Ferrum Lek

Leaflet attached to the packaging: patient information

Ferrum Lek, 100 mg, chewable tablets

Ferri hydroxidum polymaltosum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Ferrum Lek and what is it used for
• 2. Important information before taking Ferrum Lek
• 3. How to take Ferrum Lek
• 4. Possible side effects
• 5. How to store Ferrum Lek
• 6. Package contents and other information

1. What is Ferrum Lek and what is it used for

Iron is an essential component of red blood cells, muscles, and enzymes. Iron deficiency can cause chronic fatigue, lack of concentration, irritability, nervousness, headaches, loss of appetite, susceptibility to stress and infection, pallor, cracks in the corners of the mouth, dry skin, brittle hair and nails.
Ferrum Lek tablets contain ironin the form of a complex of iron(III) hydroxide with a carbohydrate polymer, polymaltose. Polymaltose protects the patient's digestive tract from the harmful effects of iron. It also inhibits the interaction of food with iron. The structure of the iron(III) hydroxide complex with polymaltose is similar to the structure of the naturally occurring iron-storing protein in the body, ferritin. Due to this similarity, iron penetrates the blood as a result of natural processes.
Ferrum Lek is used:

• to treat latent iron deficiency,
• to treat iron deficiency anemia (overt iron deficiency),
• to prevent iron deficiency during pregnancy.

2. Important information before taking Ferrum Lek

When not to take Ferrum Lek

Warnings and precautions

Before starting to take Ferrum Lek, the patient should discuss it with their doctor or pharmacist if they have anemia caused by infection or a malignant process.
Ferrum Lek and other iron preparations may cause dark discoloration of the stool. This symptom is not clinically significant.
During treatment with Ferrum Lek, tooth discoloration is possible. The discoloration should disappear on its own after the end of treatment; it can also be removed by using a toothpaste with abrasive properties or by undergoing professional tooth cleaning at the dentist.
Children and adolescents
Special caution should be exercised in children, as iron overdose can lead to poisoning.
Information for patients with diabetes
One tablet contains 0.04 WW (carbohydrate exchange units).

Ferrum Lek and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions have been described so far. Due to the fact that the iron in Ferrum Lek is bound in a complex, interactions with food components (e.g., oxalates [found in vegetables], tannin [found in tea], vitamins A, D, and E, and soy) or concomitantly taken medicines (e.g., antibiotics from the tetracycline group, antacids) are unlikely.
Iron treatment does not affect the result of the occult blood test, so if the doctor has prescribed such a test, it is not necessary to discontinue Ferrum Lek.
It is not recommended to take iron in other forms (e.g., injections or tablets) at the same time. The patient should inform their doctor if they are taking any other iron-containing medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
There are no available data on the use of the medicine in the first trimester of pregnancy. No serious side effects have been reported after taking Ferrum Lek syrup in therapeutic doses for the treatment of anemia during pregnancy. Animal studies have not shown any risk to the fetus and mother.
Breastfeeding
Iron penetrates into breast milk, where it occurs in the form of lactoferrin. Only a small amount of iron from the iron(III) hydroxide complex with polymaltose penetrates into breast milk.
The risk to the breastfed child is small.
Ferrum Lek can be used during pregnancy and breastfeeding only on the doctor's recommendation.

Driving and using machines

No relevant studies have been conducted, but it is unlikely that Ferrum Lek tablets will affect the ability to drive and use machines.

Ferrum Lek contains aspartame

The medicine contains 1.5 mg of aspartame (E 951) per tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.

3. How to take Ferrum Lek

This medicine should always be taken strictly according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. The dosage and duration of treatment depend on the extent of the iron deficiency. The dosage is presented below.

Method of administration

• The medicine should be taken during or immediately after a meal. The daily dose can be dividedinto separate doses or taken once.
• Ferrum Lek tablets should be chewed or swallowed whole.

Latent iron deficiency
Treatment lasts about one to two months.

Children under 12 years of age

Ferrum Lek chewable tablets should not be used due to the too small doses that need to be administered in this age group.

Children over 12 years of age, adults, and breastfeeding women

1 Ferrum Lek tablet per day.
Iron deficiency anemia (overt iron deficiency)
Treatment lasts from three to five months. The doctor may recommend longer treatment, depending on the results of blood tests.

Children under 12 years of age

Ferrum Lek chewable tablets are not intended for children under 12 years of age.

Children over 12 years of age, adults, and breastfeeding women

The usual daily dose is 1 to 3 Ferrum Lek tablets.

Pregnant women

Iron deficiency anemia (overt iron deficiency)
2 to 3 Ferrum Lek tablets per day, then 1 tablet at least until the end of pregnancy.
Latent iron deficiency and prevention of iron deficiency
1 Ferrum Lek tablet per day.

Daily doses of Ferrum Lek in the prevention and treatment of iron deficiency

Taking a higher dose of Ferrum Lek than recommended

In case of accidental ingestion of a higher dose of the medicine than recommended, the patient should contact their doctor.
No cases of poisoning or excessive iron overload caused by Ferrum Lek chewable tablets have been reported so far.

Missing a dose of Ferrum Lek

In case of a missed dose, the next dose should be taken as soon as possible after remembering, and then the treatment should be continued according to the doctor's recommendation.
A double dose should not be taken to make up for the missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ferrum Lek can cause side effects, although not everybody gets them.
Very commonside effects (may occur more often than in 1 in 10 people):

• change in stool color

Commonside effects (may occur less often than in 1 in 10 people):

• diarrhea
• nausea
• abdominal pain (also indigestion, feeling of discomfort in the upper abdomen, feeling of bloating in the abdominal cavity)
• constipation

Uncommonside effects (may occur less often than in 1 in 100 people):

• vomiting
• tooth discoloration
• gastritis
• itching
• rash (also maculopapular rash, vesicular rash)
• hives
• flush
• headache

Rareside effects (may occur less often than in 1 in 100 people):

• muscle cramps, muscle pain

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Ferrum Lek

The medicine should be stored out of sight and reach of children!

Store in a temperature below 25°C.
Store in the original packaging.
Do not use the medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ferrum Lek contains

The active substance is iron in the form of a complex of iron(III) hydroxide with polymaltose. 1 chewable tablet contains 100 mg of iron in the form of a complex of iron(III) hydroxide with polymaltose.
The other ingredients are: aspartame, macrogol 6000, dextrates, talc, chocolate flavor.

What Ferrum Lek looks like and what the package contains

Soft foil blisters or OPA/Aluminum/PVC/Aluminum blisters, in a cardboard box, containing 30 chewable tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceutical d.d.
Trimlini 2d
9220 Lendava, Slovenia
For more detailed information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:02/2024
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