Instruction for use: Sorbifer Durules

Dosage form: Coated tablets

Active substance: Ferri sulfas+ Acidum ascorbinicum

ATX

B03AA07 Iron sulphate

Pharmacological groups

Iron preparation [Macro and microelements in combinations]

Iron preparation [Stimulants of hemopoiesis in combinations]

The nosological classification (ICD-10)

D50.9 Iron deficiency anemia, unspecified: Iron deficiency anemia; Lack of iron in food; Insufficient absorption of iron from the gastrointestinal tract; Insufficient food intake of iron; Hypochromic iron deficiency anemia; Hypochromic anemia; Iron deficiency anemia in pregnant women; Iron deficiency; Disturbance of absorption of iron from the digestive tract; Combined iron-folic-B12-deficient anemia; Anemia due to violations of hemoglobin synthesis and iron metabolism; Anemia in disorders of iron utilization and reutilization; Impaired iron absorption; Impaired absorption of iron; Insufficient absorption of iron in the digestive tract

E61.1 Insufficiency of iron: Insufficient food intake of iron; Iron deficiency; Iron deficiency in women during pregnancy; Deficiency of iron and folic acid in pregnancy; Iron deficiency after surgery; Latent iron deficiency; Lack of iron during pregnancy and lactation; Inadequate intake of iron from food; Increased need for iron; Increased need for iron during menstruation; Disturbances of iron absorption from the digestive tract; Severe iron deficiency

O25 Malnutrition in pregnancy: Hypovitaminosis during pregnancy; Deficiency of vitamins and minerals in pregnancy; Deficiency of iron and folic acid in pregnancy; Iron deficiency in women during pregnancy; Iodine deficiency in pregnancy; Iodine deficiency in lactating women; Calcium deficiency in the mother's body; Calcium deficiency in pregnant women; Mineral deficiency during pregnancy; An additional source of folic acid during pregnancy; Correction of calcium metabolism disorders during pregnancy; Lack of iron during pregnancy and lactation; Pregnancy Period; Breastfeeding period; Increased need for vitamin B1 in pregnancy

O99.0 Anemia complicating pregnancy, childbirth and the post-natal period: Anemia during pregnancy; Anemia in the mother; Iron deficiency anemia in pregnancy; Megaloblastic anemia of pregnant women; Iron deficiency anemia in pregnant women

Z52.0 Blood donor: Continuous donation

Composition

Coated tablets.

active substance: Iron sulphate 320 mg

(Equivalent to 100 mg of iron II)

Acid ascorbic acid 60 mg

Auxiliary substances: magnesium stearate - 2.3 mg; Povidone - 51 mg; Polyethene powder - 20 mg; Carbomer 934P - 9.1 mg

Shell: hypromellose - 6.9 mg; Macrogol 6000 - 3,1 mg; Titanium dioxide - 2.1 mg; Iron oxide yellow - 0.4 mg; Paraffin wax - 0.1 mg

Description of dosage form

Round biconvex tablets covered with a light yellow color, engraved with "Z" on one side, on the broken core of a gray color, with a characteristic odor.

Pharmachologic effect

Mode of action - Replenishing deficiency of iron and folic acid, anti-anemia.

Pharmacodynamics

Iron - an indispensable component of the body, necessary for the formation of hemoglobin and the flow of oxidative processes in living tissues. The drug is used to eliminate iron deficiency. Durules technology provides a phased release of the active ingredient (iron ions) for a long time. Plastic matrix tablets Sorbifer Durules is inert in the digestive juice, but disintegrates under the action of intestinal peristalsis, when the active ingredient is completely released.

Pharmacokinetics

Durules is a technology that provides a gradual release of the active substance (iron ions), a uniform intake of the drug. Admission to 100 mg twice a day provides a 30% increase in iron absorption from the drug Sorbifer Durules compared with conventional iron preparations.

Absorption and bioavailability of iron - high. Iron is absorbed mainly in the duodenum and the proximal part of the jejunum. The connection with plasma proteins is 90% or more. Deposited in the form of ferritin or hemosiderin in the hepatocytes and cells of the phagocytic macrophage system, a small amount - in the form of myoglobin in the muscles. T1 / 2 is 6 hours.

Indication of the drug Sorbifer Durules

Iron-deficiency anemia;

Iron deficiency;

Preventive use in pregnancy, lactation and blood donors.

Contraindications

Hypersensitivity to the components of the drug;

Stenosis of the esophagus and / or obstructive changes in the digestive tract;

Elevated iron content in the body (hemosiderosis, hemochromatosis);

Violation of iron utilization (lead anemia, sideroblastic anemia, hemolytic anemia);

Children under 12 years of age (due to lack of clinical data).

With caution: peptic ulcer of stomach and duodenum, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn's disease).

Application of pregnancy and breastfeeding

Sorbifer Durules can be used for pregnancy and lactation.

Side effects

Nausea, vomiting, abdominal pain, diarrhea, or constipation. The frequency of side effects from the gastrointestinal tract may increase with increasing doses from 100 to 400 mg.

Rarely (<1/100) the following side effects can occur: ulcerative esophagitis, esophageal stenosis, allergic reactions (pruritus, rash), skin hyperthermia, headache, dizziness, weakness.

Interaction

Sorbifer Durules can reduce the absorption of concomitantly used enoxacin, clodronate, grepafloxacin, levofloxacin, levodopa, methyldopa, penicillamine, tetracyclines and thyroid hormones. The simultaneous use of the drug Sorbifer Durules and antacid preparations containing aluminum hydroxide and magnesium carbonate, can reduce iron absorption. Between taking the drug Sorbifer Durules and any of these drugs should be kept the maximum possible time interval. The recommended minimum time interval between doses is 2 hours, except for tetracyclines, when the minimum interval should be 3 hours. Sorbifer Durules should not be combined with the following drugs: ciprofloxacin, doxycycline, norfloxacin and ofloxacin.

Dosing and Administration

Inside, the tablet should be swallowed whole (you cannot divide or chew) and drink at least 0.5 cup of liquid.

Adults and adolescents: 1 tab. 1-2 times a day. If necessary, patients with iron deficiency anemia, the dose can be increased to 3-4 tablets. In a day for 2 admission (in the morning and in the evening) for 3-4 months (before replenishment of the iron depot in the body).

At pregnancy and a lactemia: preventive maintenance - on 1 tab. Per day, the therapeutic dose - 1 table. 2 times a day (morning and evening).

Treatment should continue until the optimal level of hemoglobin. For further replenishment of the depot, it may be necessary to continue taking the drug for another 2 months.

Overdose

Symptoms: abdominal pain, vomiting and diarrhea with an admixture of blood, fatigue or weakness, hyperthermia, paresthesia, pale skin, cold sticky sweat, acidosis, weak pulse, decreased blood pressure, palpitations. In case of severe overdose, signs of peripheral circulatory collapse, coagulopathy, hyperthermia, hypoglycemia, liver damage, renal failure, muscle cramps and coma may appear after 6-12 hours.

Treatment: In case of an overdose, consult a doctor immediately. It is necessary to wash the stomach, inside - a raw egg, milk (to bind iron ions in the digestive tract); Introduce deferoxamine. Symptomatic therapy.

Special instructions

There may be a darkening of the stool (it has no clinical significance).

Release Form

The tablets covered with a cover, 100 mg + 60 mg. By 30 or 50 tables. In a brown glass bottle with a PE-cap with a control of the first opening and an accordion-shock absorber. 1 fl. In a cardboard box.

Manufacturer

CJSC "Pharmaceutical Plant EGIS". 1106, Budapest, st. Keresturi, 30-38, Hungary.

Produced under the license of AstraZeneca AB, Sweden.

Representation of ZAO "Pharmaceutical Plant EGIS" (Hungary) in Moscow

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Sorbifer Durules

At a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life of the drug Sorbifer Durules

3 years.

Do not use after the expiry date printed on the package.