Expiration date: 01/2025

The composition and form of issue:

Long-acting capsules. 1 caps. contains:

(1 caps. contains 3 mini-tablets of iron fumarate and 1 mini-tablet of folic acid) 

ferrous fumarate 163,56 mg

(corresponds to 152,1 mg of dry matter or 50 mg iron) 

folic acid 0.54 mg

(corresponding to 0.5 mg dry matter) 

excipients: lactose monohydrate — of 34.47 mg silica colloidal anhydrous and 2.3 mg of magnesium stearate and 2.3 mg of polyacrylate (30% dispersion) — 13,98 mg MKC — 24,25 mg 

the body of the capsule: gelatin — 36,4804 mg dye azorubin (E122) — 74,2 ICG dye quinoline yellow (E104) — 148,4 mcg titanium dioxide (E171) — 496 mcg 

cover of the capsule: gelatin — 24,3203 mg dye azorubin (E122) — 49,8 µg dye quinoline yellow (E104) — 99,6 mcg titanium dioxide (E171) — 330,3 mcg 

blistere in 10 PCs., in box 3 blister.

Description pharmaceutical form:

Hard gelatin capsule (size No. 2) red color, containing 3 flat round mini-tablets are reddish-brown (iron fumarate) and 1 round flat mini tablet yellow (folic acid). On tablets it allowed the presence of inclusions.

Pharmacokinetics:

Release of iron occurs in the feces, urine and sweat.

Folic acid is absorbed mainly in the upper intestine (the duodenum) and 64% is bound to proteins. Metabolized in the liver and excreted mainly through the kidneys, and partially with faeces.

Description pharmacological action:

For the treatment and prevention of iron-deficiency States.

The action is determined by the properties of its constituent active substances.

Ferrous fumarate — salt of iron, a trace mineral required for hemoglobin synthesis. When applying iron in the form of salts, there is a rapid replenishment of its deficit in the body, which leads to a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, soreness and dryness of the skin) and laboratory symptoms of anemia.

Folic acid is required for normal maturation of megaloblasts and normoblasts education. It stimulates erythropoiesis, is involved in the synthesis of amino acids, nucleic acids, purines and pyrimidines, in the metabolism of choline. During pregnancy protects the body from the action of teratogenic factors.

The drug helps maintain and restore normal levels iron in the blood, and prevents complications such as anemia, miscarriage, early birth and impaired child development that can occur with a lack of iron and folic acid in the body. The amount of assimilable iron varies between 5 and 35%.

Serum iron binds to transferrin, is involved in the formation of hemoglobin, myoglobin, cytochrome, catalase and peroxidase or stored in the tissues of the body in the form of ferritin.

Indications:

Treatment and prevention of iron-deficiency States (pregnancy, malabsorption of iron in the digestive tract, prolonged bleeding, unbalanced and inadequate nutrition).

Contraindications:

• hypersensitivity to the drug
  
• diseases accompanied by accumulation of iron in the body (aplastic and hemolytic anemia, thalassemia, hemosiderosis, hemochromatosis)
  
• violation of absorption of iron (sideroahrestical anemia, lead anemia, pernicious anemia (insufficient vitamin B12)
  
• anaemia not caused by iron deficiency or folic acid.
  

Application of pregnancy and breast-feeding:

Used when indicated.

Side effects:

Is usually well tolerated. In some cases there may be temporary adverse effects on the gastrointestinal tract — a sense of filling and discomfort in the stomach, nausea, vomiting, allergic reactions, constipation.

Drug interactions:

When administered simultaneously with antacids worsens the absorption of iron.

Avoid joint use with antibiotics of the tetracycline group in connection with the malabsorption of iron.

Cholestyramine, phenytoin, phenobarbital, carbamazepine, sulfasalazine, hormonal contraceptives, antagonists of folic acid, trimethoprim, triamterene, solid food, bread, raw cereals, dairy products, eggs, tea reduce the absorption of iron.

Method of application and dose:

Inside, on an empty stomach, drinking plenty of liquid, and 1 caps./day. In severe lack of iron or folic acid you need to increase the dose to 2-3 caps./day. Maintenance treatment should continue at least 4 weeks after reaching normal hemoglobin levels to normalize serum ferritin, reflecting body iron stores.

Overdose:

Symptoms: increased side effects.

Treatment: the study of serum iron and serum ferritin levels. In the case of a significant exceeding the normal values of ferritin serum should designate a chelator of iron (Desferal) in accordance with the manufacturer's recommended dose.

Special instructions:

Before therapy, iron supplementation is necessary to study the level of serum iron, ferritin serum (i.e., to document iron deficiency).

While taking the drug may be a dark staining of feces, benzidine test — false-positive.