S-Adenosyl-L-Methionine (Sam-E) Oral tablet

What is this medicine?

S-ADENOSYL-L-METHIONINE, SAM-E (S–a DEN o sil L-me THYE o neen) is a dietary supplement. It is often promoted to help support healthy moods, joints, and liver function. 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:

• if you frequently drink alcohol containing drinks

• bipolar illness or mania

• depressed mood

• immune system problems

• liver disease

• muscle weakness

• neuromuscular or neurologic illness

• Parkinson's disease

• thoughts of suicide or causing harm to others

• an unusual or allergic reaction to SAM-e, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this supplement by mouth with a glass of water. Follow the directions on the package labeling or ask your health care professional. Do not take this supplement more often than directed.

Contact your pediatrician regarding the use of this supplement 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 medicine?

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

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

• antacids

• lithium

• medications for Parkinson's disease, like levodopa

• medications for the treatment of depression, anxiety or other mood problems

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?

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

Herbal or dietary 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 should be reported to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in emotions or mood

• drooling

• restlessness

• suicidal thoughts or other mood changes

• tremors

• uncontrollable head, mouth, neck, arm, or leg movements

• unusually weak or tired

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

• heartburn

• stomach upset

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 or as directed on the package label. Protect from moisture. Throw away any unused supplement after the expiration date.