate dihydrate inhalation aerosol is not for adults and children with asthma who are well controlled with an asthma-control medicine, such as a low to medium dose of an ICS. Budesonide and formoterol fumarate dihydrate inhalation aerosol is for adults and children with asthma who need both an ICS and LABA medicine.
It is not known if budesonide and formoterol fumarate dihydrate inhalation aerosol is safe and effective in children less than 6 years of age with asthma.

• COPD: COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.

Budesonide and formoterol fumarate dihydrate inhalation aerosol 160/4.5 mcg is used long-term, as 2 inhalations 2 times each day, to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).

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