Composition.
One capsules contains active ingredients: Iron 50.00 mg, Folic acid 0.50 mg (as mixture of Iron sulfate pellets retard and Folic acid).

Pharmacological properties
Pharmacodynamics
Compound antianemiс drug with the effect based on its components’ properties. Iron (II) sulfate (iron salt) is a microelement necessary for hemoglobin synthesis. Iron is a part of hemoglobin, myoglobin and some enzymes. Iron salt provides a fast iron deficiency restore and a gradual decrease of clinical (asthenia, fatigue, dizziness, tachycardia, morbidity and xeroderma) and laboratory symptoms of anemia.
Folic acid is necessary for the normal maturation of megaloblasts and production of normoblasts. It enhances erythropoiesis, participates in synthesis of amino acids, nucleic acids, pyrin and pyrimidine, in choline metabolism. In pregnancy Folic acid protects from teratogenic factors.
Specific pellet shell assures the absorption of active ingredients mainly in upper small intestine. Minimum topical irritation of mucous coat of stomach stimulates gastrointestinal tolerance to the product.
Pharmacokinetics
Iron
Absorption
Iron absorption is an active process and occurs predominantly in the duodenum, and upper jejunum.
Combination of Iron (II) sulfate and excipients permits to liberate iron constantly and progressively. The absorption increases when iron reserves are short.
Iron absorption can be decreased because of some foodstuff or beverage, and due to concomitant intake of some medicines (see Interaction with other drugs and other types of interaction).
Distribution
Iron reserves are mainly concentrated in marrow (erythroblasts), erythrocytes, liver and spleen. Iron is transported in the blood by transferrin and principally in marrow where it is incorporated with hemoglobin.
Biotransformation
Iron is ion of metal not metabolized in liver.
Elimination
Medium excretion of iron in healthy patients is evaluated as 0.8-1 mg/daily.
Iron is excreted mainly from gastrointestinal tract (desquamation of enterocytes, degradation of heme after extravasation of erythrocytes), urogenital tract and skin.
Folic acid
Absorption
Folic acid (folate) is readily absorbed in gastrointestinal tract mainly in proximal part of small intestine.
Distribution
Folates are distributed in all the body. The main stock of folate is liver; their concentration is also found in cerebrospinal fluid. Folate enters breast milk.
Biotransformation
Folic acid is converted to an active metabolic form: 5-methyl tetrahydrofolate (5-MTHE) in plasma and liver. Folate metabolites enter enterohepatic circulation.
Elimination
Folic acid metabolites are excreted with urine. The excessive folates are secreted with urine unaltered.
Preclinical safety data
Preclinical data reported from routine studies of pharmacological safety, toxicity of multi-doses, genotoxicity, carcinogenicity of reproductive function and development did not figure out a particular risk for humans.
Indications for usage
The drug Ferrofol is indicated for prevention and treatment of Iron deficiency and Iron-deficiency anemia with Folic acid deficiency, especially in pregnancy.
Route of administration and dose
Dose regiment
Patients after 18
• Mild iron-deficiency anemia and latent iron deficiency with Folic acid deficiency or prevention of Iron and Folic acid deficiency: 1 capsule daily.
• Severe Iron and Folic acid deficiency: 1 capsule 2-3 times daily.
• In pregnancy maximum recommended dose is 2 capsules daily. Do not administer higher doses for a long course of treatment.
Patients under 18
No indications for medicine Ferrofol usage in patients under 18 are available.
Course duration
Dose and treatment duration are subject to Iron and Folic acid deficiency degree and shall be determined by a physician on an individual basis.
Follow official local guides (for example, national recommendations) for appropriate treatment of Iron deficiency.
Route of administration
Swallow a whole capsule taking a glass of water. Do not suck, masticate or hold the capsule in mouth.
Intake before or with meal subject to gastrointestinal tolerance.
Special groups of patients
Patients with liver and renal disorders
Special dose correction for patients with hepatic dysfunction is not needed.
Contraindications
- Iron overload, in particular normal or hypersideremic anemia as thalassemia, refractory anemia, anemia due to bone marrow deficiency.
- Hypersensitivity to API or any excipient in drug composition (see Composition).
- Severe liver and renal disorders
- Concomitant administration of Iron-drugs for parenteral introduction.