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|Pulmicort Flexhaler

Budesonide Inhalation Powder (Flexhaler)

Pulmicort Flexhaler is used for:

Preventing asthma symptoms. It may also be used for other conditions as determined by your doctor.

Pulmicort Flexhaler is an inhaled corticosteroid. It works by decreasing irritation and swelling in the airways, which helps to control or prevent asthma symptoms.

Do NOT use Pulmicort Flexhaler if:

• you are allergic to any ingredient in Pulmicort Flexhaler
• you are having an acute asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pulmicort Flexhaler :

Some medical conditions may interact with Pulmicort Flexhaler . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have increased pressure in the eye; glaucoma; cataracts; a herpes infection of the eye; a bacterial, fungal, or parasitic infection; a viral infection (eg, chickenpox, shingles); diarrhea; measles; tuberculosis; or osteoporosis
• if you have had a positive tuberculosis skin test or have recently been vaccinated

Some MEDICINES MAY INTERACT with Pulmicort Flexhaler . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Pulmicort Flexhaler "s effectiveness
• Hormonal contraceptives (eg, birth control pills, patches, implants), imidazole antifungals (eg, ketoconazole, itraconazole), or macrolide antibiotics (eg, erythromycin, clarithromycin) because they may increase the risk of Pulmicort Flexhaler "s side effects
• Live vaccines or ritodrine because the risk of their side effects may be increased by Pulmicort Flexhaler

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pulmicort Flexhaler may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pulmicort Flexhaler :

Use Pulmicort Flexhaler as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Pulmicort Flexhaler . Talk to your pharmacist if you have questions about this information.
• Pulmicort Flexhaler is inhaled through the mouth.
• You will need to prime a new inhaler before you use it for the first time. Twist the inhaler cover and lift it off. Hold the unit upright (mouthpiece on top) and turn the grip fully to the right, then fully to the left until it clicks. Repeat. Do not reprime the inhaler. You will only need to prime the inhaler once even if you do not use it for a long period of time. The inhaler is now ready for use.
• To use a dose, twist the inhaler cover and lift it off. Hold the unit upright (mouthpiece on top) and turn the grip fully to the right, then fully to the left until it clicks. Do NOT shake the inhaler. Turn your head away from the inhaler and breathe out fully. Place the mouthpiece between your lips and inhale forcefully and deeply. You may not feel the medicine. Remove the inhaler from your mouth and breathe out. Do NOT breathe out through the inhaler. Do not bite or chew the mouthpiece.
• Replace the mouthpiece cover after each use.
• Rinse the mouthpiece with water after each use to help prevent mouth or throat infections. Do not swallow the rinse water. Spit it out.
• Do not use Pulmicort Flexhaler with a spacer.
• Keep the inhaler clean and dry at all times.
• Continue to use Pulmicort Flexhaler even if you feel well. Do not miss any doses.
• Use Pulmicort Flexhaler on a regular schedule to get the most benefit from it.
• If you miss a dose of Pulmicort Flexhaler , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pulmicort Flexhaler .

Important safety information:

• Improvement in asthma control can occur within 24 hours of beginning treatment; the maximum effect of Pulmicort Flexhaler may take as long as 1 to 2 weeks, or longer. If symptoms do not improve within that period of time or if they become worse, contact your health care provider.
• Do NOT take more than the recommended dose or stop using without checking with your doctor.
• Do not decrease your dose or use for longer than prescribed without checking with your doctor.
• Use caution if you switch from an oral steroid (eg, prednisone) to Pulmicort Flexhaler . It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
• Tell your doctor at once if you switch from an oral corticosteroid to this medicine and you notice symptoms such as muscle and joint pain, exhaustion, depression, unusual weakness, or severe or persistent nausea or vomiting.
• Pulmicort Flexhaler may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Tell your doctor right away if you are exposed to anyone who has these infections.
• Do not receive a live vaccine (eg, measles, mumps) while you are taking Pulmicort Flexhaler . Talk with your doctor before you receive any vaccine.
• Tell your doctor or dentist that you take Pulmicort Flexhaler before you receive any medical or dental care, emergency care, or surgery.
• Pulmicort Flexhaler will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator with you at all times to treat any breathing problems that may occur between doses of Pulmicort Flexhaler (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
• Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often (eg, 4 or more times a day for more than 2 days in a row; more than 1 canister in 8 weeks), or if you have a decrease in your peak flow meter results.
• Pulmicort Flexhaler may sometimes cause severe breathing problems right after you use a dose. When this problem occurs, it is often after the first use of a new canister or vial. If this happens, use your short-acting bronchodilator and seek medical care at once. Do not use any more doses of Pulmicort Flexhaler unless instructed by your doctor.
• Lab tests, including lung function, adrenal function, and bone density and eye exams, may be performed while you use Pulmicort Flexhaler . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Pulmicort Flexhaler .
• Pulmicort Flexhaler should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pulmicort Flexhaler while you are pregnant. It is not known if Pulmicort Flexhaler is found in breast milk. Do not breast-feed while taking Pulmicort Flexhaler .

Possible side effects of Pulmicort Flexhaler :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Nasal congestion; throat irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); ear pain or discharge; new or worsening asthma symptoms (eg, increased wheezing); depression; mental or mood changes; severe or persistent diarrhea or stomach pain; shortness of breath after using Pulmicort Flexhaler ; signs of infection (eg, fever, chills, or sore throat); vision changes; white patches in the mouth or throat.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Pulmicort Flexhaler at room temperature, between 68 and 77 degrees F (20 to 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pulmicort Flexhaler out of the reach of children and away from pets.

General information:

• If you have any questions about Pulmicort Flexhaler , please talk with your doctor, pharmacist, or other health care provider.
• Pulmicort Flexhaler is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pulmicort Flexhaler . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.