Gyno-Tardiferon® (Gyno-Tardyferon®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIron sulphate + Folic acidIron sulphate + Folic acid
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  • Gyno-Tardiferon®
    pills inwards 
    Pierre Fabre Medication Production     France
    • Dosage form: & nbsp

    tablets of prolonged action, coated

    Composition:
    Tablet core composition:
    Active component
    Iron (Fe 2+) sulfate - 1 ½ H2O (corresponding to 80 mg of iron) - 256.30 mg
    Other components (core)
    Ascorbic acid - 30.00 mg
    Mucoproteosis (anhydrous) - 80.00 mg
    Potato Starch - 2.00 mg
    Eudragit S - 20.82 mg
    Dibutyl phthalate 2.08 mg
    Povidone - 17.00 mg
    Talc - 22.00 mg
    Magnesium stearate - 2.00 mg
    Castor oil 6.50 mg
    Magnesium trisilicate - up to 495.00 mg
    Composition of the tablet shell:
    Active component
    Folic acid 0.35 mg
    Other components
    Talc - 2.00 mg
    Titanium dioxide 16.0 mg
    White beeswax ≈ 0.18 mg
    Solid paraffin ≈ 0.05 mg
    Eudragit E - 2.50 mg
    Sucrose - up to 710.0 mg
    Description:

    Biconvex, coated tablets with a smooth surface from white light beige. On the cross-section - brown with a white edging.

    Pharmacotherapeutic group:The iron preparation with vitamin
    ATX: & nbsp

    B.03.A.D.03   Iron sulphate in combination with folic acid

    Pharmacodynamics:

    Combined anti-anemic drug, the effect of which is due to the properties of the components that make up its composition.

    Iron sulfate is a salt of iron, a microelement necessary for the synthesis of hemoglobin.Iron is a part of hemoglobin, myoglobin and a number of enzymes. When iron is used in the form of salts, its deficiency in the body is rapidly replenished, which leads to a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, tenderness and dry skin) and laboratory symptoms of anemia.

    Folic acid is necessary for the normal maturation of megaloblasts and the formation of normoblasts. Stimulates erythropoiesis, participates in the synthesis of amino acids, nucleic acids, purines and pyrimidines, in the exchange of choline. When pregnancy protects the body from the effects of teratogenic factors.

    Mucoproteosis, being a natural high-molecular fraction obtained from the intestinal mucosa of animals and having a certain content of amino sugars and organically bound sulfate, provides a better tolerance of the drug from the gastrointestinal tract and increases the bioavailability of iron ions. Ascorbic acid improves the absorption of iron.

    A special neutral tablet shell provides absorption of active components, mainly from the upper part of the small intestine.The absence of local irritant effect on the gastric mucosa promotes good tolerability of the drug from the gastrointestinal tract.

    Pharmacokinetics:

    After taking the drug, iron is absorbed from the digestive tract. Bioavailability of iron is 10-30%. The gradual release of iron allows prolonging its absorption, mainly in the distal part of the small intestine.

    Folic acid is absorbed mainly from the upper parts of the digestive tract (duodenum).

    The association of iron with plasma proteins is 90% or more. Deposited in the form of ferritin or hemosiderin in the cells of the phagocytic macrophage system, a small amount - in the form of myoglobin in the muscles.

    The binding of folic acid with plasma proteins is 64%; biotransformation occurs in the liver.

    Iron is excreted with feces, urine and sweat.

    Folic acid is excreted mainly by the kidneys, in part through the intestine.

    Indications:

    Prevention of deficiency of iron and folic acid in pregnant women if it is impossible to ensure sufficient supply of these elements to the body with food.

    Contraindications:
    - Hypersensitivity to the components of the drug;
    - Anemia not associated with deficiency of iron or folic acid (hemolytic anemia, megaloblastic anemia, associated with an isolated vitamin B12 deficiency);
    - Increased iron content in the body (hemosiderosis);
    - Violation of the mechanisms of iron utilization (anemia caused by lead poisoning, sideroahrestic anemia);
    - Stenosis of the esophagus and / or obstructive changes of the gastrointestinal tract.
    - Children's age (under 18 years).
    Carefully:

    With caution should take the drug for inflammatory bowel disease, alcoholism, liver or kidney failure.

    Dosing and Administration:

    For oral administration.

    1 tablet per day, starting at 24 weeks of gestation.

    Tablets should be taken before meals, washed down with plenty of water; the time of taking the drug is determined depending on the gastrointestinal tolerance.

    Tablets should be swallowed whole, without chewing. Do not dissolve and do not hold the pill long in the mouth.

    Side effects:

    Adverse reactions are listed according to the following gradation: very frequent (≥1 / 10), frequent (≥1 / 100 but <1/10), infrequent (≥1 / 1,000 but <1/100), rare (≥1 / 10,000 but <1 / 1,000), very rare (<1 / 10,000), the frequency is unknown - the frequency can not be estimated from the available data.

    Immune system disorders

    The frequency is unknown: hypersensitivity reactions, hives.

    Disturbances from the respiratory system, chest and mediastinal organs

    Infrequent: swelling of the larynx.

    Disorders from the gastrointestinal tract

    Often: constipation, diarrhea, bloating, abdominal pain, a change in the color of fecal masses, nausea. Infrequent: violations of defecation, dyspepsia, vomiting, gastritis. Frequency unknown: discoloration of tooth enamel, ulcerative stomatitis (these disorders were observed in cases of improper use of the drug - when chewing or resorbing the pill).

    Disturbances from the skin and subcutaneous tissues

    Infrequent: itching, erythematous rash.

    Overdose:

    Symptoms: it is possible to intensify the manifestations of the described side effects.

    Treatment: gastric lavage with 1% aqueous sodium bicarbonate solution, symptomatic therapy. Antidote - deferoxamine.

    Interaction:

    Not compatible with other medicines:

    Reduce absorption - antacid medicines, calcium preparations, etidronic acid, drugs that reduce the acidity of gastric juice (incl. cimetidine, medicines containing carbonates, hydrocarbonates, phosphates, oxalates), pancreatin, pancreolipase, coffee, tea, milk, vegetables, cereals, egg yolk (iron preparations should be taken 1 hour before or 2 hours after they are consumed).

    Increase absorbability - ascorbic acid, ethanol (including increases the risk of toxic complications).

    The drug reduces the absorption of fluoroquinolones, penicillamine, tetracyclines, at high doses reduces the absorption of zinc preparations (they are recommended to be taken 2 hours before or 2 hours after taking the iron preparation).

    Special instructions:

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

    During the period of taking the drug, a dark colouration of the stool can be observed, which is due to the removal of not absorbed iron and has no clinical significance.

    With caution should take the drug for inflammatory bowel disease, alcoholism, liver or kidney failure.

    Form release / dosage:

    Tablets, prolonged action, coated.

    Packaging:

    For 10 tablets in a blister of PVC / PVDS and aluminum foil, 3 blisters per pack of cardboard box together with instructions for use.

    Storage conditions:At temperatures up to 25 ° C in a place inaccessible to children.
    Shelf life:

    5 years.

    Do not use the drug after the date shown on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000300
    Date of registration:26.07.2010
    Expiration Date:Unlimited
    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: & nbsp17.04.2017
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