Feroplex

Leaflet attached to the packaging: patient information

Feroplex, 40 mg/15 ml, oral solution

Ferri proteinatosuccinas

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, pharmacist, or nurse.
• 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 any not listed in this leaflet, please tell your doctor, pharmacist, or nurse.

Table of contents of the leaflet

• 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 packaging and other information

1. What is Feroplex and what is it used for

Feroplex contains trivalent iron in the form of a protein complex. Iron protein succinylate is characterized by variable solubility depending on the acidity of the gastrointestinal tract. In an acidic environment of gastric juice (pH below 4.0), iron remains bound, protecting the stomach from irritation. In the duodenum environment, the protein fragment is digested by pancreatic juice, releasing iron and allowing it to be absorbed in an amount dependent on the body's needs. The iron in Feroplex is absorbed fairly quickly and reaches the proper concentration in serum fairly quickly. Gradual absorption and prolonged presence of iron in the serum create favorable conditions for its storage in tissues.

Indications for use

Treatment of iron deficiency and iron deficiency anemia: in adults; due to chronic blood loss; during pregnancy and breastfeeding. The medicine can also be used in children over 1 year of age.

2. Important information before taking Feroplex

When not to take Feroplex:

Warnings and precautions

Before starting treatment with Feroplex, discuss it with your doctor, pharmacist, or nurse. Before starting treatment for anemia, the doctor should determine its cause. Iron preparations should not be used for more than 6 months, except in cases of chronic bleeding, heavy menstrual bleeding, or deficiencies during pregnancy. During treatment, the doctor recommends periodic monitoring of hemoglobin and iron levels in the blood.

Feroplex and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take. If your doctor prescribes you a new medicine, they should also be informed about your 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, carbodopa, methyldopa. Feroplex should be administered at least two hours after taking any of these medicines. Iron absorption may increase during administration of ascorbic acid (vitamin C) in a dose above 200 mg, or decrease during administration with medicines that reduce gastric juice acidity.

Feroplex with food, drink, and alcohol

Feroplex should not be mixed with other medicines or beverages, except for plain water. Some ingredients found in vegetables, milk, coffee, and tea may inhibit iron absorption. Feroplex should be administered at least two hours after consuming any of these products.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking 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 often occurs.

Driving and using machines

There is no information on the negative impact of Feroplex on driving and using machines. Any impact is unlikely.

Feroplex contains propylene glycol, methyl parahydroxybenzoate sodium, propyl parahydroxybenzoate sodium, sorbitol, and sodium.

This medicine contains 61.1 mg of propylene glycol in each vial, which corresponds to 4.1 mg/ml. This medicine contains propyl parahydroxybenzoate sodium and methyl parahydroxybenzoate sodium, which may cause allergic reactions (possible late reactions). This medicine contains 1400 mg of sorbitol in each vial, which corresponds to 93.3 mg/ml. 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 patient's body does not break down fructose, you should consult your doctor before taking the medicine or giving it to your 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 common salt, in each vial. This corresponds to 2.33% of the maximum recommended daily sodium intake in the diet for adults. You should inform your doctor if you are on a sodium-controlled diet. Feroplex contains cow's milk proteins, so special precautions should be taken in people allergic to milk.

3. How to take Feroplex

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, ask your doctor 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 doses (each 1/2 vial or 1 vial), preferably before meals or as directed by your doctor. The medicine can be taken directly from the vial or after dissolving in water. Children (over 1 year of age):According to the doctor's recommendations, 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. Do not exceed the daily dose of 40 mg of Fe (1 vial). Duration of treatment According to the doctor's recommendations. Treatment should be continued until tissue iron reserves are replenished (usually 2-3 months). Maximum daily dose In clinical trials, doses of 1600 mg of iron protein succinylate 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 using higher doses.

Taking more than the recommended dose of Feroplex

If you have taken more than the recommended dose of the medicine, seek medical attention immediately, taking the packaging with you. After taking very large doses of iron salts, the following may occur: abdominal pain, nausea, vomiting, diarrhea, bloody vomiting, which is often accompanied by drowsiness, pallor, cyanosis, shock, and coma. In case of overdose, the doctor may induce vomiting and, if necessary, perform gastric lavage and initiate appropriate supportive treatment. If necessary, iron-binding agents such as deferoxamine can 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 treatment with Feroplex

If you have any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Feroplex can cause side effects, although not everybody gets them. If any of the following side effects (or any other effects not mentioned in this leaflet) are a cause for concern, you should consult your doctor or pharmacist. Very rare (less than 1 in 10,000 patients): gastrointestinal disorders such as nausea, abdominal pain, diarrhea, constipation. Side effects occur only after taking large doses and disappear after reducing the dose or discontinuing the preparation. Iron compounds may interfere with laboratory tests for the presence of hidden blood in the stool. During treatment with iron preparations, the stool may become dark.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Feroplex

Keep the medicine out of the sight and reach of children. Store in a temperature below 30°C. After the first opening of the immediate packaging (vial), Feroplex retains its stability for 4 days under the same storage conditions as the unopened medicine. Do not use this 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 containers. Ask your 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 Feroplex contains

• The active substance of the medicine is iron protein succinylate. One 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, methyl parahydroxybenzoate sodium, propyl parahydroxybenzoate sodium, blackberry flavor (composition: propylene glycol, vanillin, benzaldehyde, isoamyl acetate, ethyl acetate, ethyl laurate, gamma-decalactone, eugenol), sodium saccharin, sodium hydroxide, purified water.

What Feroplex looks like and what the packaging contains

A clear, brownish solution with a pleasant, characteristic odor. The packaging contains 20 vials. Each vial contains 15 ml.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorization 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

Date of the last update of the leaflet: