Gyno-Tardyferon^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pierre Fabre Medicament (France)

Manufactured By

Pierre Fabre Medicament Production (France)

ATC Code

B03AD03 (Iron sulfate in combination with folic acid)

Active Substances

Ferrous sulfate (USP Pharmacopoeia)

Folic acid (Rec.INN)

Dosage Form

Gyno-Tardyferon®

Modified-release film-coated tablets 256.3 mg+350 mcg: 30 pcs.

Dosage Form, Packaging, and Composition

Modified-release film-coated tablets from white to light beige in color, biconvex, with a smooth surface; on the cross-section – brown with a white border.

Excipients: ascorbic acid, mucoproteose (anhydrous), potato starch, Eudragit S, dibutyl phthalate, povidone, talc, magnesium stearate, hydrogenated castor oil, magnesium trisilicate.

Shell composition: talc, titanium dioxide, white beeswax, hard paraffin, Eudragit E, sucrose.

10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Ferrous sulfate in combination with folic acid

Pharmacological Action

A combined antianemic drug, the action of which is due to the properties of its constituent components.

Ferrous sulfate is an iron salt, a trace element necessary for hemoglobin synthesis. Iron is part of hemoglobin, myoglobin, and a number of enzymes. 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 necessary 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, and in the metabolism of choline. During pregnancy, it protects the body from the effects of teratogenic factors.

Mucoproteose, being a natural high-molecular fraction obtained from the intestinal mucosa of animals and having a certain content of amino sugars and organically bound sulfate, provides better gastrointestinal tolerance of the drug and increases the bioavailability of iron ions. Ascorbic acid helps improve iron absorption. The special neutral coating of the tablets ensures the absorption of active components mainly from the upper part of the small intestine. The absence of a local irritating effect on the gastric mucosa contributes to good gastrointestinal tolerance of the drug.

Pharmacokinetics

After oral administration of the drug, iron is absorbed from the gastrointestinal tract. The bioavailability of iron is 10-30%. The gradual release of iron prolongs its absorption, mainly in the distal part of the small intestine. Folic acid is absorbed mainly from the upper parts of the gastrointestinal tract (duodenum).

Iron binding to plasma proteins is 90% or more. It is stored as ferritin or hemosiderin in the cells of the phagocytic macrophage system, a small amount as myoglobin in the muscles.

Folic acid binding to plasma proteins is 64%; biotransformation occurs in the liver.

Iron is excreted in feces, urine, and sweat.

Folic acid is excreted mainly by the kidneys, partially through the intestines.

Indications

• Treatment and prevention of iron deficiency anemia of various etiologies (including during pregnancy, in case of impaired iron absorption from the gastrointestinal tract, in case of prolonged bleeding, in case of inadequate and unbalanced nutrition).

ICD codes

Dosage Regimen

For mild anemia, the drug is prescribed 1 tab./day before breakfast; for moderate anemia – 1 tab. 2 times/day; for severe anemia – 1 tab. 3 times/day for several weeks (on average 4-5 weeks) – until the normal hemoglobin level is restored. After restoration of the normal hemoglobin level, the drug should be continued for 2-3 months to replenish iron stores.

For prevention of iron and folic acid deficiency during pregnancy and lactation, the drug is prescribed 1 tab./day in the II and III trimesters and in the postpartum period during breastfeeding.

Adverse Reactions

From the digestive system rarely – nausea, epigastric pain, diarrhea, constipation.

Contraindications

• Anemias not associated with iron or folic acid deficiency (hemolytic anemias, megaloblastic anemia associated with isolated vitamin B₁₂ deficiency);
• Increased iron content in the body (hemosiderosis);
• Impaired iron utilization mechanisms (anemia caused by lead poisoning, sideroblastic anemia);
• Esophageal stenosis and/or obstructive changes of the gastrointestinal tract;
• Childhood (under 18 years of age);
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

For prevention of iron and folic acid deficiency during pregnancy and lactation, the drug is prescribed 1 tab./day in the II and III trimesters and in the postpartum period during breastfeeding.

Use in Hepatic Impairment

The drug should be used with caution in hepatic insufficiency.

Use in Renal Impairment

The drug should be used with caution in renal insufficiency.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Before starting therapy with the drug, it is necessary to determine the content of iron and ferritin in the blood serum.

During the drug administration, dark staining of the stool may be observed, which is due to the excretion of unabsorbed iron and has no clinical significance.

The drug should be used with caution in inflammatory bowel diseases, alcoholism, hepatic or renal insufficiency.

Overdose

Symptoms: possible intensification of the described adverse effects.

Treatment: gastric lavage with a 1% aqueous solution of sodium bicarbonate, symptomatic therapy. Antidote – deferoxamine.

Drug Interactions

Not compatible with other medicines.

Reduce absorption: antacid medicines, calcium preparations, etidronic acid, medicines that reduce gastric juice acidity (including cimetidine, medicines containing carbonates, bicarbonates, phosphates, oxalates), pancreatin, pancrelipase, coffee, tea, milk, vegetables, cereals, egg yolk (iron preparations should be taken 1 hour before or 2 hours after their consumption).

Increase absorption – ascorbic acid, ethanol (including increases the risk of toxic complications).

The drug reduces the absorption of fluoroquinolones, penicillamine, tetracyclines, and in large doses reduces the absorption of zinc preparations (they are recommended to be taken 2 hours before or 2 hours after taking the iron preparation).

Storage Conditions

Store at a temperature up to 25°C (77°F) in a place out of the reach of children.

Shelf Life

Shelf life – 5 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.