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Flovent Diskus

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Flovent Diskus

PATIENT INFORMATION

FLOVENT® DISKUS®
[flo'vent disk' us]
(fluticasone propionate) inhalation powder, 50 mcg

FLOVENT® DISKUS® 100 mcg
(fluticasone propionate) inhalation powder, 100 mcg

FLOVENT® DISKUS® 250 mcg
(fluticasone propionate) inhalation powder, 250 mcg

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

What is FLOVENT DISKUS?

FLOVENT DISKUS is a prescription inhaled corticosteroid (ICS) medicine for the long-term treatment of asthma in people aged 4 years and older.

  • ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
  • FLOVENT DISKUS is not used to relieve sudden breathing problems.
  • It is not known if FLOVENT DISKUS is safe and effective in children younger than 4 years of age.

Who should not use FLOVENT DISKUS?

Do not use FLOVENT DISKUS if you:

  • have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
  • are allergic to fluticasone propionate or any of the ingredients in FLOVENT DISKUS. See “What are the ingredients in FLOVENT DISKUS?” below for a complete list of ingredients.

What should I tell my healthcare provider before using FLOVENT DISKUS?

Tell your healthcare provider about all of your health conditions, including if you:

  • have liver problems.
  • have weak bones (osteoporosis).
  • have an immune system problem.
  • have eye problems such as glaucoma or cataracts.
  • are allergic to any of the ingredients in FLOVENT DISKUS, any other medicines, or food products. See “What are the ingredients in FLOVENT DISKUS?” below for a complete list of ingredients.
  • have any type of viral, bacterial, or fungal infection.
  • are exposed to chickenpox or measles.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if FLOVENT DISKUS may harm your unborn baby.
  • are breastfeeding. It is not known if the medicine in FLOVENT DISKUS passes into your milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FLOVENT DISKUS and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal or anti-HIV medicines.

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

How should I use FLOVENT DISKUS?

Read the step-by-step instructions for using FLOVENT DISKUS at the end of this Patient Information.

  • Do not use FLOVENT DISKUS unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • Children should use FLOVENT DISKUS with an adult's help, as instructed by the child's healthcare provider.
  • FLOVENT DISKUS comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
  • Use FLOVENT DISKUS exactly as your healthcare provider tells you to use it. Do not use FLOVENT DISKUS more often than prescribed.
  • It may take 1 to 2 weeks or longer after you start FLOVENT DISKUS for your asthma symptoms to get better. You must use FLOVENT DISKUS regularly.
  • Do not stop using FLOVENT DISKUS, even if you are feeling better, unless your healthcare provider tells you to.
  • If you miss a dose of FLOVENT DISKUS, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • FLOVENT DISKUS does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse.
    • you need to use your rescue inhaler more often than usual.
    • your rescue inhaler does not work as well to relieve your symptoms.
    • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
    • you use 1 whole canister of your rescue inhaler in 8 weeks.
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

What are the possible side effects with FLOVENT DISKUS?

FLOVENT DISKUS can cause serious side effects, including:

  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using FLOVENT DISKUS to help reduce your chance of getting thrush.
  • weakened immune system and increased chance of getting infections (immunosuppression)
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as FLOVENT DISKUS). When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death.
    Symptoms of adrenal insufficiency include:
  • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • hives
    • swelling of your face, mouth, and tongue
    • breathing problems
  • bone thinning or weakness (osteoporosis)
  • slowed growth in children. A child's growth should be checked often.
  • eye problems including glaucoma and cataracts. You should have regular eye exams while using FLOVENT DISKUS.
  • increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT DISKUS. Always have a rescue inhaler with you to treat sudden wheezing.

Common side effects of FLOVENT DISKUS include:

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

These are not all the side effects with FLOVENT DISKUS. Ask your healthcare provider or pharmacist for more information.

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

How should I store FLOVENT DISKUS?

  • Store FLOVENT DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
  • Store FLOVENT DISKUS in the unopened foil pouch and only open when ready for use.
  • Safely throw away FLOVENT DISKUS 50 mcg in the trash 6 weeks after you open the foil pouch or when the counter reads 0, whichever comes first.
  • Safely throw away FLOVENT DISKUS 100 mcg and FLOVENT DISKUS 250 mcg in the trash 2 months after you open the foil pouch or when the counter reads 0, whichever comes first.
  • Keep FLOVENT DISKUS and all medicines out of the reach of children.

General information about FLOVENT DISKUS

Medicines are sometimes prescribed for purposes not mentioned in a Patient Information leaflet. Do not use FLOVENT DISKUS for a condition for which it was not prescribed. Do not give your FLOVENT DISKUS to other people, even if they have the same condition that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about FLOVENT DISKUS. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about FLOVENT DISKUS that was written for healthcare professionals.

For more information about FLOVENT DISKUS, call 1-888-825-5249 or visit our website at www.floventdiskus.com.

What are the ingredients in FLOVENT DISKUS?

Active ingredient: fluticasone propionate

Inactive ingredient: lactose monohydrate (contains milk proteins)

Instructions for Use

For Oral Inhalation Only

Your FLOVENT DISKUS inhaler

Figure A

FLOVENT DISKUS inhaler - Illustration

Read this information before you start using your FLOVENT DISKUS inhaler:

  • Take FLOVENT DISKUS out of the foil pouch just before you use it for the first time. Safely throw away the pouch. The DISKUS will be in the closed position.
  • Write the date you opened the foil pouch in the first blank line on the label. See Figure A.
  • Write the “use by” date in the second blank line on the label. See Figure A. If you are using FLOVENT DISKUS 50 mcg, that date is 6 weeks after the date you wrote in the first line. If you are using FLOVENT DISKUS 100 mcg or 250 mcg, that date is 2 months after the date you wrote in the first line.
  • The counter should read 60. If you have a sample (with “Sample” on the back label) or institutional (with “INSTITUTIONAL PACK” on the foil pouch) pack, the counter should read 28.

How to use your FLOVENT DISKUS inhaler

Follow these steps every time you use FLOVENT DISKUS.

Step 1. Open your FLOVENT DISKUS.

  • Hold the DISKUS in your left hand and place the thumb of your right hand in the thumb grip. Push the thumb grip away from you as far as it will go until the mouthpiece shows and snaps into place. See Figure B.

Step 2. Slide the lever until you hear it click.

  • Hold the DISKUS in a level, flat position with the mouthpiece towards you. Slide the lever away from the mouthpiece as far as it will go until it clicks. See Figure C.
  • The number on the counter will count down by 1. The DISKUS is now ready to use.

Figure B

Push the thumb grip away - Illustration

Figure C

Slide the lever away - Illustration

Follow the instructions below so you will not accidentally waste a dose:

  • Do not close the DISKUS.
  • Do not tilt the DISKUS.
  • Do not move the lever on the DISKUS.

Step 3. Inhale your medicine.

  • Before you breathe in your dose from the DISKUS, breathe out (exhale) as long as you can while you hold the DISKUS level and away from your mouth. See Figure D. Do not breathe into the mouthpiece.
  • Put the mouthpiece to your lips. See Figure E. Breathe in quickly and deeply through the DISKUS. Do not breathe in through your nose.

Figure D

Hold the DISKUS level and away - Illustration

Figure E

Put the mouthpiece to your lips - Illustration

  • Remove the DISKUS from your mouth and hold your breath for about 10 seconds, or for as long as is comfortable for you.
  • Breathe out slowly as long as you can. See Figure D.
  • If your healthcare provider has told you to take more than 1 inhalation of FLOVENT DISKUS, repeat Steps 2 and 3.
  • The DISKUS delivers your dose of medicine as a very fine powder that you may or may not taste or feel. Do not take an extra dose from the DISKUS even if you do not taste or feel the medicine.

Step 4. Close the DISKUS.

  • Place your thumb in the thumb grip and slide it back towards you as far as it will go. See Figure F. Make sure the DISKUS clicks shut and you cannot see the mouthpiece.
  • The DISKUS is now ready for you to take your next scheduled dose in about 12 hours. When you are ready to take your next dose, repeat Steps 1 through 4.

Figure F

slide thumb grip back towards you - Illustration

Step 5. Rinse your mouth.

  • Rinse your mouth with water after breathing in the medicine. Spit out the water. Do not swallow it. See Figure G.

Figure G

Rinse your mouth - Illustration

When should you get a refill?

The counter on top of the DISKUS shows you how many doses are left. After you have taken 55 doses (23 doses from the sample or institutional pack), the numbers 5 to 0 will show in red. See Figure H. These numbers warn you there are only a few doses left and are a reminder to get a refill.

Figure H

The counter - Illustration

For correct use of the DISKUS, remember:

  • Always use the DISKUS in a level, flat position.
  • Make sure the lever firmly clicks into place.
  • Hold your breath for about 10 seconds after inhaling. Then breathe out fully.
  • After each dose, rinse your mouth with water and spit it out. Do not swallow the water.
  • Do not take an extra dose, even if you did not taste or feel the powder.
  • Do not take the DISKUS apart.
  • Do not wash the DISKUS.
  • Always keep the DISKUS in a dry place.
  • Do not use the DISKUS with a spacer device.

If you have questions about FLOVENT DISKUS or how to use your inhaler, call GlaxoSmithKline (GSK) at 1-888-825-5249 or visit www.floventdiskus.com.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Patient Information

FLOVENT® DISKUS®
[flovent disk' us] (fluticasone propionate) inhalation powder, 50 mcg

FLOVENT® DISKUS® 100 mcg
(fluticasone propionate) inhalation powder, 100 mcg

FLOVENT® DISKUS® 250 mcg
(fluticasone propionate) inhalation powder, 250 mcg

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

What is FLOVENT DISKUS?

FLOVENT DISKUS is a prescription inhaled corticosteroid (ICS) medicine for the long-term treatment of asthma in people aged 4 years and older.

  • ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
  • FLOVENT DISKUS is not used to relieve sudden breathing problems.
  • It is not known if FLOVENT DISKUS is safe and effective in children younger than 4 years of age.

Who should not use FLOVENT DISKUS?

Do not use FLOVENT DISKUS if you:

  • have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
  • are allergic to fluticasone propionate or any of the ingredients in FLOVENT DISKUS. See “What are the ingredients in FLOVENT DISKUS?” below for a complete list of ingredients.

What should I tell my healthcare provider before using FLOVENT DISKUS?

Tell your healthcare provider about all of your health conditions, including if you:

  • have liver problems.
  • have weak bones (osteoporosis).
  • have an immune system problem.
  • have eye problems such as glaucoma or cataracts.
  • are allergic to any of the ingredients in FLOVENT DISKUS, any other medicines, or food products. See “What are the ingredients in FLOVENT DISKUS?” below for a complete list of ingredients.
  • have any type of viral, bacterial, or fungal infection.
  • are exposed to chickenpox or measles.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if FLOVENT DISKUS may harm your unborn baby.
  • are breastfeeding. It is not known if the medicine in FLOVENT DISKUS passes into your milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FLOVENT DISKUS and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal or anti-HIV medicines.

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

How should I use FLOVENT DISKUS?

Read the step-by-step instructions for using FLOVENT DISKUS at the end of this Patient Information.

  • Do not use FLOVENT DISKUS unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • Children should use FLOVENT DISKUS with an adult's help, as instructed by the child's healthcare provider.
  • FLOVENT DISKUS comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
  • Use FLOVENT DISKUS exactly as your healthcare provider tells you to use it. Do not use FLOVENT DISKUS more often than prescribed.
  • It may take 1 to 2 weeks or longer after you start FLOVENT DISKUS for your asthma symptoms to get better. You must use FLOVENT DISKUS regularly.
  • Do not stop using FLOVENT DISKUS, even if you are feeling better, unless your healthcare provider tells you to.
  • If you miss a dose of FLOVENT DISKUS, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • FLOVENT DISKUS does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse.
    • you need to use your rescue inhaler more often than usual.
    • your rescue inhaler does not work as well to relieve your symptoms.
    • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
    • you use 1 whole canister of your rescue inhaler in 8 weeks.
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

What are the possible side effects with FLOVENT DISKUS?

FLOVENT DISKUS can cause serious side effects, including:

  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using FLOVENT DISKUS to help reduce your chance of getting thrush.
  • weakened immune system and increased chance of getting infections (immunosuppression)
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as FLOVENT DISKUS). When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death.
    Symptoms of adrenal insufficiency include:
    • feeling tired
    • lack of energy
    • weakness
    • nausea and vomiting
    • low blood pressure
  • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • hives
    • swelling of your face, mouth, and tongue
    • breathing problems
  • bone thinning or weakness (osteoporosis)
  • slowed growth in children. A child's growth should be checked often.
  • eye problems including glaucoma and cataracts. You should have regular eye exams while using FLOVENT DISKUS.
  • increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT DISKUS. Always have a rescue inhaler with you to treat sudden wheezing.

Common side effects of FLOVENT DISKUS include:

  • upper respiratory tract infection
  • throat irritation
  • nausea and vomiting
  • fever
  • headache

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

These are not all the side effects with FLOVENT DISKUS. Ask your healthcare provider or pharmacist for more information.

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

How should I store FLOVENT DISKUS?

  • Store FLOVENT DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
  • Store FLOVENT DISKUS in the unopened foil pouch and only open when ready for use.
  • Safely throw away FLOVENT DISKUS 50 mcg in the trash 6 weeks after you open the foil pouch or when the counter reads 0, whichever comes first.
  • Safely throw away FLOVENT DISKUS 100 mcg and FLOVENT DISKUS 250 mcg in the trash 2 months after you open the foil pouch or when the counter reads 0, whichever comes first.
  • Keep FLOVENT DISKUS and all medicines out of the reach of children.

General information about FLOVENT DISKUS

Medicines are sometimes prescribed for purposes not mentioned in a Patient Information leaflet. Do not use FLOVENT DISKUS for a condition for which it was not prescribed. Do not give your FLOVENT DISKUS to other people, even if they have the same condition that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about FLOVENT DISKUS. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about FLOVENT DISKUS that was written for healthcare professionals.

For more information about FLOVENT DISKUS, call 1-888-825-5249 or visit our website at www.floventdiskus.com.

What are the ingredients in FLOVENT DISKUS?

Active ingredient: fluticasone propionate

Inactive ingredient: lactose monohydrate (contains milk proteins)

Instructions for Use

For Oral Inhalation Only

Your FLOVENT DISKUS inhaler

Figure A

FLOVENT DISKUS inhaler - Illustration

Read this information before you start using your FLOVENT DISKUS inhaler:

  • Take FLOVENT DISKUS out of the foil pouch just before you use it for the first time. Safely throw away the pouch. The DISKUS will be in the closed position.
  • Write the date you opened the foil pouch in the first blank line on the label. See Figure A.
  • Write the “use by” date on the second blank line in the label. See Figure A. If you are using FLOVENT DISKUS 50 mcg, that date is 6 weeks after the date you wrote in the first line. If you are using FLOVENT DISKUS 100 mcg or 250 mcg, that date is 2 months after the date you wrote in the first line.
  • The counter should read 60. If you have a sample (with “Sample” on the back label) or institutional (with “INSTITUTIONAL PACK” on the foil pouch) pack, the counter should read 28.

How to use your FLOVENT DISKUS inhaler

Follow these steps every time you use FLOVENT DISKUS.

Step 1. Open your FLOVENT DISKUS.

  • Hold the DISKUS in your left hand and place the thumb of your right hand in the thumb grip. Push the thumb grip away from you as far as it will go until the mouthpiece shows and snaps into place. See Figure B.

Step 2. Slide the lever until you hear it click.

  • Hold the DISKUS in a level, flat position with the mouthpiece towards you. Slide the lever away from the mouthpiece as far as it will go until it clicks. See Figure C.
  • The number on the counter will count down by 1. The DISKUS is now ready to use.

Figure B

Push the thumb grip away - Illustration

Figure C

Slide the lever away - Illustration

Follow the instructions below so you will not accidentally waste a dose:

  • Do not close the DISKUS.
  • Do not tilt the DISKUS.
  • Do not move the lever on the DISKUS.

Step 3. Inhale your medicine.

  • Before you breathe in your dose from the DISKUS, breathe out (exhale) as long as you can while you hold the DISKUS level and away from your mouth. See Figure D. Do not breathe into the mouthpiece.
  • Put the mouthpiece to your lips. See Figure E. Breathe in quickly and deeply through the DISKUS. Do not breathe in through your nose.

Figure D

Hold the DISKUS level and away - Illustration

Figure E

Put the mouthpiece to your lips - Illustration

  • Remove the DISKUS from your mouth and hold your breath for about 10 seconds, or for as long as is comfortable for you.
  • Breathe out slowly as long as you can. See Figure D.
  • If your healthcare provider has told you to take more than 1 inhalation of FLOVENT DISKUS, repeat Steps 2 and 3.
  • The DISKUS delivers your dose of medicine as a very fine powder that you may or may not taste or feel. Do not take an extra dose from the DISKUS if you do not taste or feel the medicine.

Step 4. Close the DISKUS.

  • Place your thumb in the thumb grip and slide it back towards you as far as it will go. See Figure F. Make sure the DISKUS clicks shut and you cannot see the mouthpiece.
  • The DISKUS is now ready for you to take your next scheduled dose in about 12 hours. When you are ready to take your next dose, repeat Steps 1 through 4.

Figure F

slide thumbgrip back towards you - Illustration

Step 5. Rinse your mouth.

  • Rinse your mouth with water after breathing in the medicine. Spit out the water. Do not swallow it. See Figure G.

When should you get a refill?

The counter on top of the DISKUS shows you how many doses are left. After you have taken 55 doses (23 doses from the sample or institutional pack), the numbers 5 to 0 will show in red. See Figure H. These numbers warn you there are only a few doses left and are a reminder to get a refill.

Figure H

The counter - illustration

For correct use of the DISKUS, remember:

  • Always use the DISKUS in a level, flat position.
  • Make sure the lever firmly clicks into place.
  • Hold your breath for about 10 seconds after inhaling. Then breathe out fully.
  • After each dose, rinse your mouth with water and spit it out. Do not swallow the water.
  • Do not take an extra dose, even if you did not taste or feel the powder.
  • Do not take the DISKUS apart.
  • Do not wash the DISKUS.
  • Always keep the DISKUS in a dry place.
  • Do not use the DISKUS with a spacer device.

If you have questions about FLOVENT DISKUS or how to use your inhaler, call GlaxoSmithKline (GSK) at 1-888-825-5249 or visit www.floventdiskus.com.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 4/29/2014
This monograph has been modified to include the generic and brand name in many instances.

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Flovent Diskus - User Reviews

Flovent Diskus User Reviews

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Here is a collection of user reviews for the medication Flovent Diskus sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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