Ferro-Folgamma Neo^® (Tablets) Instructions for Use

Marketing Authorization Holder

Woerwag Pharma GmbH & Co. KG (Germany)

Manufactured By

Lomapharm, GmbH (Germany)

ATC Code

B03AD03 (Iron sulfate in combination with folic acid)

Active Substances

Ferrous sulfate (USP United States Pharmacopeia)

Folic acid (Rec.INN WHO registered)

Dosage Form

Ferro-Folgamma Neo®

Modified-release coated tablets 36.77 mg+0.8 mg: 20, 30, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Modified-release coated tablets of a reddish-brown color, round, biconvex.

Excipients: ascorbic acid, coated, type EC (consisting of 97.5% ascorbic acid and 2.5% ethylcellulose), corn starch, maltodextrin, sodium carboxymethyl starch (type A), calcium stearate, lactose monohydrate, cellulose powder, sodium lauryl sulfate, colloidal anhydrous silicon dioxide, sucrose, talc, titanium dioxide, calcium carbonate, magnesium stearate, hypromellose (type 3cP and 5cP), macrogol (4000 and 6000), methacrylic acid and ethyl acrylate copolymer [1:1] type B, simethicone emulsion, triethyl citrate, propylene glycol, dye iron oxide red (E172), dye iron oxide brown (E172).

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

Clinical-Pharmacological Group

Iron preparation in combination with a vitamin

Pharmacotherapeutic Group

Iron preparations in combination with folic acid

Pharmacological Action

A combined medicinal product for the treatment of anemia.

Iron sulfate is an iron salt, a trace element necessary for hemoglobin synthesis. Iron is a 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, skin soreness and dryness) 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.

Pharmacokinetics

After oral administration, iron is absorbed from the gastrointestinal tract. The bioavailability of iron is 10-30%. In modified-release dosage forms, iron is gradually released into the gastrointestinal tract, which 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).

Plasma protein binding of iron 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.

Plasma protein binding of folic acid 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 cases of impaired iron absorption from the gastrointestinal tract, in cases of prolonged bleeding, in cases of inadequate and unbalanced nutrition).

ICD codes

Dosage Regimen

Administer orally.

For treatment of iron deficiency anemia, take one tablet twice daily.

For prevention of iron deficiency, take one tablet once daily; adjust dosage based on individual patient requirements and serum iron parameters.

Swallow tablets whole with a glass of water; do not chew or crush to preserve the modified-release properties.

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

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

Continue therapy until hemoglobin levels normalize; subsequently, continue for several weeks to replenish iron stores as determined by ferritin levels.

The duration of treatment is determined by the underlying cause of the deficiency and the rate of hematological response.

In pregnant women, use during the second and third trimesters and the postpartum period for both treatment and prevention of anemia.

This product is contraindicated in children and adolescents under 18 years of age.

Adverse Reactions

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

Contraindications

Hypersensitivity to the components of the combination; 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, sideroachrestic anemia); esophageal stenosis and/or obstructive changes of the gastrointestinal tract; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Used in accordance with the dosage regimen in the II and III trimesters of pregnancy, in the postpartum period, and 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 for use in children and adolescents under 18 years of age.

Special Precautions

Before starting therapy, it is necessary to determine the serum iron and ferritin levels.

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

Should be used with caution in inflammatory bowel diseases, alcoholism, hepatic or renal insufficiency.

Drug Interactions

Incompatible with other medicinal products.

Absorption is reduced by: antacid medicinal products, calcium preparations, etidronic acid, medicinal products that reduce gastric acidity (including cimetidine, medicinal products 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).

Absorption is increased by – 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 (it is recommended to take them 2 hours before or 2 hours after taking the iron preparation).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.