Pulmicort Flexhaler contains the active ingredient budesonide, which is a corticosteroid. It comes as an inhalation-driven multi-dose dry powder inhaler with dosage strengths of 180 mcg and 90 mcg, delivering 160 mcg and 80 mcg of budesonide per actuation, respectively. Key inactive ingredients include micronized lactose monohydrate, which has trace amounts of milk proteins. The medication is designed to deliver budesonide to the lungs for therapeutic use, potentially for asthma management, depending on airflow and patient inhalation technique.

How should I use this medication?

This medication is inhaled through the mouth. Rinse your mouth with water after use. Make sure not to swallow the water. Take it as directed on the prescription label at the same time every day. Do not use it more often than directed. If you are also using a bronchodilator inhaler, like albuterol, use that inhaler first. Wait 5 minutes or more before using this medication. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 years 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, 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.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep inhaler away from extreme heat, cold or humidity. Throw away when the dose counter reads "0" or after the expiration date, whichever is first. To get rid of medications that are no longer needed or expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, ask your care team how to get rid of it safely.

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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Flu-like symptoms—fever, chills, muscle pain, cough, headache, or fatigue -Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness -Pain, tingling, or numbness in the hands or feet -Sinus pain or pressure around the face or forehead -Thrush—white patches in the mouth -Wheezing or trouble breathing that is worse after use Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Change in taste -Cough -Hoarseness -Runny or stuffy nose -Sore throat

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.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Glaucoma -Immune system problems -Infection, especially a viral infection such as chickenpox, cold sores, herpes -Injury of mouth or throat -Osteoporosis, weak bones -Receiving steroids, such as dexamethasone, prednisone -Recent surgery -An unusual or allergic reaction to budesonide, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Nefazodone -Some antibiotics, such as clarithromycin, erythromycin, telithromycin -Some antivirals for HIV or hepatitis -Some medications for fungal infections, such as itraconazole or ketoconazole

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 medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. NEVER use this medication for an acute asthma attack. You should use your short-acting rescue inhaler for an acute attack. If your symptoms get worse or if you need your short-acting inhalers more often, call your care team right away. You and your care team should develop an Asthma Action Plan that is just for you. Be sure to know what to do if you are in the yellow (asthma is getting worse) or red (medical alert) zones. This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, or sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.