Directions for use and doses
Orally (without chewing), with water, before or during meals. For medicinal purposes: children over 6 years old - 1 tablet. per day, adults and children over 10 years old - 1-2 tablets. in a day.
For preventive purposes: pregnant women - 1 tablet. per day or every other day during the last two trimesters of pregnancy (or starting from the 4th month).
Duration of admission
Adult patients should take the drug for a period that ensures correction of anemia and restoration of iron reserves in the body. The dose for women is 600 mg, for men - 1200 mg.
For iron deficiency anemia, the duration of use is from 3 to 6 months, depending on the degree of depletion of the iron reserve: if necessary, in the absence of adequate control of anemia, it is necessary to increase the duration of use of the drug.
Tardiferon tablets p/o prolonged action 80 mg No. 10x3
Name
Tardiferon tablet. ret.p/o 80 mg in blister pack No. 10x3
Main active ingredient
Ferrous sulfate
Release form
Pills
Compound
One film-coated tablet of prolonged action contains: Active substance Iron (in the form of dried iron (II) sulfate 247.25 mg) 80.00 mg Excipients Tablet core: maltodextrin, microcrystalline cellulose, triethyl citrate, talc, ammonium methacrylate copolymer dispersion type B (Eudragit RS 30D), ammonium methacrylate copolymer dispersion type A (Eudragit RL 30D), glycerol dibehenate. Tablet shell: titanium dioxide (E171), Sepifilm LP010*, yellow iron oxide (E172), red iron oxide (E172), triethyl citrate. * Composition of Sepifilm® LP010: Methylhydroxypropylcellulose (hypromellose)75 - 85% Microcrystalline cellulose5 - 15% Stearic acid8 - 12%
Description
Round, biconvex, film-coated tablets, orange-pink in color.
Dosage
80mg
Pharmacological properties
Pharmacodynamics
Iron is an essential mineral that plays a key physiological role and is required for many body functions such as oxygen transport, ATP production, DNA synthesis and electron transport. Mechanism of action Iron is the central atom of heme. It is part of hemoglobin and is also important for erythropoiesis. Pharmacological effects Iron differs from other minerals in that its balance in the human body is regulated only by its absorption, since there is no physiological mechanism for removing this substance from the body. The absorption of ferrous sulfate (FeSO4) in the proximal small intestine (duodenum and proximal small intestine) is facilitated by the iron transport protein DMT1.
Pharmacokinetics
Absorption Absorption of iron 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 drinks, or by concomitant use of certain medications (see Interactions with Other Drugs section). 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. 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.
Indications for use
- iron deficiency anemia; - prevention of iron deficiency in pregnant women, when its intake into the body in the required quantity cannot be guaranteed. Method of administration and dosage Intended for use in adults and children over 6 years of age. For oral administration. Treatment: Children over 6 years of age: 1 tablet per day. Children over 10 years of age and adults: 1-2 tablets per day. Prevention: Pregnant women: 1 tablet per day or 1 tablet every other day during the last 2 trimesters of pregnancy (or starting from the 4th month). In any case, you should strictly follow the dosage prescribed by your doctor. Directions for use: For oral administration. The tablet should be swallowed whole. Do not suck, chew or hold the tablet in your mouth. The tablet should be taken with a glass of water before or during meals, depending on gastrointestinal tolerance. The duration of use of the drug is determined by the time required to correct anemia and restore iron reserves, which in adults are about 600 mg for women and 1200 mg for men. The duration of treatment is determined by the doctor based on laboratory parameters characterizing iron metabolism. After normalization of hemoglobin levels, you should continue taking the drug for about two more months to replenish iron reserves. The total duration of taking the drug for severe iron deficiency is usually from 3 to 6 months. If you miss another dose of Tardiferon, you should not take a double dose of the drug to compensate for the missed dose; follow the established treatment regimen.
Contraindications
Do not take Tardiferon: If you are allergic (hypersensitive) to iron or to one of the other ingredients of this medicine listed in the Ingredients section. If you suffer from anemia (not enough red blood cells) not due to iron deficiency. If you have any doubts, consult your doctor or pharmacist.
Use during pregnancy and lactation
Pregnancy, breastfeeding and fertility This medicinal product may be used during pregnancy as indicated. This medicine may be used in women who are breastfeeding. Ask your doctor or pharmacist for advice before starting any medicine.
Side effect
Like other medicines, Tardiferon extended-release film-coated tablets may cause side effects, although not everyone gets them. Possible side effects, classified by frequency in descending order: Common (1 to 10 patients out of 100) constipation, diarrhea, bloating, abdominal pain, change in stool color, nausea Uncommon (1 to 10 patients out of 1000) swelling of the throat ( swelling of the larynx), unusual bowel movements, heartburn (dyspepsia), vomiting, inflammation of the stomach (gastritis), itching, redness of the skin in the form of a rash (erythematous rash) Frequency unknown (cannot be estimated from available data) allergic reaction (hypersensitivity reaction), skin rash with burning sensation (urticaria), discoloration of teeth*, oral lesions (oral ulceration)* *In case of improper use when the tablets are chewed, dissolved or kept in the mouth. Elderly patients and patients with swallowing problems may be at risk of esophageal injury or bronchial necrosis if they experience choking or aspiration. If aspiration occurs, contact your doctor or the nearest emergency room immediately to receive appropriate treatment. Reporting side effects If you experience any side effect, contact your doctor, pharmacist or nurse. 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 on the safety of this drug up to date.
Overdose
You may experience the following if you take significant amounts of iron: - Intense gastrointestinal irritation, nausea, vomiting, diarrhea, often with bleeding, which may be accompanied by a drop in blood pressure, kidney and liver failure, which can cause convulsions.
Interaction with other drugs
If you are already taking the following medicines, do not take Tardiferon unless directed by your doctor. Some medicines should not be taken at the same time as Tardiferon, and others require certain changes in taking (relating to, for example, doses and timing of administration): - if you are using injectable medicines containing iron, - if you are taking medicines containing acetohydroxamic acid, - if you are taking certain antibiotics (cyclines or fluoroquinolones), - if you are taking medicine to treat brittle bones (bisphosphonates, strontium), - if you are taking medicine to treat joint problems (penicillamine), - if you are taking medicine to treat a condition thyroid (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 medicines to treat stomach acid: gastrointestinal minerals drugs, charcoal or antacids (aluminium, calcium and magnesium salts) - if you are taking a medicine to treat hypercholesterolemia (cholestyramine). If you are currently taking, have recently taken, or may be taking any other medicines, tell your doctor or pharmacist.
Precautionary measures
Warnings Be careful when taking Tardiferon. Before taking Tardiferon, consult your doctor or pharmacist. If you are taking Tardiferon Extended Release Film-Coated Tablets to treat iron deficiency, the cause of the deficiency should be investigated. If iron deficiency is associated with an inflammatory disease, treatment with Tardiferon will not be effective. Because there is a risk of developing ulcerative stomatitis and discoloration of teeth, the tablets should not be dissolved, chewed or kept in the mouth. They should be swallowed whole with a glass of water. Precautions for Use Consuming large amounts of tea interferes with the absorption of iron. Taking this medicine at the same time as this drink is not recommended. Concomitant consumption of dairy products, tea, coffee, red wine, eggs, legumes or cereal products interferes with the absorption of iron by the body. If you have any doubts, do not hesitate to ask your doctor or pharmacist for advice. Keep out of the reach of children!
Storage conditions
Does not require special storage conditions. Keep out of the reach of children.
Pharmacological properties
Pharmacodynamics.
Tardiferon is a complex long-acting iron preparation. contains ferrous sulfate, the use of which replenishes iron deficiency in the body and stimulates hematopoiesis. The high safety of the drug is due to the presence of mucoproteose in its composition. Mucoproteosis is a natural mucopolysaccharide that protects the mucous membrane of the digestive tract from the irritating (irritating) effects of iron ions, promotes the slow release of iron (within 5-6 hours), which significantly improves the tolerability of the drug. Ascorbic acid, having an antioxidant effect, increases the bioavailability of iron and promotes its absorption.
Pharmacokinetics. Absorbed in the duodenum and proximal small intestine. Cmax of iron in the blood plasma is achieved after approximately 7 hours and remains elevated for 24 hours after taking the drug.
Overdose
If the recommended doses of tardiferon are observed, the risk of excessive iron accumulation is low. If the recommended doses are exceeded, overdose may occur.
Symptoms. Acute iron overdose can manifest as nausea and vomiting, and in severe cases can lead to collapse and death. The lethal dose of elemental iron is considered to be 180–300 mg/kg body weight. However, for some patients, a dose of 30 mg/kg elemental iron may be toxic.
Symptoms of acute iron poisoning may occur within 10–60 minutes or within a few hours. Possible abdominal pain, pain in the epigastric region, nausea, diarrhea with green and later tar-like stools, melena, vomiting with or without blood, drowsiness, weakness, pale skin, cold sticky sweat, acrocyanosis, cyanosis, threadlike pulse , lethargy, decreased blood pressure, palpitations, fatigue, shock and coma, confusion, symptoms of hyperventilation, hyperthermia, paresthesia, necrosis of the gastrointestinal mucosa, convulsions.
After approximately 4–6 hours, a period of remission usually occurs. Subsequently, after 12–48 hours, severe shock may develop, accompanied by Cheyne-Stokes respiration, oliguria, toxic liver failure and coagulopathy.
Due to the possible toxic effects of an overdose, the patient must receive immediate medical attention. Slow release of iron may slow its absorption, thereby prolonging the period for relief. If you accidentally take more tablets, the patient should consume raw eggs and milk, which will lead to the formation of insoluble iron compounds in the gastrointestinal tract and will contribute to its elimination from the body. Taken tablets can be removed from the stomach by causing the patient to vomit.
Specific therapy. Vomit should be checked for the presence of Tardiferon tablets. If the number of tablets is insufficient, gastric lavage should be performed with 0.9% sodium chloride solution or 1% aqueous sodium carbonate solution and use a laxative. It is necessary to conduct a fluoroscopic examination of the abdominal organs to determine the number of remaining tablets. If the methods used to remove the tablets do not give the desired result, surgery may be necessary.
The best method for assessing the severity of the condition is to determine the iron content in the blood plasma and the total iron-binding capacity of the blood plasma. If the level of iron in the blood plasma exceeds the total iron-binding capacity, there is a possibility of systemic poisoning.
It may be necessary to use deferoxamine. Deferoxamine chelation therapy should be used if:
- a potentially lethal dose was taken (180–300 mg/kg body weight and above);
- plasma iron concentration above 400–500 mg/dl;
- the concentration of iron in the blood plasma exceeds the total iron-binding capacity and/or if the patient has severe symptoms of iron intoxication - coma, shock.
In case of acute poisoning, 5–10 g of the drug is used orally to bind iron that is not absorbed in the gastrointestinal tract (the contents of 10–20 ampoules are dissolved in drinking water). To eliminate absorbed iron, deferoxamine is administered intramuscularly at 1–2 g every 3–12 hours. In severe cases, accompanied by the development of shock, intravenous drip administration of 1 g of the drug and symptomatic therapy are used.
Young children are at particularly high risk for acute iron toxicity; Life-threatening intoxication is possible when taking 1 g of ferrous sulfate.
If necessary, treat shock and acidosis.
For oliguria/anuria, peritoneal dialysis or hemodialysis is used.
Interactions
With simultaneous use of iron salts, the absorption of tetracycline, DNA gyrase inhibitors (for example, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), diphosphonate, penicillamine, levodopa, carbidopa and methyldopa, penicillin, sulfasalazine is reduced. Iron salts reduce the absorption of thyroxine and zinc. Iron absorption is reduced when taken concomitantly with cholestyramine, antacids (containing aluminum, magnesium, calcium, bismuth), as well as dietary supplements containing calcium and magnesium. Vitamin C and citric acid promote iron absorption. with the simultaneous use of iron salts with NSAIDs, the irritating effect of iron on the gastrointestinal mucosa may increase. Iron absorption may be slowed down by simultaneous intravenous administration of chloramphenicol. Tardiferon should not be taken within 2–3 hours after using one of the above drugs. If possible, it is necessary to monitor the effectiveness of the simultaneous use of drugs using medical or laboratory diagnostic methods. antibiotics of the tetracycline group, as well as penicillin, form complex compounds with ferrous sulfate that reduce the absorption of iron and antibiotics. glucocorticoids can stimulate erythropoiesis. simultaneous use of vitamin E can reduce the pharmacological effect of iron in the child’s body. The simultaneous use of iron salts and allopurinol should be avoided.
Contraindications
Hypersensitivity to active or other components of the drug; excess iron (hemosiderosis, hemochromatosis); other types of anemia not associated with iron deficiency (hemolytic anemia, aplastic anemia, sideroachrestic anemia, iron-refractory anemia, anemia due to lead poisoning, thalassemia, etc.); esophageal stenosis and/or other obstructive gastrointestinal diseases; intestinal diverticulum, intestinal obstruction, regular blood transfusions, simultaneous use of parenteral forms of iron; children under 7 years of age.
special instructions
It should be taken into account that iron deficiency anemia associated with inflammatory syndromes is resistant to treatment with iron supplements.
It is necessary to establish the etiology of anemia.
Since the drug contains sucrose, it is contraindicated in cases of fructose intolerance, glucose/galactose malabsorption syndrome or sucrose-isomaltase deficiency.
Castor bean oil, which is part of the drug, can cause stomach problems and diarrhea.
When using the drug, the color of stool may change to black, which may interfere with the diagnosis of chronic gastrointestinal bleeding. The fecal occult blood test may be false positive.
Eggs and milk, black tea, coffee, bread, raw cereals, and dairy products inhibit iron absorption. Oral iron supplements should not be taken within 1–2 hours after consuming the above foods. Do not take simultaneously with other medicines containing iron. Use with caution in patients with leukemia, chronic liver and kidney diseases, inflammatory diseases of the gastrointestinal tract, stomach and duodenal ulcers, intestinal diseases (enteritis, ulcerative colitis, Crohn's disease). Possible exacerbation of rheumatoid arthritis. To prevent constipation, take the drug with a sufficient amount of liquid.
Systematic monitoring of iron and hemoglobin levels in blood plasma is necessary.
If necessary, assess the following parameters approximately every 4 weeks to determine the severity of iron deficiency, response to treatment, and the need for continued therapy: hemoglobin, red blood cell count, mean erythrocyte volume (MCV), mean corpuscular hemoglobin (MCH), reticulocyte count, iron level in blood plasma, transferrin. Determination of ferritin in blood plasma allows one to assess accumulated iron; a ferritin level in the blood plasma of 15 mcg/l means a lack of iron reserves in the body.
The drug contains sucrose, which should be taken into account when used in patients with diabetes.
Children. Do not use in children under 7 years of age.
During pregnancy and breastfeeding. Animal studies have not revealed malformations in the offspring of mice and rats receiving iron supplements during pregnancy at a dose 1100 times higher than the therapeutic dose for humans.
Adequate studies have not been carried out in humans, but the analysis of bibliographic data did not reveal information about developmental defects in children of women who took iron supplements during pregnancy.
Iron is excreted in breast milk in small quantities (about 0.25 mg/day).
During pregnancy and breastfeeding, Tardiferon should be taken only after consultation with a doctor.
The ability to influence reaction speed when driving vehicles and working with other mechanisms. Not installed.
Note!
Description of the drug Tardiferon table. 80mg No. 30 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
