FERROUS GLUCONATE EG

Package leaflet: Information for the user

Ferro Gluconato EG 80 mg effervescent tablets

Generic medicine
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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ferro Gluconato EG is and what it is used for
2. What you need to know before taking Ferro Gluconato EG
3. How to take Ferro Gluconato EG
4. Possible side effects
5. How to store Ferro Gluconato EG
6. Contents of the pack and other information

1. What Ferro Gluconato EG is and what it is used for

Ferro Gluconato EG is an iron-based antianemic medicinal product.
This medicine is used for the treatment of iron deficiency anemias.

2. What you should know before taking Ferro Gluconato EG

Do not take Ferro Gluconato EG

• if you are allergic to ferro gluconato or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from hemosiderosis, haemochromatosis, or chronic haemolysis (excessive accumulation of iron in the body);
• if you suffer from any form of non-iron-deficiency anaemia (anaemia not caused by iron deficiency), particularly haemolytic anaemia (reduced number of red blood cells);
• if you suffer from chronic pancreatitis (inflammation of the pancreas) or hepatic cirrhosis (severe chronic inflammation of the liver);
• iron storage/absorption disorders (refractory anaemia (myelodysplastic syndrome), lead-induced anaemia, thalassaemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ferro Gluconato EG.
Treatment should be preceded by a precise diagnosis of iron-deficiency anaemia (anaemia caused by iron deficiency in the body).
Iron-containing products are highly toxic, especially in young children. Therefore, be very careful and store this medicine out of sight and reach of children.
To avoid the risk of overdose, your doctor will advise you to pay particular attention to the intake of certain foods particularly rich in iron and not to take supplements containing iron.
If you suffer from inflammation or ulcers of the stomach or intestine, your doctor will evaluate whether or not to prescribe this medicine.

Children and adolescents
Iron administration can be toxic, and iron overdose can be fatal, especially in children (doses exceeding 400 mg, corresponding to more than 5 tablets of Ferro Gluconato EG) (see "If you take more Ferro Gluconato EG than you should").

Other medicines and Ferro Gluconato EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

• tetracyclines, penicillamine, gold compounds, levodopa, methyldopa, and zinc-containing compounds, as their absorption is reduced;
• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), as iron interferes with their absorption;
• thyroxine, as its absorption is reduced;
• cholestyramine, antacids (calcium, magnesium or magnesium salts), and calcium and magnesium supplements, as they reduce iron absorption;
• salicylates or non-steroidal anti-inflammatory drugs (NSAIDs), as their concomitant use with iron may increase gastric and intestinal irritation caused by iron;
• substances such as phosphates, phytates, oxalates, milk, tea, and coffee, as they reduce iron absorption;
• vitamin E-containing substances, as iron reduces their effect. Do not take Ferro Gluconato EG within 2–3 hours of taking the substances listed above.

If you stop treatment with iron derivatives, there may be a risk of toxicity with penicillamine.
Vitamin C intake enhances iron absorption.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Use Ferro Gluconato EG during pregnancy and breastfeeding according to your doctor's instructions and recommended dosage.
The iron requirement during the second half of pregnancy is approximately 6 mg/day. In case of iron deficiency, your doctor will adjust the dose according to your response to therapy and gastrointestinal tolerance.
Higher doses are better tolerated if divided into 3 or 4 administrations per day.

Driving and using machines
Ferro Gluconato EG does not affect the ability to drive or operate machinery.

Ferro Gluconato EG contains aspartame (E951)
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 due to the body's inability to properly metabolize it.

Ferro Gluconato EG contains sodium
This medicine contains 180.91 mg of sodium (the main component of table salt) per tablet. This corresponds to 9% of the maximum recommended daily dietary intake for an adult.

Ferro Gluconato EG contains the colouring agent orange yellow (E110)
This medicine contains the colouring agent orange yellow, which may cause allergic reactions.

Ferro Gluconato EG contains sorbitol (E420)
Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you 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, consult your doctor before taking this medicine (or giving it to your child).

3. How to take Ferro Gluconato EG

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The daily requirement in adult males is generally 13 micrograms/kg or 1 mg/day.
The daily requirement in adult females (with normal menstruation) is generally 21 micrograms/kg or 1.4 mg/day.
During the last 6 months of pregnancy, the requirement increases: 80 micrograms/kg/day or, generally, from 5 to 6 mg/day.
The daily requirement in children is 22 micrograms/kg.
In case of iron deficiency, the dose should range between 50 and 250 mg/day, depending on the severity of anemia.

Recommended doses are:
Adults: 1 effervescent tablet per day, dissolved in water half an hour before a meal.
In case of severe anemia: the dose may be adjusted at the physician's discretion based on blood tests performed 2 or 3 times per week after starting treatment.
Use in children: half to 1 tablet depending on body weight.

If anemia persists after 3 weeks of treatment, contact your doctor, who may request further tests to determine its cause.

If you take more Ferro Gluconato EG than you should
In case of accidental ingestion/overdose of Ferro Gluconato EG, contact your doctor immediately or go to the nearest hospital.
The most common adverse effects occurring in case of overdose are nausea, vomiting, diarrhea, and abdominal pain (sometimes with blood in vomit and stools).
Overdose due to accidental administration of a high dose is fatal in children.
Therefore, it is essential to keep the medicine out of sight and reach of children.

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 everybody gets them.

Rare side effects (may affect up to 1 in 1,000 people):

• sensation of pressure in the stomach,
• loss of appetite,
• feeling of fullness in the stomach,
• harmless black discoloration of the stools.

Very rare side effects (may affect up to 1 in 10,000 people):

• constipation at the beginning of treatment (constipation often occurs when treatment is continued, but usually only in a mild form).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• nausea,
• abdominal pain,
• vomiting,
• diarrhoea,
• anorexia,
• temporary tooth discoloration,
• skin reactions (such as rashes, urticaria, pruritus, erythema, and photosensitivity reactions).

In case of overdose, nausea, vomiting and diarrhoea may be severe and complicated by gastrointestinal haemorrhage.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 Gluconato EG

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. The expiry date refers to the product in its original, unopened packaging, correctly stored.
Shelf life after first opening of the container: 3 months.
Store at a temperature not exceeding 25°C.
Keep in the original packaging.
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 Gluconato EG contains

• The active substance is ferro gluconato. Each tablet contains 695 mg of ferro gluconato (equivalent to 80 mg of Fe).
• The other components are: sorbitol (E420), ascorbic acid, citric acid, tartaric acid, sodium bicarbonate, anhydrous sodium carbonate, sodium saccharin, aspartame (E951), orange flavour, orange yellow (E110).

Description of the appearance of Ferro Gluconato EG and contents of the pack
Effervescent tablets
Pack containing 30 tablets of 80 mg.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan
Manufacturer
E-Pharma Trento S.p.A., Frazione Ravina, Via Provina n° 2 – 38123 Trento (TN)