Roflumilast Topical Foam (ROFLUMILAST FOAM - TOPICAL)

Instructions

DO NOT take this medicine by mouth.

Shake the bottle well before using the medicine.

Apply a thin layer to the affected area and rub it in.

If you are using this medicine on the scalp or other hairy areas, move hair out of the way and apply as directly to the skin as possible.

Store in original bottle, tightly closed and upright.

Keep the medicine at room temperature. Avoid heat and direct light.

This medicine should only be used on the skin.

Avoid getting the medicine in the eyes, nose, or mouth. Wash the medicine off your fingers after applying it.

Avoid getting this medicine inside the vagina.

Wash your hands before and after handling this medicine.

Wash your hands after using this medicine unless your hands are part of the area being treated.

If medicine gets in eyes, rinse with large amounts of cool water and seek medical care right away.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Do not freeze the medicine.

This medicine is flammable. Do not use it near heaters, open flame or while smoking. Do not crush, puncture, or burn container.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to use a dose on time, use it as soon as you remember. If it is almost time for the next dose, do not use the missed dose. Return to your normal dosing schedule. Do not use 2 doses of this medicine at one time.

Do not share this medicine with anyone who has not been prescribed this medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• headaches
• nausea

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.