Consumer medicine information

Maltofer

Iron polymaltose complex

BRAND INFORMATION

Brand name

Maltofer

Active ingredient

Iron polymaltose complex

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Maltofer.

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
  • if you have anaemia not caused by iron deficiency.
  • if you have iron overload (too much iron in your body) or disturbances in utilisation of iron.
  • if you are under the age of 12 years
  • if the package is torn or shows signs of tampering.
  • if the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should be taking MALTOFER®, talk to your medical practitioner or pharmacist.

BEFORE YOU START TO TAKE MALTOFER®

You must tell your medical practitioner or pharmacist if

  • you have or have had an infection or tumour
  • you are pregnant, plan to become pregnant or you are breastfeeding
  • you have or have had any other health problems.

Taking other medicines

Tell your medical practitioner or pharmacist if you are taking any other medicines, including any that you have bought with a prescription or any without a prescription from a pharmacy, supermarket or health food shop.

The following medicine can affect the absorption of MALTOFER®:

  • Injectable iron medicines. If you are treated with injectable iron medicines, you should not take MALTOFER® in addition to that therapy.

HOW TO TAKE MALTOFER®

How much to take

Always take MALTOFER® exactly as your medical practitioner or pharmacist has told you. You should check with your medical practitioner or pharmacist if you are not sure.

MALTOFER® Tablets contain 100 mg iron and should not be divided to take lower doses than 100 mg iron. In cases where lower doses are required, MALTOFER® oral liquid forms (Syrup or Drops) should be used.

Treatment of iron deficiency in adults and adolescents (Children ≥ 12 years) where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate, take 100 mg to 200 mg iron (1 to 2 tablets, 10 - 20 mL syrup, or 40-80 drops) daily preferably with food, or higher doses as directed by your medical practitioner.

Prevention of iron deficiency in adults and adolescents (Children ≥ 12 years) at high risk where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate, take 100 mg iron (1 tablet, 10 mL syrup, or 40 drops) daily preferably with food, or higher doses as directed by your medical practitioner.

You should consult your medical practitioner regularly to monitor your iron status (e.g. serum ferritin levels) during therapy.

When to take it

Take MALTOFER® during or immediately after a meal. The daily dose of MALTOFER® can be taken at once or divided into separate doses.

How to take it

MALTOFER® Tablets should be taken with a glass of water. MALTOFER® Tablets should be swallowed whole.

MALTOFER® DROPS and SYRUP: liquid can be mixed with fruit and vegetable juices. Any discolouration of the mixture does not affect the taste of the juices or the effectiveness of MALTOFER®.

To ensure accurate dosing of MALTOFER® DROPS, the bottle needs to be held upright. The drops should flow immediately. If this does not happen, tap the bottle gently until a drop forms. Do not shake the bottle.

How long to take it

This is recommended by the medical practitioner and depends upon the degree of iron deficiency.

Do not discontinue sooner than recommended as this may reduce the success of therapy.

If you forget to take it

Take the next dose at the usual time. Do not take a double dose to compensate for the forgotten dose. If you have any further questions on the use of this product, ask your medical practitioner or pharmacist.

If you take too much (overdose)

Immediately telephone your medical practitioner, or:

  • In Australia - Poisons Information Centre (telephone 13 11 26)
  • In New Zealand - The National Poisons Centre (telephone 0800 POISON or 0800 764 766),

or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much MALTOFER®. Do this even if there are no signs of discomfort or poisoning.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your medical practitioner or pharmacist.

WHILE YOU ARE TAKING MALTOFER®

Things you must do

Tell all medical practitioners, dentists and pharmacists who are treating you that you are taking MALTOFER®.

Tell your medical practitioner if you become pregnant while taking MALTOFER®.

Visit your medical practitioner regularly while you are on this therapy to monitor your iron status. If symptoms persist, consult your medical practitioner.

Things you must not do

Do not stop taking MALTOFER® or change the dose without first checking with your medical practitioner or pharmacist.

Do not give MALTOFER® to anyone else even if they have the same condition as you.

Do not use MALTOFER® to treat other complaints unless your medical practitioner or pharmacist says to.

Do not take any other medicines whether they require a prescription or not without first telling your medical practitioner or consulting a pharmacist.

Things to be careful of

Be careful driving or operating machinery until you know how MALTOFER® affects you. However, MALTOFER® has no or negligible influence on your ability to drive a car or operate machinery.

POSSIBLE SIDE EFFECTS

Like all medicines, MALTOFER® can cause side effects, although not everybody gets them.

Side effects can occur with the following frequency:

Very common, may affect more than 1 in 10 people

  • discoloured stool

Common, may affect up to 1 in 10 people

  • diarrhoea
  • nausea
  • indigestion
  • abdominal pain, discomfort or bloating
  • constipation

Uncommon, may affect up to 1 in 100 people

  • vomiting
  • tooth discolouration
  • gastritis
  • skin rash
  • itching
  • hives
  • redness of skin
  • headache

Rare, may affect up to 1 in 1000 people

  • muscle spasms
  • muscle pain

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your medical practitioner or pharmacist.

AFTER TAKING MALTOFER®

Storage

Keep MALTOFER® out of the reach and sight of children.

Do not use MALTOFER® after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Keep MALTOFER® tablets or oral liquid/drops in a cool dry place where the temperature stays below 25°C.

Do not store MALTOFER® tablets or oral liquid/drops or any other medicine, in a bathroom or near a sink.

Do not leave your medicine in the car or on window sills.

Disposal

If your medical practitioner tells you to stop taking MALTOFER®, or the tablets or adult oral liquid/drops have passed their expiry date, ask your pharmacist what to do with any that is left over.

PRODUCT DESCRIPTION

What it looks like

MALTOFER® Tablets are reddish brown, round and biconvex. They are supplied in aluminum blister packs of 30 or 100 (AUST R 229647).

MALTOFER® SYRUP, oral liquid is a dark brown solution in a 150 mL Type III brown glass bottle closed with a child resistant tamper-evident screw cap. A measuring cup for administration covers the screw cap. (AUST R 230643).

MALTOFER® DROPS, oral liquid is a dark brown solution in a 30 mL Type III brown glass bottle with child resistant tamper-evident screw cap and inserted dropper applicator. (AUST R 230644).

Not all presentations may be marketed.

Active ingredient

MALTOFER® Tablets: 100 mg iron as 370 mg iron polymaltose

MALTOFER® SYRUP, Oral liquid: 50 mg iron/5 mL as 185 mg iron polymaltose

MALTOFER® DROPS, Oral liquid: 50 mg iron/mL as 185 mg iron polymaltose

Inactive ingredients

MALTOFER® Tablets: crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, macrogol 6000, magnesium stearate, cellulose - microcrystalline and titanium dioxide.

MALTOFER® SYRUP, Oral liquid: cream flavour, ethanol, methyl hydroxybenzoate, propyl hydroxybenzoate, water-purified, sodium hydroxide, sorbitol solution (70%) non-crystallising and sucrose.

MALTOFER® DROPS, Oral liquid: water-purified, sucrose, cream flavour, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate and sodium hydroxide.

Supplied in Australia by:

Vifor Pharma Pty Ltd
Level 8, 80 Dorcas Street
South Bank, Melbourne VIC 3006
Australia
Tel: 1800 202 674

Supplied in New Zealand by:

Pharmacy Retailing
(trading as Healthcare Logistics)
58 Richard Pearce Drive,
Airport Oaks, Mangere 2022
New Zealand
Tel: 0800 996 312

This leaflet was prepared in August 2018

Published by MIMS May 2019

BRAND INFORMATION

Brand name

Maltofer

Active ingredient

Iron polymaltose complex

Schedule

S2

 

1 Name of Medicine

Iron polymaltose (AAN).

6.7 Physicochemical Properties

Chemical structure.

Iron polymaltose, the active substance of Maltofer, is a macromolecular complex in which polynuclear iron(III)-hydroxide is stabilized by polymaltose. It contains about 53% (m/m)* iron(III)-hydroxide, equivalent to about 27% (m/m) of iron, about 36% (m/m) polymaltose ligand, less than 6.4% (m/m) sodium chloride and less than 10% (m/m) of water.
*Mass fraction mass/mass.

CAS number.

53858-86-9.

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 50 kD. 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.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The polynuclear iron core of iron polymaltose is hypothesized to have a structure similar to that of the physiological iron storage protein ferritin. Iron polymaltose is a stable complex and does not release large amounts of iron under physiological conditions. Because of its size, the extent of diffusion of iron polymaltose through the membrane of the mucosa is about 40 times less than that of most water soluble iron(II) salts, existing in aqueous solution as hexaqua-iron(II) ion complex. Iron from iron polymaltose is taken up in the gut via an active mechanism.
The intended pharmacological action of iron polymaltose is to provide utilisable iron to target tissues. Iron polymaltose is effective in delivering iron across enterocytes to the iron transport protein transferrin and the iron storage protein ferritin. This iron is subsequently incorporated into haemoglobin during synthesis of red blood cells and thus facilitates correction of iron deficiency and anaemia.

Clinical trials.

The efficacy of Maltofer in normalising Hb and replenishing iron store levels has been demonstrated in several randomised, placebo or reference therapy controlled clinical trials conducted in adults and adolescents (greater than 12 years of age) with varying iron status.

Adults and adolescents.

Eleven controlled clinical studies have been performed with Maltofer in adult subjects, including 9 trials where Maltofer was compared to treatment with ferrous preparations, 2 placebo controlled trials, and one trial comparing Maltofer to no treatment. These trials included a total of approximately 900 subjects, with approximately 500 receiving Maltofer. The clinical data available for iron deficiency anaemia are up to 3 months of treatment, and up to 6 months of treatment for iron deficiency without anaemia.
No efficacy data is available related to Hb or serum ferritin concentrations after 6 months of Maltofer treatment in nonanaemic patients with iron deficiency.

Placebo controlled clinical trials in adults.

There were 2 placebo controlled trials that included a total of 91 subjects, of whom 37 received Maltofer chewable tablets.
In a randomised, placebo controlled, single blind study, Macintosh and Jacobs compared 56 days of treatment with Maltofer chewable tablets containing 100 mg iron twice daily versus placebo. The subjects were healthy males who had donated blood in the preceding 12 months. At the start of the study, subjects had normal Hb (≥ 135 g/L) and either normal (serum ferritin 50-150 nanogram/mL) or deficient (serum ferritin < 20 nanogram/mL) iron stores. Treatments were administered with food. A significant rise in Hb (from 143 to 150 g/L; p = 0.03) and repletion of body iron stores (rise in serum ferritin from 16.2 to 43.2 nanogram/mL; p = 0.002) was seen in iron deficient (ID) subjects (n = 11) treated with Maltofer. In ID subjects receiving placebo (n = 12), there was no statistically significant Hb change (143 to 149 g/L; p = 0.064), although a small but statistically significant rise in serum ferritin (16.7 to 27.3 nanogram/mL; p = 0.02) was observed. Neither placebo nor Maltofer produced a statistically significant change in Hb or serum ferritin in the non-ID control subjects. This study confirms that Maltofer will replenish iron stores in ID subjects, but not in non-ID subjects.
The second clinical trial primarily tested the hypothesis that the availability of iron influences lipid peroxidation. All male subjects (n = 45) with iron deficiency (serum ferritin ≤ 30 microgram/L and some exhibited hypochromic microcytic anaemia) were randomized into three parallel groups and treated with either, Maltofer, ferrous sulfate (FS), or placebo for 6 months, twice daily with meals. Subjects received 200 mg of iron/day as Maltofer chewable tablets, or 180 mg/day of iron as microcapsulated FS, or placebo. A 50 mg ascorbic acid tablet was taken together with the FS or placebo supplements. Three subjects in the FS group, and 2 in the Maltofer group reported stomach problems. In both groups, 1 subject discontinued treatment because of stomach problems, while for the three remaining, the dose was halved. When compared with the placebo, both FS and Maltofer treatments increased Hb, serum and erythrocyte ferritin levels. Hb increased in the Maltofer group (3.3 ± 2.2 g/L) and the FS group (1.5 ± 1.5 g/L) (Table 2). The increase in serum ferritin (a routine clinical diagnostic marker for anaemia) from baseline was significantly greater in the FS group (2.2-fold) than the Maltofer group (1.3-fold), whereas erythrocytic ferritin (diagnostic marker not routinely used in the clinical setting) increased similarly in both active treatment groups (+36% FS; +27% Maltofer) (Table 2).

Reference controlled studies.

In reference drug controlled studies, the efficacy of Maltofer compared to FS in adults with iron deficiency anaemia (IDA) indicate that FS is more efficient than Maltofer for this indication based on more efficient replenishment of depleted total body iron stores and shorter times to achieve normalization of Hb levels. Mean Hb levels at weeks 9 and 12 are similar for both treatment arms. However, there are limited comparative data on the proportion of subjects achieving normalization of Hb levels. No longer-term efficacy data was available for Maltofer in patients with IDA.

Short-term reference controlled studies (< 12 weeks duration).

In a double blind study, the efficacy and tolerability of Maltofer was compared with FS for the treatment of iron deficiency anaemia (IDA) in adults. 121 adults with IDA (defined as Hb 8.5-12.0 g/dL, MCH < 28 picogram and/or MCHC < 33 g/dL) were randomised to receive either Maltofer chewable tablets (100 mg iron twice daily [200 mg iron/day] with meals) or FS (60 mg iron three times daily [180 mg iron/day] 30 minutes before meals)] for 9 weeks. The intention to treat analysis (ITT) included 104 patients (52 patients in each group: 7 male, 45 female). In total, 89 patients completed the 9 week study, and 17 in the Maltofer group and 15 in the FS group discontinued before the end of the study. In total, 47 patients completed the study per protocol (PP). At week 9, Hb results for the two study arms for all patients in the 'all patients efficacy analysis' (i.e. ITT analysis) and 'patients in the PP analysis with at least 9 weeks treatment' are summarized in Table 3. At 9 weeks visit, the Hb levels were below the limit of normal range for 50% (20/40) treated with Maltofer compared with 29.5% (13/44) of patients treated with FS.

Reference controlled studies of ≥ 12 weeks duration.

In a single centre, open label, randomised, parallel group study, the efficacy and tolerability of oral Maltofer drops in comparison to ferrous sulfate syrup in the treatment of IDA was investigated. Eligible patients had normal laboratory results except for the IDA defined as (Hb < 136/120 g/L for men/ women; serum ferritin < 20 microgram/L). Subjects were assigned to one of the four treatment groups in which all received 100 mg of iron twice daily for 12 weeks: group 1 received Maltofer drops; group 2 received Maltofer drops with 0.9 mol/L glycerophosphate; group 3 received Maltofer drops with 1.8 mol/L glycerophosphate; and group 4 received an equivalent amount of iron as ferrous sulfate syrup. The ITT analysis included 143 subjects and 91 in the PP analysis. The endpoints were rate of Hb rise and increase in body iron stores reflected in serum ferritin concentration, as well as transferrin saturation. Secondary observations were changes in the proportion of hypochromic red cells during the course of treatment, erythropoietin levels and tolerability of the two formulations. Response in Hb (Table 4), MCV, MCH and red cell count increased to a similar extent in both treatment groups (differences not significant) (per protocol set). Higher serum ferritin was observed in the ferrous sulfate group than the three Maltofer groups. The most common adverse effect was gastrointestinal tract intolerance occurring significantly more frequently with FS than Maltofer (44.7% FS group compared to 8.6-17.5% with the Maltofer groups; p > 0.00002).
Jacobs et al, conducted a 12 week, randomised study with using Maltofer or FS treatment. Blood donors with overt IDA (n = 159) were randomly assigned to receive FS containing 60 mg iron twice daily (120 mg/day) in the fasting state (group 1); 100 mg/day of iron as Maltofer chewable tablets with breakfast (group 2); or 200 mg/day of iron as Maltofer chewable tablets with both breakfast and supper (group 3). Patients were eligible if their Hb was below normal (< 116/133 g/L, F/M), percentage saturation of transferrin < 17%, or serum ferritin levels < 20 nanogram/mL. The results for Hb and ferritin are summarized in Table 5.
A similar rise in Hb was noted with 200 mg/day Maltofer and 120 mg/day FS. At 12 weeks, all treatments groups showed improvements in Hb levels compared to baseline levels. Increased serum ferritin levels and higher percentage transferrin saturation were reported in the FS group compared to Maltofer groups.

Studies in adolescents (aged 15-18 years).

More than 130 adolescents have been treated with Maltofer in clinical trials. The efficacy results seen in adolescents were comparable to the results seen in adults.
In a placebo controlled study of 120 adolescents, aged 15 to 18 years, Maltofer was shown to improve the iron status of adolescents with iron deficiency (with and without anaemia). Subjects were divided into 4 groups with 30 subjects/group: placebo, control supplement, iron deficient (TSAT* < 16%; Hb ≥ 105/115 g/L F/M), iron deficiency with anaemia (TSAT < 16%; Hb < 105/115 g/L F/M). The 3 active treatment groups received Maltofer 100 mg iron/day, 6 days/week, for 8 months. At end of the study, all 3 treatment groups demonstrated significant increases in iron parameters compared to the placebo group, including correction of iron deficiency, anaemia and improvement in iron stores (Table 6). The greatest increase in Hb (+33 g/L) was seen in the IDA group. No gastrointestinal adverse effects were reported.
*TSAT: transferrin saturation.

Pregnant and breastfeeding women.

Clinical studies in pregnant women using Maltofer alone or Maltofer in a fixed combination with folic acid (350-400 microgram folic acid per tablet) were inconclusive.

5.2 Pharmacokinetic Properties

The iron of iron polymaltose is absorbed by a controlled mechanism in the small intestine and unabsorbed iron is excreted via faeces. After absorption, iron is transferred to the blood, where it is bound to transferrin and distributed to the sites of demand, or stored as ferritin in liver and spleen. Most iron is incorporated into the oxygen-transport protein haemoglobin (Hb) during erythropoiesis in the bone marrow. The iron from erythrocytes is recycled at the end of their life span. The breakdown products of polymaltose (maltose and gluconate) are converted into glucose which is metabolised.
Studies with radiolabelled iron polymaltose showed a good correlation between iron absorption (quantified by whole body count) and the iron incorporation into Hb. Similar to other oral iron preparations, the relative absorption of iron decreases with increasing doses. The relative amount of absorbed iron correlates positively with the extent of iron deficiency (i.e. the higher the iron deficiency, the better the relative absorption). No negative impact of food on the bioavailability of iron from iron polymaltose was found: A significantly increased bioavailability of iron (7.3 fold) with concomitant food intake was demonstrated in one clinical study, while 3 studies showed a positive trend (1.1 to 2.1 fold increased bioavailability) but no clinically relevant effects.

5.3 Preclinical Safety Data

Nonclinical data established with iron polymaltose revealed no special hazard for humans based on conventional studies of single dose and repeated dose toxicity, genotoxicity and reproductive and developmental toxicity.

Carcinogenicity.

No long-term studies of tumourigenic potential are available.

Genotoxicity.

Iron polymaltose was not genotoxic in a conventional battery of in vitro and in vivo tests.

Teratogenicity.

Embryo-foetal toxicity studies of iron polymaltose in animals did not reveal any foetal risk. Treatment of rats and rabbits with iron polymaltose during organogenesis did not induce any teratogenic or embryolethal effects. Based on these animal studies, there is no evidence of a risk during the first trimester.
No effects of iron polymaltose on the pre- and post-natal development of offspring were observed in a study in rats, in which dams were treated from Day 6 after mating to Day 20 of lactation, inclusive.

Other.

The LD50 for iron polymaltose, as determined in animal studies with mice or rats was greater than an orally administered dose of 2,000 mg of iron per kilogram body weight. The available nonclinical data on toxicity after a single dose and repeated administration have yielded no further information that has not already been mentioned in other sections.

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.

4.3 Contraindications

The use of Maltofer is contraindicated in the following cases.
Known hypersensitivity to iron polymaltose or to any of the excipients.
Iron overload (e.g. haemochromatosis, haemosiderosis).
Disturbances in iron utilisation (e.g. lead anaemia, sidero-achrestic anaemia, thalassaemia).
Anaemia not caused by iron deficiency (e.g. haemolytic anaemia or megaloblastic anaemia due to vitamin B12 deficiency).

4.4 Special Warnings and Precautions for Use

Iron deficiency anaemia.

All other causes of anaemia should be considered and treated prior to initiating therapy with Maltofer.
Regular monitoring of the haematologic response is required during Maltofer therapy as a risk of iron overload and liver damage exists if too much Maltofer is ingested by haemachromatosis patients over a long period of time. Do not administer to patients with iron overload or haemochromatosis.
The following medicines can affect the absorption of Maltofer.
Injectable iron medicines. If the patient is treated with injectable iron medicines, Maltofer should not be taken in addition to that therapy.
Infections or tumour may cause anaemia. Since iron can be utilised only after correcting the primary disease, a benefit/ risk evaluation is advisable.
During the treatment with Maltofer there may be dark discolouration of the faeces (stool), however this is of no clinical relevance.
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.
Maltofer drops, oral liquid contains the excipients sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate which may cause allergic reactions (possibly delayed).
Maltofer drops, oral liquid contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Laboratory tests.

Regular monitoring of Hb levels and serum ferritin levels should be performed to assess the response to supplementation with Maltofer as deemed appropriate by the medical practitioner.

Use in hepatic impairment.

No data available.

Use in renal impairment.

Very limited data available.

Use in the elderly.

Clinical experience with Maltofer in the elderly is limited. For use in elderly patients consult a medical practitioner.

Paediatric use.

Maltofer has not been clearly shown to be effective in children < 12 years of age. The use of Maltofer in children < 12 years of age is not recommended.
Maltofer syrup contains ethanol.

Effects on laboratory tests.

Maltofer can cause discoloured (black) stool. Discoloured (black) stool may visually mask gastrointestinal bleeding. However, the haemoccult test (selective for Hb) for the detection of occult blood is not impaired, and therefore there is no need to interrupt the therapy.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant administration of parenteral iron and Maltofer is not recommended since the absorption of oral iron would be reduced.
Interactions of iron polymaltose with tetracycline or aluminium hydroxide were investigated in 3 human studies (crossover design, 22 patients per study). No significant reduction in the absorption of tetracycline was observed. The plasma tetracycline concentration did not fall below the minimum inhibitory concentration level necessary for bacteriostasis. Iron absorption from iron polymaltose was not reduced by aluminium hydroxide or tetracycline. Iron polymaltose can therefore be administered at the same time as tetracycline or other phenolic compounds, as well as aluminium hydroxide.
Studies in rats with tetracycline, aluminium hydroxide, acetylsalicylate, sulphasalazine, calcium carbonate, calcium acetate and calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol and auranofin have not shown any interactions with iron polymaltose.
Similarly, no interactions with food constituents such as phytic acid, oxalic acid, tannin, sodium alginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soya oil and soya flour were observed in in vitro studies with iron polymaltose. These results suggest that iron polymaltose can be taken during or immediately after food intake.
The haemoccult test (selective for Hb) for the detection of occult blood is not impaired, and therefore there is no need to interrupt the therapy with iron polymaltose.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility studies of iron polymaltose in animals did not reveal any effects on fertility or early embryonic development.
(Category B1)
Australian categorization definition of Category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have not shown evidence of an increased occurrence of foetal damage.
As a precautionary measure, women of childbearing age, and women during pregnancy should only use Maltofer after consulting a medical doctor or pharmacist. A benefit/risk evaluation is advisable.
Human breast milk naturally contains iron, which is bound to lactoferrin. The amount of iron passing from iron polymaltose to the mother's milk is unknown.
No effects of iron polymaltose on development or growth of offspring were observed in a pre/ postnatal toxicity study in rats, in which nursing dams were treated throughout the preweaning lactation period. Preliminary data from studies conducted in juvenile rats showed no treatment related adverse effect when immature rats were directly treated orally with iron polymaltose from shortly after birth up to sexual maturity.
As a precautionary measure, during lactation, Maltofer should only be used after consulting a medical practitioner. A benefit/risk evaluation is advisable.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials (pre- and postauthorisation, including postauthorisation safety studies).

The safety and tolerability of Maltofer has been evaluated in a meta-analysis of 24 publications or clinical study reports encompassing a total number of 1473 exposed patients.
The principal adverse drug reactions that have been reported in these trials occurred in 4 system organ classes (see Table 1).
Discoloured faeces are a well-known adverse drug reaction of oral iron medications but this is considered of no clinical relevance and is underreported.
Other commonly seen side effects were gastrointestinal disorders (nausea, constipation, diarrhoea and abdominal pain).

Undesirable effects from postmarketing spontaneous reporting.

No additional adverse drug reactions were identified.

Laboratory abnormalities.

No data available.

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at https://www.tga.gov.au/reporting-problems.

4.2 Dose 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 required, Maltofer oral liquids (syrup or drops) should be used.
Maltofer tablets should be swallowed whole. Do not chew film-coated Maltofer tablets.
Maltofer oral liquids can be mixed with fruit and vegetable juices. The slight discolouration of the mixture does not affect either the taste of the juices or the efficacy of Maltofer.

Treatment of iron deficiency in adults and adolescents (children ≥ 12 years).

100 mg to 200 mg iron (1 to 2 tablets, 10-20 mL syrup, or 40-80 drops) daily preferably with food, or higher doses as directed by a medical practitioner.

Prevention of iron deficiency in adults and adolescents (children ≥ 12 years) at high risk.

100 mg iron (1 tablet, 10 mL syrup, 40 drops) daily preferably with food, or higher doses as directed by a medical practitioner.
Regular monitoring of haematological parameters and iron store levels are recommended to assess the patient's response to treatment.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

In case of overdose, intoxication or iron accumulation are unlikely with Maltofer. No cases of accidental poisoning with fatal outcome have been reported due to the low toxicity of iron polymaltose and controlled uptake of iron.
Acute overdose of iron polymaltose may cause headache, nausea, vomiting, diarrhoea, abdominal pain, lack of appetite or bloating.
In general, overdosage of iron causes haemosiderosis and consequent cirrhosis of the liver, diabetes and heart failure. Periodic monitoring of serum ferritin may be useful in recognizing a deleterious, progressive accumulation of iron.
Overdosage should be treated with supportive measures and, if required, an iron chelating agent.
For the information of the management of overdose, contact the Poison Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S2.

6 Pharmaceutical Particulars

6.1 List of Excipients

Maltofer tablets.

Crospovidone, hydroxypropylcellulose, hypromellose, iron oxide red, iron oxide yellow, macrogol 6000, magnesium stearate, cellulose - microcrystalline and titanium dioxide.

Maltofer syrup.

Cream flavour, ethanol, methyl hydroxybenzoate, propyl hydroxybenzoate, water - purified, sodium hydroxide, sorbitol solution (70%) (noncrystallising), and sucrose.

Maltofer drops.

Water - purified, sucrose, cream flavour, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate and sodium hydroxide.

6.2 Incompatibilities

Incompatibilities not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

3 years.

6.4 Special Precautions for Storage

Store below 25°C.
Keep in the original package (i.e. outer carton) in order to protect from light.

6.5 Nature and Contents of Container

Maltofer tablets are available in pack sizes of 30 or 100 film-coated tablets packed in aluminium blister packs.
Maltofer syrup oral liquid is available in a 150 mL Type III brown glass bottle closed with a child resistant and tamper-evident screw cap. A measuring cup for administration covers the screw cap.
Maltofer drops oral liquid is available in a 30 mL Type III brown glass bottle with child resistant inserted dropper applicator and closed with a tamper-evident screw cap.

Note.

Not all formulations of Maltofer may be marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes