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This inhaler contains 2 medications: budesonide and formoterol. It is used regularly as a long-term (maintenance) treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Before using this medication, it is important to learn how to use it properly. This medication must be used regularly to prevent breathing problems.

This product may be prescribed to treat sudden breathing problems caused by asthma (asthma attack), even though formoterol is usually used to cause a slower, longer-lasting effect. To treat an asthma attack, your doctor may instruct you to use this product or a different quick-relief medicine/inhaler (such as salbutamol, terbutaline). If you have COPD, this product should not be used for sudden breathing problems. Your doctor should instruct you to use a different quick-relief medicine/inhaler for sudden COPD breathing problems. You should always have a quick-relief inhaler with you.

When used alone, long-acting beta agonists (such as formoterol) may rarely increase the risk of serious (sometimes fatal) asthma-related breathing problems. However, combination inhaled corticosteroid and long-acting beta agonists, such as this product, do not increase the risk of serious asthma-related breathing problems. For asthma treatment, this product should be used when breathing problems are not well controlled with one asthma-control medication (such as inhaled corticosteroid) or if your symptoms need combination treatment.

How to Use This Medication

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.

Inhale this medication as directed by your doctor, usually once or twice daily. The dosage is based on your medical condition and response to treatment.

Use this medication regularly to receive the most benefit from it. This medication works best if used at evenly spaced times. To help you remember, use it at the same time(s) each day. Do not increase your dose, use this medication more often, or stop using it without talking with your doctor. Also, do not use other long-acting beta agonists while using this medication.

If your doctor has instructed you to use this product for quick relief from an asthma attack, and symptoms continue after the first inhalation, you may use another inhalation after a few minutes. Do not use more than 6 inhalations to treat a single asthma attack. Get medical help right away if symptoms last or get worse.

Do not shake the inhaler. To use the inhaler, hold the inhaler upright. Unscrew and lift off the cover. Load the inhaler with a dose by turning the grip as far as it will go in one direction and then turning it back as far as it will go in the other direction. Breathe out. Never breathe out through the mouthpiece. Place the mouthpiece gently between your teeth and close your lips. Do not chew or bite on the mouthpiece. Forcefully and deeply inhale this medication by mouth. You may or may not taste/feel the drug when you inhale. Remove the inhaler from your mouth before breathing out. If your doctor has prescribed more than 1 inhalation, repeat these steps. Always replace the cover properly after using the inhaler.

After the inhaler is loaded, if you accidentally drop, shake, or breathe out into the inhaler, you will lose your dose. If this happens, you should load a new dose and inhale it.

If your prescribed dose is 2 puffs, wait at least one minute between them. If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug last.

To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle, rinse your mouth with water and spit out after each use. Do not swallow the rinse water.

To clean your inhaler, wipe the outside of the mouthpiece once a week with a dry tissue. Do not use water or other liquids. Do not take the inhaler apart.

If you are regularly taking corticosteroids by mouth (such as prednisone), continue to follow your doctor's instructions on taking them. Do not stop taking them. Your doctor may want you to reduce your dose gradually.

If you have been using a quick-relief inhaler (such as salbutamol) on a regular daily schedule (such as 4 times daily), you must stop this schedule and only use it as needed for sudden shortness of breath/asthma attacks. Consult your doctor for details.

Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

It may take 1 week or longer before the full benefit of this drug takes effect. Tell your doctor if your condition does not improve or if it worsens.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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