Feroplex

Package leaflet: Information for the patient

Feroplex, 40 mg/15 ml, oral solution
Ferri proteinatosuccinas
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Table of contents

1. What is Feroplex and what is it used for
2. Important information before taking Feroplex
3. How to take Feroplex
4. Possible side effects
5. How to store Feroplex
6. Contents of the pack and other information

1. What is Feroplex and what is it used for

Feroplex contains trivalent iron in a protein-bound form. Iron protein succinate is characterized by variable solubility depending on the acidity of the gastrointestinal tract. In the acidic environment of gastric juice (pH below 4.0), iron remains bound, which protects the stomach from irritation.
In the duodenum, the protein component is digested by pancreatic juice, releasing iron and enabling its absorption in an amount dependent on the body's requirements.
The iron contained in Feroplex is absorbed relatively quickly and reaches adequate serum concentration equally fast.
Gradual absorption and prolonged presence of iron in serum create favorable conditions for its storage in tissues.
Indications
Treatment of iron deficiency and iron deficiency anemia:
in adults;
following chronic blood loss;
during pregnancy and breastfeeding.
The medicine may also be used in children above 1 year of age.

2. Information before using Feroplex

When not to use Feroplex:

• if the patient is allergic to iron protein succinylate or any of the other ingredients of this medicine (listed in section 6),
• if the patient has hemosiderosis or hemochromatosis (excessive iron accumulation in the body),
• if the patient has aplastic, hemolytic or sideroachrestic anemia (disorders in the utilization of absorbed iron),
• if the patient has chronic pancreatitis caused by hemochromatosis,
• if the patient has liver cirrhosis caused by hemochromatosis.

Warnings and precautions
Before starting treatment with Feroplex, please discuss this with your doctor, pharmacist or
nurse.
Before initiating anemia treatment, the doctor should determine its underlying cause. Iron preparations
should not be used for longer than 6 months, except in cases of chronic bleeding, hemorrhagic
(heavy) menstruation or deficiencies during pregnancy. During treatment, your doctor will recommend
periodic monitoring of hemoglobin and iron levels in the blood.

Feroplex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient plans to take.
If a doctor prescribes a new medicine, they should also be informed about the use of Feroplex.
Iron compounds may reduce the absorption of tetracyclines and quinolones (antibacterial antibiotics),
bisphosphonates (medicines used, among others, in osteoporosis), penicillamine, thyroxine, and
medicines used in Parkinson's disease—levodopa, carbidopa, methyldopa. Feroplex should be
administered at least two hours after any of these medicines have been taken.
Iron absorption may be increased when ascorbic acid (vitamin C) is administered in doses exceeding
200 mg, or decreased when taken with medicines that reduce gastric acid secretion.
Patients receiving the antibiotic chloramphenicol concurrently may respond with delay to iron therapy.

Feroplex with food, drink and alcohol
Feroplex should not be mixed with other medicinal products or beverages, except plain water.
Certain components present in vegetables, milk, coffee and tea inhibit iron absorption.
Feroplex should be administered at least two hours after consuming any of these products.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
The use of Feroplex during this period does not require special precautions. Like other iron
preparations, Feroplex is recommended for use in pregnant or breastfeeding women, in whom iron
deficiency commonly occurs.

Driving and operating machinery
There is no information regarding negative effects of Feroplex on driving or operating machinery.
Any such effect is, however, unlikely.

Feroplex contains propylene glycol, sodium methyl parahydroxybenzoate, sodium propyl
parahydroxybenzoate, sorbitol and sodium.
This medicine contains 61.1 mg of propylene glycol per vial, equivalent to 4.1 mg/ml.
This medicine contains sodium propyl parahydroxybenzoate and sodium methyl parahydroxybenzoate,
which may cause allergic reactions (including delayed-type reactions).
This medicine contains 1400 mg of sorbitol per vial, equivalent to 93.3 mg/ml.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the
patient (or their child), or if hereditary fructose intolerance—a rare genetic disorder in which the
patient's body cannot break down fructose—has been diagnosed, the patient should consult a doctor
before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
The medicine may contain up to 46.7 mg (2 mmol) of sodium—the main component of table salt—per
vial.
This corresponds to 2.33% of the maximum recommended daily dietary sodium intake for adults.
Inform your doctor if the patient is on a sodium-controlled diet.

Feroplex contains cow's milk proteins, therefore particular caution should be exercised in
individuals allergic to milk.

3. How to use Feroplex

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Dosage
Adults:
The contents of 1 to 2 vials per day (corresponding to 40 to 80 mg of iron per day) in two divided
doses (each \/ vial or one full vial), preferably before meals or as directed by the physician.
The medicine can be taken directly from the vial or dissolved in water.
Children (over 1 year of age):
As directed by a physician, a dose of 1.5 ml/kg/day (corresponding to 4 mg/kg/day of iron) should
be administered in two divided doses, preferably before meals. The daily dose of 40 mg Fe (1 vial)
should not be exceeded.
Duration of treatment
As directed by a physician.
Treatment should be continued until tissue iron stores are replenished (usually 2–3 months).
Maximum daily dose
In clinical studies, doses of 1600 mg of iron protein succinate per day (corresponding to
80 mg of iron per day) were used in adults. There are no clinical data on the efficacy and safety
of higher doses.
Taking more Feroplex than recommended
If more Feroplex has been taken than recommended, consult a physician or pharmacist
immediately, taking the medicine packaging along.
After ingestion of very large doses of iron salts, symptoms such as epigastric pain, nausea,
vomiting, diarrhea, and bloody vomiting may occur, often accompanied by drowsiness, pallor,
cyanosis, shock, and coma.
In case of Feroplex overdose, the physician may induce vomiting and, if necessary, perform gastric
lavage and initiate appropriate supportive treatment. If required, iron-chelating agents such as
deferoxamine may be administered.
Missing a dose of Feroplex
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Feroplex treatment
If you have any further doubts regarding the use of this medicine, consult your physician,
pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below (or any other symptoms not listed in this leaflet) cause concern, the patient should contact their doctor or pharmacist.

Very rare (occurring in fewer than 1 in 10,000 patients):
gastrointestinal disorders such as nausea, epigastric pain, diarrhoea, constipation.

Adverse effects occur only after administration of high doses and resolve after dose reduction or discontinuation of the medicinal product.

Iron compounds may interfere with laboratory tests for occult blood in faeces.

During treatment with iron preparations, darkening of the stool may occur.

Reporting of adverse effects

If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Feroplex

Keep the medicine out of sight and reach of children.
Store below 30°C.
After first opening the immediate packaging (vial), Feroplex remains stable for 4 days under the same storage conditions as the medicine in the undamaged packaging.
Do not use this medicine after the expiry date stated on the packaging. 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. This will help protect the environment.

6. Contents of the pack and other information

What Feroplex contains

• The active substance is iron protein succinylate. Each 15 ml vial contains 40 mg of iron ions (Fe) in the form of 800 mg of iron protein succinylate. The other ingredients are: sorbitol, propylene glycol, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, raspberry flavour (containing: propylene glycol, vanillin, benzaldehyde, isoamyl acetate, ethyl acetate, ethyl laurate, gamma-decalactone, eugenol), sodium saccharin, sodium hydroxide, purified water.

What Feroplex looks like and contents of the pack
A clear, brownish solution with a pleasant, characteristic odour.
Pack contains 20 vials.
Each vial contains 15 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Italfarmaco S.p.A.,
Viale Fulvio Testi 330,
20126 Milan, Italy
Manufacturer
Italfarmaco S.A.,
San Rafael 3,
28108 Alcobendas (Madrid), Spain
Lacer S.A.
C/ Boters, 5, Parc Tecnològic del Vallès
08290 Cerdanyola del Vallès – Barcelona
Spain
For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Berlin-Chemie/Menarini Polska Sp. z o.o.
ul. Zygmunta Słomińskiego 4
00-204 Warsaw
Tel.: (22) 566 21 00
Fax: (22) 566 21 01