Roflumilast Cream

What is this medication?

ROFLUMILAST (roe FLUE mi last) reduces swellingrednessitchingor rashes caused by skin conditionssuch as eczema and psoriasis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ZORYVE

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Liver disease
• An unusual or allergic reaction to roflumilastother medicationsfoodsdyesor preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is for external use only. Do not take by mouth. Wash your hands before and after use. If you are treating your handsonly wash your hands before use. Do not get it in your eyes. If you dorinse your eyes with plenty of cool tap water. Use it as directed on the prescription label at the same time every day. Do not use it more often than directed. Keep using it unless your care team tells you to stop.

Apply a thin film of the medication to the affected area. Rub it in completely.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditionsprecautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a doseuse it as soon as you can. If it is almost time for your next doseuse only that dose. Do not use double or extra doses.

What may interact with this medication?

• Estrogen and progestin hormones

Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicinesherbsnon-prescription drugsor dietary supplements you use. Also tell them if you smokedrink alcoholor use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rashitchinghivesswelling of the facelipstongueor throat

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Headache
• Irritation at application site
• Nausea
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicationcheck the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sureask your care team. If it is safe to put in the trashempty the medication out of the container. Mix the medication with cat litterdirtcoffee groundsor other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicinetalk to your doctorpharmacistor health care provider.