Instructions Folic acid tablets 5 mg No. 50
Composition
active ingredient: folic acid;
1 tablet contains 5 mg of folic acid;
excipients: glucose monohydrate, stearic acid.
Dosage form
Pills.
Main physicochemical properties: round tablets with a flat surface and a bevel, light yellow in color. Heterogeneity of color and minor inclusions are allowed.
Pharmacotherapeutic group
Folic acid and its derivatives. Folic acid.
ATX code B03B B01.
Pharmacological properties
Pharmacodynamics
After taking the drug, folic acid is reduced to tetrahydrofolate, which acts as 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 methionine, serine, glycine and histidine), nucleic acids, purines, pyrimidines, participates in choline metabolism. Performs a protective function against the effects of teratogenic factors. In addition, it contributes to the normal maturation and functioning of the placenta.
Folic acid plays an important role in the process of sperm maturation and can be used to treat male infertility.
Folic acid deficiency leads to the development of megaloblastic hematopoiesis, which in pregnant women can lead to the development of congenital defects in the fetus (neural tube defects, hydrocephalus, etc.). The most important consequence of folic acid deficiency is a decrease in the ability to repair damaged tissues.
Pharmacokinetics
Folic acid is well absorbed from the gastrointestinal tract, mainly from the duodenum and small intestine. It is evenly distributed throughout all tissues, selectively concentrated in the cerebrospinal fluid. The highest concentration in blood plasma is reached within 30 to 60 minutes after oral administration.
In plasma and liver it is metabolized to 5-methyltetrahydrofolate, an active substance that binds to glutamic acid and forms a coenzyme. Approximately 50% of the total folic acid supply is stored in the liver. About 70% is bound to plasma proteins. It is excreted in the urine by glomerular filtration. After taking a dose of 5 mg, folic acid will be excreted in the urine after 5 hours.
Indication
For the treatment and prevention of anemia associated with folic acid deficiency:
macrocytic anemia; anemia and leukopenia caused by drugs and ionizing radiation; megaloblastic anemia, post-resection anemia; anemia in inflammatory bowel diseases (Crohn's disease, ulcerative colitis), malabsorption syndrome (gluten enteropathy or celiac disease), sprue.
To prevent the development of congenital defects in the fetus: neural tube defects (hydrocephalus, brain hernias, "cleft palate", "cleft lip") in women at risk who are planning a pregnancy.
Folic acid deficiency associated with an unbalanced or inadequate diet.
For the treatment of male infertility due to reduced spermatogenesis (oligospermia).
Contraindication
Hypersensitivity to folic acid or to other components of the drug, malignant neoplasms, pernicious anemia, untreated cobalamin deficiency.
Interaction with other medicinal products and other types of interactions
Folic acid may reduce the plasma concentrations of phenobarbital, phenytoin and primidone, thereby increasing the likelihood of epileptic seizures. Chloramphenicol and co-trimoxazole may affect folate metabolism. Sulfasalazine may reduce the absorption of folic acid. Folic acid may affect the toxic and therapeutic effects of methotrexate. Antibacterial drugs, oral contraceptives, ethanol, sulfasalazine, cycloserine, glutethimide and methotrexate may affect folate metabolism. Ethanol and acetylsalicylic acid may increase the elimination of folic acid. Folic acid increases the metabolism of phenytoin. With the simultaneous use of cholestyramine and folic acid, a decrease or change in absorption is possible. Therefore, the drug should be taken 1 hour before or 4-6 hours after taking cholestyramine.
The absorption of folic acid is reduced when used simultaneously with analgesics, anticonvulsants, antacids, chloramphenicol, neomycin, polymyxins, antibiotics, sulfonamides, cytostatics.
Cannot be used together with mineral acids, alkaline substances, reducing agents, as folic acid is inactivated.
Application features
The drug should be prescribed with caution to patients with anemia of unknown etiology, since folic acid may interfere with the diagnosis of pernicious anemia by alleviating the hematological manifestations of the disease, while allowing neurological complications to progress. In the case of pernicious anemia, the drug should be used only together with cyanocobalamin, since folic acid, stimulating hematopoiesis, does not prevent the development of neurological complications (funicular myelosis, etc.); in sprue - in combination with ascorbic acid, cyanocobalamin, with hemotherapy.
Long-term use of folic acid, especially in high doses, is not recommended due to the risk of reducing blood cyanocobalamin concentrations.
When treating with folic acid, systematic monitoring of blood conditions is necessary.
In elderly patients, a cobalamin absorption test should be performed before starting long-term therapy.
The drug contains glucose, therefore, if the patient has been diagnosed with intolerance to some sugars, he should consult his doctor before taking this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
When used properly, folic acid does not affect the ability to drive or operate other machinery.
Use during pregnancy or breastfeeding
This medicine is not intended for healthy pregnant women. The medicine is prescribed to pregnant women with folic acid deficiency and to women at risk who are planning a pregnancy, to prevent the development of congenital defects in the fetus: neural tube defects (hydrocephalus, cerebral hernias, cleft palate, hare lip).
The drug can be used during breastfeeding in recommended doses. Folic acid passes into breast milk.
Folic acid deficiency, or impaired folate metabolism, has been associated with birth defects and some neural tube defects. Interference with folate metabolism or folic acid deficiency due to the effects of certain drugs, such as anticonvulsants and antineoplastic agents, in early pregnancy leads to congenital anomalies. Lack of the vitamin or its metabolites may also contribute to spontaneous abortion and intrauterine growth retardation.
Method of administration and doses
For therapeutic purposes, the drug is prescribed only to adults at a dose of 2*-5 mg per day. The maximum daily dose is 5 mg (1 tablet). The course of treatment is 20-30 days. It is recommended to conduct 2-3 courses with a break of 1 month. It is recommended to combine the use of the drug for a long time with the intake of vitamin B12 (cyanocobalamin).
Women at risk who are planning a pregnancy and pregnant women with folic acid deficiency should take 5 mg (1 tablet) once a day, daily for 4 weeks before pregnancy and continue taking it during the first 3 months of pregnancy to prevent the development of neural tube defects in the fetus.
For the prevention of folic acid deficiency associated with unbalanced or unsatisfactory nutrition - 2*-5 mg per day. The course of treatment is 20-30 days.
It is recommended to repeat the treatment course after 1 month.
For megaloblastic anemia, prescribe 5 mg (1 tablet) of folic acid per day for 4 months (for prevention, the recommended dose is 2* mg per day).
Patients with sprue, macrocytic anemia, malabsorption, and inflammatory bowel diseases are recommended to take 5-15 mg (1-3 tablets) per day.
For celiac disease, it is recommended to take 5-15 mg per day.
For the treatment of male infertility due to reduced spermatogenesis (oligospermia), it is recommended to prescribe 5 mg (1 tablet) per day. The duration of treatment is determined individually by the doctor.
*Use folic acid in the appropriate dosage.
Children
Do not use on children.
Overdose
No cases of overdose have been reported. Use in very large doses should not harm the patient.
An overdose of folic acid can mask a vitamin B12 deficiency.
Prolonged and significant excess of recommended doses can cause a dangerous accumulation of folacin crystals, leading to intoxication of the body and increased side effects.
Treatment: Discontinuation of the drug, symptomatic therapy.
Adverse reactions
The medicine is well tolerated.
Gastrointestinal: anorexia, nausea, vomiting, bloating, flatulence, feeling of bitterness.
Immune system: hypersensitivity reactions, including erythema, skin rash, itching, urticaria, shortness of breath due to bronchospasm, hypotension, anaphylactic reactions, including shock.
Central nervous system: fever, night sleep disorder, convulsions.
On the part of the urinary system: hypertrophy of epithelial cells in the renal tubules and impaired function.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister. 5 blisters in a pack.
Vacation category
According to the recipe.
Producer
PJSC "VITAMINS".
Location of the manufacturer and its business address
Ukraine, 20300, Cherkasy region, Uman city, Leninskaya Iskra st., 31.
