Instructions for Ferrofol chewable tablets 357 mg + 0.35 mg blister No. 30
Composition
active ingredients: iron (III) hydroxide polymaltozate, folic acid;
1 tablet contains iron (III) hydroxide polymaltozate 357 mg, which is equivalent to 100 mg of iron, folic acid 0.35 mg;
excipients: microcrystalline cellulose, cocoa powder, sodium cyclamate, polyethylene glycol 6000, talc, vanillin, dextrates, chocolate flavoring.
Dosage form
Chewable tablets.
Main physicochemical properties: single-layer tablets of round shape, from light brown to brown in color, with white inclusions, with a line, the upper and lower surfaces are flat, the edges of the surfaces are beveled. A relatively homogeneous structure is visible on the break under a magnifying glass.
Pharmacotherapeutic group
Antianemic agent. Complex preparations containing iron and folic acid.
ATX code B0ZA D04.
Pharmacological properties
Pharmacodynamics.
The drug Ferrofol contains maltodextrin (partially hydrolyzed starch) and an inorganic compound of iron (III). In the drug Ferrofol, trivalent iron is a component of a complex organic compound.
Iron is involved in the formation of hemoglobin. Like other iron preparations, Ferrofol does not affect erythropoiesis and is ineffective in anemias not caused by iron deficiency.
The structure of the drug is similar to the natural iron compound - ferritin. The absorbed iron binds to ferritin and is stored in the liver. Then in the bone marrow it is incorporated into hemoglobin.
Folic acid, which is part of the drug, belongs to the group of B vitamins. It is a precursor of tetrahydrofolate, which is a coenzyme of various metabolic processes, including the biosynthesis of purines and thymidylate of nucleic acids, it is necessary for the synthesis of nucleoproteins and the maintenance of normal erythropoiesis.
Pharmacokinetics.
Absorption and distribution.
A study with a radioactively labeled drug showed that absorption, namely the amount of iron incorporated into hemoglobin, is inversely proportional to the dose of the drug. There is a correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). With therapeutic use of the drug, absorption is approximately 10%. The absorption process occurs mainly in the duodenum and small intestine. At the beginning of treatment, the bioavailability of iron from the polymaltose complex of iron (III) hydroxide is lower than in preparations of bivalent iron (II).
Folic acid is absorbed mainly in the duodenum and small intestine. Peak blood concentrations are reached within 30–60 minutes. At a dose of 350 mcg, absorption is approximately 80%.
Metabolism and excretion.
Unabsorbed iron is excreted in the feces. Folic acid is metabolized, in particular, in enterocytes and hepatocytes. Folates are attached to transport proteins and enter all organs. It is excreted mainly by the kidneys and through the gastrointestinal tract.
Indication
Treatment and prevention of iron deficiency without anemia (latent iron deficiency) and iron deficiency anemia (clinically expressed iron deficiency) in conditions with increased need for folic acid during pregnancy or breastfeeding. Iron deficiency and its degree should be confirmed by appropriate laboratory tests.
Contraindication
Hypersensitivity or intolerance to the active substance or any auxiliary component of the medicinal product;
excessive iron content in the body (for example, hemochromatosis, hemosiderosis);
disorder of iron excretion mechanisms (lead anemia, sideroachrestic anemia, thalassemia);
anemias not caused by iron deficiency (e.g., hemolytic anemia, megaloblastic anemia caused by vitamin B12 deficiency);
Esophageal stenosis and/or other obstructive diseases of the digestive tract; intestinal diverticulum, intestinal obstruction, regular blood transfusions; malignant neoplasms, untreated cobalamin deficiency;
simultaneous use of parenteral forms of iron.
Interaction with other medicinal products and other types of interactions
Preclinical studies in rats using tetracycline, aluminum hydroxide, acetylsalicylic acid, sulfasalazine, calcium carbonate, calcium acetate, calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol, and auranofin did not reveal any interactions with iron (III) hydroxide polymaltose complex.
The interaction of polymaltose iron(III) hydroxide complex with tetracycline or aluminum hydroxide was investigated in three clinical studies (cross-over studies involving 22 patients each). No significant reduction in tetracycline absorption was observed. Plasma tetracycline concentrations did not fall below the level required for bacteriostatic action. The use of aluminum hydroxide and tetracycline did not reduce the absorption of iron from polymaltose iron(III) hydroxide complex. Therefore, polymaltose iron(III) hydroxide complex can be used simultaneously with tetracyclines, other phenolic compounds and aluminum hydroxide.
The use of the drug does not affect the results of the test for detecting occult blood (sensitive to hemoglobin), so there is no need to stop treatment.
The concomitant use of parenteral iron preparations and Ferrofol is not recommended, as such use will inhibit the absorption of oral iron preparations. Parenteral iron preparations may be used only when treatment with oral preparations is not appropriate.
Folic acid may increase the metabolism of phenytoin, leading to decreased serum phenytoin concentrations, especially in patients with folic acid deficiency. Some patients may experience an increase in the frequency of epileptic seizures. Folic acid enhances the effectiveness of lithium therapy.
Patients taking phenytoin or other anticonvulsants/anticonvulsants should consult their doctor before using preparations containing folic acid.
It has been reported that concomitant administration of chloramphenicol and folic acid in folate-deficient patients may result in antagonism of the hematopoietic response to folic acid. Although the significance and mechanism of this interaction are unknown, the hematopoietic response to folic acid should be carefully monitored in patients receiving both drugs concurrently.
Application features
Treatment of anemia should always be carried out under the supervision of a physician. In the event that there is no improvement in hematological parameters (an increase in hemoglobin level of approximately 20–30 g/l 3 weeks after the start of treatment), the treatment regimen should be reviewed.
The medicinal product contains folic acid, which may mask vitamin B12 deficiency. Potential vitamin B12 deficiency should be excluded in patients with anemia before starting treatment due to the risk of irreversible neurological disorders (see section "Contraindications").
When using iron polymaltose complex, a dark color of feces may be observed, but this is of no clinical significance.
Caution should be exercised in patients receiving repeated blood transfusions, as red blood cells already have a store of iron, and taking the drug may cause iron overload.
Infections and tumors can cause anemia. Oral iron supplements may be considered after the underlying condition has been treated, taking into account the benefit/risk ratio.
When prescribing the drug to patients with diabetes, it is necessary to take into account that 1 tablet contains 0.03 bread units.
Iron preparations are used with caution in patients with the following diseases: leukemia, chronic liver and kidney diseases, inflammatory diseases of the gastrointestinal tract, gastric and duodenal ulcers, intestinal diseases (enteritis, ulcerative colitis, Crohn's disease).
Ferrofol contains 9 mg of sodium per tablet. This amount is equivalent to 0.5% of the WHO recommended maximum daily intake of sodium for adults, which is 2 g.
Use during pregnancy or breastfeeding
Data on use in the first trimester of pregnancy do not indicate any adverse effects on pregnancy or the health of the fetus or newborn. Animal studies have not shown direct or indirect harmful effects on pregnancy, embryonal or fetal development. However, caution should be exercised when using the drug during pregnancy.
Human breast milk contains iron and folic acid bound to lactoferrin. It is not known how much iron from iron(III) hydroxide polymaltose complex passes into breast milk. It is unlikely that Ferrofol will have any adverse effects on a breastfed infant.
The use of the drug Ferrofol during pregnancy or breastfeeding is recommended only after consulting a doctor.
Ability to influence reaction speed when driving vehicles or other mechanisms
Relevant studies have not been conducted. It is unlikely that the drug Ferrofol affects the reaction rate when driving vehicles or working with complex mechanisms.
Method of administration and doses
The drug Ferrofol, chewable tablets, should be taken during or immediately after a meal. The tablets can be swallowed whole.
Treatment of iron deficiency anemia with increased folic acid requirement:
1 chewable tablet 2–3 times a day.
Treatment and prevention of latent iron deficiency with increased need for folic acid: 1 chewable tablet per day.
Children: There are currently no data on the use of the drug in children.
Overdose
Against the background of taking the drug Ferrofol in case of overdose, no signs of intoxication or excessive iron intake into the body were recorded due to the features of controlled release and low toxicity of the polymaltose complex of iron (III) hydroxide (LD50 in animals > 2000 mg iron / kg body weight). No cases of unintentional overdose with fatal consequences have been reported.
There are reports that an excessive dose of folic acid can cause changes in the central nervous system (changes in mental status, changes in sleep patterns, irritability and hyperactivity), nausea, bloating, and flatulence.
Side effects
The frequency of undesirable effects is classified into the following categories: very common (> 1/10), common (< 1/10, ≥ 1/100), uncommon (< 1/100, ≥ 1/1000), rare (< 1/1000).
Faecal discoloration is a well-known adverse reaction to oral iron supplements, but this phenomenon is of no clinical significance and is often underreported. Other common adverse events were gastrointestinal disturbances (nausea, constipation, diarrhoea and abdominal pain).
From the immune system.
Very rare: allergic reactions.
From the digestive tract.
Very common: change in stool color*.
Common: diarrhea, nausea, abdominal pain (including abdominal pain, dyspepsia, epigastric discomfort, abdominal bloating), constipation.
Uncommon: vomiting (including retching, eructation), tooth enamel discolouration, gastritis.
On the skin and subcutaneous tissue.
Uncommon: pruritus, rash (including rash, macular rash, bullous rash**, urticaria**, erythema**).
From the nervous system.
Uncommon: headache.
On the part of musculoskeletal and connective tissue.
Rare: muscle spasms (including involuntary muscle contractions, tremor), myalgia.
*The incidence of stool discoloration in the meta-analysis is lower, although it is a well-known adverse event with oral iron supplements. Therefore, stool discoloration was classified as a very common adverse event.
**Information on these events was obtained from spontaneous post-marketing reports; the frequency is estimated to be < 1/491 (upper limit of the 95% confidence interval).
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 tablets in a blister; 3 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
Technolog PJSC.
Location of the manufacturer and its business address.
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
