Folic acid astra

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FOLIC ACID ASTRA (Folic acid Astra)

Composition:

Active substance: folic acid hydrate;

1 tablet contains folic acid hydrate 5 mg;

Excipients: microcrystalline cellulose; lactose monohydrate; povidone; crospovidone; magnesium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: flat cylindrical tablets with bevelled edges and a score line, from pale yellow to yellow in colour. Slight orange specks on the tablet surface are permissible.

Pharmacotherapeutic group.

Folic acid and its derivatives. Folic acid.

ATC code B03B B01.

Pharmacological properties.

Pharmacodynamics.

After administration, folic acid is reduced to tetrahydrofolate, which functions as a coenzyme involved in various metabolic processes. It is necessary for the normal maturation of megaloblasts and the formation of normoblasts. It stimulates erythropoiesis and participates in the synthesis of amino acids (including methionine, serine, glycine, and histidine), nucleic acids, purines, pyrimidines, and is involved in choline metabolism. It provides protective effects against teratogenic factors. In addition, it promotes normal maturation and functioning of the placenta.

Folic acid plays an important role in the maturation process of spermatozoa and can be used for the treatment of male infertility.

Folic acid deficiency leads to megaloblastic hematopoiesis; in pregnant women, this may cause congenital malformations in the fetus (neural tube defects, hydrocephalus, etc.). The most serious consequence of folic acid deficiency is the reduced ability to regenerate damaged tissues.

Pharmacokinetics.

Folic acid is well absorbed from the gastrointestinal tract, primarily from the duodenum and small intestine. It is evenly distributed throughout all tissues and selectively concentrates in cerebrospinal fluid. The highest plasma concentration is reached within 30–60 minutes after oral administration.

It is metabolized in plasma and liver to 5-methyltetrahydrofolate, the active substance, which binds to glutamic acid and forms a coenzyme. Approximately 50% of the total folic acid stores are stored in the liver. About 70% is bound to plasma proteins. It is excreted in urine via glomerular filtration. After a 5 mg dose, it is eliminated in urine within 5 hours.

Clinical characteristics.

Indications.

For the treatment and prevention of anemias associated with folic acid deficiency: macrocytic anemia; anemia and leukopenia caused by medications and ionizing radiation; megaloblastic anemia, post-resection anemia; anemias in inflammatory bowel diseases (Crohn's disease, ulcerative colitis), malabsorption syndrome (gluten enteropathy or celiac disease), sprue.

For the prevention of fetal congenital malformations (neural tube defects: hydrocephalus, encephalocele, cleft palate, cleft lip) in women planning pregnancy and at risk.
Folic acid deficiency associated with unbalanced or inadequate nutrition.

For the treatment of male infertility due to reduced spermatogenesis (oligospermia).

Contraindications.

Hypersensitivity to folic acid or to any of the excipients, malignant neoplasms, malignant anemias, untreated cobalamin deficiency.

Interaction with other medicinal products and other forms of interaction.

Folic acid may reduce plasma concentrations of phenobarbital, phenytoin, and primidone, thereby increasing the risk of epileptic seizures. Folic acid may affect the toxic and therapeutic effects of methotrexate. Antibacterial agents, cycloserine, glutethimide, chloramphenicol, and co-trimoxazole may interfere with folate metabolism. Ethanol and acetylsalicylic acid may increase the elimination of folic acid. Concomitant administration of cholestyramine and folic acid may result in reduced or altered absorption. Therefore, the medicinal product should be taken 1 hour before or 4–6 hours after cholestyramine.

Folates enhance the efficacy of lithium. Nitrous oxide may cause acute folic acid deficiency. Concurrent use with fluorouracil should be avoided. Antacid preparations containing aluminum or magnesium may reduce the absorption of folic acid; therefore, patients should be advised to take antacids 2 hours after folic acid administration. Folic acid may reduce intestinal zinc absorption. Folic acid deficiency may be caused by such drugs as oral contraceptives, antituberculosis agents, folic acid antagonists (e.g., pyrimethamine, triamterene, trimethoprim, sulfonamides), anticonvulsants, chloramphenicol, cytostatics, and analgesics.

The medicinal product must not be used together with mineral acids, alkaline substances, or reducing agents, as inactivation of folic acid may occur.

Special precautions for use.

The medicinal product should be prescribed with caution to patients with anemias of unknown etiology, since folic acid may interfere with the diagnosis of pernicious anemia by alleviating hematological manifestations of the disease while allowing neurological complications to progress. In cases of pernicious anemia, the drug must be used only in combination with cyanocobalamin, as folic acid, while stimulating hematopoiesis, does not prevent the development of neurological complications (such as funicular myelosis). In cases of sprue, folic acid should be administered together with ascorbic acid, cyanocobalamin, and hemotherapy.

Prolonged use of folic acid, especially in high doses, is not recommended due to the risk of decreasing cyanocobalamin blood concentration.

During treatment with folic acid, regular monitoring of blood parameters is necessary.

The tablets contain lactose and therefore should not be used in patients with rare hereditary galactose intolerance, severe lactase deficiency, or glucose-galactose malabsorption.

For elderly patients, a cobalamin absorption test should be performed prior to initiating long-term therapy.

Use during pregnancy or breastfeeding.

This medicinal product is not intended for healthy pregnant women. The drug is prescribed to pregnant women with folic acid deficiency and to women at risk who are planning pregnancy, for the prevention of congenital malformations in the fetus, such as neural tube defects (hydrocephalus, encephalocele, cleft palate, cleft lip).

The drug may be used during breastfeeding at recommended doses. Folic acid passes into breast milk.

Folic acid deficiency or disturbances in folic acid metabolism are associated with the occurrence of congenital defects, including certain neural tube defects. Interference with folic acid metabolism or folic acid deficiency caused by certain medicinal products (e.g., anticonvulsants, antineoplastic agents) during early pregnancy may lead to congenital anomalies. Vitamin deficiency or lack of its metabolites may also contribute to spontaneous abortion and intrauterine growth retardation.

Ability to influence reaction rate when driving or operating machinery.

When used appropriately, folic acid does not affect the ability to drive a vehicle or operate machinery.

Dosage and Administration

For therapeutic purposes, adults and breastfeeding women should be administered 2.5–5 mg (1/2–1 tablet) daily. The treatment course lasts 20–30 days. It is recommended to perform 2–3 courses with a 1-month interval between them. Long-term use of the medication is recommended to be combined with vitamin B12 (cyanocobalamin) supplementation.

Women planning pregnancy and at risk of fetal neural tube defects should be administered 5 mg (1 tablet) daily, starting 4 weeks before conception and continuing throughout the first 3 months of pregnancy.

For prevention of folic acid deficiency associated with unbalanced or inadequate nutrition: 2.5–5 mg (1/2–1 tablet) daily. The treatment course is 20–30 days.

One month after completing a course, treatment should be repeated.

For treatment of megaloblastic anemia, 5 mg (1 tablet) of folic acid daily should be administered for 4 months (for prevention, the recommended dose is 2.5 mg (1/2 tablet) daily).

Patients with sprue, macrocytic anemia, malabsorption, or inflammatory intestinal diseases should be administered 5–15 mg (1–3 tablets) daily.

For celiac disease, a daily dose of 5–15 mg is recommended.

For treatment of male infertility due to impaired spermatogenesis (oligospermia), a daily dose of 5 mg (1 tablet) is recommended. The duration of treatment should be determined individually by the physician.

Children.

Do not use in children.

Overdose.

No cases of overdose have been reported. Administration in very high doses is not expected to harm the patient.

Overdose of folic acid may mask vitamin B12 deficiency.

Prolonged and significant exceeding of recommended doses may lead to dangerous accumulation of folacin crystals, resulting in body intoxication and increased adverse effects.

Treatment: discontinue the medication, symptomatic therapy.

Adverse reactions

"Folic Acid Astra" is well tolerated.

Adverse reactions are classified according to system organ classes and listed by frequency: very common (≥ 1/10) ≥ 10 %; common (≥ 1/100 and < 1/10) > 1 % and < 10 %; uncommon (≥ 1/1000 and < 1/100) > 0.1 % and < 1 %; rare (≥ 1/10000, < 1/1000) 0.01 % and < 0.1 %; very rare (< 1/10000) < 0.01 %; not known (cannot be estimated due to lack of data).

Gastrointestinal disorders: rare – anorexia, nausea, bloating, flatulence, vomiting, bitter taste in mouth.

Immune system disorders: rare – hypersensitivity reactions, including erythema, rash, pruritus, urticaria, dyspnea, anaphylactic reactions including shock; arterial hypotension.

Central nervous system disorders: fever, sleep disturbances, seizures.

Renal and urinary disorders: hypertrophy of epithelial cells in renal tubules and impairment of their function.

Shelf life

2 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 cardboard box.

Prescription status

By prescription only

Manufacturer

LLC "ASTRAFARM"

Manufacturer's address and location of business activities

6, Kyivska Street, Vyshneve, Kyiv-Sviatoshyn District, Kyiv Region, 08132, Ukraine