Name:
Tardiferon tab. ret.po 80mg in a blister in pack No. 10×3 The main active ingredientIron sulfate Release formPills CompositionOne 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*, iron oxide yellow (E172), iron oxide red (E172), triethyl citrate. * Composition of Sepifilm® LP010: Methylhydroxypropyl cellulose (hypromellose) 75 – 85% Microcrystalline cellulose 5 – 15% Stearic acid 8 – 12%
Description:
Dosage 80mg Pharmacological propertiesPharmacodynamicsIron is one of the most important minerals, it plays a key physiological role and is necessary for many body functions, such as oxygen transport, ATP production, DNA synthesis and electron transport. Mechanism of action Iron is the central heme atom. 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 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 section “Interaction with other drugs”). 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 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. Indications for use – iron deficiency anemia; – prevention of iron deficiency in pregnant women, when its intake in the body in the required amount cannot be guaranteed. Method of application and dosage Intended for use in adults and children over 6 years of age. For oral administration. Treatment: Children over 6 years: 1 tablet daily. Children over 10 years old and adults: 1-2 tablets daily. Prevention: Pregnant women: 1 tablet per day or 1 tablet every other day during the last 2 trimesters of pregnancy (or from the 4th month). In any case, you should strictly follow the dosage prescribed by your doctor. Method of application For oral administration. The tablet should be swallowed whole. Do not dissolve, chew the tablet or keep it in your mouth. The tablet should be taken with a glass of water before or during a meal, depending on gastrointestinal tolerance. The duration of use of the drug is determined by the time required to correct anemia and restore iron stores, which in adults are about 600 mg for women and 1200 mg for men. The duration of treatment is determined by the doctor on the basis of laboratory parameters characterizing the exchange of iron. After normalization of hemoglobin levels, you should continue taking the drug for about two more months to replenish iron stores. The total duration of taking the drug with severe iron deficiency is usually from 3 to 6 months. If you miss the next dose of Tardiferon, you should not take a double dose of the drug to compensate for the missed one, 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 Composition section. If you suffer from anemia (not enough red blood cells) not related to iron deficiency. If you have any doubts, please consult your doctor or pharmacist. Use in pregnancy and lactation Pregnancy, lactation and fertility This medicinal product may be used during pregnancy as indicated. This medicinal product may be used in women who are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. Side effects Like other medicines, Tardiferon, film-coated tablets, prolonged action can cause adverse reactions, although not all patients experience them. Possible side effects, classified by frequency in descending order: Common (1 to 10 patients in 100) constipation, diarrhea, bloating, abdominal pain, discoloration of the stool, nausea Uncommon (1 to 10 patients in 1000) swelling of the throat ( swelling of the larynx), abnormal stools, heartburn (dyspepsia), vomiting, inflammation of the stomach (gastritis), itching, reddening of the skin in the form of a rash (rash erythematous) Not known (cannot be estimated from the available data) allergic reaction (hypersensitivity reaction), skin burning rash (urticaria), discoloration of teeth*, lesions of the oral cavity (oral ulceration)* * In case of misuse when the tablets are chewed, sucked or held in the mouth. Elderly patients and patients with swallowing disorders in case of choking or aspiration may be at risk of esophageal injury or bronchial necrosis. In case of aspiration, contact your doctor or the nearest emergency room immediately for 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 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 on the safety of this medicine. Overdose You may experience the following effects if you take a significant amount 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 without your doctor’s prescription. Some medicines should not be taken at the same time as Tardiferon, while others require certain changes in administration (regarding, 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 (cyclins or fluoroquinolones) – if you are taking medicines to treat brittle bones (bisphosphonates, strontium) – if you are taking a medicine to treat joint problems (penicillamine) – if you are taking a medicine to treat diseases thyroid gland (thyroxine) – if you are taking medicines for the treatment of Parkinson’s disease (entacapone, methyldopa, levodopa, carbidopa) – if you are taking zinc or calcium – if you are taking a medicine to treat stomach acid: gastrointestinal minerals drugs, charcoal, or antacids (sol and aluminum, calcium and magnesium) – if you are taking a medicine to treat hypercholesterolemia (cholestyramine). Tell your doctor or pharmacist if you are currently taking, have recently taken or may take any other medicines. PrecautionsWarnings Be careful when taking Tardiferon Talk to your doctor or pharmacist before taking Tardiferon. If you are taking Tardiferon, long-acting film-coated tablets for the treatment of iron deficiency, the cause of this deficiency must be investigated. If iron deficiency is associated with an inflammatory disease, treatment with Tardiferon will not be effective. Since there is a 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. Precautions for use Consumption of large amounts of tea interferes with the absorption of iron. Taking this medicine at the same time as this drink is not recommended. The concomitant consumption of dairy products, tea, coffee, red wine, eggs, legumes, or grains 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 conditionsDoes not require special storage conditions. Keep out of the reach of children. Buy Tardiferon tablets p/o prolonged action 80mg №10×3
INN | IRON SULFATE+ASCORBIC ACID |
---|---|
The code | 1 027 |
Barcode | 3 573 994 003 274 |
Dosage | 80mg |
Active substance | Ferrous sulfate |
Manufacturer | Pierre Fabre Medication Production, France |
Importer | "VitPharmMarket" LLC Vitebsk, Republic of Belarus, 210004 Vitebsk, 5th Kooperativnaya st., 8; ALC "Dominantafarm", Minsk, 220140 Minsk, Dombrovskaya str., 15, room 10a, room 10a-41 |
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