Symbicort 200 Turbuhaler

This section provides information on the proper use of a number of products that contain budesonide and formoterol. It may not be specific to Symbicort 200 Turbuhaler. Please read with care.

This medicine is used with a special inhaler and usually comes with patient directions or a Medication Guide. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

When you use the inhaler for the first time, or if you have not used it for 7 days or longer, or if the inhaler has been dropped, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine 2 times into the air away from the face, and shaking it well for 5 seconds before each spray.

How to use this medicine:

• Take the inhaler out of the moisture-protective foil pouch before you use it for the first time.
• Do not use the inhaler for this medicine with any other medicine.
• Prime the inhaler before use by shaking the inhaler well for 5 seconds and then releasing a test spray. Once again, shake the inhaler and release a second test spray.
• Breathe out to the end of a normal breath (exhale). Do not breathe into the inhaler.
• Holding the inhaler level, put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
• While pressing down firmly and fully on the grey top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
• Release your finger from the grey top and then turn your head away from the inhaler. Breathe out slowly to the end of a normal breath. Do not breathe into the inhaler.
• Shake the inhaler again for 5 seconds and take the second puff following exactly the same steps you used for the first puff.
• Replace the mouthpiece cover after using the medicine.
• Gargle and rinse your mouth with water after each dose. This will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.

Each inhaler comes with a dose tracker card to track the number of puffs you have used. Mark off or punch through each of your morning and evening doses. You must discard the inhaler after you have used the number of inhalations on the product label and box, or within 3 months of opening the foil pouch.

Clean the inhaler every 7 days by wiping the mouthpiece with dry cloth. However, you must use a new inhaler with each refill of your medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form (aerosol):
  • For preventing an asthma attack:
    • Adults and children 12 years of age and older—2 puffs in the morning and another 2 puffs in the evening. Each puff contains 80 or 160 micrograms (mcg) of budesonide and 4.5 mcg of formoterol.
    • Children 6 to 11 years of age—2 puffs in the morning and another 2 puffs in the evening. Each puff contains 80 mcg of budesonide and 4.5 mcg of formoterol.
    • Children younger than 6 years of age—Use and dose must be determined by your child's doctor.
  • For treatment of COPD:
    • Adults—2 puffs in the morning and another 2 puffs in the evening. Each puff contains 160 micrograms (mcg) of budesonide and 4.5 mcg of formoterol.
    • Children 6 years of age and older—Not used for COPD in this age group.
    • Children younger than 6 years of age—Not used for COPD in this age group.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

When you store the inhaler, make sure to always place the mouthpiece down.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Body aches or pain
• chills
• cough, fever, sneezing, or sore throat
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• muscle aches
• pain or tenderness around the eyes and cheekbones
• stuffy or runny nose
• tightness of the chest
• unusual tiredness or weakness

• Abdominal or stomach pain
• bladder pain
• bloody or cloudy urine
• congestion
• cough producing mucus
• diarrhea
• difficult, burning, or painful urination
• dryness of the throat
• fast, irregular, pounding, or racing heartbeat or pulse
• frequent urge to urinate
• general feeling of discomfort or illness
• hoarseness
• joint pain
• loss of appetite
• lower back or side pain
• nausea
• noisy breathing
• shakiness in the legs, arms, hands, or feet
• shivering
• sore mouth or tongue
• sweating
• tender, swollen glands in the neck
• trembling or shaking of the hands or feet
• trouble with sleeping
• trouble with swallowing
• voice changes
• vomiting
• white patches in the mouth or on the tongue

• Blurred vision
• confusion
• decreased urine
• dizziness or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• enlarged pupils
• fainting
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased sensitivity of the eyes to light
• increased sweating, possibly with fever or cold, clammy skin
• increased thirst
• increased urination
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle cramps
• nervousness
• numbness or tingling in the hands, feet, or lips
• pounding in the ears
• seizures
• severe chest pain
• severe headache
• slow, fast, pounding, or irregular heartbeat or pulse
• stiff or sore neck
• unexplained weight loss

• Blindness
• decreased vision
• eye pain
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• tearing

Get emergency help immediately if any of the following symptoms of overdose occur:

• Arm, back, or jaw pain
• chest pain or discomfort
• darkening of the skin
• drowsiness
• mental depression
• rapid, deep breathing
• restlessness
• skin rash
• stomach cramps
• trouble sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Stomach discomfort

• Acid or sour stomach
• belching
• difficulty with moving
• heartburn
• indigestion
• muscle spasms or stiffness
• pain in the arms or legs
• stomach upset
• swollen joints

• Bad, unusual, or unpleasant (after) taste
• change in taste
• deep or fast breathing with dizziness, numbness to feet, hands, and around the mouth
• fear
• hives or welts, itching skin
• irritability
• large, flat, blue, or purplish patches in the skin
• redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.