Package leaflet: Information for the patient

Ferplex Fol 40 mg/15 ml + 0.185 mg/15 ml oral solution

Ferriprotinate + calcium folinate hydrate
Please read this leaflet carefully before taking this medicine because
it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ferplex Fol is and what it is used for
What you need to know before taking Ferplex Fol
How to take Ferplex Fol
Possible side effects
How to store Ferplex Fol
Contents of the pack and other information

1. What Ferplex Fol is and what it is used for

Ferplex Fol belongs to the therapeutic category of iron-containing medicinal products in combination with folic acid.
This medicine is used for the prevention and treatment of iron and folate deficiency states:

hypochromic anaemias (anaemia characterized by reduced haemoglobin content in red blood cells);
normochromic anaemias (anaemia characterized by normal haemoglobin concentration in red blood cells);
certain macrocytic anaemias (anaemias in which red blood cells are larger than normal);
megaloblastic anaemias of infancy (anaemias caused by deficiency of vitamin B12 or folic acid in the body) secondary to inadequate intake or absorption of iron and insufficient intake or synthesis of folates (salts of folic acid);
anaemias occurring during pregnancy, the puerperium (the period between childbirth and the resumption of normal ovarian activity, marked by the return of menstruation), and the breastfeeding period.

2. What you should know before taking Ferplex Fol

Do not take Ferplex Fol

if you are allergic to ferrous proteinate, calcium folinate, or any of the other ingredients of this medicine (listed in section 6);
if you suffer from hemosiderosis (excess iron deposited in tissues);
if you suffer from hemochromatosis (a disorder of iron metabolism leading to iron accumulation in tissues);
if you have aplastic anemia (characterized by a reduction in all three blood components: red blood cells, white blood cells, and platelets);
if you have hemolytic anemia (excessive destruction of red blood cells) or anemia due to impaired iron utilization (sideroachrestic anemia);
if you have megaloblastic anemia secondary to vitamin B_{12} deficiency (unless vitamin B_{12} is also administered);
if you suffer from chronic pancreatitis (chronic inflammation of the pancreas) or liver cirrhosis (chronic inflammation of the liver) secondary to hemochromatosis (a disorder of iron metabolism leading to iron accumulation in body tissues).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ferplex Fol.
Once the cause of iron deficiency or anemia has been identified, your doctor will recommend, alongside iron therapy, an appropriate treatment for these conditions, if available.
This medicine does not pose risks of habituation or dependence. Its administration should not exceed 6 months, unless in cases of ongoing bleeding, menorrhagia (excessive or prolonged menstruation), or pregnancy.
Exercise caution if you have milk protein intolerance, as allergic reactions may occur.
This medicine may interfere with laboratory tests for occult blood in feces.

Other medicines and Ferplex Fol
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Iron may reduce the absorption or bioavailability (the amount of medicine entering the body after administration) of:
tetracyclines (antibiotics),
bisphosphonates (medicines used to inhibit bone resorption),
quinolones (antibiotics),
penicillamine (a medicine used in rheumatoid arthritis),
thyroxine (a hormone),
levodopa and carbidopa (medicines used in the treatment of Parkinson's disease),
alpha-methyldopa (a medicine used to lower blood pressure).
Take Ferplex Fol at least 2 hours apart from these medicines.
Iron absorption may be increased by concomitant intake of more than 200 mg of ascorbic acid or reduced by concomitant administration of antacids.
Chloramphenicol (a bacteriostatic antibiotic) may delay the response to iron therapy.
Substances that bind iron (such as phosphates, phytates, and oxalates) present in vegetables, milk, coffee, and tea inhibit iron absorption. Take Ferplex Fol at least 2 hours apart from consuming these foods.
Some anticancer and antileukemic drugs (aminopterin, methotrexate, and other pteridine derivatives) act as antifolate agents (antagonists of folic acid salts). Therefore, during treatment of neoplastic diseases or leukemias with antifolate drugs, administration of Ferplex Fol, as with other folic acid or folinic acid preparations, must be carefully avoided.
Do not take this medicine simultaneously with certain antibacterial drugs (sulfonamides, trimethoprim, or other diaminobenzylpyrimidines), as their efficacy may be reduced.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
No special precautions are required during pregnancy or breastfeeding, as Ferplex Fol is particularly indicated in iron deficiency states, which may occur under these conditions.

Driving and using machines
There are no data available on the effects of this medicine on the ability to drive vehicles or operate machinery. However, such effects are unlikely.

FERPLEX FOL contains sorbitol, sodium methyl para-hydroxybenzoate, sodium propyl para-hydroxybenzoate, propylene glycol, and sodium.
This medicine contains 1400 mg of sorbitol (E-420) per single-dose container, equivalent to 93.3 mg/ml. Sorbitol is a source of fructose. If your doctor has informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance—a rare genetic disorder in which patients cannot metabolize fructose—consult your doctor before taking this medicine. Sorbitol may cause gastrointestinal disturbances and has a mild laxative effect.
FERPLEX FOL contains sodium methyl para-hydroxybenzoate and sodium propyl para-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains 61.1 mg of propylene glycol per single-dose container, equivalent to 4.1 mg/ml. If the child is less than 4 weeks old, consult your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
This medicine may contain up to 46.7 mg (2 mmol) of sodium (a main component of table salt) per single-dose container. This corresponds to 2.33% of the maximum recommended daily dietary intake for an adult.

3. How to take Ferplex Fol

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults: 1 to 2 containers per day, as prescribed by the doctor, divided into two doses, preferably taken before meals.
Use in children: Using the container, take 1.5 ml/kg/day, or as prescribed by the doctor, divided into two doses to be taken preferably before meals.
Instructions for use
Remove the over-cap and press firmly on the reservoir cap so that the powder falls into the solution. Shake until dissolved. Remove the reservoir cap and drink the solution directly from the container or diluted in still water.
Once the solution has been prepared, it is recommended to use it on the same day.
Duration of treatment: Treatment should continue until the body has replenished its normal iron stores (usually two to three months).
If you take more Ferplex Fol than you should
In case of iron salts overdose, symptoms such as epigastralgia (pain localized in the epigastrium), nausea, vomiting, diarrhoea and haematemesis (vomiting blood) may occur, often associated with drowsiness, pallor, cyanosis (bluish discoloration of the skin due to inadequate blood oxygenation), shock and even coma.
In the event of accidental ingestion or overdose of Ferplex, inform your doctor immediately or go to the nearest hospital.
Treatment must be initiated as quickly as possible and consists of administering an emetic (a medicine that induces vomiting), followed if necessary by gastric lavage, and providing appropriate supportive therapies. Administration of an iron chelator (a medicine used to remove metals accumulated in toxic concentrations from the body), such as desferrioxamine, should also be considered.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Very rarely, gastrointestinal disorders may occur:

diarrhoea,
constipation,
nausea,
epigastric pain (pain localized in the upper part of the abdomen). These adverse events occur particularly at higher doses and resolve upon discontinuation of treatment or dose reduction.

Iron-containing preparations may blacken or darken stools to a greyish colour.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ferplex Fol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The indicated expiry date applies to the product in its original, undamaged packaging and properly stored.
Store this medicine at a temperature not exceeding 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ferplex Fol contains
Solution:

The active substance is iron protoporphyrin. Each single-dose container contains 800 mg of iron protoporphyrin (equivalent to 40 mg of Fe).
The other ingredients are sorbitol E420, propylene glycol (E-1520), sodium methyl p-hydroxybenzoate (E-219), sodium propyl p-hydroxybenzoate (E-217), blackberry flavour (containing propylene glycol), sodium saccharin, sodium hydroxide, purified water.
Reservoir cap:
The active substance is calcium folinate hydrate. Each single-dose container contains 0.235 mg of calcium folinate hydrate (calculated as calcium folinate pentahydrate, equivalent to 0.185 mg of folinic acid).
The other ingredient is mannitol E421.

Description of the appearance of Ferplex Fol and contents of the pack
Ferplex Fol is a solution for oral use.
10 single-dose containers of 15 ml
20 single-dose containers of 15 ml

Marketing Authorization Holder
Italfarmaco S.p.A. - Viale Fulvio Testi, 330 - Milan

Manufacturer
Italfarmaco S.A. - Calle San Rafael, 3 - Alcobendas (Madrid)