Acidum Folicum 1mg #60 Tab
Pharmacological group: Vitamin
means.
ATC code: B03BB01.
Drug form: Tablets.
Description:
Yellowish colour pills, dark color inserts is permissible.
Composition
of one tablet:
Folic acid – 0,001g (1mg) or 0,005g (5mg);
Aiding substances:
Lactose, polyvinylpyrrolidone, stearate of calcium or magnesium, starch, talc.
Pharmacological operation: Folic
acid is a part of vitamins Bc. Folic acid metabolizes in an organism to
tetrahydrofolic acid. It is a coenzyme, which is necessary for normal
megaloblast maturing and production of normoblast. Folic acid stimulates
erythrogenesis.
It
participates: in synthesis of amino acids, in an exchange of nucleinic acids,
purine, pyrimidine and choline.
Pharmacokinetics: It is
completely soaked up peroral introduction from proximal part of duodenal gut
and small intestines. 98,5% from the entered dose are defined in blood after
3-6 hours. Before absorption in intestines folic acid restores by means of
enzyme (dehydropholatreductase).
Deposition and metabolism of folic acid is carried out in the liver. 50% from
the entered dose is eliminated with urine.
Indication:
· Anaemia
which has developed because of deficiency of folic acid chemical
(medicamentous) substances or action of ionising radiation, leucopenia,
megaloblastic anemia, sideroblastic anemia, anemia caused by small intestinal
disease);
· Treatment
and prevention of anemia during pregnancy and lactation.
Contra-indication:
Additional sensitivity toward folic
acid.
Using rule
and dosage: The preparation is taken perorally after eating.
The daily
dose for adults makes 5 mg.
Course of
treatment proceeds 20-30 days. Repeat course after 1 month.
For the
treatment of megaloblastic anemia Folic acid is prescribed 5mg/in a day for 4
month.
For the prevention of fetal’s neural tube defects
folic acid administered in a dose of 5mg/day for 4 weeks before the planned
pregnancy and treatment continues during the first trimester of pregnancy.
For children, the daily dose depends on the age.
The daily requirement for children from 1 to 6 months
is 0,025mg, from 6 to 12 months - 0,035mg, from 1 to 3 years 0,05mg, from 4 to
6 years - 0,075mg, from 7 to 10 years 0,1mg, from 11 to 14 years 0,15mg, from
15 years 0,2mg, for pregnant women – 0,4 mg, during lactation - 0,26-0,28mg.
Side effects: Allergic reactions, a bronchospasm, erythema, heat,
a rash on a skin.
Caution: Long reception of a preparation with a great doses can
cause reduction of cyanocobalamin concentration in blood. At time of pernicious
anemia for the purpose of avoiding neurologic complications the combination of
folic acid and cyanocobalamin is expedient.
Pregnancy and lactation: Based on the fact that folic acid
deficiency is particularly dangerous in the first trimester of pregnancy, the
reception of this vitamin is recommended in the preparation period of pregnancy
and during the whole period of pregnancy - 1 mg daily.
Interaction with other medical means: In combination with
chloramphenicol, neomycin, tetracycline the absorption of folic acid decreases.
In combination with pheniton,
pyrimidine, pasca, sulfasalazine, chloramphenicol, hormonal contraceptives with
folic acid their therapeutic effect decreases.
Overdose: Folic acid is well tolerated when taken in doses of
4-5mg. In the case of higher doses may develop disorders of the central nervous
system and gastrointestinal tract.
Issuing rule: Pharmaceutical
product group III group - Issued without prescription.
Shelf life: 2 years.
Storage conditions: Store on 15-25ºC temperature, keep away from
children.
In case of visual defects and expiry of validity
date, the preparation can not be used.
Packing: Folic acid – 0,001g (1mg).
Primary packing: №20 tablets on a blister.
Secondary packing: 3 blisters in a cardboard box.
Folic acid – 0.005g (5mg).
Primary packing: №20 tablets on a blister.
Secondary packing: 2 blisters in a cardboard box.
