Ferroland FOL chewable tablets 100mg+0.35mg №10×3

NAME Antianemic agent based on iron in combination with folic acid. It is used to treat and prevent latent (hidden) iron deficiency and iron deficiency anemia (clinically pronounced iron deficiency) with an increased need for folic acid during pregnancy and breastfeeding. Please note that iron deficiency and its severity must be confirmed by proper laboratory tests. PHARMACEUTICAL FORMAT Chewable tablets. DESCRIPTION Round brown tablets with numerous inclusions from white to yellow, flat, chamfered on both sides, scored on one side, with a characteristic odor. The presence of marbling, as well as streaks and spots of brown color is allowed. The score line is not intended to divide the tablet into two parts, it is used to break the tablet in order to facilitate swallowing. PHARMACOTHERAPEUTIC GROUPAntianemic agents. Iron-based products in combination with folic acid. ATC code: B03AD04. INTERNATIONAL NON-PROPRIETARY NAME Ferric oxide polymaltose complexes. COMPOSITION 1 tablet contains: active ingredients: iron – 100.0 mg in the form of iron (III) polymaltose complex hydroxide and folic acid – 0.35 mg; excipients: mannitol, sucralose, chocolate flavor (maltodextrin, dextrin, glyceryl triacetate, defatted cocoa powder, vanillin, cocoa hexanal), mint flavor (corn maltodextrin, modified corn starch, glyceryl triacetate, mentofuran, pulegone, estragol), cellulose microcrystalline, macrogol, magnesium stearate, talc. PHARMACOLOGICAL PROPERTIESPharmacodynamics The polymaltose complex of iron (III) hydroxide is a multinuclear iron (III) hydroxide centers surrounded by non-covalently bound polymaltose molecules with a total average molecular weight of about 50 kDa. The polynuclear centers of iron (III) of polymaltose hydroxide are structurally similar to the natural iron depot protein ferritin. This macromolecular complex is stable and does not release large amounts of iron under physiological conditions. Due to its large size, the degree of diffusion of iron (III) polymaltose hydroxide through the mucosal membrane is approximately 40 times lower than the degree of diffusion of the iron (II) hexaaqua complex. Iron (III) hydroxide polymaltose comes from the intestines by active transport. Folic acid belongs to the B vitamins. It is a precursor of tetrahydrofolate, a coenzyme involved in various metabolic processes, including the biosynthesis of purines and thymidylates of nucleic acids; it is also necessary for the synthesis of nucleoproteins and the maintenance of a normal level of erythropoiesis. Pharmacodynamic effects Absorbed iron binds to transferrin and is used to synthesize hemoglobin (Hb) in the bone marrow or is deposited, mainly in the liver, where it binds to ferritin. Pharmacokinetics Absorption Absorption of iron (III) polymaltose hydroxide occurs by a controlled mechanism. An increase in the level of iron in the blood serum after taking the complex does not correlate with the total absorption of iron, assessed by its inclusion in Hb. Studies using radioactively labeled iron (III) polymaltose hydroxide showed a clear correlation between the percentage of iron absorption by erythrocytes (incorporation in Hb) and absorption in terms of the whole body. The most active absorption of the iron (III) hydroxide polymaltose complex occurs in the duodenum and jejunum. As with other oral iron preparations, the relative degree of absorption of iron from iron(III) polymaltose hydroxide, as measured by its incorporation into Hb, decreased with increasing doses of iron. A correlation was also observed between the degree of iron deficiency (i.e., serum ferritin level) and the amount of iron absorbed (i.e., the greater the iron deficiency, the better the absorption). The degree of absorption is about 10%. Iron from iron(III) hydroxide complex and polymaltose is less bioavailable than from preparations containing Fe(II), at least at the start of treatment. Folic acid is mainly absorbed in the small intestine, mainly in the duodenum and jejunum. After taking 0.35 mg of folic acid, 80% of its absorption can be expected. Distribution The distribution of iron after absorption of iron(III) polymaltose hydroxide was demonstrated in a study using the double isotope technique (55Fe and 59Fe). The maximum concentration of folic acid in the blood plasma is reached after 30-60 minutes. In studies of single-dose chewable tablets in healthy volunteers, rapid absorption of folic acid was demonstrated, reaching a maximum folate concentration of 11 ng/mL at 0.75 hours post-dose. Biotransformation of Iron (III) hydroxide polymaltose after absorption is used for the synthesis of hemoglobin (Hb) in the bone marrow or is deposited, mainly in the liver, where it binds to ferritin. Folic acid is metabolized in the cells of the intestine and liver, as well as in other organs. The resulting folates bind to transport proteins and are distributed to all organs. Excretion Unabsorbed iron is excreted in the feces. Removal of folic acid is carried out by the kidneys, as well as through the digestive tract. Pharmacokinetics in special populations Renal, hepatic and heart failure. No data available. INDICATIONS FOR USE – Treatment and prevention of latent (hidden) iron deficiency and iron deficiency anemia (clinically expressed iron deficiency) with an increased need for folic acid during pregnancy and breastfeeding. Iron deficiency and its severity must be established and confirmed by appropriate laboratory tests. CONTRAINDICATIONS History of hypersensitivity to iron (III) hydroxide polymaltose, folic acid or any of the excipients that make up the drug; iron overload (eg, hemochromatosis or hemosiderosis); violations of iron utilization (anemia associated with lead poisoning, sideroahrestic anemia, thalassemia), anemia not associated with iron deficiency (for example, hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency). METHOD OF APPLICATION AND DOSE For oral administration. Treatment of iron deficiency anemia and supplementing the increased need for folic acid: 1 chewable tablet 2-3 times a day (from 200 mg of iron and 0.70 mg of folic acid to 300 mg of iron and 1.05 mg of folic acid) until hemoglobin levels normalize. After normalization of hemoglobin: 1 chewable tablet daily throughout pregnancy to build up iron stores. Treatment and prevention of latent iron deficiency and increased need for folic acid: 1 chewable tablet (100 mg of iron and 0.35 mg of folic acid) per day. Method of application The daily dose should be taken all at once or divided into several doses. Ferroland Fall should be taken with or immediately after a meal. Chewable tablets can be swallowed whole or chewed. Renal insufficiency No studies have been conducted in patients with renal insufficiency. No data available. Hepatic impairment No studies have been conducted in patients with hepatic impairment. No data available. MISSING A DRUG If you forget to take Ferroland Fall on time, continue your regular dose as soon as you remember. Do not take a double dose to make up for a single missed dose. SIDE EFFECTS Like all medicines, Ferroland Fall can cause side effects, although not everyone gets them. The following adverse reactions have been reported: very common – may affect more than 1 in 10 people: discoloration of feces1; common – may affect up to 1 in 10 people: diarrhea, nausea, dyspepsia; Uncommon – may affect up to 1 in 100 people: headache, vomiting, constipation, abdominal pain, tooth staining2, rash3, itching; very rare – may affect up to 1 in 10,000 people: allergic reactions. 1 “discoloration of feces” is a well-known side effect of iron-based oral medications. 2 “Teeth staining” is a known side effect of iron-based oral medications. 3 The term “exanthema” has been combined with the term “rash” and is referred to as “rash”. Reporting adverse reactions If you experience any adverse reactions, it is recommended that you consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the instructions for use. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. OVERDOSE In case of an overdose of iron (III) polymaltose hydroxide, signs of poisoning and iron overload are unlikely, due to the low toxicity of the drug and controlled absorption of iron. There are no reports of accidental poisoning with a fatal outcome. When using too high doses of folic acid, it is possible to develop changes in the central nervous system (changes in mental state, disturbances in sleep and wakefulness, increased irritability, hyperactivity), nausea and flatulence. PRECAUTIONS Anemia should always be treated under medical supervision. If there is no effect (hemoglobin level has not increased by about 20-30 g / l after 3 weeks), treatment should be reviewed. Caution should be exercised when prescribing the drug to patients who have had multiple blood transfusions, since iron enters with red blood cells, which can cause iron overload. During the period of treatment with Ferroland Fall, dark coloration of feces without clinical significance is possible. Ferroland Fall contains folic acid and may mask symptoms of vitamin B12 deficiency. Infections or tumors can cause anemia. Since iron can only be used if the underlying disease is under control, a benefit/risk assessment is recommended in these situations. Ferroland Fall is not expected to affect the insulin regimen in patients with diabetes mellitus. One chewable tablet contains 0.03 bread units. PREGNANCY AND BREAST-FEEDING Pregnancy Animal studies have not shown any risk to mother or fetus. There are no data from clinical studies on the use of this drug in the first trimester of pregnancy. Limited data on the use of iron hydroxide polymaltose complex and folic acid by pregnant women after the first trimester showed no adverse effects on pregnancy or the health of the fetus or newborn. However, use during pregnancy should be done with caution. Breastfeeding Breast milk normally contains lactoferrin-bound iron and folic acid. It is not known how much iron (III) polymaltose hydroxide passes into breast milk. It is unlikely that taking Ferroland Fall by breastfeeding women will cause unwanted effects in nursing infants. As a precautionary measure, women of childbearing age and women during pregnancy or breastfeeding, the use of Ferroland Fol is recommended only after consultation with a doctor in order to assess the benefit / risk ratio. EFFECT ON THE ABILITY TO DRIVE AND WORK WITH MECHANISMS Relevant studies have not been conducted. However, Ferroland Fall is unlikely to have any effect on the ability to drive or use machines. DRUG INTERACTIONS Studies in rats did not reveal any interactions with tetracycline, aluminum hydroxide, acetylsalicylates, sulfasalazine, calcium carbonate, calcium acetate and calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa , paracetamol and auranofin. Also, no in-vitro interactions were found with food components such as phytic acid, oxalic acid, tannin, sodium alginate, choline and its salts, vitamin A, vitamin D3, vitamin E, soybean oil and soy flour. These results indicate that Ferroland Fall can be taken with or immediately after meals. The interaction of iron (III) polymaltose hydroxide with tetracycline and aluminum hydroxide has been studied in clinical trials. There was no significant reduction in tetracycline absorption. The concentration of tetracycline in blood plasma did not fall below the level that provides the required effectiveness. Aluminum hydroxide and tetracycline did not reduce the absorption of iron(III) polymaltose hydroxide in human studies. Therefore, iron (III) polymaltose hydroxide can be taken simultaneously with tetracycline or other phenolic substances, as well as aluminum hydroxide. The drug does not affect the results of the test for the presence of occult blood (selective hemoglobin test), so there is no need to stop treatment for analysis. Simultaneous parenteral and oral administration of iron preparations should be avoided, since this significantly reduces the absorption of oral iron. Treatment with folic acid can increase the metabolism of phenytoin, leading to a decrease in its concentration in serum, especially in patients with folic acid deficiency. Despite the fact that this phenomenon is usually not clinically significant, in some patients taking phenytoin, the incidence of seizures may increase. Patients taking phenytoin or any other anticonvulsants should consult their doctor before starting folic acid treatment. It has been reported that the combined use of folic acid with chloramphenicol in patients with folic acid deficiency may have an antagonistic effect on the hematopoietic response to folic acid. Although the significance and mechanism of this interaction remain unclear, the hematological response to folic acid treatment in patients taking both drugs should be closely monitored. STORAGE CONDITIONS Store at a temperature not exceeding 25ºС. Keep out of the reach of children. EXPIRY DATE 2 years. Do not use the medicinal product after the expiration date. HOLIDAY CONDITIONSWithout a prescription. PACKAGING 10 tablets in a blister pack made of aluminum foil and polyvinyl chloride film. 30 tablets in a polymer jar, sealing agent – medical cotton wool. Each can or 3 blisters with leaflet in secondary packaging. INFORMATION ABOUT THE MANUFACTURER Belarusian-Dutch Joint Venture Limited Liability Company “Pharmland”, Republic of Belarus, Minsk region, Nesvizh, st. Buy Ferroland FOL chewable tablets 100mg + 0.35mg No. 10×3 Ferroland FOL chewable tablets 100mg + 0.35mg No. 10×3 ,35mg №10×3