Prasterone, DHEA Capsules or Tablets

What is this medication?

PRASTERONE (PRAS ter one) also known as DEHYDROEPIANDROSTERONE (dee hy dro eh pee an DRAA ster own), or DHEA, may support sexual function. It may also improve energy and boost mood. The FDA has not evaluated this supplement for any medical use. It may contain ingredients not listed. Discuss all supplements you are taking with your care team. They can provide you with important safety information.

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

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

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

• Cancer, such as breast, uterine, liver, prostate, or other cancer
• Diabetes
• G6PD deficiency
• History of irregular vaginal bleeding
• Immune system problems
• Liver disease
• Mental health condition
• An unusual or allergic reaction to Prasterone, DHEA, soy, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the label. You can take it with or without food. If it upsets your stomach, take it with food. Do not use it more often than directed.

Talk to your care team about the use of this medication in children. Special care may be needed.

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 dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Aspirin and aspirin-like medications
• Benzodiazepines, such as alprazolam, diazepam, or lorazepam
• Certain medications for diabetes, such as glipizide or glyburide
• Certain medications that treat or prevent blood clots, such as warfarin, enoxaparin, dalteparin, apixaban, dabigatran, rivaroxaban
• Cilostazol
• Clopidogrel
• Estrogen or progestin hormones
• Fertility treatments, such as clomiphene
• Male hormones, such as methyltestosterone or testosterone
• Leuprolide
• NSAIDs, medications for pain or inflammation, such as ibuprofen or naproxen
• Ticlopidine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or 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.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This supplement can cause serious birth defects.

This supplement is banned from use in athletes by most athletic organizations.

Some nutritional supplements do not require a prescription. These products are not regulated like medications. Rigid quality control standards are not required. The purity and strength can vary. Be sure to read product labels closely. Products made or sold by a nationally known company are more likely to be made under tight controls.

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 rash, itching, hives, swelling of the face, lips, tongue, or throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Mood swings, irritability, hostility

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

• Acne
• Breast pain or tenderness
• Headache
• Irregular menstrual cycles or spotting
• Unexpected hair growth
• Weight gain

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 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 medication, check 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 sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or 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 medicine, talk to your doctor, pharmacist, or health care provider.