Roflumilast (roe-FLUE-mi-last)

Treats plaque psoriasis, atopic dermatitis, and seborrheic dermatitis.

Brand Name(s):

Zoryve

When This Medicine Should Not Be Used:

How to Use This Medicine:

Cream, Foam

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Use this medicine only on your skin, including areas with skin folds. Do not get it in your eyes, nose, lips, mouth, or vagina. Do not apply this medicine to your nipple or areola, if you are breastfeeding. Rinse it off right away if it does get on these areas.
• Cream:
  • Wash your hands with soap and water before and after you use this medicine, unless you are using it to treat your hands.
  • Apply a thin layer of the medicine to the affected area. Rub it in gently.
• Foam:
  • Wash your hands with soap and water before and after using this medicine.
  • Shake the can well before using. Turn the can upside down and press the nozzle. Dispense a small amount into your hand.
  • Apply a thin layer of this medicine to the affected area of the skin or scalp. Rub it in gently.
  • If you are treating your scalp, part the hair so that it can be applied directly to the affected area on the skin.
  • This medicine is flammable. Do not use it near fire, flame, or while smoking when applying and right after you apply it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply 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. The foam can contents are under pressure and flammable. Do not puncture or burn the can.

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 work. Tell your doctor if you are using cimetidine, enoxacin, erythromycin, fluvoxamine, ketoconazole, or birth control pills (including ethinyl estradiol, gestodene).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• Call your doctor if your symptoms do not improve or if they get worse.
• 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
• Change in how much or how often you urinate, bloody or cloudy urine, lower back or side pain

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

• Cough, runny or stuffy nose, sore throat
• Diarrhea, nausea, vomiting
• Headache
• Pain in the area where the medicine is applied
• Trouble sleeping

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