Expiration date: 05/2025

The composition and form of issue:

Tablets, film-coated .1 tablet contains:

iron sulfate 320 mg

(equivalent to 100 mg of iron II) 

ascorbic acid 60 mg

excipients: magnesium stearate povidone K-25 politan powder carbomer 934P

shell: hypromellose macrogol 6000 titanium dioxide iron oxide yellow wax solid 

in dark glass bottles to 30 or 50 PCs. in cardboard pack 1 bottle.

Description pharmaceutical form:

Round biconvex tablets, film-coated light yellow in color, with engraved "Z" on one side, on the fracture - gray color, with a characteristic odor.

Pharmacokinetics:

The durules — a technology that provides a gradual release of the active substance (ions of bivalent iron) tablets and its uniform supply into the blood. Receiving 100 mg 2 times per day provides 30% more iron absorption from the drug sorbifer Durules in comparison with ordinary iron preparations.

Absorption and bioavailability of iron is high. Iron is absorbed mainly in the duodenum and proximal jejunum. The plasma protein binding is 90% or more. Deposited in the form of ferritin or hemosiderin in hepatocytes and cells of the phagocytic macrophages, a small amount of myoglobin in the muscles. T1/2 is 6 h.

Description pharmacological action:

Iron is an essential component of the body, necessary for the formation of hemoglobin and the occurrence of oxidative processes in tissues. Durules technology provides the gradual release of the active ingredient (iron ions) for a long time. Plastic matrix tablets sorbifer Durules inert in the digestive juice, but completely disintegrates under the influence of intestinal peristalsis when the active ingredient is fully released.

Indications:

• iron deficiency anemia
  
• iron deficiency
  
• prevention of iron deficiency in pregnancy, lactation and blood donors.
  

Contraindications:

• hypersensitivity to the drug
  
• stenosis of the esophagus and/or obstructive changes of the digestive tract
  
• the high content of iron in the body (hemosiderosis, hemochromatosis)
  
• violation of iron utilization (lead anemia, sideroblastnaya anaemia, haemolytic anaemia)
  
• children up to age 12 years (due to the lack of clinical data).
  

Caution: peptic ulcer and duodenal ulcer, inflammatory bowel disease (enteritis, diverticulitis, ulcerative colitis, Crohn's disease).

Application of pregnancy and breast-feeding:

Can be used during pregnancy and breastfeeding.

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) and ulcerative lesions of the esophagus, stenosis of the esophagus, allergic reactions (itching, rash), hyperthermia of the skin, headache, dizziness, weakness.

Drug interactions:

May reduce the absorption of simultaneously used enoxacin, clodronate, grepafloxacin, levofloxacin, levodopa, methyldopa, penicillamine, tetracyclines and thyroid hormones. The simultaneous use of the drug sorbifer Durules and antacids containing aluminum hydroxide and magnesium carbonate, may reduce the absorption of iron (the interval between their admission must be not less than 2 h) in the case of reception of tetracyclines, the minimum interval should be 3 hours, Durules should not be combined with ciprofloxacin, doxycycline, norfloxacin and ofloxacin.

Method of application and dose:

Inside, the tablet should be swallowed whole (do not divide or chew), drinking no less than 0.5 cups 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 table. per day in 2 admission (morning and evening) for 3-4 months (to replenish depot iron in the body).

Pregnant and breast-feeding: prophylaxis — 1 tab. a day therapeutic dose — 1 table. 2 times a day (morning and evening).

Treatment should continue until the optimal level of hemoglobin. For the further replenishment of the depot may require the continuation of the drug for another 2 months.

Overdose:

Symptoms: abdominal pain, vomiting and diarrhea with blood, fatigue or weakness, hyperthermia, paresthesia, pallor, cold clammy sweat, acidosis, weak pulse, decreased blood pressure, palpitations. In severe overdose the signs of peripheral circulatory collapse, coagulopathy, hyperthermia, hypoglycemia, liver damage, kidney failure, muscle cramps, and coma may occur after 6-12 hours

Treatment: you should immediately consult a doctor. Gastric lavage, inside — raw egg, milk (for binding ions of iron in the blood), the introduction of deferoxamine, symptomatic therapy.

Special instructions:

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