Gino-tardiferon tablets of prolonged action p / o No. 10×3

Name:
Gino-tardiferon tab prolong.d-i p / o in blister. in pack No. 10×3 Main active ingredient Iron sulfate + folic acid Release form tablets Composition 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 (dispersion type B), ammonium methacrylate copolymer (dispersion type A), talc, triethyl citrate, glycerol dibehenate. Shell composition: Active ingredient: Folic acid 0.350 mg. Excipients: Sepifilm® LP010*, iron oxide yellow (E172), iron oxide red (E172), titanium dioxide (E171), triethyl citrate. * Composition of Sepifilm® LP010: Methylhydroxypropyl cellulose (hypromellose) 70-90% Microcrystalline cellulose 5-15% Stearic acid 5-15%
Description:
Pale pink, round, biconvex film-coated tablets. Pharmacological propertiesPharmacodynamicsCombined antianemic drug, the action of which is based on the properties of its constituents. 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 a rapid replenishment of iron deficiency in the body and to a gradual decrease in clinical (weakness, fatigue, dizziness, tachycardia, soreness and dry skin) and laboratory symptoms of anemia. Folic acid is essential for the normal maturation of megaloblasts and the formation of normoblasts. It stimulates erythropoiesis, is involved 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 shell of the tablet ensures the absorption of the active ingredients, mainly in the upper small intestine. Minimal local irritation to the gastric mucosa promotes 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 ferrous sulfate (II) and excipients allows the release of iron in a continuous and progressive manner. Absorption increases when iron stores are depleted. Iron absorption may be reduced due to certain foods or drinks, as well as while taking certain drugs (see sections “Precautions” and “Interaction with other medicinal products and other forms of interaction”). 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 in the liver. Elimination The average excretion of iron in healthy patients is estimated at 0.8–2 mg/day. Iron is mainly excreted through the gastrointestinal tract (desquamation of enterocytes, heme degradation after erythrocyte extravasation), urogenital tract and skin. Folic Acid Absorption Folic acid (folates) is rapidly absorbed from the gastrointestinal tract, mainly in the proximal small intestine. Distribution Folate is distributed throughout the body. The main storage site for folate is the liver. They are also concentrated in the cerebrospinal fluid. Folate passes into breast milk. Biotransformation Folate is converted to its active metabolic form, 5-methyltetrahydrofolate (5-MTHF), in plasma and in the liver. Folate metabolites are involved in the enterohepatic circulation. Excretion Folate metabolites are excreted in the urine, and excess folate is excreted unchanged in the urine. Preclinical Safety Data No particular harm to humans has been identified in preclinical data from standard studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and reproductive and developmental toxicity. Indications for use Prevention and treatment of iron and folic acid deficiency during pregnancy in case of their insufficient intake with food. Should not be used for the primary prevention of risks of neural tube occlusion disorders (NTA: spina bifida, etc.). Gyno-Tardiferon is designed for use in pregnant women. Contraindications This drug MUST NOT be used if: you are allergic to iron or any of the other ingredients of this drug; if you have high levels of iron in the body (i.e. hemochromatosis). If you have any doubts, ask your doctor or pharmacist for advice. Use in Pregnancy and Lactation Negative clinical data relating to several thousand treated women appear to rule out any adverse effects of ferrous sulfate (II). Therefore, subject to the recommendations for use, this drug can be prescribed during pregnancy. Breast-feeding The excretion of iron (II) sulfate into breast milk has not been evaluated, however, given the nature of the substance, the use of this drug in women who are breastfeeding is possible. Route of administration 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 reaching normal hemoglobin values, treatment should continue 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. Consideration should be given to official local guidelines (eg national guidelines) for the appropriate management of anemia. Method of administration Tablets should not be sucked, chewed or kept in the mouth, they should be swallowed whole with water. Tablets should be taken before meals or with meals, depending on gastrointestinal tolerance. Special patient populations 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 effects Iron-related Common (may affect up to 1-10 people in 100 people taking this drug) constipation, diarrhea, bloating, abdominal pain, discoloration of stools, nausea Rare (may affect up to 1-10 people in 1000) swelling of the larynx, abnormal stools , dyspepsia, vomiting, gastritis, pruritis, rash erythematosus Frequency not known (cannot be estimated from the available data) discoloration of teeth, ulcerative stomatitis, hypersensitivity reactions, urticaria melanosis of the gastrointestinal tract (item added on French M3 recommendation) The following side effects have been reported during post-marketing surveillance: hypersensitivity reactions, urticaria, discoloration of the teeth * and ulcerative stomatitis. * The frequency of these reactions is unknown. *- In case of improper use, when the tablets were chewed, sucked or kept in the mouth. Elderly patients and patients with swallowing disorders may also be at risk of ulceration of the throat, esophagus (the part of the digestive tract that connects the throat to the stomach) or bronchi (the main air passages to the lungs) if the tablet enters the respiratory tract. In case of choking, you should immediately contact a doctor or the nearest emergency room to receive appropriate treatment. Folic acid related Rare (frequency cannot be estimated from the available data) anaphylactic reaction, gastrointestinal disturbances, angioedema, allergic dermatitis, urticaria. Cases of gastrointestinal melanosis (staining of the gastrointestinal tract) of unknown frequency have been reported in the literature in elderly patients with chronic kidney disease, diabetes (high blood sugar) and/or hypertension (increased blood pressure) who received treatment with several drugs for these diseases and treatment of anemia associated with them with iron supplements. Side effect reports If you experience any side effect, contact your doctor or pharmacist. This also applies to reactions not named in this package insert. You can also personally report a side effect by sending information to the Republican Clinical and Pharmacological Laboratory RUE “Center for Expertise and Testing in Health Care”, Minsk, Tovarishchesky per. 2a, room 202, 220037 Republic of Belarus. By reporting side effects, you can help keep up-to-date information about the safety of this drug. Overdose You may experience the following effects if you swallow a significant amount of iron: acute irritation of the gastrointestinal tract, nausea, vomiting, diarrhea, often bloody, which may be accompanied by a decrease in blood pressure, impaired kidney and liver function, which can cause convulsions. Contact your doctor or pharmacist immediately. Interactions with other drugs If you are currently taking or have recently taken any other medicines, tell your doctor or pharmacist. Some medicines should not be taken concomitantly with GYNO-TARDIFERON, while others require some dose adjustment or a change in the time of administration. If you are taking iron medicines by injection. If you are taking a medicine to treat struvite kidney stones (acetohydroxamic acid). If you are taking certain antibiotics (cyclins or fluoroquinolones). If you are taking medicines to treat bone weakness (bisphosphonates, strontium). If you are taking a medicine to treat joint problems (penicillamine). If you are taking medicines to treat thyroid disease (thyroxine). If you are taking medicines to treat Parkinson’s disease (entacapone, methyldopa, levodopa, carbidopa). If you are taking zinc or calcium. If you are taking a medicine to treat excessive acidity in the stomach: gastrointestinal minerals, charcoal, or antacids (aluminum, calcium, and magnesium salts). If you are taking medicines that relieve or reduce the frequency of epileptic seizures, such as phenobarbital, primidone, phenytoin, fosphenytoin. If you are taking a drug to treat hypercholesterolemia (cholestyramine). Precautions If you are using GYNO-TARDIFERON because of an iron deficiency in the body, the cause of this deficiency must be investigated in order to start 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 the teeth, the tablets should not be sucked, chewed or kept in the mouth, they should be swallowed whole with a glass of water. If you cannot follow these instructions or have difficulty swallowing, contact your doctor. Consumption of large amounts of tea interferes with the absorption of iron. It is not recommended to take GYNO-TARDIFERON at the same time as this drink. Storage conditions No special storage conditions are required. Keep out of the reach of children.