When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to roflumilast.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how roflumilast works. Tell your doctor if you are using any of the following:
  
  • Carbamazepine, cimetidine, enoxacin, erythromycin, fluvoxamine, ketoconazole, phenobarbital, phenytoin, rifampicin
  • Birth control pills that contain gestodene and ethinyl estradiol

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease.
• This medicine may cause depression or thoughts of suicide. Tell your doctor if you have a history of depression or mental health problems.
• This medicine is used to prevent the acute flare-ups of COPD. It is not used to stop a flare-up that has already started. Your doctor may give you a different medicine for sudden breathing problems.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, nervousness, restlessness, trouble sleeping
• Unexplained weight loss
• Unusual changes in moods or behaviors, depression, thoughts of hurting yourself

If you notice these less serious side effects, talk with your doctor:

• Diarrhea

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088