Ferlatum Fol (Solution) Instructions for Use

Marketing Authorization Holder

Italfarmaco, S.p.A. (Italy)

Manufactured By

Italfarmaco, S.A. (Spain)

Or

Abc Farmaceutici, S.p.A. (Italy)

Quality Control Release

ITALFARMACO, S.A. (Spain)

Contact Information

ITALFARMACO S.p.A. (Italy)

ATC Code

B03AB09 (Iron protein succinylate)

Active Substances

Iron proteinsuccinylate (Iph Italian Pharmacopoeia)

Calcium folinate (Rec.INN WHO registered)

Dosage Form

Ferlatum Fol

Oral solution 800 mg/15 ml and powder 0.235 mg/100 mg: bottle with cap-container 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Oral solution.

The oral solution is clear, brownish in color, with a pleasant characteristic cherry odor.

Excipients: sorbitol, propylene glycol, sodium methylparaben, sodium propylparaben, cherry flavor (concentrated wild black cherry flavor, vanillin, amyl acetate, small amounts of other esters, benzaldehyde, clove bud oil, propylene glycol, diethylene glycol monoethyl ether, water), sodium saccharin, purified water.

Powder for oral solution, white with a yellowish tint, odorless (in a sealed cap-container).

Excipients: mannitol.

15 ml – polyethylene bottles (10) with a cap-container containing 100 mg of powder – cardboard packs.
15 ml – polyethylene bottles (20) with a cap-container containing 100 mg of powder – cardboard packs.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Antianemic drugs; iron preparations; oral ferric iron preparations

Pharmacological Action

Antianemic drug. Contains iron and calcium folinate. Replenishes iron and folate deficiency in the body.

The main function of iron is oxygen transport to tissues. Iron is part of hemoglobin, myoglobin, iron-containing cytochrome enzymes, transfers electrons, and acts as a catalyst for oxidation, hydroxylation, and other metabolic processes.

Ferlatum Fol contains iron-protein succinylate, which is a complex compound where trivalent iron atoms are surrounded by a semi-synthetic protein carrier that prevents damage to the gastric mucosa. The protein carrier dissolves in the duodenum, releasing iron at the site of optimal absorption.

Trivalent iron enters the blood from the intestine through active absorption, which explains the impossibility of overdose and poisoning.

Calcium folinate is the calcium salt of folinic acid, which replenishes folate deficiency in the body.

Pharmacokinetics

Pharmacokinetic data for the drug are not provided.

Indications

• Treatment of latent and clinically expressed iron deficiency (iron deficiency anemia) and folate deficiency;
• Prevention of iron and folate deficiency during pregnancy, lactation, active growth, after prolonged bleeding, against the background of inadequate and unbalanced nutrition.

ICD codes

Dosage Regimen

Ferlatum Fol should be taken orally before or after meals.

Adults: 1-2 bottles/day in 2 divided doses (equivalent to 40-80 mg of trivalent iron and 0.235-0.470 mg of calcium folinate pentahydrate) or as directed by a physician.

Children (from the neonatal period): 1.5 ml/kg/day (equivalent to 4 mg/kg/day of trivalent iron and 0.0235 mg/kg/day of calcium folinate) in 2 divided doses or as directed by a physician.

1 bottle (15 ml) contains: Iron protein succinylate – 800 mg (equivalent to 40 mg of trivalent iron) and 0.235 mg of calcium folinate pentahydrate (equivalent to 0.185 mg of folinic acid).

Pregnant women: for prevention of iron deficiency anemia – 1 bottle/day. For treatment of latent or clinically expressed iron deficiency – 1-2 bottles/day in 2 divided doses.

After achieving normal serum iron and hemoglobin levels, treatment is continued at a maintenance dose for at least 8-12 weeks.

Solution preparation instructions

To prepare the oral solution, press firmly on the perforator of the cap-container to pour the powder into the solution in the bottle. Then shake the bottle contents vigorously, remove the cap-container, and drink the solution from the bottle.

Adverse Reactions

Rarely gastrointestinal disorders, which disappear when the dose is reduced or the drug is discontinued.

Contraindications

• Hemochromatosis;
• Impaired iron utilization (including lead anemia, sideroachrestic anemia);
• Non-iron deficiency anemias (including hemolytic anemia, megaloblastic anemia caused by vitamin B₁₂ deficiency);
• Chronic pancreatitis;
• Liver cirrhosis;
• Hypersensitivity to the drug components.

Use with caution in gastric and duodenal ulcers, malabsorption in small intestinal pathology (including enteritis, malabsorption syndrome, small intestinal resection, Billroth II gastrectomy with duodenal inclusion).

Use in Pregnancy and Lactation

The use of Ferlatum Fol is especially recommended for the prevention and treatment of iron and folate deficiency that develops during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in liver cirrhosis.

Pediatric Use

Children (from the neonatal period): 1.5 ml/kg/day (equivalent to 4 mg/kg/day of trivalent iron and 0.0235 mg/kg/day of calcium folinate) in 2 divided doses or as directed by a physician.

Special Precautions

The continuous period of use of Ferlatum Fol should not exceed 6 months, except in cases of chronic blood loss (including menorrhagia, hemorrhoids) and pregnancy.

Due to the possible development of allergic reactions, the drug should be prescribed with caution to patients with milk protein intolerance.

Ferlatum Fol contains sorbitol, therefore the drug should not be used in patients with hereditary fructose intolerance.

Effect on ability to drive vehicles and machinery

The drug does not affect the ability to engage in potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (including driving).

Overdose

To date, no signs of intoxication or excessive intake of Ferlatum Fol into the body have been described.

Drug Interactions

No interaction of Ferlatum Fol with other drugs was noted during concurrent use.

Iron absorption may be increased with concurrent use of Ferlatum Fol and ascorbic acid in a dose >200 mg.

Iron absorption may be decreased with concurrent use of Ferlatum Fol and antacids.

Chloramphenicol causes a delayed response to iron therapy.

There is no pharmacological interaction with concurrent use of Ferlatum Fol and histamine H₂-receptor antagonists.

Some antitumor and antileukemic drugs (including aminopterin, methotrexate and other pteridine derivatives) exhibit folate antagonist properties.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 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.