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PULMICORT FLEXHALER
(bew DEH so nide)
(budesonide inhalation powder, 180 mcg)

PULMICORT FLEXHALER
(budesonide inhalation powder, 90 mcg)

Read the Patient Information that comes with PULMICORT FLEXHALER (budesonide inhalation powder) before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is PULMICORT FLEXHALER (budesonide inhalation powder) ?

PULMICORT FLEXHALER (budesonide inhalation powder) is an inhaled corticosteroid medicine. PULMICORT FLEXHALER (budesonide inhalation powder) is used for long-term (maintenance) treatment of asthma and to prevent asthma symptoms in adults and children 6 years of age and older.

Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to asthma symptoms.

PULMICORT FLEXHALER (budesonide inhalation powder) helps reduce inflammation and helps keep the airways open to reduce asthma symptoms.

PULMICORT FLEXHALER (budesonide inhalation powder) does not treat the symptoms of a sudden asthma attack. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms. If you do not have an inhaled, short-acting bronchodilator, call your healthcare provider to have one prescribed for you.

It is not known if PULMICORT FLEXHALER (budesonide inhalation powder) is safe and effective in children younger than 6 years of age.

Who should not use PULMICORT FLEXHALER (budesonide inhalation powder) ?

Do not use PULMICORT FLEXHALER (budesonide inhalation powder) :

• to treat sudden severe symptoms of asthma.
• if you have a severe allergy to milk proteins. PULMICORT FLEXHALER (budesonide inhalation powder) contains a small amount of lactose (milk sugar). People with severe allergies to milk protein may have symptoms of an allergic reaction with PULMICORT FLEXHALER (budesonide inhalation powder) including: cough, wheezing, trouble breathing or feeling like your throat is closing.

What should I tell my healthcare provider before using PULMICORT FLEXHALER (budesonide inhalation powder) ?

Before using PULMICORT FLEXHALER (budesonide inhalation powder) , tell your healthcare provider if you:

• have any allergies. See the section “Who should not use PULMICORT FLEXHALER”. There is a complete list of ingredients in PULMICORT FLEXHALER (budesonide inhalation powder) at the end of this leaflet.
• have or had chicken pox or measles, or have recently been near anyone with chicken pox or measles.
• have or had tuberculosis of your respiratory tract.
• have certain kinds of serious infections that have not been treated, including:
• fungal infections
• bacterial infections
• viral infections
• parasitic infections
• herpes simplex infection of the eye (ocular herpes simplex)

PULMICORT FLEXHALER (budesonide inhalation powder) may not be right for people who have or had any of these types of infections.

• have liver problems
• have decreased bone mineral density.

You are at risk for decreased bone mineral density if you:

• are inactive for a long period of time
• have a family history of osteoporosis
• are a woman going through menopause or are past menopause (“the change of life”)
• smoke or use tobacco
• do not eat well (poor nutrition)
• are elderly
• take bone thinning medicines (such as anticonvulsant medicines or corticosteroids) for a long time.
• have eye problems such as increased pressure in the eye, glaucoma, or cataracts
• are planning to have surgery,
• are pregnant or plan to become pregnant. It is not known if PULMICORT FLEXHALER (budesonide inhalation powder) may harm your unborn baby.
• are breast-feeding or plan to breast-feed. PULMICORT FLEXHALER (budesonide inhalation powder) can pass into breast milk. You and your healthcare provider should decide if you will use PULMICORT FLEXHALER (budesonide inhalation powder) or breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, or and herbal supplements. Using PULMICORT FLEXHALER with certain other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

• a corticosteroid medicine
• anti-seizure medicine (anticonvulsants)
• medicines that suppress your immune system (immunosuppressant)
• ketoconazale (Nizoral), other medicines that affect how your liver works.

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use PULMICORT FLEXHALER (budesonide inhalation powder) ?

Use PULMICORT FLEXHALER (budesonide inhalation powder) exactly as prescribed by your healthcare provider. You must use PULMICORT FLEXHALER (budesonide inhalation powder) regularly for it to work.

• PULMICORT FLEXHALER (budesonide inhalation powder) comes in two strengths. Your healthcare provider has prescribed the strength that is best for you.
• Be sure you know the difference between PULMICORT FLEXHALER (budesonide inhalation powder) and any other inhaled medicines that are prescribed for you, including what you use them for (prescribed use) and what they look like.
• Do not stop using PULMICORT FLEXHALER (budesonide inhalation powder) , even if your symptoms get better. Your healthcare provider will change your medicines as needed.
• Do not change or stop any medicines used to control or treat your breathing problems, unless your healthcare provider tells you to.
• Rinse your mouth with water and spit the water out after each dose of PULMICORT FLEXHALER. Do not swallow the water. This will lessen the chance of getting a fungal infection (thrush) in the mouth.
• If you miss a dose, just take your next regularly scheduled dose when it is due. Do not use PULMICORT FLEXHALER (budesonide inhalation powder) more often or use more puffs than you have been prescribed.
• Make sure you always have a short-acting beta2-agonist medicine with you. Use your short acting beta2-agonist medicine if you have breathing problems between doses of PULMICORT FLEXHALER (budesonide inhalation powder) or if a sudden asthma attack happens. Call your healthcare provider right away if:
  • your short-acting rescue medicine does not work as well for relieving asthma symptoms.
  • you need to use your short-acting rescue medicines more often than usual.
  • your breathing problems worsen with PULMICORT FLEXHALER (budesonide inhalation powder) .

If you use another inhaled medicine by mouth to treat your asthma, talk with your healthcare provider for instructions about when to use the other medicine and when to use your PULMICORT FLEXHALER (budesonide inhalation powder) .

• If you have used corticosteroid medicines for a long time and the dose is now being lowered or stopped, you should carry a medical alert card. The medical alert card should state that you may need increased corticosteroids during times of stress or during an asthma attack that does not get better with bronchodilator medicines.
• Your healthcare provider may check your breathing, do blood tests and eye exams during treatment with PULMICORT FLEXHALER (budesonide inhalation powder) .
• Be sure to read, understand and follow the detailed Patient Instructions for Use at the end of this leaflet. These Instructions for Use tell you how to prime and use your PULMICORT FLEXHALER (budesonide inhalation powder) the right way.

What are the possible side effects of PULMICORT FLEXHALER (budesonide inhalation powder) ?

PULMICORT FLEXHALER (budesonide inhalation powder) can cause serious side effects, including:

• thrush (candida), a fungal infection in your mouth and throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
• worsening of asthma or sudden asthma attacks.
• allergic reactions. Tell your healthcare provider or get medical help right away if you have:
  • skin rash, redness or swelling
  • severe itching
  • swelling of the face, mouth, and tongue
  • trouble breathing or swallowing
  • chest pain
  • anxiety (feeling of doom)
• Immune system effects and a higher chance of infections. You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using PULMICORT FLEXHALER (budesonide inhalation powder) . Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your healthcare provider about any signs of infection while you are using PULMICORT FLEXHALER (budesonide inhalation powder) .
• Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency include: tiredness, weakness, nausea and vomiting and low blood pressure.
• Decrease in bone mineral density. Your healthcare provider should check you for this during treatment with PULMICORT FLEXHALER (budesonide inhalation powder) .
• Slowed or delayed growth problems in children. A child's growth should be checked regularly while using PULMICORT FLEXHALER (budesonide inhalation powder) .
• Eye problems, including glaucoma and cataracts. You should have regular eye exams while using PULMICORT FLEXHALER (budesonide inhalation powder) .
• Increased wheezing right after taking PULMICORT FLEXHALER (budesonide inhalation powder) . Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden wheezing.

Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.

Common side effects reported by patients using PULMICORT FLEXHALER (budesonide inhalation powder) include:

• sore nose and throat
• stuffy nose
• runny nose
• nausea
• hay fever
• viral infections of the upper respiratory tract
• viral irritation and inflammation of the stomach and intestine (gastroenteritis). Symptoms may include stomach area pain, diarrhea, nausea and vomiting, loss of appetite, headaches, and weakness.
• ear infections

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

These are not all of the side effects of PULMICORT FLEXHALER (budesonide inhalation powder) . Ask your healthcare provider or pharmacist for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How should I store PULMICORT FLEXHALER (budesonide inhalation powder) ?

Store PULMICORT FLEXHALER (budesonide inhalation powder) at 68° to 77°F (20° to 25°C).

• Keep PULMICORT FLEXHALER (budesonide inhalation powder) dry.
• Keep your PULMICORT FLEXHALER (budesonide inhalation powder) with the cover tightly in place when not in use.

Keep your PULMICORT FLEXHALER (budesonide inhalation powder) and all medicines out of the reach of children.

General Information about PULMICORT FLEXHALER (budesonide inhalation powder)

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information Leaflets. Do not use PULMICORT FLEXHALER (budesonide inhalation powder) for a condition for which it was not prescribed. Do not give PULMICORT FLEXHALER (budesonide inhalation powder) to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about PULMICORT FLEXHALER (budesonide inhalation powder) . If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about PULMICORT FLEXHALER (budesonide inhalation powder) that is written for health professionals.

For more information, go to pulmicortflexhaler.com or call 1800-236-9933.

What are the ingredients in PULMICORT FLEXHALER (budesonide inhalation powder) ?

Active ingredient: budesonide

Inactive ingredient: lactose

Patient Instructions for Use

How to use your PULMICORT FLEXHALER (budesonide inhalation powder)

Parts of your PULMICORT FLEXHALER (budesonide inhalation powder)

Figure 1

Priming PULMICORT FLEXHALER (budesonide inhalation powder) :

Before you use a new PULMICORT FLEXHALER (budesonide inhalation powder) for the first time, you must prime it.

To prime your PULMICORT FLEXHALER (budesonide inhalation powder) , follow the steps below:

1. Hold the inhaler by the brown grip so that the white cover points upward (upright position). With the other hand, turn the white cover and lift it off (see Figure 2).
2. Continue to hold your PULMICORT FLEXHALER (budesonide inhalation powder) upright as shown in figure 1. Use your other hand to hold the inhaler in the middle. Do not hold the inhaler at the top of the mouthpiece.
3. Twist the brown grip as far as it will go in one direction and then fully back again in the other direction until it stops (it does not matter which way you turn it first). You will hear a “click” during one of the twisting movements (see Figures 3 and 4).
4. Repeat Step 3. Your PULMICORT FLEXHALER (budesonide inhalation powder) is now primed. You are ready to load your first dose.

You do not have to prime your PULMICORT FLEXHALER (budesonide inhalation powder) again after this even if you do not use it for a long period of time.

1 Loading a dose

1. Hold your PULMICORT FLEXHALER (budesonide inhalation powder) upright as described above. With your other hand, twist the white cover and lift it off (see Figure 2).

Figure 2

2. Continue to hold your PULMICORT FLEXHALER (budesonide inhalation powder) upright to be sure that the right dose of medicine is loaded.

3. Use your other hand to hold the inhaler in the middle. Do not hold the mouthpiece when you load the inhaler.

4. Twist the brown grip fully in one direction as far as it will go. Twist it fully back again in the other direction as far as it will go (it does not matter which way you turn it first) [see Figure 3].

Figure 3

• You will hear a “click” during one of the twisting movements (see Figure 4).

Figure 4

• PULMICORT FLEXHALER (budesonide inhalation powder) will only give one dose at a time, no matter how often you click the brown grip, but the dose indicator will continue to move (advance). This means that if you continue to move the brown grip, it is possible for the indicator to show fewer doses or zero doses even if more doses are left in the inhaler.
• Do not shake the inhaler after loading it.

Figure 5
Inhaling a dose

1. Turn your head away from the inhaler and breathe out (exhale). If you accidentally blow into your inhaler after loading a dose, follow the instructions for loading a new dose.
2. Place the mouthpiece in your mouth and close your lips around the mouthpiece. Breathe in (inhale) deeply and forcefully through the inhaler (see Figure 5).
3. You may not sense the presence of any medication entering your lungs when inhaling from PULMICORT FLEXHALER (budesonide inhalation powder) . This lack of sensation does not mean that you did not get the medication. You should not repeat your inhalations even if you did not feel the medication when inhaling.
4. Do not chew or bite on the mouthpiece.
5. Remove the inhaler from your mouth and exhale. Do not blow or exhale into the mouthpiece.
6. If more than one dose is prescribed repeat the steps above.
7. When you are finished taking your dose place the white cover back on the inhaler and twist shut.
8. Rinse your mouth with water after each dose to decrease your risk of getting thrush. Do not swallow the water.

Reading the Dose Indicator Window

• The label on the box or cover will tell you how many doses are in your PULMICORT FLEXHALER.
• Your PULMICORT FLEXHALER (budesonide inhalation powder) has a dose indicator window just below the mouthpiece. The dose indicator tells you about how many doses are left in the inhaler. Look at the middle of the window to find out about how many doses are left in your inhaler (see Figure 6).

Figure 6

• The dose indicator is connected to the turning grip and moves (counts down) every time a dose is loaded. It is not likely that you will see the dose indicator move with each dose. You can usually see the indicator move each time you use about 5 doses.
• The dose indicator starts with either the number 60 or 120 when full, depending upon the strength of the inhaler. The indicator is marked in intervals of 10 doses. Markings are either with numbers or dashes (alternating), counting down to “0”.

• The dose indicator will tell you about how many doses are left in your PULMICORT FLEXHALER.
• If you complete the instructions for loading the dose more than one time before you inhale the dose, you will only receive one dose. The dose indicator will move a small amount but it is not likely that you will see the dose indicator move with each dose.
• Your inhaler is empty when the number 0 on the red background reaches the middle of the dose indicator window. Throw away this inhaler. The inhaler may not give you the right amount of medicine, even though it may not feel completely empty and may seem like it continues to work (see Figure 7).

Figure 7

• Do not put your PULMICORT FLEXHALER (budesonide inhalation powder) in water (do not immerse it) to find out if it is empty. Check the dose indicator window to see how many doses are left.
• Refill your PULMICORT FLEXHALER (budesonide inhalation powder) prescription before your medicine runs out. You will get a new inhaler each time you refill your prescription.

Cleaning your PULMICORT FLEXHALER (budesonide inhalation powder)

• Keep your PULMICORT FLEXHALER (budesonide inhalation powder) clean and dry at all times. Do not immerse it in water.
• Wipe the outside of the mouthpiece one time each week with a dry tissue.
• Do not use water or liquids when cleaning the mouthpiece.
• Do not try to remove the mouthpiece or twist it.

Do not use your PULMICORT FLEXHALER (budesonide inhalation powder) if it has been damaged or if the mouth piece has become detached. Talk to your healthcare provider or pharmacist if you have any problems with your PULMICORT FLEXHALER (budesonide inhalation powder) .

Last reviewed on RxList: 7/29/2010
This monograph has been modified to include the generic and brand name in many instances.