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.

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.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take roflumilast with or without food.

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.

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

Initial dose: 250 mcg orally once a day for 4 weeks
Maintenance dose: 500 mcg orally once a day

Comments:
-Starting the dose at 250 mcg daily may reduce the rate of treatment discontinuation, but it is not the effective/therapeutic dose.
-This drug is not a bronchodilator and is not indicated for acute exacerbation treatment.

Use(s): To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

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

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 roflumilast will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using roflumilast.

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

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

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: 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 of roflumilast 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 affect roflumilast. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.