Patient Information Leaflet

PRONTOFERRO 80 mg effervescent tablets

Ferric gluconate
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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PRONTOFERRO is and what it is used for

This medicinal product contains iron gluconate. Iron is a very important element for the human body, as it is not only involved in many processes occurring within the body, but is also necessary for the production of a protein found in red blood cells called haemoglobin. Haemoglobin is essential for transporting oxygen to all cells of our body.
PRONTOFERRO is used to treat a reduction in red blood cells caused by iron deficiency (iron deficiency anaemia).

2. What you need to know before taking PRONTOFERRO

Do not take PRONTOFERRO if:

you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
you have diseases causing increased iron levels in your body (haemosiderosis, haemochromatosis);
you have a reduced number of red blood cells (anaemia) not caused by iron deficiency, for example haemolytic anaemia (with destruction of red blood cells);
you have long-standing inflammation of the pancreas (chronic pancreatitis);
you have a severe liver disease called cirrhosis.

Warnings and precautions
Talk to your doctor or pharmacist before taking PRONTOFERRO.
During treatment with PRONTOFERRO, your doctor may ask you to undergo check-up tests to assess the effectiveness of the therapy.
If your condition does not improve after 3 weeks of treatment, your doctor will prescribe specific tests to determine whether your anaemia is due to causes other than iron deficiency.
Be careful
Iron administration can be toxic, especially in children, at doses exceeding 400 mg per day (more than 5 PRONTOFERRO tablets). Do not exceed the prescribed dose of PRONTOFERRO and do not use other iron-containing preparations without first discussing with your doctor (see section 3 - "If you take more PRONTOFERRO than you should").

Other medicines and PRONTOFERRO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as some medicines may interact with PRONTOFERRO or cause even serious adverse effects.
This is particularly important if you are taking:

tetracyclines, medicines used to treat infections;
penicillamine, a medicine used for rheumatoid arthritis;
antacids, medicines that reduce stomach acidity, used for example for reflux or ulcers. In this case, leave an interval of 2–3 hours between taking PRONTOFERRO and taking these medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, inform your doctor before taking PRONTOFERRO.
PRONTOFERRO may be administered during pregnancy and while breastfeeding.
During pregnancy, your daily iron requirement increases: your doctor will take your condition into account when prescribing the correct dose.

Driving and using machines
PRONTOFERRO does not affect the ability to drive or use machinery.

PRONTOFERRO contains sodium, E110 orange yellow, sorbitol and aspartame:

This medicine contains 212 mg of sodium (main component of table salt) per tablet. This corresponds to 10.6% of the maximum recommended daily dietary intake for an adult;
This medicine contains E110 orange yellow. It may cause allergic reactions;
This medicine contains 200 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, speak with your doctor before you (or the child) take this medicine;
This medicine contains 80 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful to you if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take PRONTOFERRO

Take this medicine exactly as directed by your doctor, who will determine the dose and duration of treatment based on the severity of your condition and your response to therapy. Your doctor will also consider your daily iron requirements. If in doubt, consult your doctor or pharmacist.

Adults
1 effervescent tablet per day.
If you have severe anaemia or are pregnant, this dose may be increased. In such cases, your doctor will advise you to divide the prescribed dose into 3–4 administrations.

Children
From ½ to 1 effervescent tablet per day, according to body weight.

Instructions for use
PRONTOFERRO is an oral medicine. Dissolve the prescribed dose in a small amount of water and take it half an hour before a meal.

If you take more PRONTOFERRO than you should
In case of accidental ingestion of excessive doses of iron (see section 2 – "Warnings and precautions"), you may experience: nausea, vomiting, diarrhoea, and gastrointestinal bleeding.
If you take more PRONTOFERRO than you should, contact your doctor immediately or go to the nearest hospital. Be aware that high doses of this medicine can be fatal in children.

If you forget to take PRONTOFERRO
Do not take a double dose to make up for the missed dose and contact your doctor.

If you stop taking PRONTOFERRO
Do not stop treatment with PRONTOFERRO without first consulting your doctor. If your condition has not improved after 3 weeks of treatment, your doctor will prescribe specific tests to determine whether your anaemia is due to causes other than iron deficiency.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody gets them.
Inform your doctor if, during treatment with PRONTOFERRO, you experience: nausea, vomiting, diarrhoea, blackening of the stools.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website:
“https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store PRONTOFERRO

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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 PRONTOFERRO contains
The active substance is: iron gluconate.
Each effervescent tablet contains: 695 mg of iron gluconate (equivalent to 80 mg of iron).
The other components are: ascorbic acid, citric acid, sorbitol, sodium bicarbonate, sodium carbonate monohydrate, sodium saccharin, aspartame, orange flavour, orange yellow (E110).

Description of the appearance of PRONTOFERRO and contents of the pack
PRONTOFERRO is available in a bottle containing 30 effervescent tablets that can be divided.

Marketing Authorization Holder
IBSA Farmaceutici Italia S.r.l., Via Martiri di Cefalonia, 2, 26900 Lodi

Manufacturer
E-Pharma Trento S.p.A., Via Provina 2, Frazione Ravina 38123 Trento (TN)