Ferretab comp. capsules, No. 30

Treatment and prevention of iron deficiency conditions caused by pregnancy, impaired absorption of iron from the gastrointestinal tract, prolonged bleeding, unbalanced and malnutrition.

FERRETAB COMP is taken orally, 1 capsule per day on an empty stomach, with plenty of liquid.

With a pronounced lack of iron or folic acid, you need to increase the dose to two or three capsules per day.

Maintenance treatment should be continued for at least 4 weeks after reaching normal hemoglobin levels to normalize serum ferritin, which reflects the body's iron stores.

One capsule contains:
3 mini-tablets with iron fumarate and 1 mini-tablet with folic acid:
active ingredients:
iron fumarate 163.56 mg (equivalent to 152.1 mg dry matter, equivalent to 50 mg of iron), folic acid 0.54 mg (equivalent to 0.5 mg dry matter);
excipients:
iron fumarate minitablets: lactose monohydrate 3.42 mg, colloidal silicon dioxide 0.6 mg, magnesium stearate 0.6 mg, methyl methacrylate and ethyl acrylate copolymer [2: 1] 4.66 mg; folic acid minitablet: lactose monohydrate 24.21 mg, microcrystalline cellulose 24.25 mg, colloidal silicon dioxide 0.5 mg, magnesium stearate 0.5 mg; capsule body: gelatin 36.4804 mg, azorubin dye 0.0742 mg, quinoline yellow dye 0.1484 mg, titanium dioxide 0.4960 mg;
capsule cap: gelatin 24.3203 mg, azorubin dye 0.0498 mg, quinoline yellow dye 0.0996 mg, titanium dioxide 03303 mg.

• Hypersensitivity to the components of the drug.

• Diseases accompanied by the accumulation of iron in the body (aplastic and hemolytic anemia, thalassemia, hemosiderosis, hemochromatosis).

• Impaired absorption of iron (sideroachrestic anemia, lead anemia, pernicious anemia (vitamin B12 deficiency).

• Anemia that is not caused by a lack of iron or folate.

Trade name of the drug:

FERRETABЃ COMP

International non-proprietary name:

not

Dosage form:

extended-release capsules

Composition

One capsule contains:
3 mini-tablets with iron fumarate and 1 mini-tablet with folic acid:
active ingredients:
iron fumarate 163.56 mg (equivalent to 152.1 mg dry matter, equivalent to 50 mg of iron), folic acid 0.54 mg (equivalent to 0.5 mg dry matter);
excipients:
iron fumarate minitablets: lactose monohydrate 3.42 mg, colloidal silicon dioxide 0.6 mg, magnesium stearate 0.6 mg, methyl methacrylate and ethyl acrylate copolymer [2: 1] 4.66 mg; folic acid minitablet: lactose monohydrate 24.21 mg, microcrystalline cellulose 24.25 mg, colloidal silicon dioxide 0.5 mg, magnesium stearate 0.5 mg; capsule body: gelatin 36.4804 mg, azorubin dye 0.0742 mg, quinoline yellow dye 0.1484 mg, titanium dioxide 0.4960 mg;
capsule cap: gelatin 24.3203 mg, azorubin dye 0.0498 mg, quinoline yellow dye 0.0996 mg, titanium dioxide 03303 mg.

Description

Hard gelatin capsule (size No. 2) red, containing 3 round flat reddish brown minitablets (iron fumarate) and 1 round flat yellow minitablet (folic acid). The presence of inclusions is allowed on the tablets.

Pharmacotherapeutic group:

iron preparation + vitamin

Pharmacological properties

Pharmacodynamics
FERRETAB COMP is a remedy for the treatment and prevention of iron deficiency conditions.
The drug contains iron fumarate and folic acid as active ingredients. Ferrous fumarate is a salt of iron, a trace element necessary for the synthesis of hemoglobin. When iron is used in the form of salts, its deficiency in the body is quickly replenished, 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 essential for the normal maturation of megaloblasts and the formation of normoblasts. It stimulates erythropoiesis, participates in the synthesis of amino acids, nucleic acids, purines and pyrimidines, in the metabolism of choline. During pregnancy, it protects the body from teratogenic factors. FERRETAB COMP helps maintain and restore normal blood iron levels, and also prevents complications such as anemia,miscarriage, early childbirth and impaired mental development of the child, which can be observed with a lack of iron and folic acid in the body. The amount of assimilated iron ranges between 5 and 35%.
In serum, iron binds to transferrin and is involved in the formation of hemoglobin, myoglobin, cytochrome oxidase, catalase and peroxidase, or is stored in body tissues as ferritin.

Pharmacokinetics
Excretion of iron occurs in feces, urine and sweat. Folic acid is absorbed mainly in the upper parts of the intestinal tract (duodenum) and is 64% protein bound. Folic acid is metabolized in the liver and excreted mainly through the kidneys, and also partly in the feces.

Indications for use

Treatment and prevention of iron deficiency conditions caused by pregnancy, impaired absorption of iron from the gastrointestinal tract, prolonged bleeding, unbalanced and malnutrition.

Contraindications

• Hypersensitivity to the components of the drug.

• Diseases accompanied by the accumulation of iron in the body (aplastic and hemolytic anemia, thalassemia, hemosiderosis, hemochromatosis).

• Impaired absorption of iron (sideroachrestic anemia, lead anemia, pernicious anemia (vitamin B12 deficiency).

• Anemia that is not caused by a lack of iron or folate.

Method of administration and dosage

FERRETAB COMP is taken orally, 1 capsule per day on an empty stomach, with plenty of liquid. With a pronounced lack of iron or folic acid, you need to increase the dose to two or three capsules per day. Maintenance treatment should be continued for at least 4 weeks after reaching normal hemoglobin levels to normalize serum ferritin, which reflects the body's iron stores.

Side effect

FERRETAB COMP is well tolerated by patients.
In some cases, a temporary adverse effect on the gastrointestinal tract is possible (feeling of fullness and discomfort in the stomach, nausea, vomiting), allergic reactions, constipation.

Overdose

Symptoms - the manifestations of the described side effects may increase. If an overdose is suspected, a study should be made of the serum iron content and serum ferritin level. In the case of a significant excess of normal serum ferritin levels, it is necessary to prescribe an iron chelator (desferal) in accordance with the manufacturer's recommended dose.

Interaction with other medicinal products

While taking FERRETAB COMP with antacids, iron absorption is impaired.
Simultaneous reception with ascorbic acid helps to improve the absorption of iron.
Avoid combined use with antibiotics of the tetracycline group due to impaired absorption of iron. Cholestyramine, phenytoin, phenobarbital, carbamazepine, sulfasalazine, hormonal contraceptives, folic acid antagonists, trimethoprim, triamterene, solid food, bread, raw cereals, dairy products, eggs, tea reduce iron absorption.

special instructions

Before starting therapy with an iron preparation, it is necessary to conduct a study of the level of serum iron, serum ferritin (i.e., to document iron deficiency).
FERRETAB COMP therapy should be carried out until the blood count normalizes (8-12 weeks).
When taking the drug, there may be a dark staining of feces, the benzidine test is false positive.

Application during pregnancy and lactation

It is possible to use FERRETAB COMP during pregnancy and breastfeeding if indicated.

Release form

Sustained-release capsules, 10 capsules in a blister made of PVC film and aluminum foil, 3 blisters each with instructions for use in a cardboard box.

Storage conditions

List B. At a temperature not exceeding 25 ? C, in a dry, dark place out of the reach of children.

Shelf life

3 years. Do not use after the expiration date.

Vacation conditions

On prescription.