Folic Acid 5 mg, 40 tablets

Dietary supplement
Folic acid – 0.005 g
Acidum folicum – 0.005 g;
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: 0.005 g (5 mg).
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:

• Anemia caused by folic acid deficiency (drug-induced or ionizing radiation-induced anemia, leukopenia, megaloblastic anemia, sideroblastic anemia, anemias associated with small intestine diseases);
• Treatment and prevention of anemia during pregnancy and lactation.

Contraindications: Hypersensitivity to folic acid.

Dosage and administration: Administered orally after meals.

• Adults: The daily dose is 5 mg. The course of treatment lasts 20–30 days. Repeating the course of treatment after 1 month is necessary.
• Megaloblastic anemia: Prescribed at 5 mg/day for 4 months.
• Prevention of fetal neural tube defects: Prescribed at 5 mg/day starting 4 weeks prior to anticipated pregnancy and continuing through the first trimester of pregnancy.

Daily requirements and pediatric dosing:
The daily requirement of folic acid is:

• 1–6 months: 0.025 mg
• 6–12 months: 0.035 mg
• 1–3 years: 0.05 mg
• 4–6 years: 0.075 mg
• 7–10 years: 0.1 mg
• 11–14 years: 0.15 mg
• Over 15 years: 0.2 mg
• Pregnant women: 0.4 mg
• Lactation period: 0.26–0.28 mg

Side effects: Allergic reactions, bronchospasm, erythema, fever, skin rash.

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: Given that folic acid deficiency is particularly dangerous during the first trimester of pregnancy, taking this vitamin is recommended during the pre-conception planning period, as well as throughout the entire gestation period at a daily dose of 1 mg.

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: Folic acid is well tolerated at doses up to 4–5 mg. In case of higher doses, central nervous system and gastrointestinal disorders may develop.

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 and out of reach of children.

Packaging:
Folic acid – 0.005 g (5 mg)
Primary packaging: 20 tablets on a blister.
Secondary packaging: 2 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.