Eritropiu 80mg effervescnt Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FERROUS GLUCONATE

Available from:

Alta Care Laboratoires Piazza di Spagna 6, 00187 Roma, Italy

ATC code:

B03AA03

INN (International Name):

FERROUS GLUCONATE 695 mg

Pharmaceutical form:

EFFERVESCENT TABLET

Composition:

FERROUS GLUCONATE 695 mg

Prescription type:

POM

Therapeutic area:

ANTIANEMIC PREPARATIONS

Authorization status:

Authorised

Authorization date:

2007-06-28

Patient Information leaflet

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

ERITROPIU 80 MG TABLETS 
Ferrous Gluconate 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
Keep this leaflet. You may need to read it again. If you
have any further questions, ask your doctor. This 
medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms 
are the same as yours. If  any of the side effects gets
serious, or if you notice any side effects not listed in this 
leaflet, please tell your doctor. 

1. 
WHAT ERITROPIU IS AND WHAT IT IS USED FOR 
Eritropiu are effervescent tablets used for
anaemia and lack of iron treatment. 

2. 
BEFORE YOU TAKE ERITROPIU 
A precise diagnosis of anaemia sideropenic must precede treatment.
The administration of iron may be toxic, 
especially in children, at doses higher than 400mg (more than 5
tablets). 
ATTENTION: each Eritropiu effervescent tablet
contains phenylalanine source.   
ATTENTION: each Eritropiu effervescent tablet contains
180.91mg or 8.01 meq. of sodium. 

DO NOT TAKE ERITROPIU  
If you are hypersensitive (allergic) to it’s active substance
or any of the other ingredients  

TAKE SPECIAL CARE WITH ERITROPIU AND INFORM YOUR DOCTOR  
if you are pregnant or breastfeeding as you may require a
different iron supplement or dose adjustment 
if you have hereditary problems dealing with iron
(Hemosiderosis, hemochromatosis, all non sideropenic 
anaemic forms, particularly haemolytic anaemia, chronic
pancreatitis, hepatic cirrhosis). 

TAKING OTHER MEDICINES 
Please tell your doctor if you are taking or have
recently taken any other medicines, including medicines 
obtained without a prescription. The efficacy of Eritropiu may be
altered if administered simultaneously with 
tetracyclines, anti-acids, quinolones. 

Eritropiu is best absorbed on an empty stomach

Summary of Product characteristics

 
Page 1 of 5 
   SUMMARY 
OF 
PRODUCT 
CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

ERITROPIU 80 mg EFFERVESCENT TABLETS 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each effervescent tablet contains: 
Active Ingredient:  

Ferrous Gluconate 695mg (equivalent to 80mg of Fe
++
). 
Excipient(s): 
For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Effervescent tablets. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Anaemia and lack of iron treatment. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 
The daily need of (males) is generally 13 
µg/kg or 1 mg per day. 
The daily need for females (normal menstruation) is generally of 21 
µg/kg or 1.4 mg per day. 
During the last six months of pregnancy, the need increases: 80 
µg/kg per day or, generally, from 5 to 6 
mg per day. 
Children: 22 
µg/kg. 
In case of iron deficiency, the dose must be between 50 and 250
mg per day, according to the anaemic 
level.  

POSOLOGY 
Adults: 1 effervescent tablet a day, diluted in water ½ hour before
meal.  
In case of severe anaemia: the dose may be modified according to the
doctor’s judgement according to 
the haematological examinations that are to be done 2 or 3 times a
week after commencing treatment.   
Children: ½ to 1 tablet according to body weight. 
If anaemia persists after three weeks of treatment, another reason
should be sought. 

4.3 CONTRAINDICATIONS 

Hypersensitivity to the active ingredient or to any of its excipients.

Hemosiderosis, hemochromatosis, all non sideropenic anaemic forms,
particularly haemolytic anaemia, 
chronic pancreatitis, hepatic cirrhosis. 

4.4  SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

A precise diagnosis of anaemia sideropenic must precede treatment. The
administration of iron may be 
toxic, especially in children, at doses higher than 400mg (more than
5 tablets). 

Page 2 of 5 
ATTENTION: each ERITROPIU effervescent tablet contai