Daliresp reduces inflammation in the lungs that leads to COPD (chronic obstructive pulmonary disease).

Daliresp is used to prevent worsening of symptoms in people with severe COPD.

Daliresp is not a bronchodilator and will not treat a bronchospasm attack that has already begun.

You should not use Daliresp if you have moderate or severe liver disease.

Some people have thoughts about suicide while taking Daliresp. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Call your doctor at once if you have rapid and unintended weight loss.

Before taking this medicine

You should not use Daliresp if you are allergic to roflumilast, or if you have moderate or severe liver disease.

To make sure Daliresp is safe for you, tell your doctor if you have ever had:

• liver disease; or

• depression, mental illness, or suicidal thoughts or actions.

Some people have thoughts about suicide while taking Daliresp. Your doctor should check your mood at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

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 roflumilast passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Do not give this medicine to a child without medical advice.

Take Daliresp exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Daliresp is usually taken once per day, with or without food. Follow your doctor's instructions.

Weight loss is a common side effect of roflumilast. While using this medicine, weigh yourself regularly and tell your doctor if you have any unplanned or unexplained weight loss.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture and heat.

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

To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations: 500 mcg orally once a day, with or without food

You should not use Daliresp if you are allergic to roflumilast, or if you have moderate or severe liver disease.

To make sure Daliresp is safe for you, tell your doctor if you have ever had:

• liver disease; or

• depression, mental illness, or suicidal thoughts or actions.

Some people have thoughts about suicide while taking Daliresp. Your doctor should check your mood at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

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 roflumilast passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Do not give this medicine to a child without medical advice.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, trouble sleeping, or if you feel impulsive, or you have thoughts about suicide or hurting yourself.

Call your doctor at once if you have rapid and unintended weight loss.

• rapid and unintended weight loss;

• tremors;

• pain or burning when you urinate;

Common Daliresp side effects may include:

• nausea, diarrhea;

• loss of appetite, minor weight loss;

• headache, dizziness;

• occasional sleep problems;

• back pain; or

• flu symptoms.

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.

Many drugs can interact with roflumilast. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.