Arcapta Neohaler inhalation

You should not use indacaterol if you are allergic to it, or if you have asthma.

Indacaterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risks and benefits of using this medicine.

To make sure indacaterol is safe for you, tell your doctor if you have:

• heart disease, high blood pressure;

• diabetes;

• epilepsy or other seizure disorder;

• a thyroid disorder;

• any allergies; or

• a condition for which you take a beta-blocker such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others.

Indacaterol may contain lactose. Tell your doctor if you have galactose intolerance, or severe problems with lactose (milk sugar).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether indacaterol passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Indacaterol is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Using too much of this medicine can cause life-threatening side effects.

Use this medicine at the same time each day, even if you feel well.

Indacaterol will not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine for an attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your COPD.

Do not take an indacaterol capsule by mouth. It is for use only in the Neohaler device.

Arcapta Neohaler is a powder that comes with a special inhaler device and blister packs containing capsules of the medicine. You will load one capsule into the inhaler device each time you use the medicine. Pushing the buttons on the side of the Neohaler device will pierce the capsule and release the medicine into the inhaler chamber.

You may have a mild cough for about 15 seconds after using the inhaler.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

You should not stop using indacaterol suddenly. Stopping suddenly may make your condition worse.

COPD is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Seek medical attention if you think your medications are not working as well.

While using indacaterol, you may need frequent blood tests.

Store at room temperature away from moisture, heat, and light. Keep each capsule in the blister pack until you ready to load your inhaler device.

Do not try to wash or take apart the Neohaler device. You may use a tissue to wipe the mouthpiece after each use. Throw away the device when your capsules run out. Always use the inhaler device that comes with each new prescription.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use this medicine more than 1 time in a 24-hour period.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of indacaterol can be fatal.

Overdose symptoms may include muscle cramps, tremors, chest pain, fast heartbeats, weak pulse, fainting, or slow breathing (breathing may stop).

Other drugs may interact with indacaterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Shakiness (tremor), nausea, headache, or cough may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: fast/pounding/irregular heartbeat, muscle weakness/cramping, increased thirst/urination.

Get medical help right away if you have any very serious side effects, including: chest pain.

Rarely, indacaterol can cause a worsening of breathing problems (paradoxical bronchospasm) that may be life-threatening. If this occurs, get medical help right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

75 mcg inhaled once daily.

Get emergency medical help if you have signs of an allergic reaction to Arcapta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;

• new or worsening cough, feeling suddenly short of breath;

• chest pain, pounding heartbeats or fluttering in your chest;

• tremors, nervousness;

• swelling of your ankles or feet;

• increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety;

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

• low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or

• worsening of your condition.

Common Arcapta side effects may include:

• runny or stuffy nose, sinus pain;

• mild cough, sore throat;

• nausea; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

There are no data on the excretion of indacaterol into human milk. The manufacturer recommends that caution be used when administering indacaterol to nursing women.