Package leaflet: Information for the patient

LOSFERRON 80 mg effervescent tablets

Ferric gluconate
Generic medicine
Please read this leaflet carefully before 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, consult 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LOSFERRON is and what it is used for

LOSFERRON contains the active substance iron gluconate, which provides iron to the body.
This medicine is used for the treatment of iron deficiency anemias.

2. What you need to know before taking LOSFERRON

Do not take LOSFERRON

if you are allergic to gluconate iron or to any of the other ingredients of this medicine (listed in section 6);
if you have haemosiderosis or haemochromatosis (excessive accumulation of iron in the body);
if you have other forms of non-iron-deficiency anaemia (anaemia not due to iron deficiency), particularly haemolytic anaemia (reduced number of red blood cells);
if you have chronic pancreatitis (inflammation of the pancreas);
if you have hepatic cirrhosis (severe chronic inflammation of the liver).

Warnings and precautions
Talk to your doctor or pharmacist before taking LOSFERRON.
Take this medicine only if you have been specifically diagnosed with anaemia caused by iron deficiency in the body (iron-deficiency anaemia).
Children
In children, this medicine must be taken under strict medical supervision. Doses exceeding 400 mg, corresponding to more than 5 effervescent tablets, may cause severe toxicity (see section “If you take more LOSFERRON than you should”).
Other medicines and LOSFERRON
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:

tetracyclines, medicines used to treat bacterial infections (antibiotics), because LOSFERRON reduces their absorption;
antacids, medicines used to reduce stomach acidity, because these medicines reduce the absorption of LOSFERRON. If antacids need to be taken during treatment with LOSFERRON, take the medicines at least 2-3 hours apart.

If you stop iron treatment, there may be a risk of toxicity with penicillamine, a medicine used in certain inflammatory diseases.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
LOSFERRON may be used during pregnancy or breastfeeding, following the doctor's instructions and recommended doses.
The daily iron requirement during the second half of pregnancy is approximately 6 mg of iron per day. In case of iron deficiency, your doctor will adjust the dose according to your response to treatment and gastrointestinal tolerance.
If you need to take high doses of this medicine, it is recommended to divide them into 3-4 daily doses.
Driving and using machines
LOSFERRON does not affect the ability to drive or use machinery.
LOSFERRON contains sodium and sunset yellow FCF (E 110):
This medicine contains 229 mg of sodium (a main component of table salt) per effervescent tablet. This corresponds to 11% of the maximum daily dietary intake recommended for an adult.
This medicine contains sunset yellow FCF (E 110), which may cause allergic reactions.

3. How to take LOSFERRON

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The daily requirement in adult males is generally 13 micrograms/kg of body weight or 1 mg/day.
The daily requirement in adult females (with normal menstruation) is generally 21 micrograms/kg of body weight or 1.4 mg/day.
During the last 6 months of pregnancy, the requirement increases: 80 micrograms/kg of body weight/day or, generally, between 5 and 6 mg/day.
The daily requirement in children is 22 micrograms/kg of body weight.
In case of iron deficiency, the dose should range between 50 and 250 mg/day, depending on the severity of anemia.
Dissolve the effervescent tablet in water before taking it.
Take the medicine half an hour before a meal.

Use in adults
The recommended dose is 1 effervescent tablet per day.
If you suffer from severe anemia, your doctor may adjust the dose based on certain blood test results, repeated 2 or 3 times per week after starting treatment.

Use in children
The recommended dose ranges from half a tablet to 1 tablet per day, depending on the child's 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 LOSFERRON than you should
In case of accidental ingestion or overdose of LOSFERRON, contact your doctor immediately or go to the nearest hospital.
An overdose due to accidental ingestion of a high dose can be fatal in children; therefore, it is essential to keep this medicine out of the reach of children.

If you forget to take LOSFERRON
Do not take a double dose to make up for the missed tablet.
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 will experience them.
The following side effects may occur:

vomiting, nausea, diarrhoea, which in case of overdose may become more severe and complicated by gastrointestinal haemorrhages (bleeding from stomach or intestine);
harmless black discoloration of the stools.

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 LOSFERRON

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.
This medicine requires no special storage precautions.
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 LOSFERRON contains

The active substance is ferro gluconato. Each effervescent tablet contains 695 mg of ferro gluconato (equivalent to 80 mg of Fe).
The other components are: acido ascorbico, acido citrico, acido tartarico, sodio bicarbonato, sodio carbonato monoidrato, sodio ciclamato, sodio saccarinato, leuteum S (E 110), aroma arancio.

Description of the appearance of LOSFERRON and package contents
Effervescent tablets
Bottle containing 30 effervescent tablets.
Blister pack containing 60 effervescent tablets.
Marketing Authorization Holder
SPA - Società Prodotti Antibiotici S.p.A.
Via Biella, 8
20143 MILAN, Italy
Manufacturer
Hermes Pharma Ges.m.b.H.
Schwimmschulweg 1a
9400 Wolfsberg (Austria)