FOBILLA [Folic acid] 5 mg Film-coated tablets
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FOBILLA
instructions for the medical use of the medicinal
product
Tradename
Fobilla, Фобилла
International
non-proprietary name or generic name
Folic acid, Фолиевая кислота
Composition
Each film coated tablet contains:
Active substance: folic acid 5 mg.
Excipients: lactose, starch, talc, magnesium stearate, PVP K-30.
Tablets.
Vitamins. Stimulants
of hematopoiesis.
Pharmacodynamics
Vitamin of group B
(vitamin Bc, B9). In the body, 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 methionine, serine), nucleic acids, purines and pyrimidines, in the
exchange of choline, histidine. During pregnancy, it protects the body from
teratogenic factors. Contributes to the normal maturation and functioning of
the placenta.
Folic acid is well and
completely absorbed in the gastrointestinal tract, mainly in the upper duodenum
(even in the presence of malabsorption syndrome against the background of
tropical sprue).
Intensively binds to plasma
proteins. Penetrates the BBB, placenta, and breast milk. Tmax - 30-60 min. It
is deposited and metabolized in the liver with the formation of tetrahydrofolic
acid (in the presence of ascorbic acid under the action of dihydrofolate
reductase).
It is excreted by the kidneys
mainly in the form of metabolites. If the dose taken significantly exceeds the
daily requirement for folic acid, then it is excreted unchanged.
- megaloblastic anemia caused
by folic acid deficiency;
- macrocytic hyperchromic
anemia;
- post-resection anemia;
- sideroblastic anemia in old
age;
- anemia and leukopenia caused
by drugs and ionizing radiation;
- anemia associated with
diseases of the gastrointestinal tract (sprue, malabsorption syndrome,
persistent diarrhea, liver failure, alcoholic cirrhosis of the liver);
- anemia of pregnant women;
- prevention of the
development of neural tube defects in the fetus (anencephaly, hydrocephalus,
cerebral hernia, cleft palate, cleft lip), multiple pregnancy, miscarriage;
- prevention of anemia during
lactation;
- anemia against the
background of nicotine, alcohol or drug addiction;
- long-term treatment with
folic acid antagonists (methotrexate, a combination of sulfametaxazole -
trimethoprim), anticonvulsants (phenytoin, primidone, phenobarbital);
- polyneuritis and
polyneuropathy;
- unbalanced or unsatisfactory
nutrition with a deficiency of folic acid.
- hypersensitivity to the active substance or to
any of the excipients;
- long-term therapy of patients with untreated
cobalamin deficiency (eg, pernicious anemia, vitamin B12 deficiency,
vegetarianism);
- malignant neoplasms;
- pregnant women without an established
deficiency of folic acid and / or the presence of risk factors for the
development of neural tube defects in the fetus;
- a period of breastfeeding without an
established deficiency of folic acid.
Method of administration and dosage
Inside before meals with a small amount of liquid.
Adults
With drug deficiency of folic acid - 5 mg per day for
4 months; with malabsorption - it is possible to use up to 15 mg daily.
For the prevention of anemia in chronic hemolytic
status: 5 mg every 1 to 7 days, depending on exacerbations of the disease.
Children with hemolytic
anemia and metabolic disorders
In children under the age of 4 years, it is allowed to
use tablets in a pre-crushed form in the form of a powder. Doses of folic acid
in children are: at the age of 1 year 0.5 mg / kg (½ tablet per 1 kg of body
weight) 1 time per day, but not more than 5 mg / day, at the age of 1 to 12
years - 2, 5 - 5 mg / day; over 12 years old - 5-10 mg / day 1 time per day.
For the treatment of macrocytic (folate deficiency)
anemia, the following is prescribed: for adults and children of any age, the
initial dose is up to 1 mg / day (1 tablet). Daily doses of more than 1 mg do
not increase the hematological effect, and most of the excess folic acid is
excreted unchanged in the urine. In resistant cases, higher doses may be required.
Initial doses are used for about 14 days or until a hematologic and clinical
response is obtained, then they are switched to supportive treatment. The total
duration of therapy can be about 4 months.
Supportive treatment: for children under 4 years old: for
infants - 0.1 mg / day, children under 4 years old - up to 0.3 mg / day;
children over 4 years old and adults - 0.5 mg (½ tablet), during pregnancy and
lactation - 1 mg / day, but not less than 0.1 mg / day.
For established folate deficiency during pregnancy: 5
mg daily throughout pregnancy. For the prevention of developmental defects of
the neural tube in the presence of a history of malformations: 4 - 5 mg daily
for 1 month before the planned conception and for 3 months after it.
If there is no history of neural tube defects (or
other predisposing factors): 0.5 mg (½ tablet) daily for 10 to 12 weeks after
the last menstrual period. During pregnancy, the appointment of folic acid in
doses higher than 0.4 mg / day can be carried out only after malignant (pernicious)
anemia associated with vitamin B12 deficiency has been excluded.
Special instructions and precautions
For the prevention of hypovitaminosis of folic acid, a
balanced diet is most preferable. Folic acid rich foods: green vegetables
(lettuce, spinach), tomatoes, carrots, fresh liver, legumes, beets, eggs,
cheese, nuts, and cereals.
Folic acid is not used to treat B12-deficiency,
normocytic, and aplastic anemia. In B12-deficiency anemia, folic acid, while
improving hematological parameters, masks neurological complications. Until
B12-deficiency anemia is ruled out, folic acid administration in doses
exceeding 0.1 mg / day is not recommended.
It should be borne in mind that patients on
hemodialysis require increased amounts of folic acid.
With the use of large doses of folic acid, as well as
therapy for a long period, a decrease in the concentration of vitamin B12
(cyanocobalamin) in the blood is possible. Long-term use of folic acid is
recommended to be combined with vitamin B12 intake.
During treatment, antacids should be used 2 hours
after taking folic acid, cholestyramine - 4-6 hours before or 1 hour after
taking folic acid.
It should be borne in mind that antibiotics can
distort (give deliberately underestimated values) the results of a
microbiological assessment of the concentration of folic acid in plasma and
erythrocytes.
Influence on the ability to drive
vehicles and mechanisms
The use of the drug does not affect
the ability to drive vehicles and engage in other potentially hazardous
activities that require increased concentration of attention and speed of
psychomotor reactions.
Application during pregnancy and during breastfeeding
It is contraindicated for use
in pregnant women without an established deficiency of folic acid and / or the
presence of risk factors for the development of neural tube defects in the
fetus. It can be used during pregnancy according to indications in recommended
doses.
It can be used during
lactation (breastfeeding) strictly according to indications, in recommended
doses and dosage forms.
Interaction with other medicinal products
When used simultaneously with
chloramphenicol, neomycin, polymyxins, tetracyclines, the absorption of folic
acid decreases.
With the simultaneous use of analgesics
(long-term therapy), anticonvulsants (including phenytoin, carbamazepine),
estrogens, parenteral contraceptives, the need for folic acid increases.
With the simultaneous use of
folic acid, a decrease in the plasma concentration of phenobarbital, phenytoin,
primidone is possible, the risk of an epileptic seizure increases.
With the simultaneous use of
antacids (including calcium, aluminum and magnesium preparations),
cholestyramine, sulfonamides (including sulfasalazine), the absorption of folic
acid decreases. Antacids should be used 2 hours after taking folic acid,
cholestyramine - 4-6 hours before or 1 hour after taking folic acid.
With the simultaneous use of
methotrexate, pyrimethamine, triamterene, trimethoprim inhibit dihydrofolate
reductase and reduce the effect of folic acid.
From the digestive system: anorexia,
nausea, bloating, flatulence, bitterness in the mouth.
From the immune system: anaphylactic
reactions (including shock).
Allergic reactions: erythema,
rash, itching, urticaria, shortness of breath.
If
any of the side effects indicated in the instructions are aggravated, or you
notice any other side effects not listed in the instructions, inform your
doctor.
Folic
acid doses up to 5 mg are well tolerated. Higher doses can cause CNS and GI
symptoms.
Treatment
- gastric lavage, symptomatic therapy.
Store in a dry and
dark place, at a temperature not exceeding 25°C.
Keep out of the reach
of children!
2 years. Do not use after
the expiration date printed on the package.
Dispensed by
prescription.
Release form
10 tablets in an
aluminum foil blister. 5 blisters together with instructions for use in a
cardboard box.