Ferrum lek

Package leaflet: Information for the user

Ferrum Lek, 100 mg, chewable tablets
Ferri hydroxidum polymaltosum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

Iron is an important component of red blood cells, muscles, and enzymes. Iron deficiency may cause chronic fatigue, lack of concentration, irritability, nervousness, headaches, loss of appetite, increased susceptibility to stress and infections, pallor, cracks at the corners of the mouth, dry skin, brittle hair and nails.
Ferrum Lek tablets contain iron in the form of iron(III) hydroxide complexed with a carbohydrate polymer, polymaltose. Polymaltose protects the patient's gastrointestinal tract from the harmful effects of iron. It also reduces interference from food on iron absorption. The structure of the iron(III) hydroxide-polymaltose complex resembles that of the naturally occurring iron-storage protein in the body, ferritin. Due to this similarity, iron is transferred into the bloodstream through natural physiological processes.
Ferrum Lek is used:

• in the treatment of latent iron deficiency,
• in the treatment of iron deficiency anaemia (overt iron deficiency),
• in the prevention of iron deficiency during pregnancy.

2. Important information before using Ferrum Lek

When not to use Ferrum Lek

• if the patient is allergic to the active substance or to any of the other ingredients of the medicine (listed in section 6);
• if the patient has excessive iron stores in the body (e.g. haemochromatosis, haemosiderosis);
• if the patient has disorders of iron incorporation into haemoglobin structure (e.g. anaemia, lead poisoning-induced anaemia, sideroblastic anaemia, thalassaemia);
• if the patient has anaemia not caused by iron deficiency (e.g. haemolytic anaemia, megaloblastic anaemia due to vitamin B deficiency).

Warnings and precautions
Before starting to take Ferrum Lek, consult a doctor or pharmacist
if the patient has anaemia caused by infection or a tumour process.
Ferrum Lek and other iron preparations may cause dark discolouration of the stool. This effect has no clinical significance.
During treatment with Ferrum Lek, tooth discolouration may occur. Discolouration should resolve spontaneously after completion of treatment; it can also be removed using an abrasive toothpaste or by undergoing professional dental cleaning.
Children and adolescents
Particular caution should be exercised in children, as iron overdose may lead to poisoning.
Information for diabetic patients
One tablet contains 0.04 carbohydrate exchange units (CEU).
Ferrum Lek with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
No interactions have been reported so far. Due to the fact that iron in Ferrum Lek is bound in a complex, interactions with food components (including oxalates [present in vegetables], tannins [present in tea], vitamins A, D and E, and soy) or concomitantly administered medicines (such as tetracyclines used to treat infections, or antacids) are unlikely.
Iron treatment does not affect the result of the occult blood test; therefore, if a doctor has recommended such a test, it is not necessary to discontinue Ferrum Lek.
Do not use iron in other forms simultaneously (e.g. injections or tablets). Inform the doctor if the patient is taking any other iron-containing medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
There are no available data on the use of the medicine during the first trimester of pregnancy. No severe adverse effects have been observed after administration of Ferrum Lek syrup in therapeutic doses for the treatment of anaemia during pregnancy. Animal studies have not shown any risk to the foetus or mother.
Breastfeeding
Iron passes into breast milk, where it occurs in the form of lactoferrin. Only a small portion of iron from the iron hydroxide-polymaltose complex passes into breast milk. The risk to the breastfed infant is low.
Ferrum Lek may be used during pregnancy and breastfeeding only on a doctor's advice.
Driving and operating machinery
Appropriate studies have not been conducted, but it is unlikely that Ferrum Lek tablets affect the ability to drive or operate machinery.
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 impaired excretion.

3. How to take Ferrum Lek

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. The dosage and duration of treatment depend on the extent of iron deficiency. Dosage recommendations are given below.

Method of administration

• Take the medicine during or immediately after a meal. The daily dose may be divided into separate doses or taken as a single dose.
• Ferrum Lek tablets should be chewed or swallowed whole.

Latent iron deficiency
Treatment lasts approximately one to two months.

Children under 12 years of age
Ferrum Lek chewable tablets are not recommended for children under 12 years of age due to the relatively high dosage, which is inappropriate for this age group.

Children over 12 years of age, adults, and breastfeeding women
1 Ferrum Lek tablet per day.

Iron deficiency anaemia (overt iron deficiency)
Treatment lasts from three to five months. Your doctor may recommend longer treatment depending on blood test results.

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 anaemia (overt iron deficiency)
2 to 3 Ferrum Lek tablets per day, followed by 1 tablet daily until at least the end of pregnancy.
Latent iron deficiency and prevention of iron deficiency
1 Ferrum Lek tablet per day.

Daily dosages of Ferrum Lek for prevention and treatment of iron deficiency

Taking a higher than recommended dose of Ferrum Lek
If you accidentally take more of the medicine than recommended, you should contact your doctor.
Cases of poisoning or iron overload caused by Ferrum Lek chewable tablets have not been reported to date.

Missing a dose of Ferrum Lek
If you miss a dose, take the next dose as soon as you remember, then continue taking the medicine as advised by your doctor.
Do not take a double dose to make up for a missed dose.

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Very common adverse reactions (may occur in more than 1 in 10 people):

• Change in stool colour

Common adverse reactions (may occur in less than 1 in 10 people):

• Diarrhoea
• Nausea
• Abdominal pain (including dyspepsia, epigastric discomfort, bloating)
• Constipation

Uncommon adverse reactions (may occur in less than 1 in 100 people):

• Vomiting
• Discoloration of teeth
• Gastritis
• Itching
• Rash (including macular rash, vesicular rash)
• Urticaria
• Erythema
• Headache

Rare adverse reactions (may occur in less than 1 in 1000 people):

• Muscle cramps, muscle pain

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ferrum Lek

Keep this medicine out of sight and reach of children!
Store below 25 °C.
Keep in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 iron(III) hydroxide complexed with polymaltose. One chewable tablet contains 100 mg of iron as iron(III) hydroxide complex with polymaltose.
The other ingredients are: aspartame, macrogol 6000, dextrates, talc, chocolate flavouring.

What Ferrum Lek looks like and contents of the pack
Soft blisters made of aluminium foil coated with PE or OPA/Aluminium/PVC/Aluminium blisters, in a cardboard box containing 30 chewable tablets.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2d
9220 Lendava, Slovenia

For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00