Roflumilast (By mouth)

Introduction

Roflumilast (roe-FLUE-mi-last)

Used to prevent the symptoms (flare-ups) of chronic obstructive pulmonary disease (COPD) from getting worse.

Brand Name(s)

Daliresp

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you are also using carbamazepine (Tegretol®), phenobarbital, phenytoin (Dilantin®), or rifampin (Rifadin®, Rimactane®). Tell your doctor if you are also using cimetidine (Tagamet®), enoxacin (Penetrex®), erythromycin (Ery-tab®), fluvoxamine (Luvox®), ketoconazole (Nizoral®), or birth control pills containing gestodene and ethinyl estradiol (Femodene®, Minulet®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have a history of depression or mental illness.
• This medicine may cause some people to be agitated or display other abnormal behaviors, such as feeling sad or hopeless, getting upset easily, having trouble sleeping, or feeling nervous or hostile. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.
• This medicine may cause you to lose weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.
• 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. You should use an inhaled medicine for the acute flare-ups that will work quickly to help you breathe better. If you do not have an inhaled medicine for acute COPD flare-ups, or if you have any questions about this, check with your doctor.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

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, or trouble sleeping.
• Confusion, unusual behaviors, depressed mood, or thoughts of hurting yourself or others.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Unexplained weight loss.

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

• Back pain.
• Decreased appetite.
• Diarrhea or nausea.
• Headache or dizziness.

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