MALTOFER CHEWABLE TABLET

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

IRON

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

IRON

Units in package:

30 Tablets

Manufactured by:

Corden Pharma Fribourg SA

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
MALTOFER
_® _
CHEWABLE TABLET
Iron (100mg)
WHAT IS IN THIS LEAFLET
1.
What
Maltofer®
Chewable
Tablet is used for
2.
How
Maltofer®
Chewable
Tablet works
3.
Before
you
use
Maltofer®
Chewable Tablet
4.
How
to
use
Maltofer®
Chewable Tablet
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MALTOFER® CHEWABLE TABLET
IS USED FOR
Maltofer® Chewable Tablet is used to
treat iron deficiency without or with
anemia(lack of red blood cells). It is
also used as prevention therapy during
pregnancy to avoid iron deficiency
HOW
MALTOFER®
CHEWABLE
TABLET
WORKS
Maltofer® Chewable Tablet contains
iron
which
is
used
to
help
in
the
formation and function of red blood
cells.
BEFORE YOU USE MALTOFER® CHEWABLE
TABLET
-
_Do not take this medicine if you: _
_ _
•
are allergic to iron or to any of
the other ingredients (listed in
product description)
_ _
•
have iron overload in the body
•
have iron utilisation disorders
•
have
anaemia
which
is
not
caused
by
iron
deficiency
because Maltofer® Chewable
Tablet will not be effective.
_ _
_Before you start to use it _
•
Your
doctor
will
want
to
monitor the progress of your
treatment with periodic follow-
up examinations and may even
carry out blood tests. This is
normal and should not alarm
you.
•
Tell your doctor or pharmacist
before
taking
Maltofer®
Chewable Tablet if you have an
infection or a tumour.
_ _
_ _
_Pregnancy and lactation _
•
Please consult your doctor or
pharmacist if you are pregnant,
planning
for
pregnancy
or
breast-feeding before using any
medicine.
-
_Taking other medicine _
•
Tell your doctor or pharmacist
if
you
have
recently
been
treated
with
injectable
iron
preparations
or
might
be
treated with these. Using such
iron preparations at the same
time as Maltofer® Chewable
Tablet is not recommended.
•
Tell
your
doctor
if
you
are
taking
any
other
medicines,
including
any
that
you
buy
wi

Summary of Product characteristics

PRODUCT
Maltofer Chewable tablets
COUNTRY
Malaysia
MANUFACTURER
VIF
SAP NUMBER
3005247-04S
MIN. VER.: 02
MANUFACTURER IDENTIFICATION NUMBER
n/a
FONTS
Helvetica (min. 9 pt)
DIMENSIONS
180 x 320 mm
COLOURS/FLATS
Black
NON-PRINTED COLOURS
Dye Cut
ID:
2304-040
3005247-04
Chewable tablets
Pharmaceutical form: chewable tablets, chocolate flavour
Qualitative and quantitative composition
Each chewable tablet contains 100 mg of iron as iron(III)-hydrox-
ide polymaltose complex (IPC).
Excipients: microcrystalline cellulose, cocoa, sodium cyclamate,
polyethylene glycol 6000, talc, vanillin, dextrates, chocolate
essence.
Properties
Pharmacotherapeutical group: iron preparation.
ATC Code: B03AB05
In the iron(III)-hydroxide polymaltose complex, the polynuclear
iron(III)-hydroxide core is superficially surrounded by a number of
non-covalently bound polymaltose molecules resulting in an over-
all average molecular weight of approximately 50 kDa. The polynu-
clear core of IPC has a structure similar to that of the physiological
iron storage protein, ferritin. IPC is a stable complex and does not
release large amounts of iron under physiological conditions.
Because of its size, the extent of diffusion of IPC through the mem-
brane of the mucosa is about 40 times less than that of the hexa-
quo-iron(II) complex. Iron from IPC is taken up in the gut via an
active mechanism.
Therapeutic Indications
Treatment of iron deficiency without anaemia and iron deficiency
anaemia. Prophylactic therapy of iron deficiency during pregnancy.
Posology
Dosage and duration of therapy are dependent upon the extent of
iron deficiency.
Treatment of iron deficiency anaemia in children over 12 years and
adults:
100 mg to 300 mg iron (1–3 chewable tablets) daily for 3–5 months
until normalisation of the haemoglobin value is achieved. After-
wards, the therapy should be continued for several weeks with 1
chewable tablet daily to replen- ish the iron stores.
Treatment of iron deficiency anaemia in pregnancy:
200 mg to 300 mg iron (2–3 tablets) daily un