Mometasone, Inhalation

________________________________________________________________________

KEY POINTS

• This medicine is inhaled through the mouth to prevent asthma attacks. Use it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: corticosteroid; controller

Generic and brand names: mometasone, inhalation; Asmanex HFA; Asmanex Twisthaler

What is this medicine used for?

This medicine is a steroid that is inhaled through the mouth as long-term treatment to prevent asthma attacks. You may be able to reduce the dose of other steroids that you take in pill form to treat asthma.

This medicine will not stop asthma attacks that have already started. Your healthcare provider will prescribe another medicine to be used during an attack.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have:

• An allergy any medicine, or to lactose or milk
• Eye problems such as glaucoma or cataracts
• Liver disease
• Osteoporosis or other problems with bone density
• Tuberculosis

Also tell your provider if you have recently had an infection.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant while using this medicine. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while using this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Use this medicine regularly and exactly as your healthcare provider prescribes. You may feel better in a day or two, or you may need to use the medicine for 1 week or more to receive its full benefit. Do not use more of it or use it more often than prescribed. Do not use this medicine for other conditions unless your healthcare provider approves. Do not stop using this medicine without your provider's approval. Continue to take any other medicines that your healthcare provider has prescribed.

An adult should supervise the use of this medicine by a child.

If you have the Asmanex Twisthaler, check with your healthcare provider before using this medicine in children under age 4 years. Do not remove the canister from the actuator. You may not get the correct dose of medicine and it will not keep track of your doses.

If you have the Asmanex HFA, check with your provider before using in children under age 12. Before using the Asmanex HFA, shake well and remove the cap from the mouthpiece.

Rinse your mouth with water and spit out the rinse right after you use this medicine to help prevent thrush (a fungal infection that shows up as white spots on your tongue and in your mouth).

If you are using other inhaled medicines, ask your healthcare provider or pharmacist which you should use first.

What if I miss a dose?

If you miss a dose, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

If you have switched from steroid tablets taken by mouth to this medicine, you may need extra doses of steroid tablets during periods of stress such as injury, surgery, infection, or severe asthma attacks. Talk with your healthcare provider about this.

Do not use this medicine for sudden breathing problems or asthma attacks that have already started. Your healthcare provider will prescribe a short-acting inhaled medicine to use when you have an asthma attack.

This medicine may cause an increase in wheezing or trouble breathing right after using the medicine. You should always have a fast-acting inhaled bronchodilator medicine with you to treat sudden wheezing. Talk with your healthcare provider about this.

Treatment with this medicine may affect bone density. Your healthcare provider may order tests to determine if this medicine is affecting your bones.

This medicine may affect growth in children. Talk to your healthcare provider about this.

You may get infections more easily when you are taking this medicine. Infections may be more serious than usual while you are using this medicine. Stay away from people with colds, flu, or other infections. If you are exposed to an infectious disease such as chickenpox, measles, or pneumonia while taking this medicine, contact your healthcare provider right away. Also, do not have any vaccines without getting your healthcare provider's approval first.

If you use this medicine for a long time, you will need to have checkups regularly to see how this medicine affects you. Keep all appointments.

Contact your healthcare provider if your symptoms do not improve in 2 weeks or if they get worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. Carry an ID card or wear a medical ID bracelet or necklace that says you have asthma and are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Sore throat, cough, fever, chills, shortness of breath, increased trouble breathing, changes in vision, unusual tiredness or weakness, severe nausea or vomiting, severe dizziness or fainting, painful white or red patches inside your mouth.

Other: headache, nausea, vomiting, runny or stuffy nose, dry throat, hoarseness, muscle or joint pain, back pain, painful menstrual periods, heartburn.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Aldesleukin (Proleukin)
• Antibiotics such as clarithromycin (Biaxin) and telithromycin (Ketek)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Oravig), posaconazole (Noxafil), and voriconazole (Vfend)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Nefazodone
• Ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Write down the date when you first open the foil package. Dispose of the Twisthaler 45 days after this day or when the dose counter reads 00, whichever comes first.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.