Instruction for use: Folic acid 9 months

Dosage form: Coated tablets

Active substance: Acidum folicum

ATX

B03BB01 Folic acid

Pharmacological groups:

Vitamin [Stimulants of hemopoiesis]

Vitamin [Vitamins and vitamin-like products]

The nosological classification (ICD-10)

E53.8.0 * Vitamin deficiency: Hypovitaminosis; Deficiency of iron and folic acid in pregnancy; Deficiency of folic acid; An additional source of folic acid during pregnancy; Folate deficiency; Increased need for folic acid; Folinic hypovitaminosis

O25 Malnutrition in pregnancy: Hypovitaminosis during pregnancy; Deficiency of vitamins and minerals in pregnancy; Deficiency of iron and folic acid in pregnancy; Iron deficiency in women during pregnancy; Iodine deficiency in pregnancy; Iodine deficiency in lactating women; Calcium deficiency in the mother's body; Calcium deficiency in pregnant women; Mineral deficiency during pregnancy; An additional source of folic acid during pregnancy; Correction of calcium metabolism disorders during pregnancy; Lack of iron during pregnancy and lactation; Pregnancy Period; Breastfeeding period; Increased need for vitamin B1 in pregnancy

Composition

Tablets, coated with a film membrane 1 tab.

active substance: Folic acid 400 mcg

Auxiliary substances: lactose monohydrate (tabletose 80); Silicon dioxide colloid; Copovidone (Kollidon VA-64); Magnesium stearate

Film sheath: Opadry II (series 85) (polyvinyl alcohol, macrogol, talc, titanium dioxide E171, iron oxide yellow E172, aluminum lacquer based on quinoline yellow E104

Description of dosage form

Tablets: biconvex, round, covered with a film coating of yellow color.

At the break: light yellow with interspersed.

Pharmachologic effect

Mode of action - Replenishing deficiency of folic acid.

Pharmacodynamics

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

Pharmacokinetics

Folic acid is well and completely absorbed in the digestive tract, mainly in the upper parts of the duodenum. Almost completely binds to plasma proteins. It is activated in the liver by the action of the enzyme dihydrofolate reductase, turning into tetrahydrofolic acid. Tmax - 30-60 min. Penetrates through the blood-brain and placental barriers into breast milk.

It is excreted by the kidneys mainly in the form of metabolites; If the taken dose significantly exceeds the daily requirement for folic acid, then it is output in unchanged form.

It is deduced with the help of hemodialysis.

Indication of the drug Folic acid 9 months

Deficiency of folic acid;

Prevention of neural tube defects in the fetus in the first trimester of pregnancy.

Contraindications

Hypersensitivity to the components of the drug;

Pernicious anemia;

Malignant neoplasms;

Deficiency of cobalamin;

childhood.

Application of pregnancy and breastfeeding

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

Side effects

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

From the digestive tract: nausea, bloating, bitterness in the mouth, anorexia.

With prolonged use, it is possible to develop hypovitaminosis B12.

Interaction

Reduces the effect of phenytoin (requires an increase in its dose).

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

Antacids, colestyramine, sulfonamines (including sulfasalazine) reduce the absorption of folic acid.

Methotrexate, pyrimethamine, triamterene, trimethoprim inhibit dihydrofolate reductase and reduce the effect of folic acid (in its place, calcium folinate should be given to patients using these drugs).

With simultaneous use with chloramphenicol, neomycin, polymyxin, tetracyclines, absorption of folic acid decreases.

Dosing and Administration

Inside, after a meal.

With a deficiency of folic acid - 400 mcg (1 table) per day.

To prevent the development of neural tube defects in the fetus in the first trimester of pregnancy, 400-800 micrograms (1-2 tablets).

Overdose

It can occur with long-term use (more than 1-2 months) of folic acid in doses over 1000 mcg per day and as a result of joint application with vitamin-mineral complexes.

Precautionary measures

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

Folic acid is not used to treat B12-deficient (pernicious), normocytic and aplastic anemia, as well as anemia refractory to therapy. With pernicious (B12-deficient) anemia, folic acid, improving hematologic indices, masks neurological complications. While pernicious anemia is not ruled out, administration of folic acid in doses exceeding 100 mkg / day is not recommended (except pregnancy and lactation period).

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

During treatment, antacids should be used 2 hours after taking folic acid, colestyramine - 4-6 hours before or 1 hour after taking folic acid. It should be borne in mind that antibiotics can distort (give knowingly underestimated indicators) the results of a microbiological evaluation of the concentration of folic acid in plasma and erythrocytes. When applying large doses of folic acid, as well as therapy for a long period, it is possible to reduce the concentration of vitamin B12.

Release Form

Film-coated tablets, 400 mkg. In packs of contour mesh of PVC film and foil of aluminum printed varnished for 10 pcs. In a pack of cardboard 3, 6 or 9 packages.

Manufacturer

JSC "Valenta Pharmaceutics". 141101, Moscow Region

Conditions of supply of pharmacies

Without recipe.

Storage conditions of the drug Folic acid 9 months

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Folic acid 9 months

3 years.

Do not use after the expiry date printed on the package.