Instruction for use: Folacin

Dosage form: tablets

Active substance: Acidum folicum

ATX

B03BB01 Folic acid

Pharmacological groups:

Vitamin; Stimulator of hemopoiesis [Stimulants of hemopoiesis]

Vitamin; Stimulator of hemopoiesis [Vitamins and vitamin-like remedies]

The nosological classification (ICD-10)

D50.0 Iron deficiency anemia secondary due to loss of blood (chronic): Anemia posthemorrhagic; Anemia in chronic hemorrhage; Chronic blood loss in the digestive tract; Posthemorrhagic anemia

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

D52.0 Folic deficiency anemia associated with diet

D52.1 Folic deficiency anemia medicaments

D53.1 Other megaloblastic anemia, not elsewhere classified: Megaloblasta anemia; Megaloblastic anemia; Hyperchromic anemia

D63.0 Anemia in neoplasm: Anemia in chronic diseases; Anemia due to radiation damage; Radiation anemia; Anemia in patients with solid tumors; Pernicious anemia

D64.3 Other sideroblastic anemia: Anemia of sideroblastic; Sideroblastic anemia; Pearson's syndrome

D64.9 Anemia, unspecified: Anemic states; Anemia of various origins; Hematopoietic disorders

D72.8.0 * Leukopenia: Autoimmune neutropenia; Congenital neutropenia; Granulocytopenia; Idiopathic and drug-induced leukopenia; Idiopathic neutropenia; Leukopenia aplastic; Leukopenia radiation; Leukopenia with radiation therapy; Radiation leukopenia; Hereditary neutropenia; Neutropenia in patients with AIDS; Periodic neutropenia; Radiation leukopenia; Persistent neutropenia; Febrile neutropenia; Two-stage cytopenia; Radiation cytopenia; Neutropenia is cyclic

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

K63.9 Bowel disease, unspecified: Inflammation of small intestine; Gluten disease; Gluten enteropathy; Chronic inflammation of the intestine; Enteropathy; Inflammatory bowel disease; Melanosis of the large intestine

K90 Intestinal absorption disorders: Maldigestia; Malabsorption syndrome; Malabsorption; Disturbance of fat absorption; Disturbances of iron absorption from the digestive tract; Disorders of absorption of fats in the intestine; Syndrome of the small intestine; Malabsorption syndrome; Syndrome of impaired intestinal absorption; Syndrome of insufficiency of intestinal absorption of amino acids; Reduction of absorption in the digestive tract

K90.1 Tropical Sprue: Sprue

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

O99.0 Anemia complicating pregnancy, childbirth and the post-natal period: Anemia during pregnancy; Anemia in the mother; Iron deficiency anemia in pregnancy; Megaloblastic anemia of pregnant women; Iron deficiency anemia in pregnant women

Q07.9 Nervous system developmental disorder, unspecified: Nerve tube developmental anomalies; Nerve tube defect; Defects of the neural tube (prenatal screening)

T37.0 Sulfonamide poisoning

T42.7 Poisoning with anticonvulsant, sedative and hypnotics, unspecified: Poisoning with hypnotics

T45.1.0 * Methotrexate intoxication: intoxication with folic acid antagonists; Toxic effect of methotrexate; Intoxication with methotrexate

Composition

Tablets - 1 table.

active substance: Folic acid 5 mg

Auxiliary substances: lactose monohydrate - 133,92 mg; MCC - 50 mg; Magnesium stearate - 1 mg; Povidone - 5.04 mg; Crospovidone - 5.04 mg

Description of dosage form

Tablets: flat-cylindrical, yellow with insignificant marbling, orange inclusions are allowed, with a facet and risk on one side, odorless.

Pharmachologic effect

Mode of action - Replenishing deficiency of folic acid, hematopoietic.

Pharmacodynamics

Vitamin B. In the body it is converted into tetrahydrofolic acid, as a coenzyme involved in various metabolic processes and necessary for the normal maturation of megaloblasts and the formation of normoblasts. With a deficiency of folic acid, the megaloblastic type of hematopoiesis develops. Stimulates erythropoiesis, participates in the synthesis of amino acids (including methionine, serine, glycine), nucleic acids, purines, pyrimidines, in the exchange of choline, histidine. When pregnancy performs a protective function in relation to the action of teratogenic and damaging factors. Promotes normal maturation and functioning of the placenta.

Pharmacokinetics

After ingestion, folic acid is absorbed into the digestive tract and almost completely binds to plasma proteins. It is deposited and metabolized in the liver with the formation of tetrahydrofolic acid (in the presence of ascorbic acid under the action of the enzyme dihydrofolate reductase).

It penetrates the GEB, the placenta and into breast milk. Tmax in the blood - 30-60 min. It is excreted by the kidneys as if unchanged (if the dose taken is much higher than the daily requirement), and in the form of metabolites. It is deduced with the help of hemodialysis. 5 mg of ingested folic acid is excreted from the body after 5 hours.

Indication of the drug Folacin

Treatment and prevention of folate deficiency against a background of unbalanced or malnutrition;

Treatment and prevention of anemia on the background of folic acid deficiency: macrocytic hyperchromic anemia, anemia and leukopenia caused by drugs and ionizing radiation, megaloblastic anemia, post-resection anemia, sideroblastic anemia in old age, anemia associated with small bowel disease, sprue and malabsorption syndrome;

Treatment and prevention of anemia in pregnancy and lactation;

In pregnancy - prevention of neural tube defects in the fetus;

Long-term treatment with folic acid antagonists (methotrexate, combination of sulfamethoxazole and trimethoprim), anticonvulsant drugs (phenytoin, primidone, phenobarbital).

Contraindications

Hypersensitivity to the components of the drug;

Pernicious anemia;

Malignant neoplasms;

Deficiency of cobalamin.

Side effects

Allergic reactions: it is possible to develop skin rashes, itching, erythema, bronchospasm.

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

Interaction

At simultaneous application with chloramphenicol, neomycin, polymyxins, tetracyclines, absorption of folic acid decreases.

With the simultaneous use of folic acid reduces the effects of oral contraceptives, ethanol, sulfasalazine, cycloserine and glutetimide, methotrexate, phenytoin, primidon, chloramphenicol.

The use of folic acid can reduce the plasma level of phenobarbital, phenytoin or primidon and cause an epileptic fit.

Reduction or change in absorption is possible with simultaneous application of colestyramine and folic acid, therefore folic acid should be taken 1 hour before or 4-6 hours after colestyramine.

Dosing and Administration

Inside.

Treatment of megaloblastic anemia, caused by a deficiency of folic acid, - 5 mg / day for 4 months, prevention - 2.5 mg / day.

Prophylaxis and treatment of macrocytic anemia in malabsorption, inflammatory bowel diseases and unbalanced or malnutrition - 15 mg / day, patients with sprue - 5-15 mg / day.

Preventing the development of neural tube defects in the fetus - at 2.5 mg / day for 4 weeks before the expected pregnancy, during the first trimester of pregnancy continue taking.

Higher maintenance doses may be given to patients with alcoholism, as well as to patients with chronic infections and taking anticonvulsants.

Overdose

Cases of overdose are not marked.

Precautionary measures

Patients on hemodialysis need increased amounts of folic acid.

With prolonged use of folic acid, especially in high doses, it is possible to reduce the concentration of vitamin B12 (cyanocobalamin) in the blood.

Long-term use of the drug is recommended to combine with the intake of vitamin B12.

Influence on the ability to drive vehicles and work with mechanisms. No data.

Release Form

Tablets, 5 mg. In PVC / aluminum blister, 10 pcs. 1, 2 or 3 bl. In a cardboard box.

Manufacturer

JSC "Yadran" Galen Laboratory. 51000, Pulats b / n, Rijeka, Croatia.

Claims on the quality of the drug should be sent to the representative office of JSC "Yadran" Galen Labs in Russia: 119330, Moscow

Conditions of supply of pharmacies

Without recipe.

Storage conditions of the drug Folacin

At a temperature not higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Folacin

5 years.

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