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Roflumilast (By mouth)

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

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not use this medicine if you have had an allergic reaction to roflumilast, or if you have liver disease.

How to Use This Medicine:

Tablet

  • Take your medicine as directed.
  • You may take this medicine with or without food.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

  • 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.

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  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.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 out of the reach of children. 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 check your progress and the effects of this medicine at regular visits. 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


Last Updated: 10/4/2014


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