How to Use DULERA

For complete instructions about using DULERA, please read the Patient Information.

Read this important information for details about using DULERA.

If your healthcare provider decides DULERA is right for you, take DULERA every day as 2 puffs in the morning and 2 puffs in the evening.

Before Using DULERA® (mometasone furoate and formoterol fumarate dihydrate)

Before using DULERA

Before using the inhaler, read the complete instructions that come with it and use it only as directed.

Remove the Cap From the Mouthpiece of the Actuator Before Using DULERA® (mometasone furoate and formoterol fumarate dihydrate) Remove the Cap From the Mouthpiece of the Actuator Before Using DULERA® (mometasone furoate and formoterol fumarate dihydrate)

Remove the cap from the mouthpiece of the inhaler. Check the mouthpiece for objects before use. Make sure the canister is fully inserted into the inhaler.

Do Not Remove the Canister From the Actuator Before Using DULERA® (mometasone furoate and formoterol fumarate dihydrate) Do Not Remove the Canister From the Actuator Before Using DULERA® (mometasone furoate and formoterol fumarate dihydrate)

Do not remove the canister from the actuator because:

  • You may not receive the correct amount of medication.
  • The dose counter may not function properly.
  • Reinsertion may cause the counter to count down by 1 and may discharge a puff.

Adults may assist children with using DULERA as prescribed. Children may use DULERA with or without a spacer device.

Follow these steps each time you use DULERA

Before You Use DULERA® (mometasone furoate and formoterol fumarate dihydrate) for the First Time You Must Prime the InhalerShake the Inhaler Well Before Each Use

PRIME

Before you use DULERA for the first time, you must prime the inhaler.

  • To prime the inhaler, hold it in the upright position and release 4 actuations (puffs) into the air, away from your face.
  • Shake the inhaler well before each of the priming puffs. The dose counter will initially show the number ‘64’ or ‘124’. After priming 4 times, the dose counter should read either ‘60’ or ‘120’.
  • If you do not use the inhaler for more than 5 days, you will need to prime it again before using.
  • Confirm that the strength indicated on the actuator and canister labels matches the prescribed dosage.

SHAKE

  • Take the cap off the mouthpiece. Check the mouthpiece for objects before use. Make sure the canister is fully loaded into the inhaler.
  • Shake the inhaler well before each use.

INHALE

  • Breathe out as much as you comfortably can through your mouth. Push out as much air from your lungs as possible. Hold the inhaler in the upright position and place the mouthpiece into your mouth. Close your lips around the mouthpiece.
  • Take a deep breath in slowly through your mouth. While doing this, press down firmly and fully on the top of the canister until it stops moving. Take your finger off the canister.
  • When you have finished breathing in, hold your breath as long as you can, without discomfort, up to 10 seconds. Then remove the inhaler from your mouth. At the same time, breathe out through your nose, while keeping your lips closed.
Hold the Inhaler in the Upright Position and Place the Mouthpiece Into Your Mouth

REPEAT

  • Wait at least 30 seconds to take your second puff of DULERA.
  • Each puff from the inhaler should be done in the same manner, following the same Shake and Inhale procedure.
  • Replace the cap over the mouthpiece right away after use.
  • After you have finished taking the 2 puffs of DULERA, rinse your mouth with water. Spit out the water. Do not swallow it.
Wait at Least 30 Seconds to Take Your Second Puff of DULERA® (mometasone furoate and formoterol fumarate dihydrate)

STORE

  • The 120-puff inhaler can be stored in any position. For the 60-puff inhaler, after priming, store the inhaler with the mouthpiece down or sideways.
  • Store your inhaler at room temperature.
The 120-actuation Inhaler Can Be Stored in any Position. For the 60-actuation Inhaler, After Priming, Store the Inhaler With the Mouthpiece Down or Sideways

Follow these steps each time you use DULERA

Before you use DULERA for the first time, you must prime the inhaler.

  • To prime the inhaler, hold it in the upright position and release 4 actuations (puffs) into the air, away from your face.
  • Shake the inhaler well before each of the priming puffs. The dose counter will initially show the number ‘64’ or ‘124’. After priming 4 times, the dose counter should read either ‘60’ or ‘120’.
  • If you do not use the inhaler for more than 5 days, you will need to prime it again before using.
  • Confirm that the strength indicated on the actuator and canister labels matches the prescribed dosage.
  • Take the cap off the mouthpiece. Check the mouthpiece for objects before use. Make sure the canister is fully loaded into the inhaler.
  • Shake the inhaler well before each use.
  • Breathe out as much as you comfortably can through your mouth. Push out as much air from your lungs as possible. Hold the inhaler in the upright position and place the mouthpiece into your mouth. Close your lips around the mouthpiece.
  • Take a deep breath in slowly through your mouth. While doing this, press down firmly and fully on the top of the canister until it stops moving. Take your finger off the canister.
  • When you have finished breathing in, hold your breath as long as you can, without discomfort, up to 10 seconds. Then remove the inhaler from your mouth. At the same time, breathe out through your nose, while keeping your lips closed.
  • Wait at least 30 seconds to take your second puff of DULERA.
  • Each puff from the inhaler should be done in the same manner, following the same Shake and Inhale procedure.
  • Replace the cap over the mouthpiece right away after use.
  • After you have finished taking the 2 puffs of DULERA, rinse your mouth with water. Spit out the water. Do not swallow it.
  • The 120-puff inhaler can be stored in any position. For the 60-puff inhaler, after priming, store the inhaler with the mouthpiece down or sideways.
  • Store your inhaler at room temperature.

When to replace the inhaler

  • It is important to pay attention to the number of inhalations (puffs) left in your DULERA inhaler by reading the counter.
  • With every puff the counter counts backwards.
  • When the dose counter shows the number 20, you should refill your prescription or ask your healthcare provider if you need a new prescription.
  • Throw away the inhaler after the counter reaches 0. The inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it.
When to Replace Your Inhaler

How to clean your inhaler

The mouthpiece should be cleaned using a dry wipe after every 7 days of use.

  • Remove the cap off the mouthpiece.
  • Wipe the inside and outside surfaces of the actuator mouthpiece with a clean, dry, lint-free tissue or cloth.
  • Do not wash or put any parts of your inhaler in water.
  • Put the cap back on the mouthpiece after cleaning.
  • Do not remove the canister from the actuator.
  • Do not attempt to unblock the actuator with a sharp object, such as a pin.

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Selected Important Safety Information about DULERA

DULERA contains formoterol. LABA medicines such as formoterol when used alone increase the risk of hospitalizations and death from asthma problems. DULERA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

  • Call your healthcare provider if breathing problems worsen over time while using DULERA. You may need different treatment.
  • Get emergency medical care if breathing problems worsen quickly, and you use your rescue inhaler medicine, but it does not relieve your breathing problems.

Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

DULERA does not replace rescue inhalers for sudden asthma symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms.

Do not use DULERA more often than prescribed. Do not take DULERA with other medicines that contain a LABA for any reason, as using too much LABA may cause chest pain, increase or decrease in blood pressure, fast and irregular heartbeat, headache, tremor, nervousness, dizziness, weakness, seizures, electrocardiogram (ECG) changes, or death. Tell your doctor about medicines you take and about all of your medical conditions.

People taking DULERA may experience

  • Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of these symptoms of a serious allergic reaction: rash, hives, swelling, including swelling of the face, mouth and tongue, or breathing problems.
  • Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of these symptoms of a serious allergic reaction: rash, hives, swelling, including swelling of the face, mouth and tongue, or breathing problems.
  • Thrush (yeast infection) in the mouth and throat. After each dose (2 puffs), rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat.
  • A higher chance of infection. Avoid exposure to chickenpox or measles. If exposed, or if you have any signs of infection, tell your healthcare provider immediately. Worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex may occur.
  • A higher chance of infection. Avoid exposure to chickenpox or measles. If exposed, or if you have any signs of infection, tell your healthcare provider immediately. Worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex may occur.
  • Reduced adrenal function (may result in loss of energy). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines.
  • Increase in wheezing right after taking DULERA.
  • Lower bone mineral density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
  • Slowed growth in children.
  • Eye problems including glaucoma, cataracts, and blurred vision. You should have regular eye exams while using DULERA.
  • Decrease in blood potassium and increase in blood sugar levels.

If you are switching to DULERA from an oral corticosteroid, follow your healthcare provider’s instructions to avoid serious health risks when you stop using oral corticosteroids.

The most common side effects of DULERA include inflammation of the nose and throat, inflammation of the sinuses, headache, flu, and upper respiratory infection.

You are encouraged to report the negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch or call 1.800.FDA.1088.

Please read the Patient Information for DULERA and discuss it with your doctor. The physician Prescribing Information also is available.


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