Expiration date: 09/2026

Release form and composition:

Solution reception inside transparent, brown color with a pleasant characteristic odor.

1 FL. (15 ml)

iron protein succinylate 800 mg,

EMCO corresponds to the content of Fe3+ 40 mg

Excipients: sorbitol, propylene glycol, sodium methyl parahydroxybenzoate, sodium parahydroxybenzoate, cherry flavor, sodium saccharin, purified water.

15 ml - polyethylene bottles (10) - packs of cardboard.

Pharmacological action:

Anti-anemic drug. Perlatum contains iron protein succinylate, which is a complex compound where the atoms of ferric iron is surrounded by a semi-synthetic protein carrier, preventing damage of the gastric mucosa.

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

Pharmacokinetics:

In the acidic environment of the stomach occurs the precipitation of proteins and the formation of iron ions around a dense protein shell, eliminating the irritant effect of iron on the mucosa of the stomach.

In the alkaline environment of the duodenum, the protective protein shell dissolves and the iron is released at its best absorption.

In the blood the iron is by active transport (suction), which explains the impossibility of an overdose.

Indications:

— treatment of latent and clinically expressed iron deficiency (iron deficiency anemia)

— prevention of iron deficiency during pregnancy, lactation, active growth, with prolonged bleeding, amid inadequate and unbalanced nutrition.

Dosing regimen:

Perlatum should be taken orally before or after meals.

Adults the preparation appoint on 15-30 ml/day (equivalent to 40-80 mg of Fe3+) in 2 hours.

Children ranging from the neonatal period, the drug is administered at 1.5 ml/kg body weight/day (equivalent to 4 mg/kg/day Fe3+) in 2 hours.

The multiplicity of the drug can be established by the doctor individually.

For the prevention of iron-deficiency States during pregnancy the drug is administered at 15 ml/day for the treatment of latent or clinically expressed iron deficiency 15-30 ml/day in 2 admission.

After normalization of serum iron and hemoglobin, the therapy continues for another 8-12 weeks, assigning Perlatum maintenance dose.

Side effects:

From the digestive system: possible (often with the use of the drug in high doses) diarrhea, constipation, nausea, epigastric pain (which disappear at lower doses or drug discontinuation).

The patient should be informed that in the event of adverse reactions should consult a doctor.

Contraindications:

— hemochromatosis

— disorders of iron utilization (lead anemia, anemia sideroahrestical)

— nieestetyczne anaemia (haemolytic anaemia or megaloblastic anaemia caused by vitamin B12 deficiency)

— chronic pancreatitis

— cirrhosis of the liver

— hypersensitivity to the drug.

Pregnancy and lactation:

Perlatum is indicated for the prevention and treatment of iron deficiency States, developing during pregnancy and lactation (breastfeeding).

Special instructions:

Note that the total duration of the drug Perlatum should be no more than 6 months except in cases associated with chronic blood loss (menorrhagia, hemorrhoids), and pregnancy.

Overdose:

Symptoms: hitherto not been described signs of intoxication and excess of iron in the body in the first 6-8 h after the use of iron supplements in excessive doses may cause epigastric pain, nausea, vomiting (sometimes with blood), diarrhea, in some cases accompanied by sleepiness, pale skin. Perhaps the development of a state of shock until Tuesday.

Treatment: gastric lavage if necessary, symptomatic therapy.

Drug interactions:

While the use of Ferlatum with blockers of histamine H2-receptors pharmacological interaction is missing.

Chloramphenicol causes a delayed response to therapy with iron preparations.

Pharmacokinetic interaction

While the use of iron supplements disturb processes of absorption of tetracyclines from the gastrointestinal tract (should be avoided this combination).

Iron absorption is increased with concomitant administration of ascorbic acid in a dose of 200 mg.

Iron absorption is reduced with concomitant administration of antacids.

Terms and conditions of storage:

The drug should be stored out of reach of children at temperature not exceeding 25°C. shelf Life - 2 years.