This combination product contains two medications: indacaterol and mometasone. This medication is used to treat asthma for adults and adolescents over the age of 12 with reversible obstructive airways disease. Indacaterol belongs to the group of medications known as long-acting bronchodilators. It works by relaxing the muscles surrounding the airways and allowing the airways to open. Mometasone belongs to the group of medications known as corticosteroids. It works by reducing the swelling in the airways of the lungs.

When combined, these medications help to control the symptoms of asthma and prevent asthma attacks. These medications work in different ways to relax the muscles in the walls of the small air passages in the lungs, keeping the airways open and making it easier to breathe.

Indacaterol - mometasone is most beneficial for adults and adolescents who are still experiencing asthma symptoms after using appropriate doses of inhaled corticosteroids or those who may benefit from a long-acting bronchodilator in combination with corticosteroid.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Indacaterol - mometasone is inhaled into the lungs through the mouth using the Breezhaler™ inhaler device. Do not swallow the capsules.

The starting dose of indacaterol - mometasone is based on your current dose of mometasone and the severity of your asthma symptoms. Your doctor will determine the correct dose for you.

The contents of one capsule are to be inhaled once daily at the same time of the day each day, using the Breezhaler™ inhaler device that comes in the package with the medication. Your health care professional should show you how to use the device. If you are not sure about how to use the device, contact your doctor or pharmacist for advice.

Indacaterol - mometasone is intended as a preventative medication only. Do not use it to relieve difficulty breathing. If you need fast relief from asthma symptoms, use your fast-acting "reliever" (or "rescue") medication such as formoterol, terbutaline, or salbutamol.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

When used regularly, this medication helps to prevent episodes of severe difficulty breathing. Regular daily use is important for its effectiveness, even when you are not experiencing any symptoms. After inhaling the dose, rinse your mouth with water and spit it out.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature. Protect it from light and moisture by keeping the capsules in the blister until you are ready to use a dose. Keep this and all medications out of the reach of children. Discard the old inhaler device and use the new one that comes with each package of medication.

150/80 µg
Each hard gelatin capsule containing powder for inhalation, contains 173 µg of indacaterol acetate equivalent to 150 µg of indacaterol and 80 µg of mometasone furoate. The delivered dose of 150/80 µg (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 µg indacaterol, and 62.5 µg mometasone furoate. Nonmedicinal ingredients: gelatin and lactose (as monohydrate).

150/160 µg
Each hard gelatin capsule containing powder for inhalation, contains 173 µg of indacaterol acetate equivalent to 150 µg of indacaterol and 160 µg of mometasone furoate. The delivered dose of 150/160 µg (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 µg indacaterol, and 127.5 µg mometasone furoate. Nonmedicinal ingredients: gelatin and lactose (as monohydrate).

150/320 µg
Each hard gelatin capsule containing powder for inhalation, contains 173 µg of indacaterol acetate equivalent to 150 µg of indacaterol and 320 µg of mometasone furoate. The delivered dose of 150/320 µg (the dose that leaves the mouthpiece of the inhaler) is equivalent to 125 µg indacaterol, and 260 µg mometasone furoate. Nonmedicinal ingredients: gelatin and lactose (as monohydrate).

Do not take this medication if you are allergic to indacaterol - mometasone or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• headache
• hoarseness or voice changes
• itching skin
• muscle, bone, and joint pain
• muscle spasms
• pain and irritation in the back of the mouth and throat
• sore throat

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• fast heartbeat
• rash
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• white patches in the mouth or throat (thrush)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of angioedema (e.g., swollen mouth, lips, tongue, difficulty swallowing or breathing)
• sudden worsening of shortness of breath after using inhaler

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Asthma-related deaths: Indacaterol, as with other long-acting bronchodilators, may increase the risk of asthma-related deaths. It is not clear whether using corticosteroids, such as mometasone, reduces this risk. If you have concerns, speak with your doctor.

Bone health: Long-term use of inhaled corticosteroids has been associated with a decrease in bone density. This may lead to brittle bones or osteoporosis. If you have risk factors for thinning or brittle bones, such as a slight build; long-term, regular alcohol use; poor nutrition; or a family history of osteoporosis, you may be at a greater risk of thinning bones. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diabetes: Indacaterol - mometasone may cause changes in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease: This medication may cause increases in heart rate and blood pressure for some people. If you have heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart rhythm: Indacaterol - mometasone can cause changes to the normal rate and rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), or are taking other medications that can cause heart rhythm problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infections: Thrush infections of the inside of the mouth and throat may occur with use of this medication. If an infection develops, call your doctor. You can reduce the risk of infection by rinsing your mouth out with water after each dose and by practicing good oral hygiene. Also, tell your doctor if you are exposed to chickenpox or measles while using this medication, as you may be more prone to infection.

Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways, which make breathing difficult. If you experience this problem when using indacaterol - mometasone, stop using this medication immediately. Speak to your doctor if you experience any problems with breathing while taking this or other inhaled medication.

Liver function: Liver disease or reduced liver function may cause mometasone to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Prevention only: Indacaterol - mometasone is not useful for treating acute symptoms (as a "rescue" medication). It is meant for prevention purposes only. Short-acting medications such as salbutamol, terbutaline, or formoterol are required for relief of breathing symptoms as instructed by your doctor and should be available at all times.

Thyroid disease: People with an overactive thyroid gland may find that they are more sensitive to the effects of indacaterol. If you have thyroid problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Vision problems: Mometasone, like other corticosteroids, may increase the risk of developing cataracts or glaucoma. If you are at risk of developing either of these conditions, have your eyes checked by your doctor before starting long-term treatment with this medication. You should have your eyes monitored at regular intervals while using this medication. Report any changes in vision to your doctor as soon as possible while you are taking this medication.

Worsening symptoms: If you find you need to use your short-acting ("rescue") inhaler more often or if your condition seems to worsen, call your doctor. If you have not been given instructions beforehand, contact your doctors immediately about what to do if any of the following situations occur (they may be signs of seriously worsening asthma):

• decreased effectiveness of short-acting, inhaled bronchodilators such as salbutamol, terbutaline, or fenoterol (less than 4 hours of relief)
• need for more inhalations than usual of short-acting, inhaled bronchodilators

Do not use indacaterol - mometasone more often than your doctor has prescribed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if indacaterol - mometasone passes into breast milk. Other inhaled corticosteroids have been found in breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children younger than 12 years of age. Adolescents may experience slowing of growth while using this medication. Your doctor will monitor for this. Talk to your doctor if you have any concerns.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.