TRADE NAME Folfa
INTERNATIONAL NONPROPRIETARY NAME Folic acid
CHEMICAL NAME (2S)-2-[[4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]benzoyl]amino] pentanedioic acid
PHARMACEUTICAL FORM Tablets. Description: yellow coloured round biconvex tablets.
COMPOSITION Table contains Active ingredient: folic acid 400 mcg, 1 mg or 5 mg. Excipients: microcrystalline cellulose, magnesium stearate.
ATC CODE B03BB01
PHARMACOTHERAPEUTIC GROUP Antianemic agents. Folic acid and derivatives.
PHARMACOLOGICAL PROPERTIES PHARMACODYNAMICS Folic acid (vitamin Вс, vitamin В9) is one of the B-group vitamins, synthesized by intestinal microflora that is essential for normal blood cell production, including megaloblastic maturation and transformation of megaloblasts into normoblasts. Folic acid is regenerated in the body up to tetrahydrofolic acid, a coenzyme necessary for a number of metabolic processes. It stimulates erythropoeisis, and is required for the synthesis of amino acids (including glycine, methionine), nucleic acids, purines, pyrimidines, choline and histidine metabolism. PHARMACOKINETICS Folic acid is well and completely absorbed from the gastrointestinal tract (GIT) following oral administration, mostly in the upper duodenum. It binds almost completely to plasma proteins, is deposited and metabolized in the liver by dihydrofolate reductase enzyme converting into tetrahydrofolic acid. The peak blood plasma concentration is reached in 30-60 minutes. Folic acid crosses the blood-brain barrier and placenta; enters breast milk. Folic acid is eliminated both unchanged (if the administered dose significantly exceeds the daily demand) and as metabolites by renal excretion. Folic acid is eliminated by hemodialysis.
THERAPEUTIC INDICATIONS - treatment and prevention of folic acid deficiency due to unbalanced diet and malnutrition; - treatment and prevention of anaemia due to folic acid deficiency in the combination therapy (macrocytic hyperchromic anaemia; anaemia and leucopenia caused by medications and
ionizing radiation; megaloblastic anaemia; post-resection anaemia; anaemia associated with small bowel diseases, celiac disease and malabsorption syndrome); - treatment and prevention of anaemia during pregnancy and lactation; - prevention of fetal neural tube defects during the first trimester of pregnancy; - long-term treatment with folic acid antagonists (methothrexate, combination of sulfamethoxazole/trimethoprim), anticonvulsants (phenytoin, primidone, phenobarbital).
DOSAGE AND ADMINISTRATION Folfa should be taken orally after meals. For prevention of folic acid deficiency, adult patients and children over 14 years of age are prescribed 400 mcg/day. The folic acid daily demand is 200-300 mcg in children aged 4-13 years, 150 mcg - in children aged 1-3 years, 65-85 mcg - in children under 1 year. For prevention of anaemia and fetal neural tube defects during pregnancy - 400-800 mcg/day; during lactation – 400 mcg/day. For treatment, adult patients are prescribed up to 5 mg/day for 20-30 days, children – depending on their age. The daily dose and treatment duration should be determined by a physician on an individual basis against the disease severity.
CONTRAINDICATIONS - hypersensitivity to the medication ingredients; - malignancies.
SIDE EFFECTS Allergic reactions: skin rash, pruritus, bronchospasm, erythema, hyperthermia. Gastrointestinal disorders: nausea, abdominal distention, bitter taste in mouth, anorexia. Others: long-term administration may lead to В12 hypovitaminosis.
SPECIAL INDICATIONS The medication should be prescribed with caution to patients with anaemia of unclear etiology since folic acid may interfere with the detection of malignant anaemia by decreasing haemotologic disease manifestations. The medication shall be used only with cyanocobalamine in pernicious anaemia. Avoid long-term administration of folic acid, especially in high doses, due to a risk of decrease in cyanocobalamine blood concentrations. Increased amounts of folic acid are required for hemodialysis patients. It should be taken into account that antibiotics may distort (provide for a priori underestimated figures) microbiological evaluation findings pertaining to folic acid concentrations in plasma and red blood cells.
INFLUENCE ON ABILITY TO DRIVE AND OPERATE OTHER MECHANISMS No data on negative effects of folic acid on ability to drive and use moving machines are available.
PREGNANCY AND LACTATION Folfa is prescribed in recommended doses in the pre-pregnancy preparation period as well as in pregnancy and lactation.
PEDIATRIC USE Folfa is prescribed to children in recommended doses.
DRUG INTERACTIONS Folic acid uptake decreases in its concurrent administration with analgetics, anticonvulsants, antacids, sulfanilamides, antibiotics, cytostatics. Folic acid enhances phenytoin metabolism. Concurrent administration of colestyramine and folic acid may lead to decreased absorption or changes in absorption. Therefore the medication should be taken 1 hour prior to or 4-6 hours after administration of colestyramine.
OVERDOSE If patients exceed folic acid recommended doses, it may lead to central nervous system (irritability, insomnia) and gastrointestinal (nausea, abdominal pain, flatulency) disorders. Treatment: medication withdrawal, symptomatic treatment.
PACKAGING Tablets. 30 tablets in a blister. 1, 2 or 3 blisters with the enclosed leaflet in a carton box.
STORAGE CONDITIONS Store in a protected from moisture and light place at temperature not exceeding 25ºС. Keep out of reach of children!
SHELF LIFE 3 years from the manufacture date. Do not use after expiry date.
SALES TERMS Sold without prescription.
MANUFACTURER The holder of trade mark and Marketing Authorization is “DR SERTUS İLAÇ SANAYİ VE TİCARET LİMİTED ŞİRKETİ”, TURKEY. Manufactured by “KENDY LTD”, Bulgaria (8 Gurmazovsko shose, 2227 Bozhurishte).