9 months Folic acid - instructions for use, dose, side effects, contraindications

Shell: Opadrai II 85F22233 0.0030 g: partially hydrolysed polyvinyl alcohol 40.00%, macrogol 20.20%, talc 14.80%, titanium dioxide E 171 19.50%, iron dye oxide yellow E 172 - 0.10%, aluminum varnish based on the quinoline yellow dye E 104 -5.40%.

Description:

The tablets are round biconvex, covered with a yellow coating. At the break of light yellow color with impregnations.

Pharmacotherapeutic group:Vitamin

ATX: & nbsp

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

B.03.B.B.01 Folic acid

Pharmacodynamics:Vitamin B (vitamin B, vitamin B9) can be synthesized by the intestinal microflora. In organism folic acid is reduced to tetrahydrofolic acid, which is 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 glycine, methionine), nucleic acids, purines, pyrimidines, in the exchange of choline, histidine.

Pharmacokinetics:

Folic acid is well and completely absorbed in the gastrointestinal tract, mainly in the upper parts of the duodenum. Almost completely binds to plasma proteins. It is activated in the liver by the action of the enzyme dihydrofolate reductase, turning into tetrahydrofolic acid. The maximum concentration in the blood plasma (C_max) is reached in 30-60 minutes. Penetrates through blood-brain and placental barriers and penetrates into breast milk.

It is excreted by the kidneys mainly in the form of metabolites; if the taken dose significantly exceeds the daily requirement for folic acid, then it is output in unchanged form.

It is excreted by hemodialysis.

Indications:

Deficiency of folic acid.

Prevention of neural tube defects in the fetus in the first trimester of pregnancy.

Contraindications:

Hypersensitivity to the components that make up the drug; pernicious anemia, malignant neoplasms, deficiency of cobalamin, children's age.

Pregnancy and lactation:

Folic acid is necessary in the period of preparation for pregnancy (1-3 months before the planned pregnancy) and in the first few weeks after conception (I trimester).

Dosing and Administration:

Apply inside after eating.

With a deficiency of folic acid - 400 mcg (1 table) per day.

To prevent the development of neural tube defects in the fetus in the first trimester of pregnancy - 400 mcg - 800 mcg (1-2 tablets).

Side effects:

Allergic reactions (skin rash, itching, bronchospasm, erythema, hyperthermia); from the gastrointestinal tract: nausea, bloating, bitterness in the mouth, anorexia.

With prolonged use, it is possible to develop hypovitaminosis B12.

Overdose:

It can occur with long-term use (more than 1-2 months) of folic acid in doses over 1000 mcg per day and as a result of joint application with vitamin-mineral complexes.

Interaction:

Reduces the effect of phenytoin (requires increasing its dose).

Analgesics (long-term therapy), anticonvulsant drugs (incl. phenytoin and carbamazepine), estrogens, oral, contraceptives increase the need for folic acid.

Antacids, colestramine, sulfonamines (incl. sulfasalazine) reduce the absorption of folic acid.

Methotrexate, pyrimethamine, triamterene, trimethoprim inhibit dihydrofolate reductase and reduce the effect of folic acid (instead, patients using these drugs should be prescribed calcium folinate).

When used simultaneously with chloramphenicol, neomycin, polymyxin, tetracycline, absorption of folic acid is reduced.

Special instructions:

For prevention of hypovitaminosis, a balanced diet is most preferable. Foods rich in folic acid - green vegetables (salad, spinach, tomatoes, carrots), fresh liver, legumes, beets, eggs, cheese, nuts, cereals.

Folic acid is not used for treatment In 12-deficient (pernicious), normocytic and aplastic anemia, as well as anemia refractory to therapy. With pernicious (in 12-deficient) anemia folic acid, improving hematologic indices, masks neurological complications. While pernicious anemia is not ruled out, 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, colestramine - 4-6 hours before or 1 hour after taking folic acid. It should be borne in mind that antibiotics can distort (give deliberately low values) 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 therapy for a long period, a decrease in the concentration of vitamin B12 is possible.

Form release / dosage:

Film-coated tablets, 400 μg.

Packaging:

10 tablets per contour cell package or in a contoured cell package with perforations made of polyvinylchloride film and aluminum foil printed lacquered.

By 3, 6, 9 contour packs together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-005902/08

Date of registration:23.07.2008 / 21.12.2016

Expiration Date:Unlimited

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Information update date: & nbsp03.05.2018

Illustrated instructions

Instructions

9 months Folic acid (Folic acid 9 months)