FERRETAB® COMP.

Combined medicines of iron organic salt and folic acid in capsules of prolonged action for the iron deficiency treatment and prevention, especially during pregnancy.

 

Description

 

Size 2 solid gelatin capsules, red body and cap. Capsule contains 3 reddish-brown round flat minipills (ferrous fumarate) and 1 yellow round flat minipill (folic acid). Inclusions are allowed on tablets.

 

Indications

 

Treatment of latent iron deficiency and iron deficiency anemia, combined with folic acid deficiency, including during pregnancy.

 

Dosage Regimen

 

Adults
Ferretab comp. should be taken orally, 1 capsule daily on an empty stomach, with plenty of fluid. In cases of severe iron or folic acid deficiency, the dose should be increased to two or three capsules daily.

Children
The safety and efficacy of Ferretab comp. in children aged 0 to 18 years have not been established. No data are available.

 

Method of Administration

 

The capsules should be swallowed whole, without chewing, approximately 30 minutes before breakfast or another meal, with a sufficient amount of water.

 

Продолжительность применения

 

Once hematological parameters (serum iron and hemoglobin levels) have returned to normal, it is recommended to continue taking Ferretab comp., 1 capsule daily for 4 weeks.

 

Counterindications

 

— Hypersensitivity to the active ingredients or to any of the excipients

— Diseases accompanied by accumulation of iron in the body: hemochromatosis, hemosiderosis, chronic hemolysis

— Iron absorption disorders: sideroachrestic anemia, thalassemia, lead anemia

— Hemoglobinopathies, hemolytic anemia, aplastic anemia, pernicious anemia, anemia not caused by iron and folic acid deficiency

— Gastrointestinal disorders

— Patients with rare hereditary problems of galactose intolerance, lactase deficiency or malabsorption

— Children and adolescents under 18 years of age

 

Adverse Reactions

 

Summary of the Safety Profile

Blood and lymphatic system disorders
Very rare: treatment with iron preparations may contribute to the development of paroxysmal nocturnal hemoglobinuria, erythropoietic porphyria, or porphyria cutanea tarda.

Immune system disorders
Rare: iron may cause allergic skin reactions.
Very rare: folic acid may cause anaphylactic shock and allergic reactions such as erythema, pruritus, bronchospasm, and nausea.
Not known: anaphylactic reaction.

Gastrointestinal disorders
Not known: feeling of fullness in the stomach, colicky stomach pain, heartburn, nausea, vomiting, diarrhea, or constipation.

 

Pharmacological Properties

 

Pharmacodynamic Properties
Pharmacotherapeutic group: Antianemic preparations; iron preparations; iron preparations in combination with folic acid.
ATC code: B03AD02

 

Mechanism of Action and Pharmacodynamic Effects
Ferretab comp. is a medicinal product for the treatment and prevention of iron deficiency conditions. Ferretab comp. capsules contain ferrous fumarate and folic acid as active substances in prolonged-release mini-tablets to prevent high local concentrations of iron that may irritate the mucous membrane. Ferrous fumarate is an iron salt. Iron is a trace element essential for hemoglobin synthesis. When iron is administered in the form of salts, iron deficiency in the body is rapidly replenished, resulting in the gradual regression of both clinical symptoms of anemia (weakness, fatigue, dizziness, tachycardia, skin tenderness and dryness) and laboratory signs of anemia.
Folic acid is essential for the normal maturation of red blood cells (erythrocytes). It stimulates erythropoiesis and is involved in the synthesis of amino acids, nucleic acids, purines, and pyrimidines, as well as in choline metabolism. During pregnancy, it protects the body against the effects of teratogenic factors.
Ferretab comp. helps maintain and restore normal blood iron levels and, in pregnant women with iron deficiency anemia, prevents complications such as miscarriage, preterm birth, and impaired intellectual development of the child, which may occur in cases of iron and folic acid deficiency.

 

Preclinical Safety Data
Standard studies of pharmacological efficacy and safety were conducted for ferrous fumarate and folic acid both individually and in combination. Based on the results of these studies, the active substances of the medicinal product—ferrous fumarate and folic acid—are considered practically non-toxic compounds. The single lethal oral dose is 1,570 mg/kg for ferrous fumarate and 10,000 mg/kg for folic acid. Chronic toxicity studies of ferrous fumarate at doses considerably exceeding therapeutic doses (250–1,000 mg/kg) demonstrated iron accumulation in liver and spleen tissues and primary focal lesions. Overall, when administered repeatedly for several weeks, the active substances of the medicinal product, ferrous fumarate and folic acid, are characterized by a low level of toxicity and have no damaging effects on the major body systems. Studies of carcinogenicity, mutagenicity, and immunotoxicity have not identified any risks associated with the use of the medicinal product.