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Folacin 5 mg (30 tablets)




The instruction for medical use

of FOLACINUM medicine

the Trade name

the International unlicensed name
Folic acid

the Dosage form
of the Tablet of 5 mg

One tablet contains
active agent – folic acid – 5 mg,
excipients: lactoses monohydrate, povidone, krospovidon, cellulose microcrystalline, magnesium stearate

the Description
of the Tablet of a ploskotsilindrichesky form, yellow color, with impregnations of orange color, with a smooth surface, with the facet risky on one party, flavourless

Pharmacotherapeutic group
hematopoiesis Stimulators. Folic acid and its derivatives
the ATX B03BB01 Code

the Pharmacological

Pharmacokinetics Folic Acid properties is well soaked up from digestive tract, generally from a duodenum and a jejunum. It is distributed evenly on all fabrics. Partially concentrates in cerebrospinal fluid. The maximum concentration in plasma is reached in 30-60 minutes after intake. In plasma and a liver the active ingredient which is contacting glutaminic acid and being a coenzyme is metabolized in 5-metilentetragidrofolat. In a liver about 50% of total amount of folates concentrate. About 70% contact plasma proteins. It is removed with urine, glomerular filtration. The dose in the amount of 5 mg is removed with urine in 5 hours.

group B Vitamin (VS vitamin, B9 vitamin). Fills shortage of folic acid.
In an organism it will be transformed to a coenzyme (tetrahydrofolic acid) which participates in various metabolic processes and necessary for normal maturing of megaloblasts and formation of normoblasts. At deficiency of folic acid the megaloblastny type of a hemopoiesis develops. Stimulates an erythrogenesis, participates in synthesis of amino acids (including methionine, serine, glycine), nucleic acids, purines, pyrimidines, in exchange of sincaline, a histidine. At pregnancy performs protective function in relation to action on a fruit of teratogenic and disturbing factors. Besides, promotes normal maturing and functioning of a placenta, preventing its amotio. Folacinum plays an important role in the course of maturing of spermatozoa and can be applied as prevention of male infertility.

– the megaloblastny anemia caused by deficiency of folic acid
– macrocytic hyperchromic anemia
– post-resection anemia
– sideroblastny anemia at advanced age
– the anemia and a leukopenia caused by medicines and the ionizing radiation
– the anemia connected with digestive tract diseases (a spra, a sprue, persistent diarrhea, a liver failure, alcoholic cirrhosis)
– anemia of pregnant women
– prevention of development of defects of a neurotubule in a fruit (anencephaly, hydrocephaly, brain hernia, a wolf mouth, cleft lip), multiple pregnancies, a pregnancy miscarriage
– prevention of anemia in the period of a lactation
– anemia against the background of nicotine, alcohol or medicinal addiction
– long treatment by antagonists of folic acid (a methotrexate, a combination sulfamethoxazole – Trimethoprimum), anticonvulsant drugs (Phenytoinum, Primidonum, phenobarbital)
– polyneurites and polyneuropathy, including alcoholic etiology
– unbalanced or unsatisfactory food with deficiency of folic acid.

The route of administration and doses
Is applied inside. Adult:
– for treatment of the megaloblastny anemia, the adult caused by deficiency of folic acid: on 5 mg a day within 4 months, for prevention – on 2.5 mg a day. Course of treatment of 20-30 days. In a month the course of treatment should be repeated. Long administration of drug recommend to combine with B12 vitamin drug (cyanocobalamine)
– for prevention and treatment of macrocytic anemia at malabsorption, inflammatory bowel diseases and unbalanced or poor nutrition on 15 mg a day, to patients with a disease a spra – on 5-15 mg a day,
– for prevention of development in a fruit of defects of a neurotubule – up to 4.0 mg a day within 4 weeks before expected pregnancy and to continue reception during the I trimester of pregnancy individually on doctor’s orders.
– for prevention of deficiency of folic acid, connected with unbalanced or unsatisfactory food on 2.5 – 5 mg a day.
Higher maintenance doses can be appointed to the patients having alcoholism and also patients with persistent infections and taking the anticonvulsant drugs.

Side effects
– are possible: allergic reactions (skin rashes, an itching, an erythema, bronchospasm)
– the dispeptic phenomena, an abdominal pain
– fever
– insomnia, increase in convulsive readiness

of the Contraindication
– hypersensitivity to drug components
– pernicious anemia
– malignant new growths
– deficiency of cobalamine
– children’s age up to 12 years

Medicinal interactions
Reduces effect of Phenytoinum (increase in a dose of Phenytoinum is required).
Long intake of nonsteroid analgetics, anticonvulsants (Phenytoinum and carbamazepine), estrogen, peroral contraceptives increase the need for folic acid.
Antacids (including drugs Sa2+, Al3 + and Mg2+), Colestyraminum, alcohol, Sulfasalazinum and valproic acid reduce absorption of folic acid.
The methotrexate, Pyrimethaminum, Triamterenum, Trimethoprimum inhibit a digidrofolatreduktaza and reduce effect of folic acid.

Special instructions
the Patients who are on a hemodialysis need the increased amounts of Folacinum.
At prolonged use of Folacinum, especially in high doses, decrease in concentration in B12 vitamin blood is possible.
Prolonged use of drug is recommended to be combined with intake of B12 vitamin (cyanocobalamine).
Use at pregnancy and a lactation
At pregnancy and in the period of a lactation use of drug is shown in the recommended doses
of Feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms

the Overdose of folic acid
Symptoms does not influence: allergic reactions are possible. At prolonged use the development of hypovitaminosis of B12 is possible. The toxic effect is reached at one-stage intake of folic acid in a dosage of 300 mg and more.
Treatment: drug withdrawal. It is removed by means of a hemodialysis.

The form of release and packing
of the Tablet of 5 mg on 10 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1, 2 or 3 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a cardboard box.

To Store storage conditions at a temperature not above 25 °C
to Store out of children’s reach!

3 years
not to apply a period of storage after the expiration date specified on packing.

Prescription status
Without prescription

JSC Yadran Producer of Galenski of Laboratories 51000, Pulats/N, Rijeka, Croatia.

The name and the country of the owner of the registration certificate
of JSC Yadran Galenski of Laboratories, Croatia

the Address of the organization accepting in the territory of claim RK from consumers on quality of products: Representative office of JSC Yadran Galenski of Laboratories in Republic of Kazakhstan, Almaty, Luganskogo St. 54, a cat.9, ph. +7 272 62-14-48,

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