MALTOFER Syrup

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

iron polymaltose, Quantity: 37 mg/mL (Equivalent: iron, Qty 10 mg/mL)

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Iron polymaltose

Pharmaceutical form:

Oral Liquid

Composition:

Excipient Ingredients: propyl hydroxybenzoate; purified water; sorbitol solution (70 per cent) (non-crystallising); ethanol; sucrose; sodium hydroxide; methyl hydroxybenzoate; Flavour

Administration route:

Oral

Units in package:

150 mL

Prescription type:

(S2) Pharmacy Medicine

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:

Visual Identification: Dark brown solution; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-11-14

Patient Information leaflet

1
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

MALTOFER
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION MALTOFER
® (IRON
POLYMALTOSE) TABLETS, SYRUP AND DROPS
1. NAME OF THE MEDICINE
Iron polymaltose (AAN)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MALTOFER
®
TABLETS
contain 100 mg iron as iron polymaltose as the active
ingredient.
MALTOFER
®
SYRUP, oral liquid contains 50 mg/5 mL iron as iron polymaltose as
the active ingredient. The oral solution also contains methyl
hydroxybenzoate, propyl
hydroxybenzoate, sorbitol solution (70%) (non-crystallising), and
sucrose.
MALTOFER
®
DROPS, oral liquid contains 50 mg/mL iron as iron polymaltose as the
active
ingredient.
The
oral
liquid
also
contains
sucrose,
sodium
methyl
hydroxybenzoate and sodium propyl hydroxybenzoate.
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. It is stable and highly
water-soluble over a
broad pH range, and, unlike simple iron(III)-oxide or
iron(III)-hydroxide, does not
precipitate even in an alkaline environment.
3. PHARMACEUTICAL FORM
MALTOFER
®
TABLETS are film-coated, reddish brown, round and biconvex tablets.
MALTOFER
®
SYRUP, oral liquid is a dark brown solution.
MALTOFER
®
DROPS, 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.
MALTOFER
Page 2 of 17
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 DOSAGE AND METHOD OF ADMINISTRATION
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