Patient Information Leaflet

FERRO COMPLEX 695 mg (80 mg Fe) effervescent granules, 126 mg/10 ml (15.7 mg Fe) powder and solvent for oral solution

Ferro gluconatum
Read all of this leaflet carefully before you start 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FERRO COMPLEX is and what it is used for

FERRO COMPLEX contains the active substance iron gluconate, which belongs to a group of
medicinal products called antianaemics that work by increasing the number of red blood cells and help counteract anaemia, a condition caused by a decrease in haemoglobin levels (a protein in red blood cells that carries oxygen).
This medicinal product is indicated for the treatment of anaemia due to iron deficiency.

2. What you should know before taking FERRO COMPLEX

Do not take FERRO COMPLEX

if you are allergic to iron gluconate, to similar medicines (substances closely related chemically), or to any of the other ingredients of this medicine (listed in section 6);
if you have a condition characterized by iron accumulation in certain parts of the body (haemosiderosis, haemochromatosis);
if you suffer from other forms of anaemia not caused by iron deficiency (non-iron-deficiency haemolytic anaemias);
if you have chronic inflammation of the pancreas (chronic pancreatitis);
if you have severe liver problems (hepatic cirrhosis);
if you have stomach or intestinal lesions (active peptic ulcer);
if you suffer from inflammatory bowel diseases (Crohn's disease, ulcerative colitis);
if you receive frequent blood transfusions;
if you are receiving iron via intravenous infusion (parenterally).

Warnings and precautions
Talk to your doctor or pharmacist before taking FERRO COMPLEX.
Take this medicine with caution and inform your doctor if:

you suffer from intestinal disorders (intestinal stenosis, diverticula);
you are taking dietary supplements or other products containing iron;
you have inflammation or lesions of the stomach or intestine (gastrointestinal mucosa).

You should take this medicine only after your doctor has diagnosed you with anaemia due to iron deficiency (iron-deficiency anaemia).
Children
In children, this medicine must be taken under strict medical supervision. Doses exceeding 400 mg may cause serious toxicity problems (see section "Use in children").
Other medicines and FERRO COMPLEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

tetracyclines, penicillamine, quinolone antibiotics (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) used to treat infections;
levodopa, used for the treatment of Parkinson's disease;
methyldopa, used to treat high blood pressure;
thyroxine, used in case of thyroid problems;
cholestyramine, used to lower blood cholesterol levels;
calcium and magnesium supplements;
mycophenolate, used after organ transplantation;
non-steroidal anti-inflammatory drugs, such as salicylates, used to relieve pain and inflammation;
antacids (magnesium and aluminium salts) used for stomach disorders. If antacids are needed during treatment with FERRO COMPLEX, it is recommended to take them at least 2–3 hours apart from this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
FERRO COMPLEX may be used during pregnancy. Your doctor will determine the appropriate dose of FERRO COMPLEX based on your health status (response to therapy, gastrointestinal tolerance), considering that 6 mg of iron per day are required during the second half of pregnancy. If high doses are needed, it is recommended to divide them into 3–4 daily administrations.
Breastfeeding
This medicine is not recommended during breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
FERRO COMPLEX effervescent granules
This medicine contains:

80 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body's inability to metabolize it properly.
205.5 mg of sodium (the main component of table salt) per sachet. This corresponds to approximately 10.3% of the maximum recommended daily dietary intake for an adult. Speak with your doctor or pharmacist if you need to take more sachets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. It may be harmful to teeth.
the colouring agent orange yellow (E110), which may cause allergic reactions.

FERRO COMPLEX powder and solvent for oral solution
This medicine contains:

sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. It may be harmful to teeth.
parahydroxybenzoates (methylhydroxybenzoate, propylhydroxybenzoate) which may cause allergic reactions (including delayed reactions).

3. How to take FERRO COMPLEX

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
FERRO COMPLEX should be taken half an hour before meals.

Effervescent granules
The recommended dose is 1 sachet per day dissolved in water. Unless otherwise prescribed by the doctor.

Powder and solvent for oral solution
The recommended dose is 1 bottle, 1-2 times daily. Unless otherwise prescribed by the doctor.
Using the tear-off opening, remove the closure cap of the bottle and press the piston on top to release the contents of the cap into the solution below.
Shake for 30 seconds until the contents are completely dissolved.
You may ingest the resulting solution directly, or dilute it first in a glass of water or other beverages such as milk or fruit juice.

In more severe cases, your doctor may decide to increase the dose according to the results of blood tests, which should be performed 2–3 times per week after starting treatment.

Use in children
The recommended dose is 1 bottle of powder and solvent for oral solution, 1–2 times daily, depending on the child's weight. The medicine should be taken orally, half an hour before meals.
If no improvement occurs after 3 weeks of treatment, inform your doctor.

If you take more FERRO COMPLEX than you should
In case of accidental ingestion/overdose of FERRO COMPLEX, immediately contact your doctor or go to the nearest hospital.
Symptoms of overdose may include:

stomach pain (epigastralgia);
nausea;
vomiting, even with blood (haematemesis);
diarrhoea;
drowsiness;
pallor;
bluish discoloration of the skin (cyanosis);
severe circulatory problem (shock);
deep unconsciousness (coma);
death, especially in children.

The doctor will determine the most appropriate treatment depending on the severity of the symptoms.

If you forget to take FERRO COMPLEX
Do not take a double dose to make up for the missed dose.
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 everyone will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

vomiting;
nausea;
diarrhea;
bleeding in the stomach or intestines (gastrointestinal hemorrhage);
black stools;
dark discoloration of urine;
temporary tooth discoloration;
allergic reactions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 FERRO 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 "Exp.".
The expiry date refers to the last day of that month, provided the product is in its original intact packaging
and stored correctly.
Effervescent granules: store below 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 FERRO COMPLEX contains
FERRO COMPLEX 695 mg (80 mg Fe) effervescent granules

The active substance is ferro gluconate. Each sachet contains 695 mg (equivalent to 80 mg of Fe).
Other components are: ascorbic acid, citric acid, tartaric acid, sodium bicarbonate, sodium carbonate monohydrate, sodium saccharin, aspartame, sucrose, orange flavour, sunset yellow (E110).

FERRO COMPLEX 126 mg /10 ml (15.7 mg Fe) powder and solvent for oral solution

The active substance is ferro gluconate. Each single-dose vial contains 126 mg (equivalent to 15.7 mg of Fe++).
Other components are: sucrose, caramel, methyl hydroxybenzoate, propyl hydroxybenzoate, caramel flavour, purified water.

Description of the appearance of FERRO COMPLEX and contents of the pack

FERRO COMPLEX 695 mg (80 mg Fe) effervescent granules
Box of 30 sachets.

FERRO COMPLEX 126 mg /10 ml (15.7 mg Fe) powder and solvent for oral solution
Box of 10 single-dose vials with reservoir cap and closure capsule.

Marketing Authorisation Holder
PHARMAFAR S.r.l. - Corso Vittorio Emanuele II, 82 - 10121 - Turin – Italy

Manufacturers
Effervescent granules
LA.FA.RE. S.r.l. - Pharmaceutical Laboratory - Via Sac. Benedetto Cozzolino 77 - Ercolano (NA) – Italy
Powder and solvent for oral solution
ABC FARMACEUTICI S.p.A. - Strada Vicinale dei Moretti – Ivrea (TO) – Italy