Glucoferrum

GLUCOFERRO 
Ferrous Gluconate
COMPOSITION
Each reservoir cap contains: Active substance: ferrous gluconate 300 mg (equivalent to
elemental iron 37.5 mg). Excipients: glucose; dimethicone; anhydrous colloidal silica.
Each solvent vial contains the following excipients: fructose; sorbitol; glycerol; citric
acid; strawberry flavor; peppermint essence; methyl p-hydroxybenzoate; propyl p-
hydroxybenzoate; caramel color (E 150); purified water.
PHARMACEUTICAL FORM AND CONTENT
Powder and solvent for oral solution; 10 vials with reservoir cap
THERAPEUTIC CATEGORY
Antianaemic.
MARKETING AUTHORISATION HOLDER
Laboratori Guidotti S.p.A. - Via Livornese, 897 – PISA – La Vettola
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. Menarini Manufacturing Logistics and Services s.r.l. - L’Aquila
INDICATIONS
Treatment of absolute or relative iron deficiency states; latent and manifest sideropenic
anaemias in childhood and adulthood, due to inadequate iron intake or absorption;
anaemias secondary to acute or chronic bleeding or to parasitic infectious diseases;
pregnancy and lactation.
CONTRAINDICATIONS
Known hypersensitivity to the product. Haemosiderosis, haemochromatosis, haemolytic
anaemia, chronic pancreatitis, hepatic cirrhosis.
USE PRECAUTIONS
In cases of anaemia, determine the underlying cause before initiating therapy.
INTERACTIONS
Iron may form complexes with orally administered tetracyclines, resulting in reduced
absorption and therapeutic activity of these antibiotics.
Antacids reduce the absorption of ferrous salts, while ascorbic acid enhances it.
SPECIAL WARNINGS
Ferrous gluconate, like other oral iron preparations, may cause a dark discoloration of
the stools.
In rare cases, as with other liquid iron-based preparations, it may cause transient
discoloration of tooth enamel. To prevent this, it is advisable to drink the solution in a
way that minimizes contact with teeth, and to rinse the mouth or brush teeth after
administration.
DOSAGE, METHOD AND ROUTE OF ADMINISTRATION
Adults: 1 vial, 1–3 times daily,
orally during meals.
Children: 1 vial, 1–2 times daily, depending on age and body weight,
orally during meals.
Instructions for use
Place the cap onto the vial's neck and press firmly to release the powder into the liquid.
Shake while pressing the cap for 30 seconds to dissolve the powder in the liquid, or
until completely dissolved. Remove the cap, the security ring, and then the stopper, and
take the preparation directly from the vial or diluted with water, milk, fruit juice, etc. (see
also instructions for use reported at the end of the text).
UNDESIRABLE EFFECTS
Occasionally, at high doses, gastrointestinal disturbances (diarrhoea, constipation,
nausea, epigastric pain) may occur; these usually resolve upon dose reduction or
treatment discontinuation.
If undesirable effects not described in the package leaflet occur, consult your physician
or pharmacist.
STORAGE CONDITIONS
No special storage precautions required.
Once the powder in the cap has been dissolved in the underlying liquid, the preparation
should be taken immediately or within 24 hours.
Do not use after the expiry date stated on the packaging.
DATE OF LAST REVIEW: September 2006

GLUCOFERRO EFFERVESCENT TABLETS
B03AA03 ferrous gluconate
COMPOSITION
Each effervescent tablet contains:
Active substance: ferrous gluconate 650 mg (equivalent to 75 mg of bivalent iron).
Excipients: anhydrous citric acid, sodium bicarbonate, sorbitol, sodium saccharinate, L-
leucine, powdered lemon flavor, powdered orange flavor.
PHARMACEUTICAL FORM AND CONTENT
EFFERVESCENT TABLETS FOR ORAL SOLUTION, SPLITTABLE.
30 and 60 tablets.
THERAPEUTIC CATEGORY
ANTIANAEMIC.
MARKETING AUTHORISATION HOLDER
Laboratori Guidotti S.p.A. - Via Livornese, 897 – PISA – La Vettola.
MANUFACTURER
E-Pharma Trento S.p.A., Via Provina, 2 - Ravina di Trento (TN).
INDICATIONS
Treatment of absolute or relative iron deficiency states; latent and manifest sideropenic
anaemias in childhood and adulthood, due to inadequate iron intake or absorption;
anaemias secondary to acute or chronic bleeding or to parasitic infectious diseases;
pregnancy and lactation.
CONTRAINDICATIONS
Known hypersensitivity to the product. Haemosiderosis, haemochromatosis, haemolytic
anaemia, chronic pancreatitis, hepatic cirrhosis.
USE PRECAUTIONS
In cases of anaemia, determine the underlying cause before initiating therapy.
INTERACTIONS
Iron may form complexes with orally administered tetracyclines, resulting in reduced
absorption and therapeutic activity of these antibiotics.
Antacids reduce the absorption of ferrous salts.
SPECIAL WARNINGS
Ferrous gluconate, like other oral iron preparations, may cause a dark discoloration of
the stools.
In rare cases, as with other liquid iron-based preparations, it may cause transient
discoloration of tooth enamel. To prevent this, it is advisable to drink the solution in a
way that minimizes contact with teeth, and to rinse the mouth or brush teeth after
administration.
The product contains sodium. This should be taken into account when prescribing to
patients on a low-sodium diet.
The medicine is not contraindicated in patients with coeliac disease.
DOSAGE, METHOD AND ROUTE OF ADMINISTRATION
Adults: from ½ tablet to 1 tablet daily, dissolved in water, to be taken during meals.
Children: from ½ tablet to 1 tablet daily, depending on age and body weight,
dissolved in water, to be taken during meals.
UNDESIRABLE EFFECTS
Occasionally, at high doses, gastrointestinal disturbances (diarrhoea, constipation,
nausea, epigastric pain) may occur; these usually resolve upon dose reduction or
treatment discontinuation.
If undesirable effects not described in the package leaflet occur, consult your physician
or pharmacist.
STORAGE CONDITIONS
No special storage precautions required.
Do not use after the expiry date stated on the packaging.
DATE OF LAST REVIEW: July 2005