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  • Dosage form: & nbsppills
    Composition:

    Each tablet contains:

    active substances: folic acid 0.4 mg, cyanocobalamin (vitamin B12) 0.002 mg (commercial mixture 0.1%) *;

    Excipients: sodium carboxymethyl starch (type A) 0.70 mg, magnesium stearate 0.70 mg, lactose monohydrate 23 mg, microcrystalline cellulose 43.20 mg.

    * trisodium citrate 0.06 mg, citric acid 0.02 mg, maltodextrin 1.918 mg.

    Description:

    Flat, round, yellow tablets.

    Pharmacotherapeutic group:multivitamin
    ATX: & nbsp

    A.11.B.A   Multivitamins

    Pharmacodynamics:

    Folate deficiency causes a broken DNA synthesis in the cell, which is preparing for chromosome replication and division. The mechanism of action is due to the participation of folic acid in the form of tetrahydrofolate in the synthesis of nucleic acids and in cell division, and also as a coenzyme in the synthesis of purines and pyrimidines, which makes it the decisive factor in the formation of the central nervous system that develops in humans for 15-28 days after fertilization. The conversion of 5-methyl tetrahydrofolate to tetrahydrofolate in the body can occur only as a result of the addition of the methyl group to homocysteine ​​to form methionine as a result of the action of methionine synthetase.

    In this process, vitamin B12 participates as a limiting cofactor, therefore, vitamin B deficiency12 is similar in the effects of insufficient folic acid activation; In addition, vitamin B12 is also involved in the capture of folic acid by cells, so when a cell is experiencing a primary vitamin B deficiency12, then she also experiences a deficit in folate.

    Pharmacological action of the drug Foliber is that its use allows you to overcome the metabolic blockade, which is observed by the mothers of children with neural tube defects. The specific nature of this metabolic blockade is the metabolism of the essential amino acid methionine, in which folate and vitamin B12 are key elements, as they are responsible for re-methylation of homocysteine ​​in methionine. 400 micrograms of folic acid is the minimum effective daily dose recommended by the Centers for Disease Prevention (US, UK and Australia) by healthy women as an additional daily intake to prevent the development of neural tube defects in the fetus. The recommended daily intake of vitamin B12 is 2 micrograms.

    Pharmacokinetics:

    Folic acid is rapidly absorbed in the jejunum, subject to reduction and methylation to 5-methyltetrahydrofolate, which is present in the portal circulation. The maximum concentration in plasma is observed after 30-60 minutes.

    On the other hand, the vitamin B12 can be absorbed after its interaction in the stomach with the "internal Factor of Castle," a glycoprotein that is secreted by parietal cells of the stomach. The maximum concentration in plasma is observed after 8-12 hours. As with folic acid, vitamin B12 is subject to significant intestinal hepatic recirculation. Both components largely bind to plasma proteins, excess accumulates in the liver.

    Every day, 4-5 μg of folate is excreted in the urine in the form of folic acid, 10-formyltetrahydrofolate and 5-methyl tetrahydrofolate. Folate is also excreted in breast milk. The average half-life of vitamin B12 is about 6 days. Part of the administered dose is excreted in the urine for the first 8 hours, although most of it is excreted with bile. 25% is excreted with feces. In addition, the vitamin B12 penetrates the placenta and is present in breast milk.

    Indications:

    Prevention of deficiency of folic acid and vitamin B12 (cyanocobalamin) in women of childbearing age at the stages of pregnancy planning (at least 1 month before conception), and I trimester of pregnancy to prevent the development of neural tube defects in the fetus.

    Contraindications:

    Increased individual sensitivity to the components of the drug.

    Carefully:

    This preparation contains 23 mg of lactose in a tablet, which must be taken into account for patients with impaired glucose absorption or galactose, patients with galactosemia or with lactase deficiency.

    Dosing and Administration:

    1 tablet a day, before meals.

    Side effects:

    Allergic reactions are possible.

    Interaction:

    The drug Foliber should not be taken in combination with methotrexate, because it acts as a folic acid antagonist, inhibiting the enzyme hydrophosphate reductase.

    Taking Foleiber in combination with anti-epileptic drugs from the hydantoin group can reduce the effect of the latter.
    Effect on the ability to drive transp. cf. and fur:

    Foiber does not affect the ability to drive and work with machinery.

    Form release / dosage:

    Pills.

    Packaging:

    For 28 tablets in blisters of opaque polyvinyl chloride / aluminum.

    Each blister along with the instruction for use is placed in a cardboard box.

    Storage conditions:

    In a dry place, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-002050
    Date of registration:04.05.2010
    The owner of the registration certificate:Italfarmaco SpAItalfarmaco SpA Italy
    Manufacturer: & nbsp
    Representation: & nbspITALFARMAKO SpA ITALFARMAKO SpA Italy
    Information update date: & nbsp21.08.2015
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