You are on page 1of 2

10-14

FEROSE -F
Spimaco
Iron III hydroxide polymaltose complex & folic acid
For Iron and folic acid deficiencies

The folic acid content corresponds to the recommendation of the WHO.

QUALITATIVE AND QUANTITATIVE


COMPOSITION:
Each chewable or swallowable tablet contains
100mg of iron as Iron III (Ferric) hydroxide polymaltose complex (IPC) plus 350mcg of folic acid.

Pharmacokinetic properties:
The highest absorption of iron is in the duodenum
and jejunum. The iron of IPC is absorbed by a controlled mechanism.
The absorbed iron is used in the bone marrow for
Hb synthesis or is stored mainly in liver, bound to
ferritin. Iron that is not absorbed is excreted via the
feaces.
Folic acid is mainly absorbed in the small intestine,
particularly in the duodenum and jejunum. The highest concentration in the blood is reached within 30
to 60 minutes. Folic acid is metabolized in the intestinal and hepatic cells, among others. These folates
bound to transport proteins, are then distributed to
all organs. Elimination occurs via the kidneys and
also via gastrointestinal tract.

CLINICAL PARTICULARS:
Therapeutic Indications:
Prevention of iron and folic acid deficiency and treatment of latent and manifest iron and folic acid deficiency before, during pregnancy and after pregnancy (during lactation).
POSOLOGY AND METHOD OF
ADMINISTRATION:
Treatment of manifest iron deficiency in pregnancy:
2-3 tablets daily until normalisation of hemoglobin
value is achieved.
Afterwards, the therapy should be continued with
1 tablet daily at least until the end of pregnancy to
replenish iron stores.
Treatment of latent iron deficiency and prevention of
iron and folic acid deficiency: 1 tablet per day.
The daily dose can be divided into separate doses
or can be taken at once. Ferose-F should be taken
during or immediately after a meal.
Ferose-F tablets can be chewed or swallowed
whole.
PHARMACOLOGICAL PROPERTIES:
Pharmacodynamic properties:
Iron polymaltose, the active iron ingredient of
Ferose-F tablets is essentially non-ionic; therefore, it
has the following properties unlike ionised iron salt
preparations:
It does not give rise to irritation of the intestinal
mucosa and does not stain the teeth.
It has palatable, non metallic taste (chocolate flavor).
It has excellent tolerance.

CONTRAINDICATIONS:
Known hypersensitivity to IPC, folic acid or any of
the excipients.
Iron overload (haemochromatosis, haemosiderosis).
Disturbances in iron utilization (lead anemia,
thalassaemia).
Megaloblastic anemia due to vitamin B12 deficiency.
Patients with phenylketonuria.
SPECIAL WARNING & SPECIAL PRECAUTION
FOR USE:
As with all oral iron preparations, a dark colouration
of the stool may occur, which is without clinical significance.
INTERACTION WITH OTHER MEDICAL
PRODUCTS AND OTHER FORMS OF
INTERACTION:
There is no interaction between iron polymaltose
and food or drugs due to its non-ionic nature.
SPIMACO-FEROSE -F - p.1/2

SPIMACO-FEROSE -F - p.2/2

Concomitant administration of parenteral and oral


iron must be avoided since the absorption of oral
iron would be inhibited drastically.
Folic acid therapy may increase phenytoin metabolism, resulting in decreased phenytoin serum concentrations, particularly in folate deficient patients.
Although this interaction is not usually clinically
important, an increase in seizure frequency may
occur in some patients. Anyone taking phenytoin or
other anti-convulsant medication should consult with
medical doctor before taking a folic acid supplement.
It has been reported that the concurrent administration of chloramphenicol and folic acid in folatedeficient patients may result in antagonism of the
haematopoietic response to folic acid. Although the
importance and mechanism of the interaction is
unclear, the haematologic response to folic acid in
patients receiving both drugs should be carefully
monitored.
PREGNANCY AND LACTATION:
Embryo-foetal toxicity studies of IPC in animals did
not reveal any foetal risk. Based on these animal
studies, there is no evidence of a risk during the first
trimester. Studies in pregnant women after the first
trimester have not shown any undesirable effect of
IPC or IPC plus folic acid on mothers and/or neonates. Therefore a negative influence on the foetus
is unlikely with the administration of Ferose-F.
Human breast milk normally contains iron, which
is bound to lactoferrin. The amount of iron passing
from the complex to the mothers milk is unknown.
It is unlikely that the administration of Ferose-F in
women who are breast-feeding causes undesirable
effects to the infant.
EFFECT ON ABILITY TO DRIVE AND USE
MACHINES:
Ferose-F has no or negligible Influence on the ability
to drive and use machines>
UNDESIRABLE EFFECTS:
The safety and tolerability of IPC with Folic acid has
been evaluated in numerous clinical trials and published reports.
The principal adverse reactions that have been
reported were:

Gastrointestinal disorders: very rare (less than


1/10000) abdominal pain, constipation, diarrhea,
nausea, dyspepsia, and vomiting.
Skin and subcutaneous tissue disorders: very
rare(less than 1/10000): urticaria, rash, and pruritus.
OVERDOSE:
In case of overdose, iron overload or intoxication are
unlikely with Ferose-F due to the low toxicity of IPC
and controlled iron uptake. No cases of accidental
poisoning with fatal outcome have been reported.
It has been reported that an excessive dose of folic
acid may cause central nervous system changes
(namely changes in mental state, altered sleep pattern, irritability, and hyperactivity), nausea, and flatulence.
PHARMACEUTICAL PARTICULARS:
List of excipients
Polyethylene Glycol, Aspartame, Purified Talc,
Chocolate Essence Powder, Ethanol 96%, Emdex
STORAGE:
Store below 25C.
AVAILABILITY:
Ferose-F is available as 100mg of iron as Iron III
(Ferric) hydroxide polymaltose complex (IPC) plus
350mcg of folic acid in chewable or swallowable
tablets formulation.
Revision date: December 2009.