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Iron Supplement — Iron Deficiency Anaemia in Children Pregnancy: Verbatim UK SPC 4.6: 'Administration of drugs during the first trimester of pregnancy requires careful assessment of potential risks versus benefits to be gained. No adverse events associated with Sytron administration during pregnancy and lactation have been reported.'

Iron Supplementation (Paediatric)

Brand names: Sytron (sodium feredetate), Ferrous Sulfate, Niferex (iron polysaccharide)

Oral iron supplements are used in children to prevent and treat iron-deficiency anaemia, including in preterm infants and children with dietary or absorptive deficiency.

Adult dose

Dose: ⚠️ THIS PAGE IS PAEDIATRIC — the clinically relevant figure is in the paediatric dose section below. Adult reference only, for iron-deficiency anaemia, taken from the fetched product's own label (Sytron 27.5 mg iron per 5 ml oral solution): adults and the elderly (over 65 years) 5 ml increasing gradually to 10 ml three times daily. This is a Sytron-specific VOLUME and does not transfer to ferrous sulfate or iron polysaccharide, which have different strengths.
Route: Oral. For instructions on dilution of the medicinal product before administration, see section 6.6 of the SPC.
Frequency: Three times daily
Max: 10 ml per dose, three times daily — the fetched SPC twice refers to 10 ml as 'the maximum dose'.
The fetched product is 'Sytron 27.5 mg iron per 5 ml Oral Solution' (UK SPC via eMC, product 8791). The paediatric figure is stated in ELEMENTAL IRON per kg per day, not in Sytron millilitres, so it is preparation-independent and legitimately serves a page that also names ferrous sulfate and iron polysaccharide — the adult figure above is NOT preparation-independent and is flagged as Sytron-specific. || VERBATIM UK SPC 4.2, adults: 'Adults and the elderly (over 65 years): 5 ml increasing gradually to 10 ml three times daily.' || SCOPE: the fetched 4.2 is COMPLETE in this bundle (no truncation marker in any section) and contains both a treatment and a prophylaxis regimen; both are reproduced in the paediatric notes below, so nothing licensed has been omitted. || The fetched product is sodium feredetate, not ferrous sulfate. || ⚠️ OVERDOSE WARNING carried on the pack, verbatim 4.4: 'Important warning: Contains iron. Keep out of the sight and reach of children, as overdose may be fatal.' || EXCIPIENT CAUTIONS (4.4): contains methyl hydroxybenzoate (E218), Ponceau 4R (E124) and propyl hydroxybenzoate (E216), which may cause allergic reactions (possibly delayed); contains less than 100 mg ethanol in the maximum dose of 10 ml; contains approximately 23 mg sodium in the maximum dose of 10 ml; contains 1400 mg sorbitol in each 5 ml dosage unit (280 mg/ml) — patients with hereditary fructose intolerance should not be given this product, and sorbitol may cause gastrointestinal discomfort and a mild laxative effect at levels at or above 140 mg/kg/day. || INTERACTIONS (4.5): avoid concomitant oral iron with dimercaprol (formation of toxic compounds). Iron reduces the absorption of penicillamine, mycophenolate, fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates, may reduce the hypotensive effect of methyldopa, and mutually reduces absorption with tetracyclines and with zinc. Oral chloramphenicol delays plasma iron clearance. Iron absorption is reduced by entacapone, proton pump inhibitors, bicarbonates, carbonates, calcium, zinc, magnesium and other mineral supplements, trientine, antacids, cholestyramine, tea, eggs and/or milk, and possibly coffee; it may be increased by ascorbic acid and/or citric acid.

Paediatric dose

Dose: 3 mg/kg/day
Route: Oral (as elemental iron). For instructions on dilution before administration, see section 6.6 of the SPC.
Frequency: The daily total is given in 2 to 3 divided doses
Max: Maximum 200 mg elemental iron daily
⚠️⚠️ THIS IS A DAILY TOTAL, NOT A PER-DOSE FIGURE. VERBATIM UK SPC 4.2, Paediatric population: 'Treatment of iron-deficiency anaemia in all paediatric age groups is 3-6 mg/kg (max 200 mg) of elemental iron daily given in 2-3 divided doses.' The licensed range is 3 to 6 mg/kg of elemental iron PER DAY; dosePerKg is set to the LOWER end of that range (3) and the unit is 'mg/kg/day' so that the weight calculator returns a daily total. The result must then be DIVIDED into 2 or 3 doses across the day — it is not the amount to give at each administration. The stated ceiling is 200 mg of elemental iron daily. || ALL FIGURES ARE ELEMENTAL IRON, not the millilitres or milligrams of any particular preparation. The fetched product is Sytron 27.5 mg iron per 5 ml oral solution; ferrous sulfate and iron polysaccharide (the other two preparations named on this page) contain different amounts of elemental iron per unit, so the elemental-iron total must be converted to the volume or tablet strength of whichever preparation is actually being prescribed. This is the classic paediatric iron error and is why paedDose.concentration is DELIBERATELY LEFT UNPOPULATED: publishing Sytron's strength as a page-level concentration would make the site render a single volume for a page that names three preparations of different strengths, and would render that volume against a DAILY total that still has to be split into 2 to 3 doses. No concentration has been invented. || PROPHYLAXIS is a separate, much lower regimen — do not confuse it with the treatment dose above. VERBATIM UK SPC 4.2: 'Babies of low birth weight who are solely breast-fed: A daily dose of 5 mg of elemental iron as prophylactic iron supplementation for babies of low birth weight who are solely breast-fed is recommended. Higher doses up to 2 mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation is started 4-6 weeks after birth and continued until mixed feeding is established. Other children (elemental iron per day): Age 6 - 24 months: 12.5 mg Age 2 - 5 years: 20-30 mg Age 6 - 11 years: 30 - 60 mg Adolescents: 60 mg'. || ⚠️ 4.4: 'Prolonged or excessive use in children may lead to toxic accumulation.' Pack warning, verbatim: 'Important warning: Contains iron. Keep out of the sight and reach of children, as overdose may be fatal.' || The sorbitol content (1400 mg per 5 ml, 280 mg/ml) matters at paediatric weights: 4.4 notes gastrointestinal discomfort and a mild laxative effect at 140 mg/kg/day or above, and that patients with hereditary fructose intolerance should not be given this product. || Verify any paediatric dose against a children's formulary before prescribing.

Dose adjustments

Renal

No renal dose adjustment is stated anywhere in the fetched sections of this SPC — none has been asserted here.

Hepatic

No hepatic dose adjustment is stated anywhere in the fetched sections of this SPC. The only related caution is 4.4: 'Care should be taken in patients with haemolytic anaemia, iron-storage or iron-absorption diseases or existing gastrointestinal diseases.'

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Paediatric weight-based calculator

⚠️⚠️ THIS IS A DAILY TOTAL, NOT A PER-DOSE FIGURE. VERBATIM UK SPC 4.2, Paediatric population: 'Treatment of iron-deficiency anaemia in all paediatric age groups is 3-6 mg/kg (max 200 mg) of elemental iron daily given in 2-3 divided doses.' The licensed range is 3 to 6 mg/kg of elemental iron PER DAY; dosePerKg is set to the LOWER end of that range (3) and the unit is 'mg/kg/day' so that the weight calculator returns a daily total. The result must then be DIVIDED into 2 or 3 doses across the day — it is not the amount to give at each administration. The stated ceiling is 200 mg of elemental iron daily. || ALL FIGURES ARE ELEMENTAL IRON, not the millilitres or milligrams of any particular preparation. The fetched product is Sytron 27.5 mg iron per 5 ml oral solution; ferrous sulfate and iron polysaccharide (the other two preparations named on this page) contain different amounts of elemental iron per unit, so the elemental-iron total must be converted to the volume or tablet strength of whichever preparation is actually being prescribed. This is the classic paediatric iron error and is why paedDose.concentration is DELIBERATELY LEFT UNPOPULATED: publishing Sytron's strength as a page-level concentration would make the site render a single volume for a page that names three preparations of different strengths, and would render that volume against a DAILY total that still has to be split into 2 to 3 doses. No concentration has been invented. || PROPHYLAXIS is a separate, much lower regimen — do not confuse it with the treatment dose above. VERBATIM UK SPC 4.2: 'Babies of low birth weight who are solely breast-fed: A daily dose of 5 mg of elemental iron as prophylactic iron supplementation for babies of low birth weight who are solely breast-fed is recommended. Higher doses up to 2 mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation is started 4-6 weeks after birth and continued until mixed feeding is established. Other children (elemental iron per day): Age 6 - 24 months: 12.5 mg Age 2 - 5 years: 20-30 mg Age 6 - 11 years: 30 - 60 mg Adolescents: 60 mg'. || ⚠️ 4.4: 'Prolonged or excessive use in children may lead to toxic accumulation.' Pack warning, verbatim: 'Important warning: Contains iron. Keep out of the sight and reach of children, as overdose may be fatal.' || The sorbitol content (1400 mg per 5 ml, 280 mg/ml) matters at paediatric weights: 4.4 notes gastrointestinal discomfort and a mild laxative effect at 140 mg/kg/day or above, and that patients with hereditary fructose intolerance should not be given this product. || Verify any paediatric dose against a children's formulary before prescribing.

Verify in a children's formulary

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Haemochromatosis and haemosiderosis — 'Iron preparations are contraindicated in patients with haemochromatosis and haemosiderosis'
  • Patients receiving repeated blood transfusions
  • Patients receiving parenteral iron therapy
  • Not a contraindication but an explicit 4.4 caution: care should be taken in patients with haemolytic anaemia, iron-storage or iron-absorption diseases, or existing gastrointestinal diseases
  • Not a contraindication but an excipient bar (4.4): patients with hereditary fructose intolerance (HFI) should not be given this product, which contains 1400 mg sorbitol per 5 ml

Side effects

  • Hypersensitivity — frequency unknown (immune system disorders)
  • Nausea — frequency unknown (gastrointestinal disorders)
  • Mild diarrhoea — frequency unknown (gastrointestinal disorders)
  • Not listed as an adverse reaction but stated in 4.4: iron preparations colour the faeces black, which may interfere with tests used for detection of occult blood in the stools
  • Not listed as an adverse reaction but stated in 4.4: prolonged or excessive use in children may lead to toxic accumulation
  • Excipient reactions (4.4): methyl hydroxybenzoate (E218), Ponceau 4R (E124) and propyl hydroxybenzoate (E216) may cause allergic reactions, possibly delayed; sorbitol may cause gastrointestinal discomfort and a mild laxative effect
  • Note: the tabulated 4.8 in this bundle lists only the three reactions above.

Monitoring

  • Watch for toxic accumulation with prolonged or excessive use in children — 4.4: 'Prolonged or excessive use in children may lead to toxic accumulation'
  • Take account of black discolouration of the faeces, which may interfere with faecal occult blood testing
  • Separate iron from interacting drugs and foods — iron mutually reduces absorption with tetracyclines and zinc, reduces absorption of fluoroquinolones, penicillamine, mycophenolate, levodopa, carbidopa, thyroxine and bisphosphonates, and its own absorption is reduced by antacids, proton pump inhibitors, calcium, magnesium, cholestyramine, trientine, tea, eggs and milk
  • Exercise care in haemolytic anaemia, iron-storage or iron-absorption disease, and existing gastrointestinal disease
  • No haemoglobin, ferritin or transferrin-saturation target and no testing interval is given anywhere in the fetched sections, so none is asserted here
  • Store safely — the pack must carry: 'Important warning: Contains iron. Keep out of the sight and reach of children, as overdose may be fatal.'

Clinical monograph

How it works

Supplemental iron provides the elemental iron required for haemoglobin synthesis, replenishing depleted stores and restoring effective erythropoiesis.

Prescribing in practice

  • Iron is a leading cause of accidental childhood poisoning, so emphasise that preparations be stored safely out of reach of children and given strictly as prescribed.
  • Iron impairs absorption of certain medicines and is itself reduced by milk, antacids and tea, so attention to timing and co-administered drugs is needed.
  • Choose the preparation and dose using a children's formulary, accounting for the elemental iron content of the salt.

Monitoring

Monitor haemoglobin and reticulocyte response with iron indices such as ferritin, and review adherence if the expected response is not achieved.

Counselling the patient

  • Keep iron preparations well out of reach of children, as overdose can be very dangerous.
  • Liquid iron can stain teeth, so give with a straw or beaker and rinse the mouth afterwards.
  • Black stools are expected and harmless; give with vitamin C-rich juice rather than milk to aid absorption.

Evidence & guidelines

Iron supplementation is a long-established, guideline-endorsed treatment for childhood iron-deficiency anaemia, with preterm infants recognised as being at particular risk of deficiency.

Reference: NICE NG24 (Iron Deficiency Anaemia); WHO Guidelines on Iron Supplementation; BSH Iron Deficiency Anaemia Guidelines 2021; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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