Tardiferon® (Tardyferon®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIron sulfateIron sulfate
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  • Tardiferon®
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    Pierre Fabre Medication Production     France
    • Dosage form: & nbsp

    Tablets of prolonged action, covered with sugar shell.

    Composition:

    One tablet contains:

    The core of the tablet

    Active substance: iron sulphate (II) sesquioxide - 256.30 mg (in terms of iron - 80 mg)

    Excipients: ascorbic acid - 30,00 mg; mucoproteosis (anhydrous) - 80,00 mg; potato starch - 2.00 mg; methacrylic acid and methyl methacrylate copolymer (Eudragit S) - 20.84 mg; triethyl citrate 2.08 mg; povidone - 17.00 mg; talc - 22.00 mg; magnesium stearate - 2.00 mg; castor oil hydrogenated - 6.50 mg; magnesium trisilicate - how much is required to 495.0 mg

    Sheath:

    Talc - 8.00 mg; titanium dioxide - 9,10 mg; rice starch - 7,00 mg; carnauba wax 0.21 mg; methyl methacrylate, dimethylaminoethyl methacrylate and butyl methacrylate copolymer (Eudragit E) 1.25 mg; sucrose - sk. requires up to 650.0 mg.

    Description:

    Biconvex tablets, covered with sugar shell, with a smooth, even surface almost white (from white to light beige).

    Pharmacotherapeutic group:The iron preparation.
    ATX: & nbsp

    B.03.A.A.07   Iron sulfate

    Pharmacodynamics:Iron is an indispensable trace element necessary for the synthesis of hemoglobin.
    Pharmacokinetics:

    For iron salts, as a rule, a weak absorption (10-20% of the dose) is characteristic. Absorption increases with the depletion of iron stores in the body.

    Absorption occurs mainly in the duodenum and proximal small intestine.

    Indications:

    Iron-deficiency anemia; prevention of iron deficiency during pregnancy with insufficient intake of iron from food.

    Contraindications:

    Elevated levels of iron in the body, in particular, anemia with normal or high iron levels (thalassemia, refractory anemia, aplastic anemia); hypersensitivity to any of the components of the drug; intestinal obstruction; fructose intolerance, glucose-galactose malabsorption syndrome, and isomaltase deficiency.

    Carefully:

    Due to the presence of castor oil, there is a risk of developing sensitization.

    In view of the risk of developing ulcerative stomatitis and discoloration of tooth enamel, tablets can not be absorbed, chewed or kept in the mouth.

    Pregnancy and lactation:

    Pregnancy

    Tardiferone® can be used throughout the gestation period in accordance with the recommendations in these instructions for use.If it is necessary to use Tardifiron ® in the first trimester of pregnancy, it should be administered under the supervision of a doctor.

    Breast-feeding

    Data on the ability of ferrous sulfate to penetrate into breast milk are not available, however, taking into account the nature of the substance, Tardifiron® can be used during breastfeeding.

    Dosing and Administration:

    For oral administration.

    The drug is intended for use in adults and children older than 6 years.

    It is recommended to take the drug immediately before meals or during meals, with plenty of water (at least 200 ml); The time of reception is determined depending on individual tolerability.

    The tablet is swallowed whole, without chewing; Do not dissolve or hold in your mouth.

    Treatment of iron deficiency anemia

    Adults and children over 10 years: 1-2 tablets per day.

    Children from 6 to 10 years: 1 tablet per day.

    The duration of treatment is 3-6 months, depending on the severity of iron deficiency.

    After three months of the drug is recommended to evaluate the effectiveness of treatment.

    If necessary, in the absence of adequate control of anemia, the duration of treatment can be increased.

    Prevention of iron deficiency during pregnancy

    1 tablet once a day or 1 time in 2 days in the second and third trimesters of pregnancy (that is, starting from the 4th month of pregnancy).

    Side effects:

    Adverse reactions are listed according to the following gradation: very frequent (> 1/10), frequent (> 1/100 to <1/10), infrequent (> 1/1000 to <1/100), rare (from> 1/10000 to <1/1000), very rare (<1/10000), the frequency is unknown (the frequency can not be estimated from the available data).

    Impaired immune system.

    The frequency is unknown: hypersensitivity reactions, urticaria (urticaria).

    Disturbances from the respiratory system, chest and mediastinal organs

    Infrequent: swelling of the larynx. The frequency is unknown: in elderly patients and patients with impaired swallowing in a fit of choking or falling into the airway, there is a risk of damage to the esophagus or the development of bronchial necrosis.

    Disorders from the gastrointestinal tract

    Often: constipation, diarrhea, bloating, abdominal pain, discoloration of stool, nausea. Infrequent: violations of defecation, dyspepsia, vomiting, gastritis. The frequency is unknown: a discoloration of the tooth enamel, ulcerative stomatitis (undesirable phenomena were observed during chewing or resorption of the tablet).

    Disturbances from the skin and subcutaneous tissues

    Infrequent: itching, erythematous rash.

    Overdose:

    Cases of overdose of iron salts were noted in adults and children (especially younger than 2 years) after using iron preparations in high doses.

    Symptoms included irritation and necrosis of the gastrointestinal tract, accompanied by nausea, vomiting and shock.

    Treatment should be performed immediately and include gastric lavage with a 1% solution of sodium bicarbonate (baking soda). It is advisable to use chelating agents, the most specific of which is deferoxamine, especially in cases where the serum iron level is more than 5 μg / ml. Shock condition, dehydration and acid-alkaline disorders should be eliminated by appropriate therapeutic method.

    Interaction:

    Unrecommended combinations of drugs

    Ferric salts (injection): Lipotymia (short-term loss of consciousness, fainting), shock caused by the rapid release of iron from its complex form and saturation of transferrin.

    Combinations that require special precautions when using

    Preparations of the cyclin group (oral administration): There is a decrease in absorption of the preparations of the cyclin group in the gastrointestinal tract (formation of complex compounds).

    Observe the interval between the Tardiferon® and preparations of the cyclin group (minimum 2 hours).

    Magnesium trisilicate (antacids): there is a decrease in absorption of iron salts in the gastrointestinal tract.

    It is necessary to observe the interval between the antacid and Tardiferon® (minimum 2 hours).

    Other types of interaction

    Drinking plenty of tea helps reduce iron absorption.

    Special instructions:

    Before the beginning of therapy it is necessary to determine the content of iron and ferritin in the blood serum.

    In the period of taking the drug must take into account that coffee, milk, vegetables, cereals reduce the absorption of iron.

    During the period of taking the drug, a dark colouration of the stool can be observed, which is due to the excretion of non-absorbed iron and has no clinical significance, as well as a false positive benzidine test.

    Due to the presence of sucrose in the formulation, it is contraindicated for its use by persons with intolerance to fructose,syndrome of impaired glucose absorption and galactose or invertase / isomaltase deficiency syndrome (rare metabolic disorders).

    Form release / dosage:

    Tablets of prolonged action, covered with sugar shell. 80 mg, 10 pieces in a blister of PVC / PVDC and aluminum foil, 3 blisters per cardboard pack with instructions for use.

    Packaging:

    For 10 pieces in a blister of PVC / PVDC and aluminum foil, 3 blisters per cardboard pack with instructions for use.

    Storage conditions:

    Store at temperatures below 30 ° C. Keep out of the reach of children. Shelf life.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013865 / 01
    Date of registration:26.11.2007
    The owner of the registration certificate:Pierre Fabre Medication ProductionPierre Fabre Medication Production France
    Manufacturer: & nbsp
    Representation: & nbspPIER FABR PIER FABR France
    Information update date: & nbsp16.01.2015
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