Ferrum Lek

Package Leaflet: Information for the Patient

Ferrum Lek, 50 mg/5 ml, Syrup

Ferri hydroxidum polymaltosum

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack 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 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 protein that stores iron 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

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have been diagnosed with excessive iron stores in the body (e.g., hemochromatosis, hemosiderosis);
• if you have disorders of iron incorporation into the hemoglobin structure (e.g., anemia, lead poisoning-induced anemia, sideroblastic anemia, thalassemia);
• if you have 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, discuss it with your doctor or pharmacist if you 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
Particular caution should be exercised in children, as iron overdose can lead to poisoning.

Ferrum Lek and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
No interactions have been described so far. Due to the fact that 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 your doctor has prescribed such a test, it is not necessary to discontinue Ferrum Lek.
Do not take iron in other forms (e.g., injections or tablets) at the same time. Inform your doctor if you are taking Ferrum Lek and any other iron-containing medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your 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 advice of a doctor.

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 you have previously been diagnosed with intolerance to some sugars, you should contact your 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 you have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the body does not break down fructose, you should contact your doctor before taking the medicine or giving it to your child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Ethanol

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 cause 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 7.5 mg of propylene glycol in every 5 ml (1 measuring spoon). Before administering the medicine to a child under 4 weeks of age, consult your 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 exactly as advised by your doctor. If you are unsure, consult your doctor or pharmacist. The dosage and duration of treatment depend on the extent of 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 food given to the child from a bottle. A slight change in the color of 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 package. 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 for about one to two months.

Infants up to 1 year of age

Do not use Ferrum Lek syrup 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. Your 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, your 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 indications marked with a (-) sign in the table due to the too small volumes of the medicine (doses) required 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, consult your 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, take the next dose as soon as you remember, and then continue taking the medicine as advised by your doctor.
Do not take a double dose to make up for the missed dose.
If you have any further doubts about taking the medicine, consult your 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 affect more than 1 in 10 people):

• change in stool color

Commonside effects (may affect up to 1 in 10 people):

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

Uncommonside effects (may affect up to 1 in 100 people):

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

Rareside effects (may affect up to 1 in 100 people):

• muscle cramps, muscle pain

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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 01, fax: + 48 22 49 21 09, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ferrum Lek

Keep the medicine out of the sight and reach of children!

Store in a temperature below 25 ° C.
Shelf life after opening the bottle: 2 months.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the package after: EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 ml of the syrup contains 10 mg of iron in the form of a complex of iron (III) hydroxide with polymaltose .
5 ml (1 measuring spoon) of the syrup contains: 50 mg of iron in the form of a complex of iron (III) hydroxide with polymaltose.
The other ingredients are: sucrose, sorbitol solution 70%, methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol 96%, vanilla flavor (does not contain lactose), purified water, sodium hydroxide.

What Ferrum Lek looks like and contents of the pack

Brown glass bottle with a capacity of 125 ml, with a graduation mark at the 100 ml level, with an aluminum or polyethylene (HDPE) cap and a measuring spoon, in a cardboard box, containing 100 ml of syrup (brown, clear solution).

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer/importer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
To obtain 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:

Sandoz logo