Elfolate

Folate is a type of B vitamin found naturally in many foods. Folic acid is the synthetic form of folate that is added to processed foods or vitamin and mineral supplements. The body needs folate to produce red blood cells.

Not having enough folate (deficiency) can happen because of certain diseases, certain medications, or not getting enough folate in your diet. A folate deficiency can lead to fewer red blood cells, which is known as anemia. It can also lead to high levels of a specific amino acid in the blood, a condition called hyperhomocysteinemia (HYE-per-HOE-moe-sis-tin-EE-mee-a).

Elfolate is a medical food designed for people with conditions related to folate deficiency. This medicine is also used for people with major depressive disorder who have a folate deficiency, or for those with schizophrenia who have hyperhomocysteinemia related to folate deficiency.

Elfolate is not an antidepressant or anti-psychotic medication. However, it may enhance the effects of antidepressant medications.

Elfolate may also be used for reasons not listed in this medication guide.

Follow all directions on your prescription label. Do not take Elfolate in larger or smaller amounts or for longer than recommended.

Use only the strength of l-methylfolate that your doctor has prescribed. Do not switch brands without your doctor's advice.

You may take Elfolate with or without food. Follow your doctor's instructions.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Do not share this medication with another person, even if they have the same symptoms you have.

Elfolate is only part of a complete program of treatment that may also include other medications and psychological counseling when used in people with depression or schizophrenia. Follow your medication and counseling routines very closely.

Store at cool room temperature away from moisture, heat, and light.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

You should not use Elfolate if you are allergic to it.

To ensure Elfolate is safe for you, inform your doctor if you have:

• seizures or epilepsy;
• a history of vitamin B12 deficiency or pernicious anemia; or
• a history of bipolar disorder (manic depression).

Notify your doctor if you are pregnant or breast-feeding. Your dose may need to change during pregnancy or while you are nursing.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may happen, and you may have none at all.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not take extra medicine to make up for the missed dose.

An overdose of Elfolate is unlikely to result in life-threatening symptoms.

Follow your doctor's guidance regarding any limitations on food, drinks, or activities.

Tell your doctor about all the medicines you are currently taking and any that you begin or stop using, especially:

• capecitabine;
• fluoxetine (Prozac);
• isotretinoin;
• methotrexate;
• methylprednisolone;
• pancrelipase;
• pyrimethamine;
• triamterene;
• trimethoprim;
• warfarin (Coumadin, Jantoven);
• birth control pills;
• oral diabetes medicine that contains metformin (Glucophage, Avandamet, Metaglip, and others);
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
• seizure medicine--carbamazepine, lamotrigine, phenobarbital, phenytoin, primidone, valproic acid.

This list is not complete. Other drugs may interact with l-methylfolate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.