Instruction for use: Folic acid

Dosage form: Substance; Substance-powder; Tablets; Film-coated tablets

Active substance: Acidum folicum

ATX

B03BB01 Folic acid

Pharmacological groups:

Stimulators of hematopoiesis

Vitamins and vitamin-like remedies

The nosological classification (ICD-10)

D52 Folic deficiency anemia: Folate deficiency anemia; Combined iron-folic-B12-deficient anemia; Macrocytic anemia; Iron / folic deficiency anemia

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

Composition

Tablets - 1 table.

active substance: Folic acid 1 mg

Auxiliary substances: sucrose (sugar) - 21.3 mg; Dextrose monohydrate (glucose monohydrate) - 89.8 g; Stearic acid - 1.2 g; Talc - 1,5 g

Description of dosage form

Tablets are flat-cylindrical with a bevel, from pale yellow to yellow. Minor inclusions of yellow color are allowed.

Pharmachologic effect

Mode of action - Metabolic.

Pharmacodynamics

Vitamin B (vitamin B, vitamin B9) can be synthesized and necessary for the normal maturation of megaloblasts and the formation of normoblasts. 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 (even in the presence of malabsorption syndrome in the background of tropical sprue).

Intensively binds to plasma proteins. It penetrates the GEB, the placenta, and also into breast milk. Tmax - 30-60 min. It is deposited and metabolized in the liver with the formation of tetrahydrofolic acid (in the presence of ascorbic acid under the action of dihydrofolate reductase).

It is excreted by the kidneys mainly in the form of metabolites. If the dose is significantly higher than the daily requirement for folic acid, then it is displayed unchanged.

It is deduced with the help of hemodialysis.

Indication of the drug Folic acid

Folate deficiency anemia;

Hypo-and avitaminosis folic acid (including in tropical sprue, celiac disease, malnutrition).

Contraindications

Hypersensitivity to the components of the drug;

B12-deficiency anemia;

Shortage of sugar;

Isomaltase deficiency;

Intolerance to fructose;

Glucose-galactose malabsorption;

Children's age (up to 3 years).

With caution: folic deficiency anemia with a deficiency of cyanocobalamin.

Application of pregnancy and breastfeeding

Given that the deficiency of folic acid is especially dangerous in the first weeks of pregnancy, this vitamin is recommended to be taken during the preparation for pregnancy, and also during the entire period of carrying the fetus at 1 mg daily.

Dose and risk cannot be determined on their own, this should only be done by the attending physician.

Side effects

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

Interaction

Anticonvulsants (including phenytoin and carbamazepine), estrogens, oral contraceptives increase the need for folic acid.

Antacids (including preparations of calcium, aluminum and magnesium), colestyramine, sulfonamides (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).

There is no unambiguous information about zinc preparations: some studies show that folates inhibit the absorption of zinc, others refute these data.

Dosing and Administration

Inside.

Folic deficiency anemia: for adults and children of any age, the initial dose is 1 mg / day. When using large doses, resistance may occur.

Supportive treatment: for newborns - 0.1 mg / day; For children under 4 years - 0.3 mg / day; For children over 4 years and adults - 0.4 mg / day; During pregnancy and lactation - from 0.1 to 0.8 mg / day.

With hypo-and avitaminosis folic acid (depending on the severity of avitaminosis): adults - up to 5 mg / day; Children - in smaller doses depending on the age. The course of treatment is 20-30 days.

With concomitant alcoholism, hemolytic anemia, chronic infectious diseases, after gastrectomy, malabsorption syndrome, with hepatic insufficiency, cirrhosis, stress, the dose of the drug should be increased to 5 mg / day.

Overdose

Doses of folic acid to 4-5 mg are well tolerated. Higher doses can cause abnormalities in the CNS and GI tract.

Precautionary measures

For the prevention of hypovitaminosis folic acid is the most preferred balanced diet. Foods rich in folic acid: green vegetables (salad, spinach), tomatoes, carrots, fresh liver, beans, beets, eggs, cheese, nuts, cereals.

Folic acid is not used to treat B12-deficient, normocytic and aplastic anemia. With B12-deficient anemia, folic acid, improving hematologic indices, masks neurological complications. While B12-deficiency anemia is not excluded, administration of folic acid in doses exceeding 0.1 mg / 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 using large doses of folic acid, as well as during therapy for a long period, a decrease in the concentration of vitamin B12 (cyanocobalamin) is possible.

Influence on ability to drive vehicles, mechanisms. The use of the drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release Form

Tablets, 1 mg. For 10 tab. In a planar cell packaging made of PVC film and aluminum foil. For 50 tables. In cans of polymer material. The bank or 5 outline packages are placed in a pack of cardboard for consumer packaging.

Manufacturer

OJSC "Marbiopharm".

424006, Russia, Republic of Mari El

Conditions of supply of pharmacies

Without recipe.

Storage conditions of the drug Folic acid

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

3 years.

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