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Gyno-tardiferon extended-release tablets p/o No. 10x3

Name

Gyno-tardiferon long-term tablet p/o in blister pack No. 10x3

Main active ingredient

Iron sulfate + folic acid

Release form

pills

Compound

Core composition: Active ingredient: Iron 80.00 mg (equivalent to 247.25 mg of dried iron (II) sulfate with a theoretical content of 88% m/m) Excipients: maltodextrin, microcrystalline cellulose, ammonium methacrylate copolymer (type B dispersion), ammonium methacrylate copolymer (type A dispersion), talc, triethyl citrate, glycerol dibehenate. Shell composition: Active ingredient: Folic acid 0.350 mg Excipients: Sepifilm® LP010*, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), triethyl citrate. * Composition of Sepifilm® LP010: Methylhydroxypropylcellulose (hypromellose)70–90% Microcrystalline cellulose5–15% Stearic acid5–15%

Description

Round, biconvex, pale pink, film-coated tablets.

Pharmacological properties

Pharmacodynamics

A combined antianemic drug, the action of which is based on the properties of its components. Iron (II) sulfate, an iron salt, is a trace element necessary for the synthesis of hemoglobin. Iron is an integral part of hemoglobin, myoglobin and some enzymes. The use of iron salt leads to the rapid replenishment of iron deficiency in the body and to a gradual reduction in clinical (weakness, fatigue, dizziness, tachycardia, soreness and dry skin) and laboratory symptoms of anemia. Folic acid is necessary for normal maturation of megaloblasts and the formation of normoblasts. It stimulates erythropoiesis, participates in the synthesis of amino acids, nucleic acids, purines and pyrimidines, and in the metabolism of choline. During pregnancy, folic acid protects the body from teratogenic factors. The special neutral tablet shell ensures the absorption of active ingredients, mainly in the upper parts of the small intestine. Minimal local irritation to the gastric mucosa contributes to good gastrointestinal tolerance to the product.

Pharmacokinetics

Iron Absorption Iron absorption is an active process occurring primarily in the duodenum and proximal small intestine. The combination of iron(II) sulfate and excipients allows iron to be released continuously and progressively. Absorption increases when iron stores are depleted. Iron absorption may be reduced by certain foods or beverages or by concomitant use of certain medications (see Precautions and Drug Interactions and Other Interactions). Distribution In the body, iron stores are mainly found in the bone marrow (erythroblasts), red blood cells, liver and spleen. In the blood, iron is transported by transferrin, mainly to the bone marrow, where it is incorporated into hemoglobin. Biotransformation Iron is a metal ion that is not metabolized by the liver. Elimination The average iron excretion in healthy patients is estimated to be 0.8–2 mg/day. Iron is mainly excreted through the gastrointestinal tract (exfoliation of enterocytes, heme degradation after extravasation of red blood cells), urogenital tract and skin. Folic Acid Absorption Folic acid (folates) is rapidly absorbed from the gastrointestinal tract, primarily in the proximal small intestine. Distribution Folates are distributed throughout the body. The main storage site for folate is the liver. They are also concentrated in the cerebrospinal fluid. Folates pass into breast milk. Biotransformation Folate is converted to its active metabolic form, 5-methyltetrahydrofolate (5-MTHF), in the plasma and liver. Folate metabolites are involved in enterohepatic circulation. Excretion Folate metabolites are excreted in the urine, and excess folate is excreted unchanged in the urine. Preclinical safety data Preclinical data obtained from standard studies of pharmacological safety, repeated dose toxicity, genotoxicity, carcinogenic potential and reproductive and developmental toxicity did not reveal any particular harm to humans.

Indications for use

Prevention and treatment of iron and folic acid deficiency during pregnancy when their intake from food is insufficient. It should not be used for primary prevention of the risks of neural tube disorders (NTD: spina bifida, etc.). Gyno-Tardiferon is designed for use in pregnant women.

Contraindications

This drug SHOULD NOT BE USED if: you are allergic to iron or any other substance in the drug; if you have high iron levels in your body (i.e. hemochromatosis). If you have any doubts, ask your doctor or pharmacist for advice.

Use during pregnancy and lactation

Negative clinical data from several thousand treated women appear to rule out any adverse effects of ferrous(II) sulfate. Therefore, provided that the instructions for use are followed, this drug can be prescribed during pregnancy. Breastfeeding The exposure of iron (II) sulfate to breast milk has not been assessed, however, given the nature of the substance, this drug may be administered to women who are breastfeeding.

Directions for use and doses

Dosage regimen: 1 tablet per day, equivalent to 80 mg of elemental iron and 350 mcg of folic acid, during the last six months of pregnancy (or from the 4th month). Duration of treatment Hemoglobin values recovered after 4–12 weeks of treatment. After achieving normal hemoglobin values, treatment should be continued for at least another 4 to 12 weeks, 1 tablet per day to replenish iron stores in the body under the control of serum ferritin. The dosage and duration of treatment depend on the degree of iron and folic acid deficiency and are determined by the doctor individually. Official local guidelines (eg national guidelines) for the appropriate management of anemia should be considered. Directions for use The tablets cannot be sucked, chewed or kept in the mouth; they must be swallowed whole with water. The tablets should be taken before or during meals, depending on gastrointestinal tolerance. Special groups of patients Patients with impaired renal or hepatic function: No special adjustment is required for patients with hepatic dysfunction. Check with your doctor or pharmacist before taking any medicines.

Side effect

Iron-related Common (may occur in 1 to 10 in 100 people taking this drug) constipation, diarrhea, bloating, abdominal pain, change in stool color, nausea Rare (1 to 10 in 1,000 people) swelling of the larynx, abnormal bowel movements, dyspepsia, vomiting, gastritis, pruritis, erythematous rash Frequency unknown (cannot be estimated from available data) discoloration of teeth, ulcerative stomatitis, hypersensitivity reactions, urticaria melanosis of the gastrointestinal tract (item added according to the recommendation of M3 France) The following side effects were reported during post-marketing surveillance: hypersensitivity reactions, urticaria, discoloration of teeth* and ulcerative stomatitis.* The incidence of these reactions is unknown. *- In case of improper use, when the tablets were chewed, dissolved or kept in the mouth. Elderly patients and patients with swallowing problems may also be at risk of ulceration of the throat, esophagus (the part of the digestive tract that connects the pharynx to the stomach), or bronchi (the main air passages to the lungs) if the tablet is inhaled. If you are suffocating, you should immediately contact your doctor or the nearest emergency room to receive appropriate treatment. Folic acid-related Rare (frequency cannot be estimated from available data) anaphylactic reaction, gastrointestinal disorders, Quincke's edema, allergic dermatitis, urticaria. The literature has reported cases of gastrointestinal melanosis (discoloration of the gastrointestinal tract) with an unknown incidence in elderly patients with chronic kidney disease, diabetes (high blood sugar) and/or hypertension (high blood pressure) who were receiving treatment with several drugs for these diseases and treatment of associated anemia with iron supplements. Reports of side effects If you experience any side effect, contact your doctor or pharmacist. This also applies to reactions not listed in this leaflet. You can also personally report a side effect by sending information to the Republican Clinical and Pharmacological Laboratory of the Republican Unitary Enterprise “Center for Expertise and Testing in Healthcare”, Minsk, Tovarishchesky Lane. 2a, room 202, 220037 Republic of Belarus. By reporting side effects, you can help keep information about the safety of this drug up to date.

Overdose

You may experience the following effects if you ingest significant amounts of iron: severe gastrointestinal irritation, nausea, vomiting, diarrhea, often bloody, which may be accompanied by low blood pressure, kidney and liver dysfunction, which can cause cramps. Contact your doctor or pharmacist immediately.

Interaction with other drugs

If you are currently using or have recently taken any other medicines, tell your doctor or pharmacist. Some medications cannot be taken at the same time as GYNO-TARDIFERONE, while others require some dose adjustment or change in the timing of administration. If you are using injectable iron-containing medications. If you are using medicine to treat struvite kidney stones (acetohydroxamic acid). If you are using certain antibiotics (cyclines or fluoroquinolones). If you are using medicines to treat weak bones (bisphosphonates, strontium). If you are using a medicine to treat joint problems (penicillamine). If you are using medicines to treat thyroid disease (thyroxine). If you are using medicines to treat Parkinson's disease (entacapone, methyldopa, levodopa, carbidopa). If you are using zinc or calcium. If you are using a medicine to treat excessive stomach acid: gastrointestinal minerals, charcoal or antacids (aluminium, calcium and magnesium salts). If you are using medicines that weaken or reduce the frequency of epileptic seizures, such as phenobarbital, primidone, phenytoin, fosphenytoin. If you are using a medicine to treat hypercholesterolemia (cholestyramine).

Precautionary measures

If you are using GINO-TARDIFERON due to iron deficiency in the body, then the cause of this deficiency must be investigated in order to begin its treatment. If iron deficiency is caused by an inflammatory disease, treatment with GYNO-TARDIFERON will not be effective. Due to the risk of developing ulcerative stomatitis and discoloration of teeth, the tablets should not be dissolved, chewed or kept in the mouth, but should be swallowed whole with a glass of water. If you are unable to follow these instructions or have difficulty swallowing, contact your doctor. Drinking large amounts of tea interferes with iron absorption. It is not recommended to take GINO-TARDIFERON at the same time as this drink.

Storage conditions

No special storage conditions are required. Keep out of the reach of children.