Package leaflet: Information for the user

FERROGYN 80 mg effervescent tablets

Ferric gluconate
Equivalent medicine
Please read all of this leaflet carefully before you start using 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See Section 4.

Contents of this leaflet:

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

1. What FERROGYN is and what it is used for

FERROGYN belongs to the class of antianaemic medicinal products and contains as its active substance iron gluconate.
FERROGYN is indicated for the treatment of iron-deficiency anaemias.
If anaemia persists after 3 weeks of treatment, inform your doctor.

2. What you need to know before taking FERROGYN

Do not take FERROGYN if:

you are allergic to ferric gluconate or to any of the other ingredients of this medicine (listed in section 6)
you suffer from hemosiderosis or hemochromatosis (diseases caused by excess iron)
you suffer from non-iron-deficiency anemias (not characterized by low blood iron levels), particularly hemolytic anemias
you have chronic inflammatory disease of the pancreas (chronic pancreatitis)
you have liver cirrhosis

Warnings and precautions:
Talk to your doctor or pharmacist before taking FERROGYN.
Before starting treatment with ferric gluconate, your doctor must make a precise diagnosis of iron-deficiency anemia (anemia caused by a lack of iron in the body).
Children
Iron administration can be toxic, especially in children, at doses exceeding 400 mg (more than 5 tablets) (see "If you take more FERROGYN than you should").
Accidental overdose may be fatal in children; therefore, it is essential to keep this medicine out of sight and reach of children.
Other medicines and FERROGYN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ferric gluconate may affect the action of other medicines, and conversely, other medicines may affect the action of ferric gluconate. Therefore, it is important to inform your doctor if you are taking:

tetracyclines (antibiotics used to treat bacterial infections), as their absorption is impaired;
antacids, which reduce iron absorption (an interval of 2–3 hours should be maintained between taking this product and antacids);
penicillamine (anti-inflammatory). Risk of toxicity may occur when treatment with iron derivatives is discontinued.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
FERROGYN may be taken by pregnant women and during breastfeeding.
The daily iron requirement during the second half of pregnancy is approximately 6 mg/day.
In case of iron deficiency, your doctor will adjust the dosage according to the response to treatment and gastrointestinal tolerance. Higher doses are better tolerated when divided into 3 or 4 administrations per day.
Driving and using machines
No effects on the ability to drive or use machinery have been observed.
FERROGYN contains aspartame
This medicine contains 80 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
FERROGYN contains sodium
This medicine contains 205.66 mg of sodium (the main component of table salt) per tablet. This corresponds to 10.5% of the maximum recommended daily dietary intake for an adult. Please bear this in mind if you are following a low-sodium diet.
FERROGYN contains sunset yellow FCF (E 110)
It may cause allergic reactions.

3. How to take FERROGYN

Take this medicine exactly as your doctor has told you.
If you are unsure, consult your doctor or pharmacist.
If anaemia persists after 3 weeks of treatment, another cause should be investigated; inform your doctor.
The usual dose in adults is 1 effervescent tablet daily, dissolved in water, taken ½ hour before a meal.
In cases of severe anaemia: the dose may be adjusted at the doctor's discretion, based on haematological tests performed 2 or 3 times weekly after starting treatment.

Use in Children
The usual dose in children is from ½ to 1 tablet, depending on body weight.

If you take more FERROGYN than you should
If you take more ferrous gluconate than prescribed, inform your doctor and go immediately to the nearest hospital for appropriate emergency treatment.
Overdose due to accidental ingestion of a large dose can be fatal in children (see "Warnings and Precautions" and section 4).

If you forget to take FERROGYN
Do not take a double dose to make up for the missed dose. Simply take the next dose at the usual time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Do not take FERROGYN and contact your doctor immediately if any of the following occur:

Nausea, vomiting, diarrhoea (severe and complicated by gastrointestinal bleeding in case of overdose)

Black discolouration of the stools may occur.
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 through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store FERROGYN

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.
Store below 25 °C.
Do not dispose of medicines 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 FERROGYN contains
The active substance is Ferrous gluconate.
Each effervescent tablet contains 695 mg of ferrous gluconate, equivalent to 80 mg of Fe.
The other components are: Ascorbic acid, citric acid, tartaric acid, sodium bicarbonate, sodium carbonate monohydrate, sodium saccharin, aspartame, orange flavour, orange yellow (E110).

Description of the appearance of FERROGYN and contents of the pack
Effervescent tablets
Supplied in a plastic bottle with cap and silica gel desiccant, containing 30 effervescent tablets.

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)
Italy

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy