MALTOFER SYRUP

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:

150 ml

Manufactured by:

Corden Pharma Fribourg SA

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
MALTOFER
_ ® _
SYRUP
Iron (10mg/ml)
WHAT IS IN THIS LEAFLET
1.
What Maltofer® Syrup
_ _
is used
for
2.
How Maltofer® Syrup
_ _
works
3.
Before you use Maltofer® Syrup
4.
How to use Maltofer® Syrup
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Maltofer® Syrup
_ _
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MALTOFER® SYRUP IS USED FOR
Maltofer® Syrup is used to treat iron
deficiency without and with anaemia
(lack of red blood cells). It is also used
as
prevention
therapy
during
pregnancy
to
avoid
iron
deficiency
HOW MALTOFER® SYRUP WORKS
Maltofer® Syrup contains iron which
plays
a
role
in
the
formation
and
function of red blood cells.
BEFORE YOU USE MALTOFER® SYRUP
-
_When you must not use it _
Do not take this medicine
•
if you are allergic to iron (III)
hydroxide polymaltose complex
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
_ _
-
_Before you start to use it _
_ _
•
Your
doctor
will
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® Syrup if
you have an infection or a tumour.
•
Tell
your
doctor
if
you
are
diabetic. One mL of Maltofer®
Syrup
contains
200
mg
of
sucrose. Sucrose can be harmful
to the teeth.
_ _
_ _
_Pregnancy and lactation _
_ _
•
Please
consult
your
doctor
or
pharmacist if you are pregnant,
planning for pregnancy or breast
feeding
before
using
any
medicine.
•
Before
you
start
taking
Maltofer® Syrup, a doctor should
confirm
the
blood’s
iron
and
haemoglobin
levels
using
appropriate tests.If the symptoms
are not caused by iron deficiency,
Maltofer®
Syrup
will
not
be
effective.
-
_Taking other medicine _
Tell your doctor or pharmacist if you
h

Summary of Product characteristics

PRODUCT
Maltofer 150 Syrup
COUNTRY
Malaysia
MANUFACTURER
VIF
SAP NUMBER
3005249-04S
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:
2304-044
3005249-04
Syrup
Pharmaceutical form: oral solution, cream flavour
Qualitative and quantitative composition
1 ml contains 10 mg of iron as iron (III)-hydroxide polymaltose
complex (IPC)
Excipients: purified water, sorbitol solution (70%), sucrose, etha-
nol (96%), cream essence, methyl hydroxybenzoate (E218), pro-
pyl hydroxybenzoate (E216) and sodium hydroxide.
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 poly-
nuclear core of IPC has a structure similar to that of the physiolog-
ical 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.
_Iron deficiency anaemia:_ the therapy takes about 3–5 months until
a normalisation of the haemoglobin value is achieved. Afterwards
the therapy should be continued for several weeks or for pregnant
women, at least until the end of the pregnancy with a dosage such
as described for iron deficiency without anaemia to replenish the
iron stores.
_Iron deficiency without anaemia:_ the therapy takes about 1–2
months.
Method