SUMMARY CMI

MALTOFER^® TABLETS
MALTOFER^® SYRUP
MALTOFER^® DROPS

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using MALTOFER^®

MALTOFER^® contains the active ingredient iron as iron polymaltose, an iron carbohydrate compound. MALTOFER^® is used to treat iron deficiency in adolescents and adults where the use of ferrous iron supplements is not tolerated, or otherwise inappropriate. MALTOFER^® is also 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.

For more information, see Section 1. Why am I using MALTOFER^®? in the full CMI.

2. What should I know before I use MALTOFER^®?

Do not use if you have ever had an allergic reaction to MALTOFER^® or any of the ingredients listed at the end of the CMI.

Talk to your doctor or pharmacist if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use MALTOFER^®? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with MALTOFER^® and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use MALTOFER^®?

• 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. More instructions can be found in Section 4. How do I use MALTOFER^®? in the full CMI.

5. What should I know while using MALTOFER^®?

For more information, see Section 5. What should I know while using MALTOFER^®? in the full CMI.

6. Are there any side effects?

Common side effects include discoloured stool, diarrhoea, nausea, indigestion, gut or stomach pain, discomfort or bloating and constipation.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

MALTOFER^® TABLETS
MALTOFER^® SYRUP
MALTOFER^® DROPS

Active ingredient: iron as iron polymaltose

Consumer Medicine Information (CMI)

This leaflet provides important information about using MALTOFER^®. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using MALTOFER^®.

Where to find information in this leaflet:

1. Why am I using MALTOFER^®?
2. What should I know before I use MALTOFER^®?
3. What if I am taking other medicines?
4. How do I use MALTOFER^®?
5. What should I know while using MALTOFER^®?
6. Are there any side effects?
7. Product details

1. Why am I using MALTOFER^®?

MALTOFER^® contains the active ingredient iron as 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.

MALTOFER^® is used for 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.

2. What should I know before I use MALTOFER^®?

Warnings

Do not use MALTOFER^®:

• if you are allergic to iron polymaltose, or any of the ingredients listed at the end of this leaflet. 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
  Always check the ingredients to make sure you can use this medicine.
• 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
• for children under the age of 12 years.

Check with your doctor or pharmacist if you:

• you have or have had an infection or tumour
• you have or have had any other health problems
• take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

The following medicines 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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect MALTOFER^®.

4. How do I use 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. Follow the instructions provided with the medicine.
• Do not exceed the recommended dosage.

When to take MALTOFER^®

• 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 MALTOFER^®

• 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 MALTOFER^®

• 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 use too much MALTOFER^®

If you think that you have used too much MALTOFER^® you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (in Australia by calling 13 11 26 or in New Zealand by calling The National Poisons Centre 0800 POSION or 0800 764 766), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using MALTOFER^®?

Things you should do

• Remind any doctor, dentist or pharmacist you visit that you are using 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 should 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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how MALTOFER^® affects you.

However, MALTOFER^® has either no or negligible influence on your ability to drive a car or operate machinery.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Looking after your medicine

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

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

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.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date. The expiry date refers to the last day of that month.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems or, in New Zealand, nzphvc.otago.ac.nz/reporting. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What MALTOFER^® Tablets contains

What MALTOFER^® Syrup contains

Maltofer^® Syrup contains sorbitol and sucrose/sugar. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

The maximum daily dose of Maltofer^® Syrup contains 5.6 g of sorbitol. Products containing sorbitol may have a laxative effect or cause diarrhoea.

Maltofer^® Syrup contains small amounts of ethanol/alcohol, 3.25 mg per mL.

What MALTOFER^® Drops contains

Do not take this medicine if you are allergic to any of these ingredients.

What MALTOFER^® 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, is a dark brown solution in a 150 mL 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, is a dark brown solution in a 30 mL brown glass bottle with child resistant tamper-evident screw cap and inserted dropper applicator. (AUST R 230644)

Not all presentations may be marketed.

Who distributes MALTOFER^®

Supplied in Australia by:

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

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 April 2024

Published by MIMS June 2024

1 Name of 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 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.

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

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).

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

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.

Laboratory tests.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

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.

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.

4.8 Adverse Effects (Undesirable Effects)

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

Undesirable effects from post-marketing spontaneous reporting.

Laboratory abnormalities.

Reporting suspected adverse reactions.

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).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Placebo controlled clinical trials in adults.

Reference controlled studies.

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

Reference controlled studies of ≥ 12 weeks duration.

Studies in adolescents (aged 15-18 years).

Pregnant and breastfeeding women.

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.

Genotoxicity.

Teratogenicity.

Other.

6 Pharmaceutical Particulars

6.1 List of Excipients

Maltofer tablets.

Maltofer syrup.

Maltofer drops.

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

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

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.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S2 (Pharmacy medicine).

Summary Table of Changes