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  • Ferrifol
    / CTS


    Active Ingredient *
    Iron (as Iron (III) Hydroxide Polymaltose Complex) 100 mg
    Folic Acid 0.4 mg

    Status in Israel
    OTC

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    30

    not in the basket chart 60447 6346

    Related information


    Dosage

    Adults and children above 12 years of age:
    For prevention of anaemia:
    one tablet per day.
    For treatment of anaemia: 3 tablets per day taken as one daily dose or as separate doses.
    The tablets should be taken with or directly after meals and can be chewed or swallowed whole.
    Paediatric Population:
    The tablets are not indicated for children and adolescents below 12 years of age.


    Indications

    Prevention and treatment of anemia caused by iron and folic acid deficiency including anemia of pregnancy and lactation.


    Contra-Indications

    – Known hypersensitivity to or intolerance of the active substances or one of the excipients.
    – Patients with iron overload ( e.g. haemochromatosis, haemosiderosis).
    – Patients with iron metabolism disorders (lead anaemia, sideroachrestic anaemia, thalassaemia).
    – Patients with any anaemia not caused by iron deficiency (e.g. haemolytic anaemia or megaloblastic anaemia caused by vitamin B12 deficiency.


    Special Precautions

    Anaemias should always be treated under the supervision of a doctor.
    If therapeutic success (increase in haemoglobin by about 2 – 3 g/dL after 3 weeks) is not achieved, treatment should be reconsidered.
    This medicinal product contains folic acid which can mask a vitamin B12 deficiency. A potential vitamin B12 deficiency must be ruled out before the start of treatment in anaemic patients due to the risk of irreversible neurological dysfunctions.
    During treatment with this medicinal product there may be dark discolouration of the faeces (stool), however this is of no clinical relevance.
    Caution is recommended in patients who receive repeated blood transfusions, as there is a supply of iron with erythrocytes, which can lead to iron overload.
    Infections or tumours can cause anaemia. As oral iron can be utilised only after the primary disease has been treated, a benefit/risk analysis is indicated.


    Side Effects

    Very common: Viscoloured faeces.
    Common: Diarrhoea, nausea, abdominal pain (includes: abdominal pain, dyspepsia, epigastric discomfort, abdominal distension), constipation.


    Drug interactions

    Interactions of the iron (III) hydroxide polymaltose complex (IPC) with tetracycline or aluminium hydroxide were investigated in three human studies (cross-over design, 22 patients per study). No significant reduction in the absorption of tetracycline was shown. The plasma concentration of tetracycline did not fall below the level necessary for bacteriostasis. The absorption of iron from IPC was not reduced by aluminium hydroxide and tetracycline. The iron (III) hydroxide polymaltose complex can therefore also be administered at the same time as tetracyclines or other phenolic compounds, as well as aluminium hydroxide.
    Studies in rats with tetracycline, aluminium hydroxide, acetylsalicylate, sulfasalazine, calcium carbonate, calcium acetate, calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillinamine, methyldopa, paracetamol and auranofin have not shown any
    interactions with the iron (III) hydroxide polymaltose complex.
    There were also no interactions of the iron(III) hydroxide polymaltose complex with food components, such as phytic acid, oxalic acid, tannin, sodium alginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soy oil and soy flour observed in in-vitro studies. These results indicate that iron (III) hydroxide polymaltose complex can be taken during or immediately after food intake.
    The haemoccult test (selective for Hb) for the detection of occult blood is not impaired, and therefore there is no need to interrupt the therapy.
    Concomitant administration of parenteral iron preparations and Ferrifol is not indicated because it would reduce the absorption of the oral iron preparation.
    Folic acid could increase the metabolism of phenytoin resulting in decreased concentrations of phenytoin in the serum, particularly in patients with folic acid deficiency. There may be an increased frequency of epileptic seizures in some patients. Patients who take phenytoin or another antiepileptic/anticonvulsive
    medicinal product should consult a doctor before taking a folic acid supplement.
    There are reports that the concurrent administration of chloramphenicol and folic acid in patients with folic acid deficiency may result in antagonism of the haematopoietic response to folic acid.
    Although the importance and mechanism
    of this interaction is unclear, the haematopoietic response to folic acid in patients taking both medicinal products concomitantly should be carefully monitored.


    Pregnancy and Lactation

    Pregnancy:
    Clinical data of exposed pregnancies exhibited no undesirable effects on pregnancy or on the health of the foetus or newborn infant. Data from epidemiological studies is not available.
    Animal studies did not show any reproductive toxicity. Caution is advised for use during pregnancy. As a precautionary measure, this medicinal product should only be taken after consulting a doctor.
    Breast-feeding:
    It is not known whether iron from the iron (III) hydroxide polymaltose complex is excreted in human milk. Human milk naturally contains iron bound to lactoferrin. As a precautionary measure, this medicinal product should only be taken during breast-feeding after consulting a doctor.


    Overdose

    In the case of overdoses, an intoxication or iron accumulation are unlikely due to the low toxicity of the iron (III) hydroxide polymaltose complex (in mice and rats the 50% lethal dose (LD50) is > 2000 mg Fe/kg of body weight) and the expected saturation of iron uptake. No cases of accidental poisoning with fatal outcome are known.
    There are reports that an excessive dose of folic acid may cause changes to the central nervous system (namely changes in mental state, changes to the sleep pattern, irritability and hyperactivity), nausea, abdominal distension and flatulence.


    Manufacturer
    CTS Chemical Industries Ltd
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