Package leaflet: Information for the patient

Ferplex 60 mg/22.5 ml oral solution, mg granules for oral solution, mg tablets

Ferriprotinate
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 may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ferplex 60 is and what it is used for
What you need to know before taking Ferplex 60
How to take Ferplex 60
Possible side effects
How to store Ferplex 60
Contents of the pack and other information

1. What Ferplex 60 is and what it is used for

Ferplex contains the active substance ferriprotinato, which belongs to the therapeutic category
of oral trivalent iron antianaemic agents.
This medicine is used to treat absolute or relative iron deficiency states: latent or manifest
sideropenic anaemias (anaemia caused by lack of iron in the body) in children and adults,
due to inadequate intake or inadequate absorption of iron, or resulting from chronic haemorrhages,
infectious diseases, pregnancy, or breastfeeding.

2. What you should know before taking Ferplex 60

Do not take Ferplex 60

if you are allergic to ferrous protoporphyrin or to any of the other ingredients of this medicine (listed in section 6);
if you have haemosiderosis (excess iron deposited in tissues);
if you have haemochromatosis (a disorder of iron metabolism leading to iron accumulation in tissues);
if you have aplastic anaemia (characterized by a reduction in all three blood components: red blood cells, white blood cells and platelets);
if you have haemolytic anaemia (excessive destruction of red blood cells);
if you have sideroachrestic anaemia (due to defective iron utilization);
if you suffer from chronic pancreatitis (chronic inflammation of the pancreas) secondary to haemochromatosis;
if you suffer from hepatic cirrhosis (chronic liver inflammation) secondary to haemochromatosis.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ferplex 60.
Once the cause of iron deficiency or anaemia has been identified, your doctor will advise you on appropriate treatment for these conditions, in addition to iron therapy, if available.
Exercise particular caution when using Ferplex 60 if you have hepatic insufficiency (reduced liver function). The liver is one of the major sites of iron storage; in case of hepatic insufficiency (reduced liver function), increased iron accumulation may occur.
This medicine does not pose any risk of habituation or dependence. Its administration should not exceed 6 months unless you have ongoing bleeding, menorrhagia (excessive or prolonged menstruation), or are pregnant.
Be cautious if you have milk protein intolerance, as allergic reactions may occur.

Other medicines and Ferplex 60
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Iron may reduce the absorption or bioavailability (the amount of medicine that enters the body after administration) of:
tetracyclines (medicines belonging to the antibiotic class),
bisphosphonates (medicines used to inhibit bone resorption),
quinolones (medicines belonging to the antibiotic class),
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 60 at least 2 hours apart from these medicines.
Iron absorption may be increased by concomitant administration of more than 200 mg of ascorbic acid, or reduced by concomitant intake of antacid medicines.
Chloramphenicol (a bacteriostatic antibiotic) may delay the response to iron therapy.
Substances that bind to iron (such as phosphates, phytates and oxalates) present in vegetables, milk, coffee or tea may inhibit iron absorption. Take Ferplex 60 at least 2 hours apart from consuming these foods.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
There are no special precautions required during pregnancy or breastfeeding, as Ferplex 60 is particularly indicated for iron deficiency states, which may occur under these conditions.

Driving and using machines
Ferplex 60 does not affect the ability to drive vehicles or operate machinery.

Ferplex 60 mg/22.5 ml oral solution (single-dose container) contains sorbitol, sodium, methyl hydroxybenzoate and propyl hydroxybenzoate
Ferplex 60 contains sorbitol. If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine.
Ferplex 60 contains 2.85 mmol of sodium per dose. This should be taken into account in patients with impaired renal function or those on a low-sodium diet.
Ferplex 60 contains E218 sodium methyl hydroxybenzoate and E216 sodium propyl hydroxybenzoate, which may cause allergic reactions (including delayed ones).

Ferplex 60 mg granules for oral solution (sachet) contains sorbitol, lactose, methyl hydroxybenzoate and propyl hydroxybenzoate
Ferplex 60 contains sorbitol and lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine.
Ferplex 60 contains E218 methyl hydroxybenzoate and E216 propyl hydroxybenzoate, which may cause allergic reactions (including delayed ones).

Ferplex 60 mg tablets contain methyl hydroxybenzoate and propyl hydroxybenzoate
Ferplex 60 contains E218 methyl hydroxybenzoate and E216 propyl hydroxybenzoate, which may cause allergic reactions (including delayed ones).

3. How to take Ferplex 60

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Ferplex 60 mg/22.5 ml oral solution (single-dose containers)
Adults: 2 containers per day (equivalent to 120 mg of Fe 3+), divided into two administrations,
before meals.
Use in children: 1 container per day (equivalent to 60 mg of Fe 3+) before meals for body weight
below 40 kg;
2 containers per day (equivalent to 120 mg of Fe 3+) for body weight
above 40 kg, in two administrations.
Ferplex 60 mg granules for oral solution (sachets)
Adults: 2 sachets per day (equivalent to 120 mg of Fe 3+), divided into two administrations, before
meals.
Ferplex 60 mg tablets
Adults: 2 tablets per day (equivalent to 120 mg of Fe 3+), divided into two administrations, before
meals.
Duration of treatment: Treatment should continue until the body has restored its normal iron stores (usually two to three months).
Maximum daily dose: There is no information available regarding the use of this medicine at doses higher than those recommended.
If you take more Ferplex 60 than you should
In case of iron salts overdose, epigastralgia (pain localized in the epigastrium, an abdominal region), nausea, vomiting, diarrhoea and haematemesis (vomiting of blood) may occur, often associated with drowsiness, pallor, cyanosis (bluish discoloration of the skin due to inadequate blood oxygenation), shock, and even coma.
In case of accidental ingestion/overdose of Ferplex 60, contact your doctor immediately or go to the nearest hospital.
Treatment must be initiated as soon as possible and consists of administering an emetic (a medicine that induces vomiting), followed if necessary by gastric lavage, and providing necessary supportive therapies. Administration of an iron chelator, such as deferoxamine, should also be considered.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Very rarely, gastrointestinal disorders may occur, such as:

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

Iron-containing preparations may turn stools black or dark grey.
Following the instructions provided in this leaflet reduces the risk of adverse effects.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Ferplex 60

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp.. The expiry date refers to the last day of that month.
The stated expiry date applies to the product in its original, unopened packaging and properly stored.
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 60 contains
Ferplex 60 mg/22.5 ml oral solution (single-dose containers)

The active substance is ferriprotinate. Each single-dose container containing 22.5 ml of oral solution contains 1200 mg of ferriprotinate (equivalent to 60 mg of Fe).
The other components are: sorbitol, propylene glycol, E218 sodium methylhydroxybenzoate, E216 sodium propylhydroxybenzoate, Morella flavour, sodium saccharin, sodium hydroxide, purified water q.s. to 22.5 ml.

Ferplex 60 mg granules for oral solution (sachets)

The active substance is ferriprotinate. Each 7.5 g sachet contains 1200 mg of ferriprotinate (equivalent to 60 mg of Fe).
The other components are: sorbitol, lactose, sodium lauryl sulfate, E218 methylhydroxybenzoate, E216 propylhydroxybenzoate, Caramel Mou flavour, Morella flavour, sodium saccharin.

Ferplex 60 mg tablets

The active substance is ferriprotinate. Each tablet contains 1200 mg of ferriprotinate (equivalent to 60 mg of Fe).
The other components are: glycerol palmitostearate, sodium carboxymethylcellulose, E218 methylhydroxybenzoate, E216 propylhydroxybenzoate.

Description of the appearance of Ferplex 60 and contents of the pack
Ferplex 60 mg/22.5 ml oral solution
10 single-dose containers of oral solution containing 1200 mg (equivalent to 60 mg of Fe).
Ferplex 60 mg granules for oral solution
10 single-dose sachets for oral use containing 1200 mg (equivalent to 60 mg of Fe).
Ferplex 60 mg tablets
10 oral tablets containing 1200 mg (equivalent to 60 mg of Fe).

Marketing Authorization Holder
Italfarmaco s.p.a., Viale F. Testi, 330, 20126 Milano
Manufacturer
Ferplex 60 mg/22.5 ml oral solution
Italfarmaco s.a., Calle San Rafael, 3 - Alcobendas (Madrid)
Ferplex 60 mg granules for oral solution and tablets
Officina Farmaceutica Italfarmaco S.p.A., v.le F. Testi, 330 - Milano