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Risks and Side Effects

What is OLUX-E Foam?

OLUX-E Foam is a prescription corticosteroid medicine used on the skin (topical) to treat adults and children 12 years and older with certain skin conditions that cause red, flaky, and itchy skin.

OLUX-E Foam should not be used:

• on your face, underarms, or groin area
• if you have skin thinning (atrophy) at the treatment area

You should not use OLUX-E Foam for longer than 2 weeks in a row.

You should not use more than 50 grams or 21 capfuls of OLUX-E Foam in 1 week.

What should I tell my doctor before using OLUX-E Foam?

Before you use OLUX-E Foam, tell you doctor if you:

• have had irritation or other skin reaction to a steroid medicine in the past
• have a skin infection. You may need medicine to treat the skin infection
  before using OLUX-E Foam.
• have diabetes
• have adrenal gland problems
• have liver problems
• plan to have surgery
• have any other medical condition
• are pregnant or plan to become pregnant. It is not known if OLUX-E Foam will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breast-feeding or plan to breast-feed. It is not known if OLUX-E Foam passes into your breast milk.

Do not apply OLUX-E Foam to your chest area if you are breastfeeding a baby. This will help to prevent the baby from accidentally getting OLUX-E Foam into his/her mouth.

Tell your doctor about all the medicine you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

How should I use OLUX-E Foam?

• Use OLUX-E Foam exactly as your doctor tells you to use it.
• This medicine is for use on the skin only. Do not get OLUX-E Foam in your eyes, mouth, or vagina.
• Apply OLUX-E Foam 2 times each day, one time in the morning and one time at night, or as directed by your doctor.
• Do not bandage or cover your treated area unless your doctor tells you to.
• Talk to your doctor if your skin does not improve after 2 weeks of treatment with OLUX-E Foam.
• See your doctor regularly to check your symptoms and side effects while taking OLUX-E Foam.

What should I avoid while using OLUX-E Foam?

OLUX-E Foam is flammable. Avoid heat, flame, or smoking during and right after you apply it to your skin.

If you are taking other corticosteroid medicines, either by mouth or injection, your doctor may advise you to stop taking them once you begin using OLUX-E Foam.

What are the possible side effects of OLUX-E Foam?

OLUX-E Foam may cause serious side effects, including:

• Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment. Your doctor may do blood tests to check you for adrenal insufficiency while you are using OLUX-E Foam. Tell your doctor if you have any of these persistent symptoms of adrenal insufficiency:
  • tiredness that worsens and does not go away
  • muscle weakness
  • loss of appetite
  • nausea or vomiting
  • dizziness or fainting
  • irritability and depression
  • weight loss
• Cushing’s syndrome, when the body is exposed to too much of the hormone cortisol. Your doctor may do tests to check for this. Symptoms can include:
  • weight gain, especially around your upper back and midsection
  • tiredness and muscle weakness
  • roundness of your face (moon face)
  • slow healing of cuts, insect bites and infections
  • depression, anxiety and irritability
  • new or worsening high blood pressure
• high blood sugar (hyperglycemia) or diabetes mellitus that has not been diagnosed can happen with treatment. Your doctor may do tests to check you for this.
• skin problems, including reactions where the medicine is applied, skin infections, and allergic reactions (allergic contact dermatitis). Tell your doctor if you get any new skin problems.
• effects on growth and weight in children.

The most common side effects of OLUX-E Foam include:

• thinning of skin
• burning
• redness
• itching
• dryness

Tell your doctor if you have any reaction on your treated skin such as pain, tenderness, swelling, or healing problems.

These are not all the side effects of OLUX-E Foam. Ask your doctor or pharmacist for more information.

How should I store OLUX-E Foam?

• Store the OLUX-E Foam at room temperature, between 68°F to 77°F (20°C to 25°C). OLUX-E Foam is flammable. Keep the can away from fire and heat.
• Do not pierce or burn the OLUX-E Foam can. Never throw the can into a fire, even if the can is empty.

Keep OLUX-E Foam and all medicines out of the reach of children.

General information about OLUX-E Foam

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use OLUX-E Foam for a condition for which it was not prescribed. Do not give OLUX-E Foam to other people, even if they have the same condition that you have. It may harm them.

This section summarizes the most important information about OLUX-E Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about OLUX-E Foam that is written for health professionals.

Important Safety Information for OLUX-E Foam

Before you use OLUX-E Foam, tell your doctor if you:

• have had irritation or any other skin reaction to a steroid medicine in
  the past
• have a skin infection, diabetes, adrenal gland problems, liver problems, or any
  other medical condition
• plan to have surgery

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if OLUX-E Foam will harm your unborn baby.

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if OLUX-E Foam passes into your breast milk. Do not apply OLUX-E Foam to your chest area if you are breastfeeding to prevent the baby from accidentally getting OLUX-E Foam into his or her mouth.

Use OLUX-E Foam exactly as your doctor tells you to use it. Do not bandage or cover your treated area unless your doctor tells you to. Talk to your doctor if your skin does not improve after 2 weeks of treatment with OLUX-E Foam.

OLUX-E Foam is flammable. Avoid heat, flame, or smoking during and right after using OLUX-E Foam.

If you are taking other corticosteroid medicines, either by mouth or injection, your doctor may advise you to stop taking them once you begin using OLUX-E Foam.

OLUX-E Foam may cause serious side effects, including:

• Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment. Tell your doctor if you have any of these persistent symptoms of adrenal insufficiency:
  • tiredness that worsens and does not go away
  • muscle weakness
  • loss of appetite
  • nausea or vomiting
  • dizziness or fainting
  • irritability and depression
  • weight loss
• Cushing’s syndrome, when the body is exposed to too much of the hormone cortisol. Symptoms can include:
  • weight gain, especially around your upper back and midsection
  • tiredness and muscle weakness
  • roundness of your face (moon face)
  • slow healing of cuts, insect bites and infections
  • depression, anxiety and irritability
  • new or worsening high blood pressure
• high blood sugar (hyperglycemia) or diabetes mellitus that has not been diagnosed can happen with treatment.
• skin problems, including reactions where the medicine is applied, skin infections, and allergic reactions (allergic contact dermatitis). Tell your doctor if you get any new skin problems, including pain, tenderness, swelling, or healing problems on your treated skin.
• effects on growth and weight in children.

Your doctor may do tests to check for some of these side effects.

The most common side effects of OLUX-E Foam include thinning of skin, burning, redness, itching, and dryness. These are not all the side effects of OLUX-E Foam. Ask your doctor or pharmacist for more information.