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Patient's Instructions For Use

Please read this leaflet carefully before you start to take your medicine. It provides a summary of information on your medicine. Following these instructions helps to ensure that you are inhaling the medication correctly.

FOR FURTHER INFORMATION ASK YOUR DOCTOR OR PHARMACIST.

WHAT YOU SHOULD KNOW ABOUT PULMICORT TURBUHALER (budesonide)

Your doctor has prescribed PULMICORT TURBUHALER 200 mcg. It contains a medication called budesonide, which is a synthetic corticosteroid. Corticosteroids are natural substances found in the body that help fight inflammation. They are used to treat asthma because they reduce the swelling and irritation in the walls of the small air passages in the lungs and ease breathing problems. When inhaled regularly, corticosteroids also help to prevent attacks of asthma.

PULMICORT TURBUHALER (budesonide) treats the inflammation—the “quiet part” of asthma that you cannot hear, see, or feel. When inflammation is left untreated, your asthma symptoms and attacks can increase. PULMICORT TURBUHALER (budesonide) works to prevent and reduce your asthma symptoms and attacks.

IMPORTANT POINTS TO REMEMBER ABOUT PULMICORT TURBUHALER (budesonide)

MAKE SURE that this medicine is suitable for you (see “BEFORE USING YOUR PULMICORT TURBUHALER (budesonide) ”).

It is important that you inhale each dose as your doctor has advised.

Use your Turbuhaler as directed by your doctor. DO NOT STOP TREATMENT OR REDUCE YOUR DOSE EVEN IF YOU FEEL BETTER, unless told to do so by your doctor.

DO NOT inhale more doses or use your Turbuhaler more often than instructed by your doctor.

This medicine is NOT intended to provide rapid relief of your breathing difficulties during an asthma attack. It must be taken at regular intervals as recommended by your doctor, and not as an emergency measure.

Your doctor may prescribe additional medication (such as bronchodilators) for emergency relief if an acute

If you also use another medicine by inhalation, you should consult your doctor for instructions on when to use it in relation to using your PULMICORT TURBUHALER (budesonide) .

BEFORE USING YOUR PULMICORT TURBUHALER (budesonide)

TELL YOUR DOCTOR BEFORE STARTING TO TAKE THIS MEDICINE IF YOU:

• are pregnant (or intending to become pregnant),
• are breast-feeding a baby,
• are allergic to budesonide or any other orally inhaled corticosteroid,
• have any infections,
• have or had tuberculosis,
• have osteoporosis,
• have recently been around anyone with chicken pox or measles,
• are planning to have surgery,
• have been taking an oral corticosteroid medicine like prednisone. You may have to follow specific instructions to avoid health risks associated with stopping the use of these types of medicines.

In some circumstances, this medicine may not be suitable and your doctor may wish to prescribe a different medicine. Make sure that your doctor knows what other medicines you are taking including prescription and non-prescription medicines, as well as any vitamins or dietary and herbal supplements.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF PULMICORT TURBUHALER (budesonide) ?

As with all inhaled corticosteroids, you should be aware of the following side effects:

• Increased wheezing right after taking PULMICORT TURBUHALER (budesonide) . Always have a short-acting bronchodilator medicine with you to treat sudden wheezing. Short-acting bronchodilator medicines help to relax the muscles around the airways in your lungs. Wheezing happens 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.
• Immune system effects and a higher chance of infections.
• Eye problems including glaucoma and cataracts. Eye examinations should be considered while using PULMICORT TURBUHALER (budesonide) .
• A child's growth should be checked regularly while taking PULMICOR TURBUHALER because of the potential for slowed growth.

Based on clinical trials, the most common side effects reported by patients using PULMICORT TURBUHALER (budesonide) are:

• respiratory infection
• headache
• flu symptoms
• sore throat
• sinusitis

These are not all of the possible side effects of PULMICORT TURBUHALER (budesonide) . For more information, ask your doctor, healthcare professional, or pharmacist.

USING YOUR PULMICORT TURBUHALER (budesonide)

• Follow the instructions shown in the section “HOW TO USE YOUR PULMICORT TURBUHALER”. If you have any problems, tell your doctor or pharmacist.
• It is important that you inhale each dose as directed by your doctor. The pharmacy label will usually tell you what dose to take and how often. If it doesn't, or you are not sure, ask your doctor or pharmacist.

DOSAGE

• Use as directed by your doctor.
• It is VERY IMPORTANT that you follow your doctor's instructions as to how many inhalations to take and how often to use your PULMICORT TURBUHALER (budesonide) .
• DO NOT inhale more doses or use your PULMICORT TURBUHALER (budesonide) more often than your doctor advises.
• It may take 1 to 2 weeks or longer before you feel maximum improvement, so IT IS VERY IMPORTANT THAT YOU USE PULMICORT TURBUHALER (budesonide) REGULARLY. DO NOT STOP TREATMENT OR REDUCE YOUR DOSE EVEN IF YOU ARE FEELING BETTER, unless told to do so by your doctor.
• If you miss a dose, just take your regularly scheduled next dose when it is due. DO NOT DOUBLE the dose.

HOW TO USE YOUR PULMICORT TURBUHALER (budesonide)

Read the complete instructions carefully and use only as directed.

PRIMING INSTRUCTIONS:

Before you use a new PULMICORT TURBUHALER (budesonide) for the first time, you should prime it. To do this, turn the cover and lift off. Hold PULMICORT TURBUHALER (budesonide) upright (with mouthpiece up), then twist the brown grip fully to the right and back again to the left. Repeat. Now you are ready to take your first dose (see instructions for “TAKING A DOSE”). You do not have to prime it any other time after this, even if you put it aside for a prolonged period of time.

TAKING A DOSE:

LOADING A DOSE

• Twist the cover and lift off.
• In order to provide the correct dose, PULMICORT TURBUHALER (budesonide) must be held in the upright position (mouthpiece up) whenever a dose of medication is being loaded.
• Twist the brown grip fully to the right as far as it will go. Twist it back again fully to the left.
• You will hear a click.

INHALING THE DOSE

• When you are inhaling, PULMICORT TURBUHALER (budesonide) must be held in the upright (mouthpiece up) or horizontal position.
• Turn your head away from the inhaler and breathe out. Do not shake the inhaler after loading it.
• Place the mouthpiece between your lips and inhale deeply and forcefully. You may not taste or feel the medication.
• Do not chew or bite on the mouthpiece.
• Remove the inhaler from your mouth and exhale. Do not blow or exhale into the mouthpiece.
• If more than one dose is required, just repeat the steps above.
• When you are finished, place the cover back on the inhaler and twist shut. Rinse your mouth with water. Do not swallow.
• Keep your PULMICORT TURBUHALER (budesonide) clean and dry at all times.
• Do not use PULMICORT TURBUHALER (budesonide) if it has been damaged or if the mouthpiece has become detached.

STORING YOUR PULMICORT TURBUHALER (budesonide)

• After each use, place the white cover back on and twist it firmly into place.
• Keep PULMICORT TURBUHALER (budesonide) in a dry place at controlled room temperature, 68-77°F (20-25°C).
• Keep your PULMICORT TURBUHALER (budesonide) in a secure place out of the reach of young children.
• DO NOT use after the date shown on the body of your Turbuhaler.

HOW TO KNOW WHEN YOUR PULMICORT TURBUHALER (budesonide) IS EMPTY

The label on the box or cover will tell you how many doses are in your PULMICORT TURBUHALER. Your PULMICORT TURBUHALER (budesonide) has a convenient dose indicator window just below the mouthpiece.

• When a red mark appears at the top of the window, there are 20 doses of medicine remaining. Now is the time to get your next PULMICORT TURBUHALER (budesonide) .
• When the red mark reaches the bottom of the window, your inhaler should be discarded as it may no longer deliver the correct amount of medication. (You may still hear a sound if you shake it—this sound is not the medicine. This sound is produced by the drying agent inside the Turbuhaler.)
• Remember, you will get a new inhaler each time you refill your prescription.
• Do not immerse it in water to find out if it is empty. Simply check your dose indicator window.

FURTHER INFORMATION ABOUT PULMICORT TURBUHALER (budesonide)

• PULMICORT TURBUHALER (budesonide) delivers your medicine as a very fine powder. Because of this, you may not taste, smell, or feel any medication entering your lungs when inhaling from PULMICORT TURBUHALER (budesonide) This does not mean that you are not getting your medication.
• PULMICORT TURBUHALER (budesonide) should not be used with a spacer.
• PULMICORT TURBUHALER contains only budesonide and does not contain any inactive ingredients.
• PULMICORT TURBUHALER (budesonide) is specially designed to deliver only one dose at a time, no matter how often you click the brown grip. If you accidentally blow into your inhaler after loading a dose, simply follow the instructions for loading a new dose.

This leaflet does not contain the complete information about your medicine. If you have any questions, or are not sure about something, then you should ask your doctor or pharmacist.

You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished your medicine.

REMEMBER: This medicine has been prescribed for you by your doctor. DO NOT give this medicine to anyone else.

USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR DOCTOR.

If you have further questions about the use of PULMICORT TURBUHALER (budesonide) , call: 1-800-236-9933.

Last reviewed on RxList: 9/11/2007
This monograph has been modified to include the generic and brand name in many instances.