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FEOSPAN SPANSULE CAPSULES

Active substance(s): DRIED FERROUS SULPHATE / DRIED FERROUS SULPHATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Feospan Spansule Capsules

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Ferrous sulfate ……………………………………….………150.0 mg
equivalent to elemental iron…………….…………………….47 mg
Excipients with known effect
Sucrose ………………………………………..…………….105.9 mg
E110 (Sunset Yellow)*
* as contained within Green Lake 180790
(aluminium lakes of E132, E110 and E104)...............................2.1 mg
For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM
"Spansule" Capsules.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Prevention and treatment of iron deficiency.

4.2

Posology and method of administration

Method of administration
Oral

The capsules should not be sucked, chewed or kept in the mouth, but swallowed
whole with water. Capsules should be taken before meals or during meals, depending
on gastrointestinal tolerance.
Dosage
Adults: one capsule per day. In more severe cases 2 capsules a day may be required.
Elderly patients: dosage as above.
Children over 1 year: 1 capsule a day.
The capsule may be opened and the pellets mixed with soft, cool food, but they must
not be chewed.
Treatment should continue for at least 3 months after correction of anaemia and then
be reviewed.
4.3

Contraindications
Hypersensitivity to any ingredients in the formulation; patients receiving
repeated blood transfusions; concomitant parenteral iron; haemochromatosis
and other iron overload syndromes.

4.4

Special warnings and precautions for use

Administer with caution in patients with haemolytic anaemia, haemoglobinopathies,
iron storage or iron absorption diseases, existing gastrointestinal disease.
Due to the risk of mouth ulcerations and tooth discolouration, capsules should not
be sucked, chewed or kept in the mouth, but swallowed whole with water.
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.
This product contains sucrose. Patients with rare hereditary problems of galactose
intolerance or fructose intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this medicinal
product.
Failure to respond to treatment may indicate other causes of anaemia and
should be further investigated.
This medicine contains sunset yellow (E110), which may cause allergic reactions
4.5

Interaction with other medicinal products and other forms of interaction
Concurrent administration with tetracyclines may impair absorption of both
agents.

The absorption of ciprofloxacin, norfloxacin and ofloxacin and
bisphosphonates is reduced by oral iron. Cholestyramine may bind iron to the
gastrointestinal tract, thus preventing its absorption.
The absorption of iron salts is also decreased in the presence of antacids,
preparations containing zinc, calcium, phosphorus, trientine, or when taken
with tea, coffee, milk, eggs and whole grains.
Iron supplements should not be taken within one hour before or two hours
after ingestion of these products.
Iron salts may reduce the bioavailability of methyldopa. The absorption of
levodopa and penicillamine may be reduced. Absorption of iron salts is
enhanced by ascorbic acid and meat.
Dimercaprol: Avoid the concomitant use of iron with dimercaprol.
Thyroid hormones: Oral iron reduces the absorption of levothyroxine
(thyroxine) thus should be given at least 2 hours apart.
4.6

Pregnancy and lactation
Ferrous salts are recommended for use in pregnancy and lactation, and no
contraindications to such are known.

4.7

Effects on ability to drive and use machines
None known

4.8

Undesirable effects

Although iron preparations are best absorbed on an empty stomach, they may be
taken after food to reduce gastrointestinal side-effects. Large doses may produce
gastrointestinal irritation, nausea, vomiting, epigastric pain, diarrhoea.
The following ADRs have been reported during post-marketing surveillance. The
frequency of these reactions is considered not known (cannot be estimated from
the available data).
Gastrointestinal disorders:
Mouth ulceration:
In the context of incorrect administration, when the capsules are chewed, sucked or
kept in mouth.
Elderly patients and patients with deglutition disorders may also be at risk of
oesophageal lesions or of bronchial necrosis, in case of false route.
Constipation may be caused by continual administration, particularly in older
patients, and may lead to faecal impaction.
Iron supplementation may cause the blackening of stool.
Feospan Spansule Capsules are designed to reduce the possibility of
gastrointestinal irritation.

Hypersensitivity reactions have been reported. These range from rashes, sometimes
severe, to anaphylaxis.
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. Healthcare professionals are asked to report any suspected
adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
Acute iron overdosage can be divided into four stages.
In the first phase, which occurs up to 6 hours after oral ingestion,
gastrointestinal toxicity, notably vomiting and diarrhoea predominates. Other
effects may include cardiovascular disorders such as hypotension and
tachycardia, metabolic changes including acidosis and hyperglycaemia, and
CNS depression ranging from lethargy to coma. Patients with only mild to
moderate poisoning do not generally pass this first phase.
The second phase may occur at 6-24 hours after ingestion and is characterised
by a temporary remission or clinical stabilisation.
In the third phase, gastrointestinal toxicity recurs together with shock,
metabolic acidosis, convulsions, coma, hepatic necrosis and jaundice,
hypoglycaemia, coagulation disorders, oliguria or renal failure and pulmonary
oedema.
The fourth phase, may occur several weeks after ingestion and is characterised
by gastrointestinal obstruction and possibly late hepatic damage.
The sustained-release “spansule” capsule presentation of ferrous sulfate may
delay excessive absorption of iron and allow more time for initiation of
appropriate countermeasures.
Overdosage of ferrous salts is particularly dangerous to young children.
Treatment consists of gastric lavage followed by the introduction of 5g
desferrioxamine into the stomach. Serum iron levels should be monitored and
in severe cases iv desferrioxamine should be given together with supportive
and symptomatic measures as required.
Gastric lavage with 5% sodium bicarbonate and saline cathartics (e.g. sodium
sulfate 30g for adults); milk and eggs with 5g bismuth carbonate every hour as
demulcents. Blood or plasma transfusion for shock, oxygen for respiratory
embarrassment. Chelating agents (e.g. disodium calcium edetate) may be tried
(500mg/500ml by continuous iv infusion). Dimercaprol should not be used
since it forms a toxic complex with iron.
Desferrioxamine is a specific iron chelating agent and severe acute poisoning
in infants should always be treated with desferrioxamine at a dose of 90mg/kg

im followed by 15mg/kg per hour iv until the serum iron is within the plasma
binding capacity.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC CODE: B03A A07
Ferrous sulfate is used in the treatment of iron deficiency anaemias.
Iron preparations have no intrinsic therapeutic activity except as a nutrient
source: their use without evidence of iron deficiency, or reasonable
expectation of its occurrence, is to be deprecated. Excessive iron is toxic and
haemochromatosis can result from chronic injection of iron preparations used
as tonics, especially in individuals with undiagnosed blood disorders. Patients
with chronic anaemia are particularly at risk from iron storage disease.
Recently a severe iron overload myopathy has been described in patients given
prophylactic iron indiscriminately while receiving haemodialysis. Genetic
factors probably contribute to the risk of an iron storage disease.
It should be clear that although iron deficiency is easily treated, its detection
does not constitute a complete diagnosis. Every effort should be made to
determine why the patient has a state of negative iron balance. Attention
should be given to hidden sources of haemorrhage (which may indicate serious
urinary or gastrointestinal conditions) and also the possibility of malabsorption
of iron caused by latent disease of the small intestine.

5.2

Pharmacokinetic properties
The product is formulated to avoid iron release in the stomach where gastric
irritation may be caused.
Iron is irregularly and incompletely absorbed from the gastrointestinal tract,
the main sites of absorption being the duodenum and the jejunum. Absorption
is aided by the acid secretion of the stomach or by dietary acids and is more
readily affected when the iron is in the ferrous state or is part of the haem
complex (haem-iron unit).
Absorption is also increased in conditions of iron deficiency or in the fasting
state but decreased if the body stores are overloaded. Around 5-15% of the
iron ingested in food is absorbed. Following absorption, the majority of iron
is bound to transferrin and transported to the bone marrow where it is
incorporated into haemoglobin. The remainder is stored within ferritin or
haemosiderin or is incorporated into myoglobin with smaller amounts
occurring in haem-containing enzymes or in plasma bound to transferrin. Only
very small amounts are excreted as the body reabsorbs the iron after the
haemoglobin has broken down.

5.3

Preclinical safety data

Not applicable.
6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Maize Starch EP
Talc EP
Kaolin Heavy EP
Sucrose EP
Gelatin BP
Titanium Dioxide (E171)
Red Iron Oxide (E172)
Povidone 30 BP
Glyceryl monostearate HSE
White beeswax USP
Green Lake 180790
(Aluminium Lakes of E132, El10 and E104)
Hard Gelatin Capsules
Erythrosine (E127)
Patent Blue V (E131)
Gelatin BP

6.2

Incompatibilities
None known.

6.3

Shelf life
60 months (all pack sizes).

6.4

Special precautions for storage
Store in a dry place at a temperature below 25°C.

6.5

Nature and contents of container
Standard Securitainers in packs of 30 and 250 capsules.
Blister packs of PVC/aluminium foil (with secondary perforated paper layer)
of 15 and 30 capsules.

6.6

Instructions for use/handling

Not applicable.

7

MARKETING AUTHORISATION HOLDER
Intrapharm Laboratories Limited
The Courtyard Barns
Choke Lane
Cookham Dean
Maidenhead
Berkshire SL6 6PT
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 17509/0009

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/01/2005

10

DATE OF REVISION OF THE TEXT
10/01/2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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