Prasterone Oral tablet

What is this medicine?

PRASTERONE (also known as DHEA), is similar to a hormone produced in the body. It is often used as a dietary supplement. The FDA has not approved this supplement for any medical use.

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

What should I tell my health care provider before I take this medicine?

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

• breast cancer (men or women)

• cancer of the lining of the uterus (endometrial cancer)

• diabetes or high blood sugar

• immune system problems

• infertility

• liver disease

• post-menopause

• prostate cancer or an enlarged prostate gland

• rheumatoid arthritis

• uterine cancer

• vaginal bleeding or menstrual problems

• vaginal cancer

• an unusual or allergic reaction to Prasterone, DHEA, soy, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

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 medicine?

Do not take this medicine with any of the following medications:

• dietary supplements containing DHEA

This medicine may also interact with the following medications:

• alprazolam

• aspirin

• cilostazol

• clopidogrel

• male hormones (such as methyltestosterone or testosterone)

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• fertility treatments (such as clomiphene, or fertility injections)

• leuprolide

• medicines for diabetes

• medicines for sleep

• saw palmetto

• steroid medicines like prednisone or cortisone

• ticlopidine

• warfarin

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 medicine?

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

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

DHEA use is banned in competitive sports. Both college (NCAA) and olympic (USOC) committees do not allow DHEA use among athletes.

Supplements are not regulated like medicines. Rigid quality control standards are not required for dietary supplements. The purity and strength of these products can vary. The safety and effect of this dietary supplement for a certain disease or illness is not well known. This product is not intended to diagnose, treat, cure or prevent any disease.

The Food and Drug Administration suggests the following to help consumers protect themselves:

• Always read product labels and follow directions.

• Natural does not mean a product is safe for humans to take.

• Look for products that include USP after the ingredient name. This means that the manufacturer followed the standards of the US Pharmacopoeia.

• Supplements made or sold by a nationally known food or drug company are more likely to be made under tight controls. You can write to the company for more information about how the product was made.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

acne

• breast pain, swelling, or change in breast appearance

• trouble passing urine or change in the amount of urine

• dark urine

• general ill feeling or flu-like symptoms

• hair growth in unusual places

• hoarseness of the voice

• light-colored stools

• nausea, vomiting

• menstrual changes

• right upper belly pain

• unusually weak or tired

• yellowing of the eyes or skin

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

• change in sex drive or performance

• headache

• loss of appetite

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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.