Daliresp Tablet

What is roflumilast?

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

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

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

Roflumilast may also be used for purposes not listed in this medication guide.

Important Information

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

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

Sometimes it is not safe to use certain medications at the same time. Tell your doctor about all your current medicines and any you start or stop using.

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

Before taking this medicine

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

To make sure roflumilast 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 while taking roflumilast. Your doctor should check your progress 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.

How should I take roflumilast?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Roflumilast 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 roflumilast, 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.

What happens if I miss a dose?

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.

What should I avoid while taking roflumilast?

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

Roflumilast side effects

Get emergency medical help if you have signs of an allergic reaction: 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 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.

What other drugs will affect roflumilast?

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.