Folic Acid 400 mcg, 60 tablets

Dietary supplement
Folic Acid – 400 mcg
Acidum folicum – 400 mcg
Instructions for use

Pharmacotherapeutic group: Vitamin preparation.

Dosage form: Tablets.

Description: Light yellow tablets. The presence of dark inclusions is permissible.

Composition per tablet: Folic acid: 0.4 mg (400 mcg).
Excipients: Lactose, polyvinylpyrrolidone, calcium stearate, starch, talc.

Pharmacological action: Folic acid belongs to the B-complex group of vitamins (B9). Folic acid is metabolized in the body into tetrahydrofolic acid, a coenzyme essential for the normal maturation of megaloblasts and the formation of normoblasts. Folic acid stimulates erythropoiesis and participates in the synthesis of amino acids, as well as the metabolism of nucleic acids, purines, pyrimidines, and choline.

Pharmacokinetics: Upon oral administration, it is fully absorbed from the duodenum and proximal small intestine. Approximately 98.5% of the administered dose is detected in the blood after 3–6 hours. Prior to intestinal absorption, folic acid undergoes reduction by the enzyme dihydrofolate reductase. Metabolism and storage of folic acid occur in the liver. About 50% of the ingested dose is eliminated via urine.

Recommendations for use: Used in complex therapy as an adjuvant treatment for:

• Prevention and treatment of anemia during pregnancy and lactation;
• Anemia caused by folic acid deficiency.

Contraindications: Hypersensitivity to folic acid, pernicious anemia, cobalamin deficiency, pediatric age.

Dosage and administration: Administered orally after meals.

• For folic acid deficiency: 400 mcg (1 tablet) per day is prescribed.
• For the prevention of neural tube defects in the fetus during the first trimester of pregnancy: Folic acid is prescribed at a dosage of 400–800 mcg (1–2 tablets) per day.

Side effects:

• Allergic reactions: Skin rash, itching, bronchospasm, erythema, fever.
• Gastrointestinal tract: Nausea, abdominal bloating, bitter taste in the mouth, anorexia.
• Other: Prolonged use may induce B12 hypovitaminosis.

Warnings and precautions: Prolonged administration of high doses may decrease cyanocobalamin concentration in the blood. To prevent neurological complications in pernicious anemia, the combination of folic acid and cyanocobalamin is recommended.

Pregnancy and lactation: Folic acid is essential during the pre-conception planning period (1–3 months prior to planned pregnancy) and throughout the first trimester of pregnancy.

Drug interactions: Concomitant use with chloramphenicol, neomycin, or tetracycline decreases folic acid absorption. When combined with phenytoin, primidone, PAS, sulfasalazine, chloramphenicol, or hormonal contraceptives, their therapeutic efficacy may be reduced.

Overdose: Overdose may occur following prolonged administration (over 1–2 months) of folic acid at doses exceeding 1000 mcg per day, or upon simultaneous ingestion with other vitamin-mineral complexes.

Prescription status: Group III pharmaceutical product, non-prescription (OTC).

Shelf life: 2 years.
The preparation must not be used after the expiry date or if defects are detected upon visual inspection.

Storage conditions: Store at a temperature of 15–25°C, protected from light, and out of reach of children.

Packaging:
Folic acid – 400 mcg (0.4 mg)
Primary packaging: 20 tablets on a blister.
Secondary packaging: 3 blisters in a cardboard box.

Manufacturer: "Neopharm" LLC.

Georgia. Tbilisi. David Agmashenebeli Avenue, 12th km.
Tel/Fax: +995 (032) 259-64-46; 259-57-90.