Maltofer Syrup

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Iron polymaltose 37 mg/mL equivalent to iron 10mg/mL

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Dosage:

10 mg/mL

Pharmaceutical form:

Syrup

Composition:

Active: Iron polymaltose 37 mg/mL equivalent to iron 10mg/mL Excipient: Cream flavour 225082 Ethanol Methyl hydroxybenzoate Propyl hydroxybenzoate Purified water Sodium hydroxide Sorbitol Sucrose

Prescription type:

Pharmacy only

Therapeutic indications:

Treatment of iron deficiency in adults and adolescents where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate. Prevention of iron deficiency in adults and adolescents at high risk where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, brown coloured with child resistant screw cap - 150 mL - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2017-01-25

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
MALTOFER
®
TABLETS
MALTOFER
®
SYRUP
MALTOFER
®
DROPS
MALTOFER
®
PRODUCTS contain iron as iron polymaltose, an iron carbohydrate
compound.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about MALTOFER
®
. It does not contain all the
available information. This does not replace talking with your medical
practitioner or pharmacist.
All medicines have risks and benefits. Your medical practitioner or
pharmacist has weighed the
risks of you taking MALTOFER
®
against the benefits this medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR MEDICAL
PRACTITIONER OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT IS MALTOFER
®
MALTOFER is a medicine that is used in the treatment of iron
deficiency in adolescents and
adults where the use of ferrous iron supplements is not tolerated, or
otherwise inappropriate.
It contains iron in the form of iron polymaltose, an iron carbohydrate
compound.
Iron is an essential element required for the oxygen-carrying capacity
of haemoglobin (the red
pigment in red blood cells) and of myoglobin (the red pigment in
muscle tissue). Moreover, iron
plays an important role in many other vital processes in the human
body.
WHAT MALTOFER IS USED FOR
MALTOFER
®
is used for the treatment of iron deficiency in adults and adolescents
where the
use of ferrous iron supplements is not tolerated, or otherwise
inappropriate.
MALTOFER
®
is used for the prevention of iron deficiency in adults and
adolescents at high risk
where the use of ferrous iron supplements is not tolerated, or
otherwise inappropriate.
BEFORE YOU TAKE MALTOFER
®
WHEN YOU MUST NOT TAKE IT
−
if you are hypersensitive (allergic) to iron polymaltose or any of the
other ingredients in
MALTOFER
®
tablets or oral liquid.
Symptoms of an allergic reaction may include:
•
rash, itching, hives on the skin
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or other parts of the body
�

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Maltofer 2023-02-06 MAL_NZ_Data Sheet
Page 1 of 12
1 MALTOFER® 100 MG TABLETS AND 50 MG/5 ML SYRUP
MALTOFER® TABLETS 100 mg tablets
MALTOFER® SYRUP 50 mg/5 mL syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
MALTOFER® TABLETS contains 100 mg iron as iron polymaltose as the
active ingredient.
MALTOFER® SYRUP contains 50 mg/5 mL iron as iron polymaltose as the
active ingredient.
MALTOFER®
SYRUP,
oral
liquid
contains
the
excipients
methyl
hydroxybenzoate
and
propyl
hydroxybenzoate which may cause allergic reactions (possibly delayed).
MALTOFER® SYRUP, oral liquid contains sorbitol and sucrose. Patients
with rare hereditary problems
of fructose intolerance, glucose-galactose malabsorption or
sucrase-isomaltase insufficiency should
not take this medicine.
MALTOFER® SYRUP, oral liquid contains small amounts of ethanol, 3.25
mg/ml.
For the full list of excipients, see section 6.1 List of excipients.
Iron polymaltose is a polynuclear iron(III)-hydroxide core surrounded
by polymaltose and has a
molecular weight of about 50kD.
3 PHARMACEUTICAL FORM
MALTOFER® TABLETS are film-coated, reddish brown, round and biconvex
tablets. Tablets cannot be
halved.
MALTOFER® SYRUP, oral liquid is a dark brown solution.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of iron deficiency in adults and adolescents where the use
of ferrous iron supplements is
not tolerated, or otherwise inappropriate.
Prevention of iron deficiency in adults and adolescents at high risk
where the use of ferrous iron
supplements is not tolerated, or otherwise inappropriate.
4.2
Dose and method of administration
Dose
The dosage and duration of treatment depend upon the extent of iron
deficiency. The daily dose can
be divided into separate doses or can be taken at once. MALTOFER®
should be taken during or
immediately after a meal.
Doses below 100 mg iron cannot be achieved with MALTOFER® TABLETS. In
cases where lower doses
are required, MALTOFER® SYRUP should be used.
NEW ZEALAND DATA SHEET
Maltofer 2023-02-06 MAL_