What is it?

Folic acid is a vitamin used as a supplement for many health conditions including: AIDS, anemia, atherosclerosis (hardening of the arteries), cancer prevention and treatment, osteoporosis, preventing birth defects, periodontal (gum) disease, depression, heart disease, and ulcerative colitis. It is also taken when there is a loss of Folic Acid from the body caused from taking birth control pills or anticonvulsants (medicine).

Other names for Folic acid include: Folate, Folacin, and Pteroylmonoglutamate.

Ask your doctor, nurse, or pharmacist if you need more information about this medicine or if any information in this leaflet concerns you.

Before Using:

Tell your doctor if you

• are taking medicine or are allergic to any medicine (prescription or over-the-counter (OTC) or dietary supplement)
• are pregnant or plan to become pregnant while using this medicine
• are breastfeeding
• have any other health problems, such as high blood pressure or heart or blood vessel disease

Dosage:

Talk with your caregiver about how much Folic Acid you should take. The amount depends on the strength of the medicine and the reason you are taking Folic Acid. If you are using this medicine without instructions from your caregiver, follow the directions on the medicine bottle. Do not take more medicine or take it more often than the directions tell you to.

To store this medicine:

Keep all medicine locked up and away from children. Store medicine away from heat and direct light. Do not store your medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down and not work the way it should work. Throw away medicine that is out of date or that you do not need. Never share your medicine with others.

Drug and Food Interactions:

Do not take Folic Acid without talking to your doctor first if you are taking:

• Medicines used to treat seizures (phenytoin (Dilantin(R)), fosphenytoin (Cerebyx(R))
• Pyrimethamine (Daraprim(R))

Warnings:

• Before taking Folic Acid, tell your doctor if you are pregnant or breastfeeding
• Talk with your doctor before taking more than 0.8 milligrams of Folic Acid daily

Side Effects:

Stop taking your medicine right away and talk to your doctor if you have any of the following side effects. Your medicine may be causing these symptoms which may mean you are allergic to it.

• Breathing problems or tightness in your throat or chest
• Chest pain
• Skin hives, rash, or itchy or swollen skin

Other Side Effects:

You may have the following side effects, but this medicine may also cause other side effects. Tell your doctor if you have side effects that you think are caused by this medicine.

• High doses of Folic Acid may cause upset stomach, loss of appetite (hunger) and gas and bloating (2)

References:

1. National Academy of Sciences: Recommended Dietary Allowances 10th ed. National Academy Press, Washington, DC; 1989.

2. Murray, MT: Encyclopedia of Nutritional Supplements. Prima Publishing, Rocklin, CA; 1996.

3. Werler MM, Sharpiro S, and Mitchell AA : Periconceptional folic acid exposure and risk of occurrence neural tube defects. JAMA 1993; 269:1257-1261.

4. Milunsky A, Jick H, Jick SS et al: Multivitamin/folic acid supplementation in early pregnancy reduces the prevalence of neural tube defects. JAMA 1989;262:2847-2852.

5. Hibbard ED & Smitherlls RW: Folic acid metabolism and human embryopathy. Lancet 1965;I:1254.

6. Smithells RW, Shepared S & Schorah CJ: Vitamin deficiencies and neural tube defects. Arch Dis Chil 1976;51:944-950.

7. Laurence KM, et al: Double-blind randomized controlled trial of folate treatment before conception to prevent recurrence of neural tube defects. Br Med J 1981;282:1509-1511.

8. Smithelles RW, Nevin NC, Seller MJ et al: Further experience of vitamin supplementation for the prevention of neural tube defects. Lancet 1983; I:1027-1033.

9. Streiff, R: Folate deficiency and oral contraceptives. JAMA 1970;214:105-108.

10. Butterworth C, Hatch K, Gore H, et al: Improvement in cervical dysplasia associated with folic acid therapy in users of oral contraceptives. AM J Clin Nutr 1982;35:73-82.

11. Crellin R, Bottiglieri T, and Reynolds EH: Folates and psychiatric disorders. Clinical potential. Drugs 1993;45:623-636.

12. Godfrey PSA, Toone BK, Carney MWP et al: Enhancement of recovery form psychiatric illness by methyl folate. Lancet 1990;336:392-395.

13. Thornon W &Thornton BP:Geriatric mental function and folic acid, a review and survery. Southern Med J 1997;70:919-922.

14. Wesson VA, et al: Change in folate status with antidepressant treatment. Psychiatry Res 1994;53:313-322.

15. Marz RB: Medical Nutrition From Marz, 2nd ed. Omni-Press, Portland, OR;1997.

Botez, Cadotte, Beaulieu,& Pichette: Neurologic disorders responsive to folate therapy. Cam Med Assoc J 1976; 115:217-223.

16. Berg MJ, Rivey MP, Vern BA et al: Phenytoin and folic acid: individualized drug-drug interaction. Ther Drug Monit 1983; 5(4):395-399.

17. Product Information: Folic acid tablets, USP(R), folic acid. Halsey Drug Co, Inc, Brooklyn, NY; 1995.

18. Leonard JP, Desager JP, Beckers C et al: In vitro binding of various biological substances by two hypocholesterolaemic resins, cholestyramine and colestipol. Arzneimittelforschung 1979; 29(7): 979-981.

19. Russell RM, Dutta SK, Oaks EV et al: Impairment of folic acid absorption by oral pancreatic extracts. Dig Dis Sci 1980; 25(5): 369-373.

20. Richards FO Jr, Kovac GJ & Luft BJ: Preventing toxoplasmic encephalitis in persons infected with human immunodeficiency virus. Clin Infect Dis 1995; 21(suppl 1): S49-S56.

21. Anon: Vitamin supplements. Med Lett Drugs Ther 1985; 27(693): 66-68.

22. Anon: Drug Facts and Comparisons. Facts and Comparisons Inc, JB Lippincott Co, St. Louis, MO; 1998.

23. Whitehead N, Reyner F and Lindernbaum J: Megaloblastic changes in the cervical epithelium association with oral contraceptive therapy and reversal with folic acid. JAMA 1973; 226:1421-1424.

24. Anon: Lowering blood homocysteine with folic acid based supplements: meta-analysis of randomized trials. Homocysteine Lowering Trialists' Collaboration. BMJ 1998; 316(7135):894-898.

25. Heimburger DC, Alexander CB, Birch R et al: Improvement in bronchial squamous metaplasia in smokers treated with folate and vitamin B12: report of a preliminary randomized double-blind intervention trial. JAMA 1988; 259(10):1525-1530.

26. Vogel RI, Fink RA, Frank O et al: The effect of topical application of folic acid on gingival health. J Oral Med 1978; 33(1):20-22.

27. Biasco G, Zannoni U, Paganelli GM et al: Folic acid supplementation and cell kinetics of rectal mucosa in patients with ulcerative colitis. Cancer Epidemiol Biomarkers Prev 1997; 6(6):469-471.

28. Juhlin L & Olsson MJ: Improvement of vitiligo after oral treatment with vitamin B12 and folic acid and the importance of sun exposure. Acta Derm Venereol (Stockh) 1997; 72:460-462.

29. Montes L, Diaz ML, Lajous J et al: Folic acid and vitamin B12 in vitiligo: a nutritional approach. Cutis 1992; 50(1):39-42.

30. Schnyder G, Roffi M, Pin R et al: Decreased rate of coronary restenosis after lowering of plasma homocysteine levels. N Engl J Med 2001; 345(22):1593-1600.