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SODIUM
FEREDETATE
ORAL SOLUTION
190MG/5ML
1.NAME OF THE MEDICINAL PRODUCT
Sodium Feredetate 190mg/5ml Oral Solution.
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each 5ml dose contains Sodium Feredetate
190mg (equivalent to 27.5mg of elemental
iron/5ml)
Excipients with known effect: Ponceau 4R lake
(E124), Methyl hydroxybenzoate (E218), Propyl
hydroxybenzoate (E216), Sorbitol liquid (E420),
Ethanol
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral Solution.
Red coloured liquid.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Sodium Feredetate is indicated for Iron
deficiency anaemia,
• Notably in paediatrics.
• In pregnancy when other forms of oral iron
may not be well tolerated.
• Anaemias secondary to rheumatoid arthritis.
4.2 Posology and method of administration
Posology:
Treatment:
Children:
Treatment of iron-deficiency anaemia in all
paediatric age groups is 3-6 mg/kg (max 200
mg) of elemental iron daily given in 2-3 divided
doses.
Adults: 5ml increasing gradually to 10ml three
times daily.
Elderly (over 65 years): As for adults.
Prophylaxis:
Babies of low birth weight who are solely
breast-fed:
A daily dose of 5 mg of elemental iron as
prophylactic iron supplementation for babies of
low birth weight who are solely breast-fed is
recommended. Higher doses up to 2 mg/kg of
elemental iron per day might be needed to cover
the needs of growing exclusively breastfed
infants. Supplementation is started 4-6 weeks
after birth and continued until mixed feeding is
established.
Other children (elemental iron per day):
Age 6 - 24 months: 12.5 mg
Age 2 - 5 years: 20-30 mg
Age 6 - 11 years: 30 – 60 mg
Adolescents: 60 mg
Method of administration
Oral
For instructions on dilution of the medicinal
product before administration, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substance or to
any of the excipients listed in section 6.1
Iron preparations are contraindicated in patients
with haemochromatosis and haemosiderosis.
Iron is contraindicated in patients receiving
repeated blood transfusions or in patients
receiving parenteral iron therapy.
4.4 Special Warnings and precautions for use
Care should be taken in patients with haemolytic
anaemia, iron-storage or iron-absorption
diseases or existing gastrointestinal diseases.
Iron preparations colour the faeces black, which
may interfere with tests used for detection of
occult blood in the stools.

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Prolonged or excessive use in children may lead
to toxic accumulation.
This medicinal product contains the following:
- Sorbitol; patients with rare hereditary problems
of fructose intolerance should not take this
medicine. Sorbitol may also cause mild laxative
effects.
- Methyl hydroxybenzoate (E218)) and Propyl
hydroxybenzoate (E216) which may cause
allergic reactions (possibly delayed).
- Ponceau 4R (E124) which may cause allergic
reactions.
- Small amounts of ethanol (alcohol), less than
100mg per ml.
The label will state:
“Important warning: Contains iron. Keep out of
the sight and reach of children, as overdose may
be fatal.”
This will appear on the front of the pack within a
rectangle in which there is no other information.
4.5 Interaction with other medicinal products
and other forms of interaction
Avoid concomitant administration of oral iron
with dimercaprol (formation of toxic
compounds).
Iron reduces the absorption of penicillamine,
mycophenolate, fluoroquinolones, levodopa,
carbidopa, thyroxine and bisphosphonates.
Administration of oral iron may reduce the
hypotensive effect of methyldopa.
Iron and tetracyclines reduce the absorption of
each other.
Iron and zinc reduce the absorption of each
other.
Oral chloramphenicol delays plasma iron
clearance, incorporation of iron into red blood
cells and interferes with erythropoiesis.
Absorption of iron is reduced with entacapone,
proton pump inhibitors, bicarbonates,
carbonates, calcium, zinc, magnesium and other
mineral supplements, trientine, antacids,
cholestyramine, tea, eggs and/or milk, but may
be increased by ascorbic acid and/or citric acid.
Coffee may be a factor in reducing iron
bioavailability.
4.6 Fertility, Pregnancy and lactation
Administration of drugs during the first trimester
of pregnancy requires careful assessment of
potential risks versus benefits to be gained. No
adverse events associated with sodium feredetate
administration during pregnancy and lactation
have been reported.
4.7 Effects on ability to drive and use
machines
None known.
4.8 Undesirable Effects
Adverse reactions reported as possibly
associated to sodium feredetate are presented in
the following table by MedDRA System Organ
Class (SOC), Preferred Term and frequency.
The following frequency categories are used:
Very common (>1/10)
Common (>1/100, <1/10)
Uncommon (>1/1,000, <1/100)
Rare (>1/10,000, <1/1,000)
Very rare (<1/10,000)
Post-marketing adverse reactions are reported
voluntarily from a population with an unknown
rate of exposure. Therefore it is not possible to
estimate the true incidence of adverse reactions
and the frequency is “unknown”.
Tabulated summary of adverse reactions
SYSTEM
ORGAN CLASS
(SOC)
FREQUENCY ADVERSE
REACTION
Immune system
disorders
Unknown Hypersensitivity
Gastrointestinal
disorders
Unknown Nausea, mild
diarrhoea
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is
important. It allows continued monitoring of the
benefit/risk balance of the medicinal product.
4.9 Overdose

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Initial symptoms of iron overdosage include
nausea, vomiting, diarrhoea, abdominal pain,
haematemesis, rectal bleeding, lethargy and
circulatory collapse. Hyperglycaemia and
metabolic acidosis may occur.
Treatment of overdosage
1. Administer an emetic.
2. Emesis should be followed by gastric lavage
with desferrioxamine solution (2g/l).
Desferrioxamine 5g in 50ml to 100ml water
should be introduced into the stomach following
gastric emptying.
3. Keep the patient under constant surveillance
to detect possible aspiration of vomitus.
Maintain suction apparatus and standby
emergency oxygen in case of need.
4. In adults, a drink of mannitol or sorbitol
should be given to induce small bowel
emptying. Inducing diarrhoea in children may be
dangerous and should not be undertaken in
young children.
5. Severe poisoning: in the presence of shock
and/or coma with high serum iron levels (adults
>142μmol/l, children >90μmol/l), immediate
supportive measures should be introduced.
Desferrioxamine should be given by slow iv
infusion (adults 5mg/kg/h, children 15mg/kg/h).
The maximum dose is 80mg/kg/24h. Warning:
hypotension may occur if the infusion rate is too
rapid.
6. Less severe poisoning: im desferrioxamine
should be administered (adults 50mg/kg to a
maximum of 4g, children 1g 4 to 6 hourly).
Serum iron levels should be monitored
throughout.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Iron preparations
After absorption, elemental iron is available for
haemoglobin regeneration and reversal of
anaemia associated with iron-deficient states.
5.2 Pharmacokinetic properties
Sodium Feredetate is not an iron salt as it
contains iron in an un-ionised form. In this
compound the iron is “insulated” or
“sequestered” with the sodium salt of
ethylenediamine tetra-acetic acid (EDTA) to
form a chelate. This accounts for the fact that
Sodium Feredetate is not astringent and does not
discolour teeth. Studies using radioactive tracers
have shown that the iron chelate is split within
the gastro-intestinal tract, releasing elemental
iron which is absorbed and rendered available
for haemoglobin regeneration.
Iron absorption is enhanced in iron-deficiency
states. Post-absorption distribution of elemental
iron is as follows: 60% to 70% is incorporated
into haemoglobin and most of the remainder is
present in storage forms, either as ferritin or
haemosiderin, in the reticulo-endothelial system
and to a lesser extent, hepatocytes. A further 4%
is present in myoglobin and haeme-containing
enzymes, or bound to transferrin in plasma.
Excretion is mainly in the faeces.
EDTA passes through the body unchanged. The
compound is poorly absorbed, and that which
reaches the bloodstream is eliminated by both
glomerular filtration and tubular excretion.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the
prescriber which are additional to that already
included in other sections of the Summary of
Product Characteristics.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate (E216)
Saccharin Sodium
Glycerol
Sorbitol liquid (E420)
Ethanol
Black cherry flavour
Ponceau 4R (E124)
Citric acid monohydrate
Water

4. SodiumFered etate 190mg/5ml Oral Solution SMPC, Taj Phar mac euticals
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6.2 Incompatibilities
None known.
6.3 Shelf life
Unopened: 3 years.
Opened: 3 months from date of opening
6.4 Special precautions for storage
Store in the original package in order to protect
from light.
6.5 Nature and contents of container
Amber glass bottle with a white child resistant
tamper evident plastic cap. Each bottle contains
500ml of Sodium Feredetate oral solution.
6.6 Special precautions for disposal and other
handling
None.
7. MANUFACTURER:
Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad
438225, Gujarat, INDIA