Folacin - instructions for use, dose, side effects, contraindications

Composition: 1 tablet contains: active substance - folic acid - 5 mg; auxiliary substances - lactose monohydrate, povidone, crospovidone. cellulose microcrystalline, magnesium stearate.

Description:

Description

Round flat cylindrical tablets of yellow color with insignificant marbling, it is supposed presence of inclusions of orange color, with a facet and risk on one side, without a smell.

Pharmacotherapeutic group:Vitamin; hemopoiesis stimulant

ATX: & nbsp

B.03.B.B Folic acid and its derivatives

B.03.B.B.01 Folic acid

Pharmacodynamics:

Vitamin B group.

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, a 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 oral administration folic acid, connecting in the stomach with the internal Factor factor (specific glycoprotein), is well and completely absorbed into the digestive tract. 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). Penetrates through the blood-brain barrier, the placenta and into breast milk.Stah in the blood is reached in 30-60 minutes. 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 excreted by hemodialysis. 5 mg of ingested folic acid is excreted after 5 hours.

Indications:

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

- Treatment and prevention of anemia, against the background of a deficiency of folic acid: 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 syndrome malabsorption. - Treatment and prevention of anemia in pregnancy and lactation;

- In pregnancy, to prevent the development of neural tube defects in the fetus;

-continuous treatment with folic acid antagonists (methotrexate, a combination of sulfamethoxazole - trimethoprim), anticonvulsants (phenytoin, primidon, phenobarbital)

Contraindications:

Hypersensitivity to the drug components, pernicious anemia, malignant neoplasms, deficiency of cobalamin.

Dosing and Administration:

It is applied inside.

-for the treatment of megaloblastic anemia due to a deficiency of folic acid: 5 mg per day for 4 months, for prophylaxis - 2.5 mg per day.

-for the prevention and treatment of macrocytic anemia in malabsorption, inflammatory bowel diseases and unbalanced or inadequate nutrition-15 mg per day, for patients with spruce disease, 5-15 mg per day.

-to prevent the development of neural tube defects in the fetus - 2.5 mg per day for 4 weeks before the expected pregnancy and continue taking during the first trimester of pregnancy.

Higher maintenance doses may be administered to patients with alcoholism, as well as to patients with chronic infections and taking anticonvulsant drugs.

Side effects:

Perhaps the manifestation of allergic reactions (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 simultaneous application folic acid reduces the effects of oral contraceptives, ethanol, sulfasalazine, cycloserine and glutetimide, methotrexate, phenytoin, primidin, chloramphenicol. The use of folic acid can reduce the plasma level of phenobarbital, phenytoin or primidon and cause an epileptic fit. Cases of decrease or change in absorption may occur with simultaneous

the use of cholestyramine and folic acid, therefore, folic acid should be taken 1 hour before or 4-6 hours after cholestyramine.

Special instructions:

Patients on hemodialysis need elevated amounts of folic acid.

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

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

Form release / dosage:Tablets 5 mg

Packaging:

For 10 tablets in PVC / Al blister.One, two or three blisters are placed together with instructions for use in a cardboard box.

Storage conditions:

At a temperature not higher than 25 ° C, out of the reach of children.

Shelf life:

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

Terms of leave from pharmacies:On prescription

Registration number:LS-001513

Date of registration:10.08.2010

The owner of the registration certificate:Yadran Galensky Laboratories a.o.Yadran Galensky Laboratories a.o. Croatia

Manufacturer: & nbsp

Yadran Galensky Laboratories JSC Croatia

Representation: & nbspYadran Galen Laboratory as.Yadran Galen Laboratory as.Croatia

Information update date: & nbsp25.09.2015

Illustrated instructions

Instructions

Folacin (Folacin)