Zincteral tablets p/o 124mg №25×2

Name:
Zincteral. Forms of release Tablets. MNNZinc sulfate. FTHCinc drug. Composition Each coated tablet contains: Active ingredient: Zinc sulfate 124 mg (corresponding to 45 mg of zinc ion) Auxiliary components: Lactose monohydrate, potato starch, povidone, talc, magnesium stearate; shell: hypromellose, titanium dioxide (E171), polyethylene glycol, dye azorubine (E122).
Description:
Round biconvex tablets of violet-pink color, with a uniform surface, without spots and damage. Pharmacotherapeutic group Other mineral additives. Zinc-based products. ATX code: A12CB01. Pharmacological properties Zinc is one of the most important trace elements involved in intracellular metabolism, and one of the main factors stabilizing cell membranes. It is part of many enzyme systems that regulate the basic metabolic processes, in particular, it is involved in protein synthesis and carbohydrate metabolism. Indications for use Treatment of clinically proven zinc deficiency conditions in adults, provided that it cannot be replenished with appropriate nutrition. Zinc deficiency can occur in individuals with an inadequate diet, with malabsorption, with increased tissue loss due to trauma, burns, in conditions of protein loss, during parenteral nutrition. Contraindications Hypersensitivity to the active substance or to any of the components of the drug. Childhood. copper deficiency. Dosing and Administration Inside. Zincteral is taken orally, one hour before a meal or two hours after a meal (as a whole, the tablets cannot be divided or chewed). Recommended doses depend on the severity of zinc deficiency and are usually 1-3 tablets per day, divided into 1-3 doses. The maximum recommended dose of zinc should not exceed 200 mg/day. The duration of the course of treatment is determined by the doctor individually, depending on the degree of clinically proven zinc deficiency and the therapeutic effect achieved. If you miss the next dose of the drug, you must take the pill as soon as possible, until the time of the next dose approaches. If by this time it is time to take the next dose of the medicine, do not take the missed dose. Do not double the next dosage of the drug to make up for the missed dose. Further, the drug is used according to the recommended dosage regimen. Overdose In humans, acute toxic effects of zinc can be observed in doses of about 200 mg or more. Zinc sulfate has a pronounced irritant effect in overdose, which leads to irritation and inflammation of the mucous membranes of the mouth and stomach. Therefore, lavage of the stomach and induction of vomiting should be avoided. Symptoms: burning pain in the mouth and throat, abdominal pain, nausea, vomiting, watery or bloody diarrhea, dehydration, electrolyte imbalance, painful urge to defecate, belching, profuse sweating, arterial hypotension (dizziness), jaundice (yellow eyes, skin), hyperamylasemia, pulmonary edema (chest pain, difficulty breathing), sideroblastic anemia, anxiety, incoordination, lethargy, dizziness, liver and kidney failure, pancreatitis. May also be observed: blood in the urine, anuria, collapse, convulsions, hemolysis. Long-term use of high doses can interfere with the absorption of iron and copper, leading to a deficiency of these minerals, which is accompanied by nausea, vomiting, headache, fever, general malaise and abdominal pain. A fatal case has been described following the use of 10 g of zinc sulfate, and the occurrence of hyperglycemia during fatal poisoning with zinc sulfate has also been described. Treatment: discontinuation of zinc intake and symptomatic therapy. To reduce the symptoms of irritation of the mucous membranes and the level of zinc, it is recommended to drink plenty of milk and water, if necessary, chelating agents are administered intramuscularly or intravenously, such as disodium salt of ethylenediaminetetraacetic acid at a dose of 50-75 mg / kg of body weight per day, for 3-6 injections, not more than 5 days, calcium trisodium penteate (1 g as an infusion in 250 ml saline over 6 hours, then 2 g over 24 hours, also in NaCl solution) or D-penicillamine (for acute intoxications, 1 g intravenously or 12, 5 mg/kg po twice a day, but not more than 40 mg/kg per day in case of long-term treatment). Side effects Like all medicines, Zincteral can cause side effects, although not everyone gets them. Rare (may affect up to 1 in 1,000 people): metallic taste in the mouth, gastritis, stomach irritation, epigastric pain; lethargy, irritability, headache. Not known (cannot be estimated from the available data): hematologic disorders due to copper deficiency, including leukopenia (with fever, chills, sore throat), neutropenia (with ulcers or pain in the mouth and throat), sideroblastic anemia (accompanied by increased fatigue, weakness), allergic reactions to the components of the drug, such as itching and skin rashes, dyspepsia, abdominal pain, nausea, vomiting, diarrhea, heartburn, loss of appetite (when taking the drug in high doses), a decrease in the concentration of copper in blood plasma. Reporting Adverse Reactions If you experience any adverse reactions, please consult your physician. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Interaction with other drugs Antibiotics of the tetracycline group Zinc salts reduce the absorption of tetracyclines when taken together, and tetracyclines reduce the absorption of zinc (the interval between taking tetracyclines and Zincteral should be at least 2 hours). Copper preparations Zinc and copper, when taken together, exhibit antagonistic properties, one of which interferes with the absorption in the gastrointestinal tract of the other, thus, there is a possibility of developing an imbalance in the content of these elements in the body. With the simultaneous use of zinc in high doses and copper preparations, a decrease in the absorption of copper is possible (the interval between taking copper preparations and Zincteral should be at least 2 hours). With oral administration of iron and zinc, antagonism is also observed during absorption in the gastrointestinal tract (the interval between taking iron preparations and Zincteral should be at least 2 hours). Zinc in high doses reduces the absorption of calcium and magnesium, and, conversely, a high calcium content in the diet can reduce the absorption of zinc. Fluoroquinolone antimicrobials Zinc may reduce the absorption of fluoroquinolones such as ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin. Thiazide diuretics With the simultaneous use of Zincteral and thiazide diuretics, the excretion of zinc in the urine increases. With the simultaneous use of penicillamine and other chelating agents, the absorption of zinc decreases. The interval between the use of these drugs and zinc salts should be at least 2 hours. Trientine Trientine can reduce the absorption of zinc, as well as the absorption of trientine can be reduced by zinc when used together. Zinc may reduce the absorption of penicillamine when used together. Folic acid may slightly interfere with zinc absorption. When using simultaneously with Zincteral multivitamin preparations with minerals, which include zinc, it is necessary to take into account the possibility of an overdose. Precautions When using zinc preparations, the risk of copper deficiency should be taken into account (when taking Zincteral for more than 3-4 months, it is advisable to additionally prescribe copper preparations). Long-term use of high doses of zinc can lead to secondary copper deficiency in the body. Symptoms of this condition include hypocupremia, impaired iron mobilization, anemia, leukopenia, neutropenia, decreased activity of superoxide dismutase (SOD, superoxide dismutase), in particular erythrocyte superoxide dismutase (ESOD, erythrocyte SOD), decreased levels of ceruloplasmin, decreased activity of cytochrome C- oxidase, an increase in plasma cholesterol levels, an increase in the ratio of low-density lipoprotein cholesterol relative to high-density lipoprotein cholesterol, a decrease in glucose clearance, a decrease in the level of methionine and leucine-enkephalin, a violation of cardiac activity and the activity of pancreatic enzymes, amylase and lipase. When following a diet rich in phytin (eg bran), phosphate (eg dairy products), whole grain baked goods and phytates, zinc absorption is reduced due to the formation of complexes. The interval between the use of the above products and the intake of zinc preparations should be at least 2 hours. It is recommended to constantly monitor the level of zinc in the blood of patients receiving zinc in doses higher than usual. Special groups of patients In patients with impaired renal function, a dose reduction may be required. Zinc can accumulate in acute renal failure. Patients taking Zincteral should refrain from drinking alcohol. In the event of gastrointestinal disorders, the drug should be used immediately before or during meals. The composition of the drug includes the dye azorubine (E122), which can cause allergic reactions. Due to the fact that the drug contains the dye azorubin (E122), Zincteral is contraindicated for use in children. The drug contains lactose, so it should not be used in patients with rare hereditary forms of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome. Pregnancy and lactation The safety and efficacy of Zincteral during pregnancy and lactation (breastfeeding) have not been established. However, zinc crosses the placental barrier and is excreted in breast milk. Therefore, during pregnancy, the drug is used only in cases where, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus. It is necessary to prescribe the drug with caution during lactation. Influence on the ability to drive vehicles and work with mechanisms The drug does not impair the ability to concentrate and does not affect the speed of psychomotor reactions. Packing: 25 tablets in an aluminum foil/PVC blister. One or two blisters, together with the leaflet, are placed in a cardboard box. 150 tablets in a plastic jar with a protective membrane and a child-resistant lid. One can, together with the leaflet, is placed in a cardboard box. Shelf life 3 years. Do not use after the expiry date stated on the package. Storage conditionsStore at a temperature of 15°C – 25°C in a dry place. Keep out of the reach of children. Terms of saleWithout a prescription. Buy Zincteral tablets p/o 124mg No. 25×2