Ferroplex (Dragee) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Pharmaceutical Works, Private Limited Company (Hungary)

ATC Code

B03AE03 (Iron preparations in combination with multivitamins)

Active Substances

Ferrous sulfate (USP)

Ascorbic acid (Rec.INN)

Dosage Form

Ferroplex

Dragees 50 mg+30 mg: 100 pcs.

Dosage Form, Packaging, and Composition

Dragee of a grayish-white or yellowish-white color, biconvex with a smooth shiny surface; on the fracture – of a grayish-beige color, with a white coating.

Excipients : lactose monohydrate, potato starch, sucrose, talc, stearin, gelatin.

Coating composition sucrose, talc, magnesium oxide, vegetable oil, acacia gum (gum arabic).

100 pcs. – glass jars (1) – cardboard packs.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Iron preparation + vitamin

Pharmacological Action

Long-acting antianemic agent.

Iron, being a part of numerous cellular structures and participating in the activity of many enzymatic systems (cytochromes, catalases), plays a very important role in oxygen transport and oxidative metabolic processes, and is also an important element of the human body, which is especially necessary for the formation of hemoglobin. The drug is used to eliminate iron deficiency.

Ascorbic acid improves iron absorption, conversion of Fe³⁺ to Fe²⁺.

Pharmacokinetics

Iron is absorbed mainly from the duodenum and jejunum. Maximum absorption is observed when iron is taken on an empty stomach. Absorption varies significantly and depends on iron stores in the body and physiological needs. In iron deficiency states, its absorption is enhanced. The total amount of assimilated iron in the body increases with increasing its dose. T_max in blood is 1-2 hours. After absorption, the main part of iron binds to transferrin and is transported to the bone marrow, where it is captured by erythroid cells of the bone marrow for hemoglobin synthesis; the rest is contained in the blood and deposited in organs in the form of ferritin, hemosiderin or myoglobin. A small amount of iron is excreted from the body after cyclic destruction of the hemoglobin molecule.

Indications

Iron deficiency anemia (treatment and prevention), caused by various reasons: increased need for iron during pregnancy and lactation, during periods of intensive growth and convalescence after prolonged severe illnesses; prolonged bleeding (including with gastric and duodenal ulcers); decreased iron absorption in chronic diarrhea; inadequate and unbalanced nutrition.

ICD codes

Dosage Regimen

Administer orally. Take dragees with a sufficient amount of water.

For treatment of iron deficiency anemia in adults and adolescents over 12 years, the typical daily dose is 2 to 4 dragees.

For prevention of iron deficiency and for maintenance therapy, the typical daily dose is 2 dragees.

Divide the total daily dose into multiple administrations.

Take on an empty stomach, at least one hour before a meal, for maximum absorption.

If gastrointestinal discomfort occurs, administer with or immediately after a meal; note that this may reduce the extent of iron absorption.

The duration of treatment is determined by the physician based on clinical and laboratory parameters.

Do not exceed the prescribed daily dose.

Avoid concomitant intake with antacids, milk, tea, or coffee; separate administration by at least 2 hours.

Adverse Reactions

From the digestive system nausea, vomiting, constipation, diarrhea, abdominal pain, ulcerative lesions of the esophagus, esophageal stenosis.

Allergic reactions: itching, rash, skin hyperemia.

From the nervous system : headache, dizziness.

Other weakness.

Contraindications

Increased iron content in the body (hemosiderosis, hemochromatosis); impaired iron utilization (aplastic anemia); condition after gastric resection; bleeding; children under 12 years of age; hypersensitivity to the components of the combination.

With caution

Gastric and duodenal ulcer.

Use in Pregnancy and Lactation

An indication for use is an increased need for iron during pregnancy and lactation.

Pediatric Use

Contraindication — children under 12 years of age.

Special Precautions

Effective only for iron deficiency anemias and ineffective for anemias of other etiologies.

Avoid simultaneous administration with other iron-containing medicines (risk of overdose).

Stool discoloration to dark (black) color while taking iron-containing drugs has no clinical significance.

Drug Interactions

Mutually reduce absorption when used concomitantly with tetracyclines, D-penicillamine, tea, egg yolk.

Antacids containing aluminum, magnesium and calcium salts reduce the absorption of iron preparations.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.