Tardiferon tablets p/o prolonged action 80 mg No. 10x3


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® (Tardyferon®)

Combinations not recommended

— Iron salts (injection)

: lipothymia (short-term loss of consciousness, fainting), shock, caused by the rapid release of iron from its complex form and saturation of transferrin.

Combinations to Consider

— Acetohydroxamic acid:

decreased absorption of both drugs in the gastrointestinal tract (formation of complex compounds).

Combinations requiring precautions

— Tetracycline antibiotics (tetracycline, doxycycline, minocycline) for oral administration:

decreased absorption of tetracyclines in the gastrointestinal tract (formation of complex compounds).

The simultaneous use of iron salts and tetracycline antibiotics should be avoided (if possible, it is recommended to maintain an interval between taking these drugs of more than 2 hours).

Bisphosphonates

: decreased absorption of bisphosphonates in the gastrointestinal tract due to the formation of poorly absorbed compounds.

The simultaneous use of iron salts and bisphosphonates should be avoided (the interval between doses of these drugs should, if possible, be at least 30 minutes, and in some cases up to 2 hours or more, depending on the type of bisphosphonate).

Calcium

: decreased absorption of iron in the gastrointestinal tract. Iron salts should not be taken with calcium supplements or foods high in calcium.

Entacapone

: decreased absorption of entacapone and iron in the gastrointestinal tract (formation of complex compounds). Concomitant use of iron salts and entacapone should be avoided (if possible, it is recommended

— Fluoroquinolones:

decreased absorption of fluoroquinolones in the gastrointestinal tract (formation of complex compounds). The simultaneous use of iron salts and fluoroquinolones should be avoided (if possible, it is recommended to maintain an interval of more than 2 hours between taking these drugs).

— Thyroid hormones

: decreased absorption of thyroid hormones in the gastrointestinal tract.

The simultaneous use of iron salts and thyroid hormones should be avoided (if possible, it is recommended to maintain an interval between taking these drugs of more than 2 hours).

Levodopa, methyldopa:

decreased absorption of dopamine derivatives in the gastrointestinal tract.

You should not take iron salts together with methyldopa and levodopa (if possible, it is recommended to keep an interval of more than 2 hours between taking these drugs).

Penicillamine

: decreased absorption of penicillamine in the gastrointestinal tract.

The simultaneous use of iron salts and penicillamine should be avoided (if possible, it is recommended to maintain an interval between taking these drugs of more than 2 hours).

— Zinc, strontium:

decreased absorption of zinc and strontium in the gastrointestinal tract.

You should not take iron salts together with zinc and strontium preparations (if possible, it is recommended to maintain an interval between taking these drugs of more than 2 hours).

Magnesium, aluminum and calcium salts, oxides and hydroxides (antacids)

: decreased absorption of iron in the gastrointestinal tract. The simultaneous use of iron salts and antacids should be avoided (if possible, it is recommended to maintain an interval between taking these drugs of more than 2 hours).

Cholestyramine

: decreased absorption of iron in the gastrointestinal tract. Iron salts should be taken 1-2 hours before taking cholestyramine or 4-6 hours after.

Other types of interaction

Phytic acid (found in whole grain cereals), polyphenols (tea, coffee, red wine), calcium (milk, dairy products) and protein (eggs) reduce the absorption of iron in the gastrointestinal tract. The interval between taking iron salts and the specified food products should be observed (for example, 2 hours).

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.

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