Expiration date: 09/2025

Pharmaceutical form and composition

Tablets, film-coated. 1 tablet contains active substance: 

folic acid 400 mcg

excipients: lactose monohydrate (tablettose 80), silicon dioxide colloidal, copovidone (Kollidon VA-64), magnesium stearate 

shell film: Opadry II (85 series) (polyvinyl alcohol, macrogol, talc, titanium dioxide E171, iron oxide yellow E172, aluminum varnish quinoline yellow E104 

Description pharmaceutical form

The tablets are biconvex, round shaped, film-coated yellow, on a break — light yellow color with a splash.

Pharmacological action:

Pharmacological action of complementary folic acid deficiency.

Pharmacodynamics

B-vitamin (vitamin BC, vitamin B9) can be synthesized by intestinal microflora. In the body, folic acid is reduced to tetrahydrofolic acid is a coenzyme involved in various metabolic processes. Essential for the normal maturation of megaloblasts and normoblasts education. Stimulates erythropoiesis, participates in the synthesis of amino acids (including glycine, methionine), nucleic acids, purines and pyrimidines, in the metabolism of choline, histidine.

Pharmacokinetics

Folic acid is well and completely absorbed in the gastrointestinal tract, mainly in the upper parts of the duodenum. Almost entirely associated with plasma proteins. Undergoes activation in the liver under the influence of the enzyme dihydrofolate reductase, turning tetragidrofolievu acid. Cmax is achieved after 30-60 min. crosses the blood-brain and placental barriers in breast milk.

Excreted by the kidneys mainly as metabolites if the dose far exceeds the daily requirement of folic acid is excreted unchanged.

Displayed by hemodialysis.

The testimony of the drug 9 months Folic acid

folic acid deficiency,

to prevent the development of neural tube defects in the fetus in the first trimester of pregnancy.

Contraindications:

• hypersensitivity to the drug component
  
• pernicious anemia,
  
• malignant neoplasms,
  
• a deficiency of cobalamin
  
• the children's age.
  

Application of pregnancy and breastfeeding

Folic acid is essential in the period of preparation for pregnancy (1-3 months before the planned pregnancy) and in the first few weeks after conception (the first trimester).

Side effects:

Allergic reactions: skin rash, itching, bronchospasm, erythema, hyperthermia.

Gastrointestinal: nausea, bloating, bitter taste in the mouth, anorexia.

With prolonged use may develop B12 deficiencies.

Interaction

Reduces the effect of phenytoin (requires increasing dose).

Analgesics (prolonged therapy), anticonvulsants (including phenytoin and carbamazepine), estrogens, oral contraceptives increase the need for folic acid.

Antacids, cholestyramine, sulfonamide (including sulfasalazine) decrease the absorption of folic acid.

Methotrexate, pyrimethamine, triamterene, trimethoprim digidrofolatreduktaza inhibit and reduce the effect of folic acid (instead of patients using these drugs should designate calcium folinate).

While the use of chloramphenicol, neomycin, polimiksinami, tetracyclines the absorption of folic acid decreases.

Method of application and doses

Inside.

Be taken after meals.

At deficiency of folic acid — 400 mcg (1 table.) a day.

To prevent the development of neural tube defects in the fetus in the 1st trimester of pregnancy — 400-800 mcg (1-2 table).

Overdose:

May occur with prolonged use (more than 1-2 months) folic acid in doses above 1,000 mg per day and as a result of joint application of vitamin-mineral complexes.

Special instructions:

For prevention of hypovitaminosis, most preferably a balanced diet. Foods rich in folic acid — green vegetables (lettuce, spinach, tomatoes, carrots), fresh liver, legumes, beets, eggs, cheese, nuts, cereals.

Folic acid is used to treat B12 deficiency (pernicious), normocytes and aplastic anemia as well as anemia refractory to therapy. In pernicious (B12-deficiency) anemia, folic acid, improving hematologic parameters, masks neurological complications. Not yet eliminated pernicious anemia, folic acid in doses exceeding 100 mg/day not recommended (with the exception of pregnancy and lactation).

It should be borne in mind that patients are on dialysis, need increased amounts of folic acid.

During treatment antacids should be used after 2 h after administration of folic acid, cholestyramine for 4-6 hours before or after 1 h after administration of folic acid. It should be borne in mind that antibiotics can distort (to give a deliberately understated performance) results of microbiological assessment of the concentration of folate in plasma and erythrocytes. The application of high doses of folic acid, as well as therapy for an extended period, may reduce the concentration of vitamin B12.

Release form

Tablets, film-coated, 400 mg. In packages the contour of the PVC film and aluminum foil printed patent 10 PCs., in a cardboard pack of 3, 6 or 9 packs.

Storage conditions:

In a dry, protected from light place, at temperature not above 25 °C.

Keep out of reach of children.

The shelf:

3 years.