Mamifol
Producer: Italfarmaco (Italfarmako) Italy
Code of automatic telephone exchange: B03BB01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: folic acid – 0.400 mg.
Excipients: magnesium stearate, lactoses monohydrate, cellulose microcrystallic, sodium carboxymethylstarch (type A).
Description: round biconvex tablets of yellow color.
Pharmacological properties:
Insufficiency of folivy acid causes disturbance of synthesis of DNA in the cell preparing for chromosome replication and division. The mechanism of action is caused by participation of folic acid in the form of tetrahydrofolate in synthesis of nucleic acids and in cell fission and participation as coenzyme in synthesis of purines and pyrimidines that does it by a decisive factor in formation of the central nervous system which develops at the person for 15-28 day after fertilization. Transformation 5 methyltetrahydrofolates in tetrahydrofolate in an organism can result only from transfer of methyl group to a gomotsistein with formation of methionine as a result of action of a metioninsintetaza. Mamifol adjusts metabolism of irreplaceable amino acid of methionine which is broken at mothers of children with defects of a neurotubule.
Pharmacokinetics. Folic acid is quickly soaked up in a jejunum, being exposed to recovery and methylation to 5 methyltetrahydrofolates which is present at portal blood circulation. Its bioavailability after oral administration is high and makes from 76% to 93%. The maximum concentration in plasma is observed in 60 minutes. There is an enterohepatic circulation of folate which is irreplaceable for maintenance of a homeostasis, therefore, that methyltetrahydrofolate from a liver generally gets to bile, and again gets into a large intestine where it is repeatedly soaked up. Folates are substantially connected with proteins of plasma, the liver is the main depot. Folates are removed with urine in the form of metabolites, 10 formyltetrahydrofolates and 5 methyltetrahydrofolates. Folates get through a placental barrier and are removed with maternal milk.
Indications to use:
The prevention of insufficiency of folic acid at women of childbearing age, at pregnancy planning stages, for prevention of development of defects of a neurotubule in a fruit.
Route of administration and doses:
1 tablet a day within one month before pregnancy and during the first trimester of pregnancy. The daily dose can be doubled in case of deficit of folic acid. Drug is accepted inside before food.
Features of use:
There are no data on drug influence Mamifol on ability to drive the car and work with mechanisms. However, it is necessary to be careful when performing these types of works. This drug contains lactose, patients at whom difficulties with absorption of glucose or a galactose, to patients with a galactosemia or with insufficiency of lactase are noted need to consider it. Drug has no effective effect for the prevention of defects of a neurotubule if administration of drug is begun after the fourth week of pregnancy. Patients with pernicious anemia should accept folic acid only in combination with cyanocobalamine.
Side effects:
Allergic reactions (erythema, itch, skin rash). At treatment by the doses exceeding recommended disturbances from digestive tract (nausea, abdominal pains, a meteorism) are possible, and also irritability and sleeplessness. At emergence of any side effects undescribed in this instruction, it is necessary to inform the attending physician.
Interaction with other medicines:
Drug Mamifol should not be accepted in combination with antagonists of folic acid: a methotrexate and Sulfasalazinum as it inhibits enzyme to a gidrofolatreduktaz. Administration of drug Mamifol in combination with antiepileptic drugs from group of hydantoin (Phenytoinum, phenobarbital, Primidonum, carbamazepine or valproic acid) can reduce effect of the last.
Contraindications:
Hypersensitivity to drug components, malignant new growths, deficit of cobalamine. With care: pernicious anemia.
Overdose:
Doses of folic acid to 4-5 mg are transferred well. Higher doses can cause: disturbances from the central nervous system and digestive tract.
Storage conditions:
To store at a temperature not over +30 ºС. To store in the place, unavailable to children. Period of validity 2 years. Not to use drug after a period of validity.
Issue conditions:
Without recipe
Packaging:
Tablets of 0,4 mg. On 28 tablets in the blister from opaque polyvinylchloride / aluminum. Each blister together with the application instruction in a cardboard pack.