Ferrum Lek - instructions for use, dose, side effects, contraindications

Excipients: sucrose - 1,000 g; sorbitol (solution) - 2,000 g; methylparahydroxybenzoate 2,915 mg; propyl parahydroxybenzoate 0.830 mg; ethanol 16.250 mg; cream flavoring - 15,000 mg; sodium hydroxide - up to pH 5.0-7.0; water - up to 5 ml.

Description:Transparent solution of brown color.

Pharmacotherapeutic group:Anti-anemic agent. The preparation of iron.

ATX: & nbsp

B.03.A.B Preparations of iron (trivalent) for oral administration

B.03.A.B.05 Iron hydroxide polymaltosate

Pharmacodynamics:

The molecular mass of the complex is so great - about 50 kDa, that its diffusion through the mucous membrane of the gastrointestinal tract is 40 times slower than the diffusion of ferrous iron. The complex is stable and under physiological conditions does not release iron ions. The iron of multinuclear active zones of the complex is connected in a structure similar to the structure of a natural iron-ferritin compound. Due to this similarity, iron (III) of this complex is absorbed only by active absorption. The iron-binding proteins on the surface of the intestinal epithelium and in the gastrointestinal fluid absorb iron (III) from the complex through competitive ligand exchange. Absorbed iron is mainly deposited in the liver where it binds to ferritin. Later in the bone marrow it is included in the hemoglobin.

The polymaltose complex of iron (III) hydroxide, unlike iron (II) salts, does not possess pro-oxidant properties. The sensitivity of lipoproteins (eg, very low density lipoproteins and low density lipoproteins) to oxidation is reduced.

Pharmacokinetics:

Studies using the double isotope method (⁵⁵Fe and ³⁹Fe) showed that iron absorption, measured by hemoglobin level in erythrocytes, is inversely proportional to the dose (the higher the dose, the lower the absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of absorbed iron (the higher the iron deficiency, the better the absorption). The maximum absorption of iron occurs in the duodenum and jejunum. Unabsorbed iron is excreted with feces. Its excretion with exfoliating cells of the epithelium of the gastrointestinal tract and skin, and also with sweat, bile and urine is approximately 1 mg of iron per day. In women during menstruation, there is an additional loss of iron, which must be taken into account.

Indications:

treatment of latent iron deficiency;
treatment of iron deficiency anemia;
prevention of iron deficiency during pregnancy.

Contraindications:

hypersensitivity to the components of the drug,
Iron overload (for example, in cases of hemochromatosis, hemosiderosis);
impairment of iron utilization (eg, anemia caused by lead intoxication, sidero-achestic anemia, thalassemia);
anemia not related to iron deficiency (eg, hemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency);
rare hereditary forms of fructose intolerance, glucosogalactose malabsorption and sucrose isomaltase insufficiency (since the preparation contains sucrose and sorbitol).

Carefully:

Patients with diabetes mellitus.

Pregnancy and lactation:

During controlled studies in pregnant women (the 2nd and 3rd trimester of pregnancy), there was no adverse effect on the mother and fetus organisms. There was no adverse effect on the fetus when taking drugs in the first trimester of pregnancy.

When using a breast-feeding medicine, only a small part of iron from its complex with polymaltose enters the breast milk; thus, the occurrence of undesirable effects in breastfed infants is unlikely.

Dosing and Administration:

Inside.

The drug is recommended to be taken during or immediately after a meal. Syrup Ferrum Lek® can be mixed with fruit or vegetable juices or added to baby food. The daily dose can be divided into several receptions.The measuring spoon enclosed in the packaging is used to accurately dispense the Ferrum Lek® syrup.

Doses and duration of treatment depend on the degree of iron deficiency.

Latent iron deficiency

The duration of treatment is about 1-2 months.

Children under the age of 1 year

Due to the low dosage, the use of syrup for this indication is not possible.

Children from 1 to 12 years old

2.5-5 ml (1 / 2-1 scoop) of Ferrum Lek® syrup per day.

Children over 12 years of age, adults and mothers breastfeeding

5-10 ml (1- 2 measuring spoons) of Ferrum Lek® syrup per day.

Iron-deficiency anemia

Duration of treatment is about 3-5 months. After the normalization of the hemoglobin concentration, the drug should be continued for several more weeks to replenish the iron stores in the body.

Children under the age of 1 year

The initial dose of Ferrum Lek® syrup is 2.5 ml (1/2 measuring spoon) per day. The dose is gradually increased to 5 ml (1 measuring spoon) of Ferrum Lek® syrup per day.

Children from 1 to 12 years old

5-10 ml (1-2 scoops) of Ferrum Lek® syrup per day.

Children over 12 years of age, adults and mothers breastfeeding

10-30 ml (2-6 measuring spoons) of Ferrum Lek® syrup per day.

Pregnant women

Latent iron deficiency

10 ml (2 measuring spoons) of Ferrum Lek® syrup per day.

Prevention of iron deficiency

5-10 ml (1-2 scoops) of Ferrum Lek® syrup per day

Iron-deficiency anemia

20-30 ml (4-6 measuring spoons) of Ferrum Lek syrup per day, until the hemoglobin concentration is normalized. After that, continue taking 10 ml (2 measuring spoons) of Ferrum Lek® syrup per day, at least until the end of pregnancy, to replenish iron stores in the body.

Daily doses of the drug Ferrum Lek® syrup for the prevention and treatment of iron deficiency in the body

	Iron Deficiency anemia	Latent iron deficiency	Prevention of iron deficiency
Children under 1 year old	2.5-5 ml (25-50 mg of iron)	----	----
Children from 1 to 12 years old	5-10 ml (50-100 mg of iron)	2.5-5 ml (25-50 mg of iron)	----
Children over 12 years of age, adults and nursing mothers	10-30 ml (100-300 mg of iron)	5-10 ml (50-100 mg of iron)	----
Pregnant women	20-30 ml (200-300 mg of iron)	10 ml (100 mg of iron)	5-10 ml (50-100 mg of iron)

Side effects:

Ferrum Lek® is generally well tolerated. Side effects are mainly of an easy and transient nature.

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10000,<1/1000) and very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the gastrointestinal tract rarely: pain in the abdomen, nausea, constipation, diarrhea, indigestion, vomiting, change in color of feces (due to the excretion of non-absorbed iron, has no clinical significance).

From the skin and subcutaneous tissue rarely: urticaria, rash, itching of the skin.

If any of the instructions specified in the instruction side effects are exacerbated, or you notice any other side effects not listed in the instructions - inform your doctor about it.

Overdose:

In case of an overdose of Ferrum Lek®, there were no signs of intoxication or excess iron in the body, since iron from the active substance is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.

Interaction:

Interaction with other drugs or food products is not revealed.

Simultaneous application with parenteral preparations of iron and other oral preparations of iron (III) hydroxide of polymaltozate is not recommended due to the expressedinhibiting the absorption of orally iron.

Special instructions:

Syrup Ferrum Lek® does not cause tooth enamel staining.

In cases of anemia caused by an infectious or malignant disease, iron accumulates in the reticulo-endothelial system, from which it is mobilized and utilized only after the cure of the underlying disease.

When using the preparation of Ferrum Lek®, the stool can be stained in a dark color, which does not have any clinical significance. The preparation of Ferrum Lek® does not affect the results of the test for latent blood (selective for hemoglobin); thus, it is not required to stop iron therapy.

Due to low dosage, the preparation of Ferrum Lek® for children under 1 year of age should not be used to treat latent iron deficiency.

Note for patients with diabetes mellitus: 1 ml of Ferrum Lek® syrup contains 0.04 XE.

Effect on the ability to drive transp. cf. and fur:Ferrum Lek does not affect the ability to drive a car and control mechanisms that require increased concentration of attention.

Form release / dosage:

Syrup 50 mg / 5ml.

Packaging:

Primary packaging

Lek dd Slovenia

To 100 ml of syrup in bottles of dark glass with a graduated level of 100 ml or without it, sealed with a metal screw cap with a control ring of the first opening and a polyethylene liner inside.

Sandoz Ilach Sanayi ve Tidjaret AS, Turkey

To 100 ml of syrup in bottles of dark glass with a graduated level of 100 ml or without it, sealed with a polyethylene screw cap with a control ring of the first opening and a polyethylene seal inside.

Secondary packaging

One bottle per cardboard pack together with instructions for use, a measuring spoon with ring marks in the cavity for 2.5 ml and 5 ml ("2.5 CC" and "5 CC", the maximum filling mark of 6 ml ("6 CC" ) on the handle of the spoon.

Storage conditions:

At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N012698 / 02

Date of registration:06.04.2007

The owner of the registration certificate: Lek dd Lek dd Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp18.05.2015

Illustrated instructions

Instructions

Ferrum Lek® (Ferrum Lek®)