Maltofer
Iron Polymaltose Complex Oral Drops for Iron Deficiency
Quick Facts About Maltofer
Key Takeaways About Maltofer
- Gentler on the stomach: Iron polymaltose complex generally causes fewer gastrointestinal side effects than traditional ferrous iron salts such as ferrous sulphate
- Can be taken with food and milk: Unlike ferrous iron supplements, Maltofer absorption is not significantly affected by food, beverages, or milk, making it easy to administer to infants and children
- Flexible dosing for all ages: The oral drops formulation allows precise weight-based dosing for infants from 2 kg, as well as convenient dosing for older children and adults
- Dark stool is normal: Discolouration of stool is very common and completely harmless – it is simply a sign that the iron is passing through the digestive system
- Do not stop early: Continue treatment for the full duration recommended by your doctor to ensure iron stores are fully replenished, even after symptoms improve
What Is Maltofer and What Is It Used For?
Maltofer is an oral iron supplement containing iron in the form of iron(III)-hydroxide polymaltose complex (IPC). It is used to treat and prevent iron deficiency, including iron deficiency anaemia, in patients of all ages from infancy through to the elderly.
Iron is an essential mineral that plays a critical role in many body functions. It is a key component of haemoglobin, the protein in red blood cells that carries oxygen from the lungs to every cell in the body. Iron is also vital for myoglobin (oxygen storage in muscles), enzyme function, energy metabolism, and immune system activity. When the body does not have enough iron, it cannot produce sufficient healthy red blood cells, leading to iron deficiency anaemia – one of the most common nutritional deficiencies worldwide.
The World Health Organization (WHO) estimates that iron deficiency anaemia affects approximately 1.62 billion people globally, with the highest prevalence in preschool children, pregnant women, and women of reproductive age. Left untreated, iron deficiency can cause fatigue, weakness, impaired cognitive function, reduced exercise capacity, and increased susceptibility to infections. In children, it can affect growth, development, and learning ability. During pregnancy, severe iron deficiency anaemia is associated with increased risks of preterm delivery, low birth weight, and maternal complications.
Maltofer contains iron in its ferric (Fe3+) form, complexed with polymaltose (a type of dextrin). This iron(III)-hydroxide polymaltose complex has a structure that closely resembles ferritin, the body's natural iron storage protein. This structural similarity means that iron is absorbed through an active, controlled transport mechanism in the intestinal mucosa, rather than by passive diffusion. The body regulates how much iron it absorbs based on its current needs, which significantly reduces the risk of iron overload and the oxidative stress associated with free iron ions in the gut.
There is an increased risk of developing iron deficiency in the following situations, all of which may warrant treatment or prevention with Maltofer:
- Pregnancy and breastfeeding – increased iron demands for foetal development and milk production
- Adolescence – rapid growth increases iron requirements
- Elderly individuals – reduced dietary intake and absorption efficiency
- Vegetarian or vegan diets – non-haem iron from plant sources is less readily absorbed
- Bodybuilders and athletes engaged in intensive sports – increased iron losses through sweat and haemolysis
- Heavy menstrual bleeding (menorrhagia) – regular significant blood loss
- Blood donors – frequent blood donation depletes iron stores
- After blood loss or surgery – need to replenish lost iron
A key advantage of iron polymaltose complex over traditional ferrous iron salts (such as ferrous sulphate or ferrous fumarate) is that its absorption is not affected by food, tea, coffee, or milk. This makes Maltofer particularly practical for infants and young children, as the drops can be mixed directly into breast milk, formula, juice, or baby food without losing effectiveness.
What Should You Know Before Taking Maltofer?
Before taking Maltofer, it is essential to confirm that you actually have iron deficiency. Not all forms of anaemia are caused by iron deficiency, and taking iron supplements when they are not needed can be harmful. Your doctor can check your iron levels with a simple blood test.
Contraindications
You should not take Maltofer if any of the following conditions apply to you:
- Allergy to iron(III)-hydroxide polymaltose complex or any other ingredient in Maltofer (listed in the ingredients section below)
- Iron overload conditions such as haemochromatosis or haemosiderosis – these hereditary or acquired conditions cause the body to absorb and store too much iron, leading to organ damage
- Anaemia not caused by iron deficiency, including:
- Haemolytic anaemia (increased destruction of red blood cells)
- Megaloblastic anaemia caused by vitamin B12 or folate deficiency
- Disorders of iron utilisation such as:
- Lead poisoning anaemia
- Sideroblastic (sidero-acrastic) anaemia
- Thalassaemia
Taking iron supplements when you have any of these conditions can worsen iron overload and potentially cause serious organ damage, particularly to the liver, heart, and pancreas. This is why it is important to have a proper diagnosis before starting iron supplementation.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Maltofer in the following situations:
- Infections or tumours – both can cause anaemia of chronic disease, which does not respond to iron supplementation and in which iron may accumulate harmfully
- Chronic kidney disease – iron metabolism may be altered, and your doctor should monitor iron parameters closely
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis) – oral iron may exacerbate inflammation in some patients
- Previous gastrointestinal surgery – absorption may be altered after procedures such as gastric bypass
During treatment with Maltofer, dark discolouration of the stool is very common and completely harmless. This is simply unabsorbed iron passing through the digestive system and should not be a cause for concern. However, if you notice black, tarry stools accompanied by other symptoms such as abdominal pain, you should contact your doctor, as this could indicate gastrointestinal bleeding unrelated to Maltofer.
Keep Maltofer out of the sight and reach of children. Iron overdose is a leading cause of accidental poisoning in children under 6 years of age. If a child accidentally ingests a large quantity of Maltofer, seek immediate medical attention or contact your local poison control centre.
Pregnancy and Breastfeeding
Available data suggest that Maltofer is unlikely to have adverse effects on fertility, the developing foetus, or the mother during pregnancy or breastfeeding. Iron supplementation during pregnancy is commonly recommended by the WHO and many national health authorities to prevent and treat iron deficiency anaemia, which can have serious consequences for both mother and baby.
However, as a precautionary measure, you should consult your doctor or pharmacist before using Maltofer if you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding. Your healthcare provider can assess your individual iron needs through blood tests measuring haemoglobin and serum ferritin levels, and recommend the appropriate dose and duration of supplementation.
Maltofer drops can be mixed with breast milk without affecting the iron absorption, which is a practical advantage for breastfeeding mothers who also need to supplement their infant's iron intake.
Drug Interactions
A significant clinical advantage of iron polymaltose complex over ferrous iron salts is that it has very few known drug interactions. Traditional ferrous iron preparations are known to interact with numerous medications, including tetracycline antibiotics, quinolone antibiotics, levodopa, methyldopa, levothyroxine, bisphosphonates, and penicillamine. Iron polymaltose complex does not share these interactions because of its different absorption mechanism.
However, you should be aware of the following:
- Injectable iron preparations – should not be used at the same time as Maltofer, as concurrent use may reduce the absorption of oral iron
Always tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including over-the-counter medicines and herbal supplements.
Food and Drink Interactions
One of the most important practical advantages of Maltofer is that food and drink do not significantly affect how well the body absorbs the iron from this formulation. This is in stark contrast to ferrous iron salts, whose absorption can be reduced by up to 50–70% when taken with food, tea, coffee, dairy products, or calcium-containing foods.
Maltofer can be taken without food or together with meals. However, taking it during or immediately after a meal is recommended, as this can help reduce any gastrointestinal side effects. Maltofer drops may be mixed with breast milk, cow's milk, fruit and vegetable juices, or baby food. Any slight colour change of the mixed food does not affect the taste or the effectiveness of the iron.
Driving and Operating Machinery
Maltofer has no or negligible effect on the ability to drive or operate machinery. You are unlikely to experience any impairment of alertness or reaction time from taking this medication.
Important Information About Excipients
Maltofer oral drops contain the following excipients that some patients should be aware of:
- Parahydroxybenzoates (sodium methylhydroxybenzoate E219 and sodium propylhydroxybenzoate E217) – these preservatives may cause allergic reactions, which may be delayed
- Sucrose – if you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking Maltofer. Sucrose may also be harmful to teeth
- Sodium – Maltofer contains 5 mg sodium per ml (0.25 mg per drop), equivalent to 0.25% of the WHO recommended maximum daily intake of 2 g sodium for an adult
How Does Maltofer Interact with Other Drugs?
Maltofer (iron polymaltose complex) has significantly fewer drug interactions than traditional ferrous iron supplements. Its unique molecular structure means it does not interfere with the absorption of most common medications. The only notable interaction is with injectable iron preparations.
One of the key clinical advantages of iron(III)-hydroxide polymaltose complex is its favourable interaction profile. Traditional ferrous (Fe2+) iron salts interact with many drugs because free ferrous ions in the gut form insoluble complexes with other substances, reducing the absorption of both the iron and the co-administered drug. Because the iron in Maltofer is tightly bound within the polymaltose complex and absorbed via a controlled, active transport mechanism, these interactions do not occur.
Several clinical studies have confirmed that iron polymaltose complex does not significantly reduce the absorption of tetracycline antibiotics, aluminium hydroxide antacids, or other drugs that are commonly affected by ferrous iron salts. This makes Maltofer a particularly suitable choice for patients who need to take multiple medications.
| Drug / Substance | Ferrous Iron Salts | Iron Polymaltose Complex (Maltofer) | Clinical Significance |
|---|---|---|---|
| Injectable iron preparations | Interaction | Interaction – may reduce oral iron absorption | Avoid concurrent use |
| Tetracycline antibiotics | Significant interaction – reduced absorption of both | No significant interaction | Advantage of Maltofer |
| Quinolone antibiotics | Significant interaction – reduced antibiotic absorption | No significant interaction | Advantage of Maltofer |
| Levothyroxine | Reduced levothyroxine absorption | No significant interaction | Advantage of Maltofer |
| Levodopa / Methyldopa | Reduced absorption of both drugs | No significant interaction | Advantage of Maltofer |
| Food, tea, coffee, milk | Reduced iron absorption by 50–70% | No significant effect on absorption | Major advantage of Maltofer |
Despite the favourable interaction profile, always inform your healthcare provider about all medications and supplements you are taking. This includes prescription drugs, over-the-counter medicines, vitamins, and herbal products. Your doctor or pharmacist can provide personalised advice on the best timing and dosing schedule.
What Is the Correct Dosage of Maltofer?
The dosage of Maltofer depends on the severity of iron deficiency and the patient's age and weight. Dosing is measured in drops, with each drop containing 2.5 mg of elemental iron. The daily dose can be taken all at once or divided into separate doses.
Always take Maltofer exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. The dose and duration of treatment depend on the degree of iron deficiency. Your doctor will determine the appropriate dose based on blood test results, including haemoglobin levels and serum ferritin (a measure of iron stores).
Infants (2 kg to less than 15 kg)
Recommended dose
1–2 drops per kg body weight per day (equivalent to 2.5–5 mg iron per kg body weight per day)
For a 5 kg infant, this would be 5–10 drops per day. For a 10 kg infant, 10–20 drops per day.
Maltofer oral drops are particularly well-suited for infants because of their liquid formulation and the ability to mix the drops with breast milk, formula, juice, or baby food. The cream flavour helps improve acceptance. Always use the dropper provided with the bottle to ensure accurate dosing.
Children (15 kg to 30 kg)
Recommended dose
10–40 drops per day (equivalent to 25–100 mg iron per day)
The exact dose within this range depends on the severity of iron deficiency and the child's weight.
Children (over 30 kg), Adults, and Pregnant Women
Recommended dose
20–60 drops per day (equivalent to 50–150 mg iron per day)
If more than 150 mg iron daily (60 drops) is required, consider switching to Maltofer chewable tablets (2 tablets = 200 mg iron).
For daily doses exceeding 20 drops, it is recommended to divide the dose into separate administrations to avoid calculation errors and improve tolerability. The following table provides examples of how to split the daily dose:
| Total Daily Drops | Iron (mg) | Suggested Split |
|---|---|---|
| 20 drops | 50 mg | 20 drops once daily |
| 30 drops | 75 mg | 15 drops twice daily |
| 40 drops | 100 mg | 20 drops twice daily |
| 50 drops | 125 mg | 15 drops twice + 20 drops once daily |
| 60 drops | 150 mg | 20 drops three times daily |
How to Take Maltofer Drops
Hold the bottle upside down in a vertical position to ensure correct dosing. The drops should flow freely. If they do not, gently tap the bottom of the bottle until a drop forms. Do not shake the bottle.
Maltofer can be taken without food or together with meals. However, it is recommended to take it during or immediately after a meal to help reduce potential gastrointestinal side effects. If mixed with liquid food, this can also help prevent tooth discolouration.
The drops may also be mixed with fruit juice, vegetable juice, baby food, or bottle feeds. Any slight discolouration that occurs does not affect the taste or the effectiveness of the product.
Duration of Treatment
The duration of treatment depends on the severity of iron deficiency and is monitored through laboratory tests, including:
- Haemoglobin levels – to assess correction of iron deficiency anaemia
- Serum ferritin levels – to assess replenishment of iron stores
Consult your doctor if your symptoms have not improved after 2 months of treatment. During pregnancy, discuss the dosage and duration of treatment with your doctor or midwife. It is important to continue treatment even after haemoglobin levels normalise, to ensure that the body's iron stores are fully replenished. This typically requires an additional 1–3 months of supplementation after anaemia has resolved.
Missed Dose
If you forget to take a dose, do not take a double dose to make up for the missed one. Simply take the next dose at the usual time. Do not exceed the maximum daily dose recommended above.
Overdose
Due to the controlled absorption mechanism of iron polymaltose complex, the risk of acute iron toxicity from Maltofer overdose is significantly lower than with ferrous iron salts. However, if you or a child accidentally takes too much Maltofer, contact your doctor, hospital emergency department, or poison control centre immediately for risk assessment and advice.
Signs of iron overdose may include nausea, vomiting, abdominal pain, and diarrhoea. In severe cases (more likely with ferrous salts), iron poisoning can cause metabolic acidosis, liver damage, and cardiovascular collapse. Although these severe effects are much less likely with iron polymaltose complex, medical assessment is still essential after any significant overdose.
What Are the Side Effects of Maltofer?
Like all medicines, Maltofer can cause side effects, although not everyone gets them. The most common effect is harmless dark discolouration of the stool. Gastrointestinal symptoms such as nausea, constipation, diarrhoea, and abdominal pain are also common but generally milder than with ferrous iron salts.
Clinical studies comparing iron polymaltose complex with ferrous sulphate have consistently shown that iron polymaltose complex causes significantly fewer and milder gastrointestinal side effects. A systematic review published in the journal Alimentary Pharmacology & Therapeutics found that patients taking iron polymaltose complex reported gastrointestinal adverse effects approximately 50% less frequently than those taking ferrous sulphate, with a lower rate of treatment discontinuation due to side effects.
The following side effects have been reported with Maltofer at the frequencies listed below:
Very Common
- Discoloured (dark) stool – this is harmless and simply indicates that iron is passing through the digestive system
Common
- Diarrhoea
- Nausea
- Abdominal pain
- Constipation
Uncommon
- Vomiting
- Tooth discolouration
- Gastritis (inflammation of the stomach lining), including burning sensation or upper abdominal discomfort
- Itching (pruritus)
- Rash, red-streaked skin, skin redness (erythema)
- Headache
Rare
- Muscle spasms (cramps)
- Muscle pain (myalgia)
Tooth Discolouration
Tooth discolouration is a known side effect of oral iron preparations, not unique to Maltofer. It occurs because iron can deposit on the tooth surface when the oral solution comes into contact with the teeth. This discolouration is not permanent and can be managed in several ways:
- Intensive tooth brushing – regular, thorough brushing can remove iron staining from tooth surfaces
- Mix with liquid food – adding the drops to juice, milk, or baby food reduces direct contact with the teeth
- Use a straw – for older children and adults, drinking the mixed solution through a straw minimises tooth contact
- Professional dental cleaning – in stubborn cases, a dental hygienist can remove the discolouration
Reporting Side Effects
If you experience any side effects, including any not listed above, talk to your doctor or pharmacist. You can also report suspected side effects directly to your national pharmacovigilance authority (e.g., the Medicines and Healthcare products Regulatory Agency [MHRA] in the UK, the European Medicines Agency [EMA] in Europe, or the Food and Drug Administration [FDA] in the United States). By reporting side effects, you help provide more information on the safety of this medicine.
How Should You Store Maltofer?
Store Maltofer at room temperature, out of sight and reach of children. Do not freeze. Use before the expiry date printed on the label and carton.
Proper storage of Maltofer is important to maintain the stability and effectiveness of the medication. Follow these storage guidelines:
- Keep out of the sight and reach of children – iron supplements can be dangerous for children if taken in excessive amounts
- Store at room temperature – no special temperature requirements, but avoid extreme heat
- Do not freeze – freezing may alter the physical properties and stability of the oral drops
- Check the expiry date – do not use Maltofer after the expiry date printed on the label and outer carton. The expiry date refers to the last day of that month
- Close the bottle tightly after each use to prevent contamination and maintain product quality
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
What Does Maltofer Contain?
Each drop (0.05 ml) of Maltofer oral drops contains 2.5 mg of elemental iron as iron(III)-hydroxide polymaltose complex. One ml contains 50 mg iron, equivalent to 20 drops.
Active Ingredient
The active substance is iron in the form of iron(III)-hydroxide polymaltose complex. Each millilitre of oral drops contains 50 mg of elemental iron. Since 1 ml corresponds to 20 drops, each individual drop (0.05 ml) provides 2.5 mg of elemental iron.
Inactive Ingredients (Excipients)
The other ingredients in Maltofer oral drops are:
- Purified water
- Sucrose
- Cream flavour (contains propylene glycol and vanillin)
- Sodium methylparahydroxybenzoate (E219)
- Sodium propylparahydroxybenzoate (E217)
- Sodium hydroxide
Appearance and Packaging
Maltofer oral drops are a dark brown solution with a cream-like flavour. The product is supplied in a 30 ml amber glass bottle fitted with a dropper applicator and sealed with a tamper-evident screw cap. The glass bottle protects the solution from light degradation.
Frequently Asked Questions About Maltofer
Maltofer contains iron in its ferric (Fe3+) form as a polymaltose complex, while ferrous sulphate contains iron in its ferrous (Fe2+) form. The key differences are: (1) Maltofer can be taken with food and milk without reduced absorption, whereas ferrous sulphate absorption is significantly reduced by food; (2) Maltofer generally causes fewer gastrointestinal side effects; (3) Maltofer has fewer drug interactions; (4) Maltofer has a lower risk of accidental iron poisoning due to its controlled absorption mechanism. Both are effective in treating iron deficiency, though ferrous sulphate is often less expensive.
Maltofer oral drops can be used in infants from a body weight of 2 kg onwards. The dose is calculated based on body weight: 1–2 drops per kg per day. However, iron supplementation in newborns should always be initiated and monitored by a paediatrician, as the iron needs of newborns depend on many factors including gestational age, birth weight, type of feeding, and maternal iron status. Premature infants have a particularly high risk of iron deficiency and may require supplementation from an early age.
Most patients begin to feel an improvement in energy and fatigue within 2–4 weeks of starting treatment. However, it typically takes 2–3 months for haemoglobin levels to normalise fully. After haemoglobin has normalised, treatment should continue for an additional 1–3 months to replenish iron stores (ferritin). If you do not notice any improvement after 2 months, consult your doctor, as the cause of your anaemia may need further investigation.
Dark or black stool is a very common and completely harmless effect of oral iron supplements, including Maltofer. It occurs because not all the iron is absorbed from the gut – the unabsorbed iron passes through the digestive tract and is excreted in the stool, giving it a dark colour. This is normal and expected, and should not be a cause for concern. However, if you experience black, tarry stools accompanied by abdominal pain or other symptoms, contact your doctor, as this could indicate gastrointestinal bleeding.
Yes, iron polymaltose complex (Maltofer) does not significantly interact with levothyroxine (thyroid medication), unlike traditional ferrous iron salts which can reduce levothyroxine absorption by forming insoluble complexes in the gut. However, as a general precaution, it is still advisable to discuss the timing of your medications with your doctor or pharmacist to optimise the absorption of both drugs.
Maltofer oral drops do not contain any animal-derived active ingredients. The iron is synthetic iron(III)-hydroxide in a polymaltose complex. However, some excipients (such as the cream flavour) may vary. If you follow a strict vegan diet and want to be certain, check the specific product information or contact the manufacturer. Vegetarians and vegans are at higher risk of iron deficiency because non-haem iron from plant sources is less efficiently absorbed than haem iron from animal sources, making supplementation often necessary.
References
- World Health Organization. Iron deficiency anaemia: assessment, prevention and control. WHO/NHD/01.3. Geneva: WHO; 2001.
- World Health Organization. Guideline: Daily iron supplementation in adult women and adolescent girls. Geneva: WHO; 2016.
- World Health Organization. Guideline: Daily iron supplementation in infants and children. Geneva: WHO; 2016.
- Geisser P, Burckhardt S. The pharmacokinetics and pharmacodynamics of iron preparations. Pharmaceutics. 2011;3(1):12–33. doi:10.3390/pharmaceutics3010012
- Toblli JE, Brignoli R. Iron(III)-hydroxide polymaltose complex in iron deficiency anemia: review and meta-analysis. Arzneimittelforschung. 2007;57(6A):431–438.
- Ortiz R, Toblli JE, Romero JD, et al. Efficacy and safety of oral iron(III) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia: a multicenter, randomized, controlled study. J Matern Fetal Neonatal Med. 2011;24(11):1347–1352.
- Cancelo-Hidalgo MJ, Castelo-Branco C, Palacios S, et al. Tolerability of different oral iron supplements: a systematic review. Curr Med Res Opin. 2013;29(4):291–303.
- European Medicines Agency. Summary of Product Characteristics: Iron(III)-hydroxide polymaltose complex. EMA Assessment Report.
- British National Formulary (BNF). Iron deficiency anaemia: Treatment. NICE; 2024.
- Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015;372(19):1832–1843. doi:10.1056/NEJMra1401038
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