Ferrum Lek

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Ferrum Lek (Ferrum Lek 10 mg/ml), 50 mg iron(III)/5 ml, syrup

Ferri hydroxidum polymaltosum
Ferrum Lek and Ferrum Lek 10 mg/ml are different trade names for the same drug.

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a 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 tell 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. Contents of the packaging 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.
The Ferrum Lek syrup contains ironin the form of an iron(III) hydroxide complex 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. Thanks 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

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has been found to have excessive iron stores in the body (e.g., hemochromatosis, hemosiderosis);
• if the patient has disorders of iron incorporation into the hemoglobin structure (e.g., anemia, lead poisoning, sideroblastic anemia, thalassemia);
• if the patient has anemia that is not caused by iron deficiency (e.g., hemolytic anemia, megaloblastic anemia due to vitamin B deficiency).

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 tumor.
Ferrum Lek and other iron-containing products may cause dark discoloration of the stool.
This symptom has no clinical significance.
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 teeth cleaning at the dentist.
Children and adolescents
Special caution should be exercised in children, as iron overdose in them can lead to poisoning.

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.
Treatment with iron 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 Ferrum Lek and 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 adverse reactions have been reported after the use of Ferrum Lek syrup in therapeutic doses in 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 syrup will affect the ability to drive and use machines.
Ferrum Lek contains sucrose, sorbitol, alcohol (ethanol), parahydroxybenzoates, propylene glycol, and sodium

Sucrose

Ferrum Lek syrup contains 1 g of sucrose in every 5 ml (1 measuring spoon). This should be taken into account in patients with diabetes.
If the patient has previously been found to have intolerance to some sugars, the patient should consult their doctor before taking the medicine.

Sorbitol

Ferrum Lek syrup contains 2 g of sorbitol in every 5 ml (1 measuring spoon). Sorbitol is a source of fructose. If the patient (or their child) has previously been found to have intolerance to some sugars or has been found to have hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine or giving it to their child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Etanol

Ferrum Lek syrup contains 16.25 mg of alcohol (ethanol) in every 5 ml (1 measuring spoon). The amount of alcohol in 5 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)

The medicine may cause allergic reactions (possible late-type reactions).

Propylene glycol

The medicine contains 1.5 mg of propylene glycol in every 5 ml (1 measuring spoon). Before administering the medicine to a child under 4 weeks of age, the patient should consult their doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of syrup (1 measuring spoon), which means the medicine is considered "sodium-free".

3. How to take Ferrum Lek

This medicine should always be taken 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 syrup can be mixed with fruit or vegetable juice or added to the food given to the child in a bottle. A slight change in the color of the food or drink does not affect the taste or action of the medicine.
• The dose of the syrup should be measured with the measuring spoonattached to the packaging. The spoon has two lines indicating a volume of 2.5 ml and 5 ml. The volume of a full measuring spoon is 6 ml.

Latent iron deficiency
Treatment lasts about one to two months.

Infants up to 1 year of age

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

Children from 1 year to 12 years of age

From 2.5 to 5 ml (from 1/2 to 1 measuring spoon) of Ferrum Lek syrup per day.

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

From 5 to 10 ml (from 1 to 2 measuring spoons) of Ferrum Lek syrup 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.

Infants up to 1 year of age

The initial dose of Ferrum Lek syrup is 2.5 ml (1/2 measuring spoon) per day. Then, the doctor may gradually increase the dose to 5 ml (1 measuring spoon) per day.

Children from 1 year to 12 years of age

From 5 to 10 ml (from 1 to 2 measuring spoons) of Ferrum Lek syrup per day.

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

The usual daily dose is from 10 to 30 ml (from 2 to 6 measuring spoons).

Pregnant women

Latent iron deficiency and prevention of iron deficiency
From 5 to 10 ml (from 1 to 2 measuring spoons) per day.
Iron deficiency anemia (overt iron deficiency)
From 20 to 30 ml (from 4 to 6 measuring spoons) of Ferrum Lek syrup per day, then 10 ml (2 measuring spoons) at least until the end of pregnancy.

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

Ferrum Lek syrup should not be used in the indications marked with a minus sign (-) in the table due to the too small volumes of the medicine (doses) necessary for administration to the patient.

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 syrup 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 medicine 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 related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, abdominal distension)
• constipation

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

• vomiting
• tooth discoloration
• gastritis
• itching
• rash (also maculopapular rash, vesicular rash)
• urticaria
• 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 this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of 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.
By reporting side effects, more information can be collected 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 30°C.
Shelf life after first opening the bottle: 2 months.
Do not use the medicine after the expiry date stated on the packaging. 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. Contents of the packaging and other information

What Ferrum Lek contains

The active substance is iron(III) in the form of an iron(III) hydroxide complex with polymaltose.
1 ml of the syrup contains 10 mg of iron(III) in the form of an iron(III) hydroxide complex with polymaltose.
5 ml (1 measuring spoon) of the syrup contains: 50 mg of iron(III) in the form of an iron(III) hydroxide complex with polymaltose.
The other ingredients are: sucrose, sorbitol, 70% solution, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), ethanol 96%, vanilla flavor (contains propylene glycol (E 1520)), purified water, sodium hydroxide.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

Sandoz d.d.
Verovškova 57
SI-1000 Ljubljana
Slovenia

Manufacturer:

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:00-0561

Parallel import authorization number: 132/25

Date of approval of the leaflet: 08.04.2025

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