Patient Information Leaflet: Instructions for the Patient

FERRITIN COMPLEX 62.5 mg / 8 ml + 0.3 mg / 8 ml oral solution

Sodium ferric gluconate complex and calcium folinate hydrate
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask 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 adverse effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Ferritin Complex is and what it is used for

Ferritin Complex contains two active substances: sodium ferric gluconate complex and calcium folinate monohydrate.
The sodium ferric gluconate complex supplies the body with iron necessary to restore red blood cell and haemoglobin levels (erythrocyte and haemoglobin values) to normal. Calcium folinate monohydrate is a folic acid supplement, a vitamin important for DNA production, for preventing fetal malformations during pregnancy, and for the production of red blood cells.
This medicinal product is indicated for the treatment of reduced red blood cell count in the blood due to deficiency of iron (iron deficiency anaemia) or folic acid (folate deficiency anaemia) during pregnancy, the postpartum period, and during breastfeeding (see section “Pregnancy and breastfeeding”).

2. What you need to know before taking Ferritin Complex

Do not take Ferritin Complex

if you are allergic to sodium ferric gluconate complex, calcium folinate monohydrate, or any of the other ingredients of this medicine (listed in section 6);
if you suffer from chronic inflammation of the pancreas (chronic pancreatitis);
if you suffer from severe blood disorders (aplastic, haemolytic, or sideroachrestic anaemias);
if you suffer from a hereditary disease characterized by iron accumulation in the body (haemochromatosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ferritin Complex.
Other medicines and Ferritin Complex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine if you are taking tetracyclines, antibiotics used to treat infections, as iron and its derivatives may reduce their effectiveness.
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.
Ferritin Complex is indicated for the treatment of iron and folic acid deficiency, which may occur during pregnancy and breastfeeding (see section “What Ferritin Complex is and what it is used for”).
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Ferritin Complex contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
May be harmful to teeth.
Ferritin Complex contains p-hydroxybenzoates
Ferritin Complex contains methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Ferritin Complex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 8 ml vial, i.e. essentially "sodium-free".
Ferritin Complex contains ethanol
This medicine contains 1.8 mg of alcohol (ethanol, contained in the Dutch cream flavouring) per 8 ml vial. This amount is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce any significant effects.

3. How to take Ferritin Complex

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 bottle, twice daily, during meals.
Remove the closure seal of the bottle and press the plunger on top, so that the contents of the cap fall into the solution below.
Shake for a few minutes until the contents are completely dissolved.
You may ingest the resulting solution directly, or dilute it first in a glass of water or other beverage.
If you take more Ferritin Complex than you should
If you take an excessive dose of this medicine, temporary gastrointestinal disturbances may occur (see section "Possible side effects").
In case of accidental ingestion/overdose of Ferritin Complex, contact your doctor immediately or go to the nearest hospital.
If you forget to take Ferritin Complex
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of 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.

The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

diarrhoea, heartburn (pyrosis), nausea, vomiting, particularly if you take excessive doses of the medicine (see "If you take more Ferritin Complex than you should");
constipation (stipsis), especially if you take Ferritin Complex for a long time;
darkening of the stools, which is not of pathological significance.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ferritin Complex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Ferritin Complex contains
The active substances are sodium ferric gluconate complex and calcium folinate dihydrate. Each vial (8 ml) contains 177.5 mg of sodium ferric gluconate complex (equivalent to 62.5 mg of Fe). Each reservoir cap contains 0.3 mg of calcium folinate dihydrate.
Other components:

in the solution: glycerol, sucrose, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, dehydroacetic acid (sodium salt), Dutch cream flavour, purified water;
in the reservoir cap: mannitol, sucrose.

Description of the appearance of Ferritin Complex and contents of the pack
Pack of 10 vials with reservoir caps.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin – Italy
Exclusive concessionaire for sale in Italy
SOFAR S.p.A. – Trezzano Rosa (MI)
Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (TO) – Italy