Patient Information®
ASMANEX HFA (AZ-ma-neks) 50 mcg®
ASMANEX HFA 100 mcg®
ASMANEX HFA 200 mcg(mometasone furoate)
Inhalation Aerosol
What is ASMANEX HFA?
ASMANEX HFA is an inhaled corticosteroid (ICS) prescription medicine used as maintenance treatment for the prevention
and control of asthma symptoms in people 5 years of age and older.
 ASMANEX HFA is not used to treat sudden severe symptoms of asthma.
 ASMANEX HFA should not be used as a rescue inhaler.
 It is not known if ASMANEX HFA is safe and effective in children less than 5 years of age.
Who should not use ASMANEX HFA?
Do not use ASMANEX HFA:
 to treat sudden severe symptoms of asthma.
 if you are allergic to mometasone furoate or any of the ingredients in ASMANEX HFA. See the end of this Patient
Information leaflet for a complete list of ingredients in ASMANEX HFA.
What should I tell my doctor before and during treatment with ASMANEX HFA?
Before you use ASMANEX HFA, tell your healthcare provider if you: have liver problems.
 have osteoporosis.
 have an immune system problem.
 have eye problems such as increased pressure in the eye, glaucoma, cataracts, blurred vision, or other changes in yourvision.
 are allergic to any medicines.
 are exposed to chickenpox or measles.
 have or had tuberculosis (TB).
 have any other medical problems.
 are pregnant or planning to become pregnant. It is not known if ASMANEX HFA may harm your unborn baby.
 are breastfeeding. It is not known if ASMANEX HFA passes into your breast milk and if it can harm your baby. You andyour healthcare provider should decide if you will either take ASMANEX HFA or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
ASMANEX HFA may affect the way other medicines work, and other medicines may affect how ASMANEX HFA works.
Especially, tell your healthcare provider if you take antifungal medicines, antibiotic medicines, or anti-HIVmedicines such as: ritonavir
 ketoconazole nefazodone nelfinavir
 indinavir
 atazanavir
 clarithromycin
 saquinavir telithromycin itraconazole
 cobicistatcontaining
products
Ask your healthcare provider if you are not sure if any of your medicines are the kinds listed above.
For some medicines (including medicines for HIV such as ritonavir, cobicistat-containing products, and certain antifungals
and antibiotics) your doctor may wish to monitor you carefully.
Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a newmedicine.
How should I use ASMANEX HFA?
Read the step-by-step instructions for using ASMANEX HFA in the Instructions for Use.
 Use ASMANEX HFA exactly as prescribed. Do not use ASMANEX HFA more often than prescribed.
 You must use ASMANEX HFA regularly. It may take 1 week or longer after you start using ASMANEX HFA for yourasthma symptoms to get better. Do not stop using ASMANEX HFA even if you are feeling better, unless your healthcare
provider tells you to.
 Do not change or stop using ASMANEX HFA or other asthma medicines used to control or treat your breathingproblems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines asneeded.
 ASMANEX HFA comes in 3 strengths. Your healthcare provider has prescribed the strength that is best for you. Pay
attention to the differences between ASMANEX HFA and your other inhaled medicines, including their prescribed use
and the way they look.
 For children aged 5 to less than 12 years, use ASMANEX HFA 50 mcg.
 For adults and adolescents 12 years of age and older, use ASMANEX HFA 100 mcg or 200 mcg.
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 Take ASMANEX HFA every day, with 2 puffs in the morning and 2 puffs in the evening.
 If you miss a dose of ASMANEX HFA, skip your missed dose and take your next dose at your regular time. Do not take
ASMANEX HFA more often or use more puffs than you have been prescribed.
 If you take more ASMANEX HFA than your healthcare provider has prescribed, call your healthcare provider right away.
 ASMANEX HFA does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden
symptoms. Use your rescue inhaler if you have breathing problems between doses of ASMANEX HFA. If you do nothave a rescue inhaler, call your healthcare provider to have a rescue inhaler prescribed for you.
 Do not use the ASMANEX HFA canister or actuator with any other medicines. Do not use any other medicine canisteror actuator with ASMANEX HFA.
 Rinse your mouth with water after each dose (2 puffs) of ASMANEX HFA. Spit out the water. Do not swallow it. This will
help to lessen the chance of getting a yeast infection (thrush) in your mouth and throat.
 Do not spray ASMANEX HFA in your eyes. If you accidentally get ASMANEX HFA in your eyes, rinse your eyes withwater and if redness or irritation continues, call your healthcare provider.
 Call your healthcare provider or get medical care right away if:o your breathing problems worsen with ASMANEX HFAo you need to use your rescue inhaler more often than usualo your rescue inhaler does not work as well for you at relieving symptoms
o you need to use 4 or more inhalations of your rescue inhaler for 2 or more days in a row
o you use 1 whole canister of your rescue inhaler within 8 weeks
o your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
o you have asthma and your symptoms do not improve after using ASMANEX HFA regularly for 1 to 2 weeks
What are the possible side effects of ASMANEX HFA?
ASMANEX HFA can cause serious side effects, including Thrush in your mouth and throat. You may develop thrush, a yeast infection (Candida albicans), in your mouth or
throat. After each dose (2 puffs) of ASMANEX HFA, rinse your mouth with water. Spit out the water. Do not swallow it.
This will help to prevent thrush in your mouth or throat.
 Immune system effects and a higher chance for infections.
Tell your healthcare provider about any signs of infection such as:o fevero feeling tiredo body aches
o vomiting o paino nauseao chills
 Adrenal insufficiency that can lead to death can happen when you stop taking oral corticosteroid medicines and start
using inhaled corticosteroid medicines. Adrenal insufficiency can also happen in people who take higher doses of
ASMANEX HFA than recommended over a long period of time. When your body is under stress such as from fever,trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse. Symptoms of adrenal
insufficiency include:
o feeling tired or exhausted (fatigue)o lack of energy
o low blood pressure (hypotension)o weaknesso nausea and vomitingo dizziness or feeling faint Increased wheezing right after taking ASMANEX HFA. Always have a rescue inhaler with you to treat suddenwheezing.
 Serious allergic reactions. Stop taking ASMANEX HFA and call your healthcare provider or get emergency medicalcare right away if you get any of the following symptoms of a serious allergic reaction:o rasho hiveso swelling, including swelling of the face, mouth, and tongue
o breathing problems
 Lower bone mineral density. This may be a problem for people who already have a higher chance for low bonedensity (osteoporosis).
 Slowed growth in children. A child’s growth should be checked often.
 Eye problems including glaucoma, cataracts, and blurred vision. You should have regular eye exams while using
ASMANEX HFA.
The most common side effects reported while using ASMANEX HFA include: inflammation of the nose and throat (nasopharyngitis) headache flu infection (influenza) inflammation of the sinuses (sinusitis)
 bronchitis
Other side effects: Worsening asthma or sudden asthma attacks have been reported with the use of inhaledmometasone furoate.
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 ASMANEX HFA. 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 ASMANEX HFA?
 Store ASMANEX HFA at room temperature between 68°F to 77°F (20°C to 25°C).
 The contents of your ASMANEX HFA are under pressure. Do not puncture. Do not use or store near heat or openflame. Storage above 120°F may cause the canister to burst.
 Do not throw container into fire or incinerator.
 Keep ASMANEX HFA and all medicines out of the reach of children.

2General Information about the safe and effective use of ASMANEX HFA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use
ASMANEX HFA for a condition for which it was not prescribed. Do not give your ASMANEX HFA 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 ASMANEX HFA. If you would like more
information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information aboutASMANEX HFA that was written for healthcare professionals.
For more information about ASMANEX HFA go to www.ASMANEX.com, or to report side effects call 1-844-674-3200.
What are the ingredients in ASMANEX HFA?
Active ingredient: mometasone furoate
Inactive ingredients: hydrofluoroalkane (HFA-227: 1,1,1,2,3,3,3-heptafluoropropane), ethanol and oleic acid
This Patient Information has been approved by the U.S. Food and Drug Administration.

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Revised Date: 6/2021

Instructions for Use®
ASMANEX HFA (AZ-ma-neks) 50 mcg®
ASMANEX HFA 100 mcg®
ASMANEX HFA 200 mcg(mometasone furoate)
Inhalation Aerosol
Read these Instructions for Use before you start using ASMANEX HFA and each time you get a refill.
There may be new information. This leaflet does not take the place of talking to your healthcare provider
about your medical condition or your treatment.
The parts of your ASMANEX HFA:
There are 2 main parts to your ASMANEX HFA inhaler: the metal canister that holds the medicine andthe blue plastic actuator that sprays the medicine from the canister.
 The inhaler also has a pink cap that covers the mouthpiece of the actuator (see Figure 1). The
cap from the mouthpiece must be removed before use. The inhaler contains “120” actuations(puffs).

Figure 1


The inhaler comes with a dose counter located on the plastic actuator (see Figure 1). The
counter display will show the number of actuations (puffs) of medicine remaining. The first time
you use ASMANEX HFA the dose counter will show “124” actuations remaining. Each time youpress the canister, a puff of medicine is released and the counter will count down by 1. Thecounter will stop counting at 0.

Important Information:
 Use ASMANEX HFA exactly as your healthcare provider tells you to. Adults may assist children
with using ASMANEX HFA as prescribed. Children may use ASMANEX HFA with or without aspacer device.
 Remove the cap from the mouthpiece of the actuator before using ASMANEX HFA.
 Do not remove the canister from the actuator because:o you may not receive the correct amount of medication.
o the dose counter may not function properly.
o if you try to insert the canister back into the actuator this may cause the dose counter tocount down by 1 and may discharge a puff.
 Use the ASMANEX HFA canister only with the actuator supplied with the product. Do not use
parts of the ASMANEX HFA inhaler with parts from any other inhalation medicine.
Before using your ASMANEX HFA:
Remove the cap from the mouthpiece of the actuator before using ASMANEX HFA (see Figure 2).
Check the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator.

4Figure 2
Priming your ASMANEX HFA Inhaler:
Before you use ASMANEX HFA for the first time, you must prime the inhaler.
1. To prime the inhaler, hold it in the upright position away from your face, and press down firmly
and fully on the top of the canister until it stops moving in the actuator. Do this 4 times to releasea total of 4 actuations (puffs) into the air.
2. Shake the inhaler well before each of the priming actuations. After priming 4 times, the dosecounter should read “120”.
3. If you do not use your ASMANEX HFA for more than 5 days, you will need to prime it again
before use.
Using your ASMANEX HFA:
4. Confirm that the strength indicated on the actuator and canister labels matches the prescribeddosage.
5. Remove the cap from the mouthpiece of the actuator (see Figure 3). Check the mouthpiecefor objects before use. Make sure the canister is fully inserted into the actuator.
6. Shake the inhaler well before each use.
7. Breathe out as fully as you comfortably can through your mouth. Push out as much air from yourlungs as possible. Hold the inhaler in the upright position and place the mouthpiece into yourmouth (see Figure 4). Close your lips around the mouthpiece.

Figure 3

Figure 4

8. Take a deep breath (inhale) in slowly through your mouth. While doing this, press down firmly andfully on the top of the canister until it stops moving in the actuator. Take your finger off thecanister.
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9. When you have finished breathing in, hold your breath as long as you comfortably can, up to 10
seconds. Then remove the inhaler from your mouth and breathe out through your nose, whilekeeping your lips closed.
10. Wait at least 30 seconds to take your second puff of ASMANEX HFA.
11. Shake the inhaler well again and repeat steps 6 through 8 to take your second puff of ASMANEX
HFA.
After using your ASMANEX HFA inhaler:
12. Replace the cap over the mouthpiece right away after use (see Figure 5).

Figure 5
13. After you finish taking ASMANEX HFA (2 puffs), rinse your mouth with water.
Reading the counter:
The dose counter identifies the number of inhalations (puffs) left in your inhaler (see Figure 6).

The counter will count down each time you release a puff of medicine (either when preparing yourASMANEX HFA inhaler for use or when using the medicine).

Figure 6
When to replace your ASMANEX HFA:
It is important that you pay attention to the number of inhalations (puffs) left in your ASMANEX
HFA inhaler by reading the counter.

6When the counter reads “20”, you should refill your prescription or ask your healthcare provider if
you need a new prescription for ASMANEX HFA.

Throw away ASMANEX HFA after the counter reaches “0”, indicating that you have used thenumber of actuations on the product label and box. Your 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.

Never try to change the numbers on the counter or remove the counter from the actuator.

Do not use the inhaler after the expiration date.

How to clean your ASMANEX HFA:The mouthpiece should be cleaned using a dry wipe after every 7 days of use.
Routine cleaning instructions:Remove the cap off the mouthpiece. Wipe the inside and outside surfaces of the actuatormouthpiece with a clean, dry, lint-free tissue or cloth. Do not wash or put any parts of yourinhaler 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.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by: Kindeva Drug Delivery Limited, Loughborough, United Kingdom.
For patent information: www.organon.com/our-solutions/patent/
The trademarks depicted herein are owned by their respective companies.
Copyright © 2021 Organon Global Inc.
All rights reserved.
Revised: 6/2021
usppi-og0887-ao-2106r000

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