Sytron® 27.5 mg/5 ml Oral Solution
1. Disclaimer
This drug information is provided for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis, treatment, prescribing information, or the official product leaflet approved by the relevant regulatory authority. Product composition, indications, dosage recommendations, excipients, manufacturers, marketing authorisation holders, and availability may vary between countries, formulations, and manufacturing periods.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
2. Summary
Sytron® is an oral iron preparation containing sodium feredetate trihydrate (sodium iron edetate), providing 27.5 mg of elemental iron per 5 ml. It is used for the treatment of iron-deficiency anaemia and is documented for use in adults, children, and infants. The product is a liquid oral preparation and is particularly used in paediatric patients; the current UK product information also lists use during pregnancy when other oral iron preparations are not well tolerated and in anaemia secondary to rheumatoid arthritis.
The current documented formulation contains 207.5 mg of sodium feredetate trihydrate per 5 ml, equivalent to 27.5 mg elemental iron. This differs from the older composition of 189.7 mg sodium ironedetate stated in the supplied text.
3. Brand Name
Sytron®
Current documented product name: Sytron 27.5 mg iron per 5 ml Oral Solution.
In Egyptian public medicine directories, Sytron 27.5 mg/5 ml syrup, 125 ml is still listed as an available product, although these directories are not equivalent to an official Egyptian regulatory database.
4. Category
Therapeutic category: Iron preparation / oral iron supplement
ATC classification: B03A — Iron preparations.
It is used primarily for iron-deficiency anaemia.
5. Active Ingredient
Sodium feredetate trihydrate (sodium iron edetate)
Each 5 ml contains:
- Sodium feredetate trihydrate: 207.5 mg
- Equivalent to 27.5 mg elemental iron.
The terminology sodium feredetate, sodium iron edetate, and related historical naming may be encountered in drug references. The currently documented product specification uses sodium feredetate trihydrate.
6. Pharmaceutical Form & Strength
Dosage form: Oral solution / liquid oral preparation
Appearance: Clear red liquid, free of particles
Strength: 27.5 mg elemental iron per 5 ml
Commonly documented pack: 125 ml bottle
The current UK product information documents amber glass bottles containing 125 ml, 500 ml, or 2250 ml, although not all pack sizes are necessarily marketed in every country.
7. Manufacturer & Marketing Authorization Holder
Egyptian-market information
Current publicly available Egyptian medicine directories list the 125 ml Sytron 27.5 mg/5 ml product under:
Hikma Pharma > Johnson & Johnson USA
This information is repeated across current Egyptian drug-directory listings, including listings crawled in August 2026. However, these directories do not constitute an official Egyptian regulatory confirmation of the current marketing-authorisation structure.
Current documented UK product
For the currently documented UK formulation:
Marketing Authorisation Holder: Grünenthal Ltd., UK
Manufacturer: Laleham Health and Beauty Limited, UK.
Because manufacturer and marketing-authorisation arrangements may differ by country and historical manufacturing period, the information printed on the specific Egyptian package should be regarded as authoritative for that particular local presentation.
8. Mechanism of Action
Sytron supplies elemental iron, which is required for the synthesis of haemoglobin and other iron-containing proteins.
Sodium feredetate is an iron chelate in which iron is associated with the sodium salt of EDTA. Within the gastrointestinal tract, the chelate releases elemental iron, which can then be absorbed and utilized for haemoglobin regeneration and restoration of iron stores.
9. Spectrum of Activity
Not applicable.
Sytron is an iron replacement preparation, not an antibacterial, antiparasitic, antiviral, or antifungal drug. It therefore has no antimicrobial spectrum of activity.
The older description implying treatment of anaemia caused by infections should not be interpreted as indicating that Sytron treats the underlying infection. Iron may be used to correct documented iron deficiency associated with or occurring alongside other conditions, but treatment of the underlying infectious disease requires appropriate therapy separately.
10. Pharmacokinetics
Iron absorption is increased when body iron stores are depleted. Following absorption, iron is incorporated into haemoglobin and distributed into storage pools including ferritin and haemosiderin; additional iron is present in myoglobin, haem-containing enzymes, and transferrin-bound plasma iron. The current product information states that approximately 60–70% of absorbed elemental iron is incorporated into haemoglobin, with most of the remainder entering storage compartments. Excretion of iron is predominantly through the faeces.
The EDTA component is poorly absorbed; the fraction reaching the systemic circulation is eliminated by glomerular filtration and tubular excretion.
11. Indications
Sytron is indicated for the treatment of iron-deficiency anaemia in adults, children, and infants. The current product information specifically notes:
- Iron-deficiency anaemia, particularly in paediatric patients.
- Iron-deficiency anaemia during pregnancy when other oral iron preparations are not well tolerated.
- Anaemia secondary to rheumatoid arthritis.
The older wording in the supplied text referring specifically to post-infectious weakness, post-haemorrhagic weakness, malaria, and ankylostomiasis is not retained as a general indication in the current SmPC. Iron treatment should be directed toward confirmed or appropriately suspected iron deficiency rather than used as treatment for an infection itself.
12. Administration
Route: Oral.
Current documented treatment dosage
Adults and elderly patients over 65 years:
5 ml three times daily initially, increased gradually to 10 ml three times daily according to the current product information.
Children and infants:
For treatment of iron-deficiency anaemia, the current SmPC gives 3–6 mg/kg/day of elemental iron, in 2–3 divided doses, with a maximum of 200 mg elemental iron per day.
Because paediatric dosing depends on age, body weight, indication, and clinical assessment, the older fixed age-based doses in the supplied text should not be reproduced as universal current dosing instructions.
The product information also provides separate prophylactic regimens for selected infants and children; these should not be confused with treatment dosing.
13. Method of Preparation
Sytron is supplied as a ready-to-use oral liquid.
The current product information states that water is the recommended diluent when dilution is required. If the product has been diluted with water, the prepared dilution should be used within 14 days.
For routine administration, the product should be measured accurately using an appropriate measuring device.
14. Contraindications
Sytron should not be used in patients with:
- Hypersensitivity to sodium feredetate trihydrate or any of the product's excipients.
- Haemochromatosis.
- Haemosiderosis.
- Repeated blood transfusions or concurrent parenteral iron therapy, where iron accumulation may occur.
The simple statement “Iron overload” in the supplied text is therefore incomplete and has been replaced by the more precise contraindications documented in the current product information.
15. Warnings & Precautions
Caution is required in patients with:
- Haemolytic anaemia.
- Disorders of iron storage or iron absorption.
- Existing gastrointestinal disease.
Prolonged or excessive iron administration in children can result in toxic accumulation. Accidental iron overdose can be particularly dangerous in children and may be fatal.
Iron preparations may cause black discoloration of the stools, which can interfere with certain tests for occult gastrointestinal blood loss.
The formulation contains sorbitol, and patients with hereditary fructose intolerance should not take this medicine. Sorbitol may also cause gastrointestinal discomfort and a mild laxative effect.
The documented formulation also contains methyl hydroxybenzoate, propyl hydroxybenzoate, and Ponceau 4R (E124), which may cause allergic reactions, including delayed reactions. It also contains small amounts of ethanol and sodium.
16. Drug Interactions
Oral iron can interact with a number of medicines and substances by reducing absorption or altering drug effects.
Important documented interactions include:
- Tetracyclines — absorption of both iron and the tetracycline may be reduced.
- Fluoroquinolones — iron reduces their absorption.
- Penicillamine — reduced absorption.
- Mycophenolate — reduced absorption.
- Levothyroxine / thyroxine — reduced absorption.
- Bisphosphonates — reduced absorption.
- Levodopa and carbidopa — absorption may be reduced.
- Methyldopa — oral iron may reduce its hypotensive effect.
- Zinc and other mineral supplements — absorption of iron may be reduced.
- Calcium, magnesium, antacids, bicarbonates and carbonates — may reduce iron absorption.
- Proton-pump inhibitors — may reduce iron absorption.
- Cholestyramine and trientine — may reduce iron absorption.
- Entacapone — may reduce iron absorption.
- Dimercaprol — concomitant administration with oral iron should be avoided because of formation of potentially toxic compounds.
- Chloramphenicol — may delay plasma iron clearance and interfere with erythropoiesis.
Food and beverages can also affect absorption. The product information identifies tea, coffee, eggs, milk, and other mineral-containing products as potentially reducing iron bioavailability, whereas ascorbic acid (vitamin C) and citric acid may increase iron absorption.
17. Side Effects
Documented adverse reactions associated with Sytron include:
- Nausea.
- Mild diarrhoea.
- Hypersensitivity reactions.
The current SmPC classifies the frequencies of these reactions as unknown, because available post-marketing data do not permit a reliable estimation of incidence.
Iron therapy may also cause black stools, which is a known effect of oral iron and is addressed in the product warnings.
The older statement that Sytron's laxative effect is “very rare” is overly specific. The current information instead notes that the product's sorbitol content may cause gastrointestinal discomfort and a mild laxative effect.
18. Use in Special Populations
Pregnancy
Sytron is documented for use in pregnancy when other oral iron formulations are not well tolerated. The current information advises an individual risk-benefit assessment, particularly during the first trimester. No adverse events specifically associated with Sytron administration during pregnancy and lactation have been reported in the product information.
Breast-feeding
No specific adverse events associated with Sytron during lactation have been reported in the current SmPC. Medical advice should nevertheless be obtained before use during breast-feeding.
Infants and children
Sytron is specifically indicated for paediatric use, including infants. Treatment dosing is weight-based in the current SmPC, and excessive or prolonged administration can cause toxic iron accumulation.
Elderly
The documented adult dosage applies to patients over 65 years, unless individual clinical circumstances require otherwise.
Renal or hepatic impairment
No specific additional dosing recommendation was identified in the currently reviewed product information. Individual clinical assessment remains appropriate, particularly in patients with significant comorbidity or disorders affecting iron metabolism.
19. Storage Conditions
The current product information states:
Do not store above 25°C.
The originally supplied statement “Store below 30°C” should therefore not be presented as the current universal storage instruction for all Sytron formulations. Storage instructions printed on the locally marketed Egyptian package should be followed when they differ.
Keep the medicine out of the sight and reach of children. The product information specifically warns that iron overdose can be fatal.
20. Additional Sections
Composition / Excipients
The current documented formulation contains:
- Methyl hydroxybenzoate (E218)
- Propyl hydroxybenzoate (E216)
- Citric acid monohydrate
- Saccharin sodium
- Glycerol
- Sorbitol solution
- Ethanol 96%
- Black cherry flavour
- Ponceau 4R (E124)
- Potable water.
Each 5 ml contains approximately 1,400 mg sorbitol.
Overdose
Iron overdose may initially produce nausea, vomiting, diarrhoea, abdominal pain, gastrointestinal bleeding, lethargy, circulatory collapse, and may be associated with hyperglycaemia and metabolic acidosis. Severe poisoning requires urgent medical management.
Because accidental paediatric iron poisoning can be life-threatening, suspected overdose requires immediate emergency medical assessment.
Shelf Life
The current UK product information documents:
- 36 months unopened
- 3 months after opening
- If diluted with water: use within 14 days.
Shelf life may differ for locally marketed formulations; the package-specific expiry date and local leaflet should therefore be followed.
Pack Size
A 125 ml bottle is documented for Sytron and is the pack size currently listed for the Egyptian-market product in public drug directories. Other documented international pack sizes include 500 ml and 2250 ml, although not all sizes are necessarily marketed in every country.
21. Frequently Asked Questions (FAQ)
What is Sytron used for?
Sytron is an oral iron preparation used for the treatment of iron-deficiency anaemia.
What is the active ingredient in Sytron?
It contains sodium feredetate trihydrate, also referred to as sodium iron edetate, providing 27.5 mg of elemental iron per 5 ml.
Is Sytron an antibiotic?
No. It is an iron replacement preparation and has no antimicrobial activity.
Can Sytron be used in children?
Yes. The current product information specifically includes infants and children, with treatment dosing based on elemental iron and body weight.
Can Sytron be used during pregnancy?
It is documented for use during pregnancy when other oral iron preparations are not well tolerated, but treatment should be medically supervised.
Can Sytron cause diarrhoea?
Yes. Mild diarrhoea and nausea are documented adverse reactions. The sorbitol contained in the formulation may also contribute to gastrointestinal discomfort or a mild laxative effect.
Why can stools become black while taking Sytron?
Iron preparations can cause black stool discoloration. This effect can interfere with some occult-blood testing methods.
Does Sytron contain sugar?
The documented formulation is described as a sugar-free oral liquid, but it contains sorbitol as an excipient.
Should Sytron be taken with tea or milk?
Tea, coffee, eggs, milk, calcium and several mineral-containing products may reduce iron absorption. The product information notes that vitamin C and citric acid may enhance absorption.
Is Sytron the same in every country?
Not necessarily. Brand name, manufacturer, marketing-authorisation holder, excipients, packaging, and regulatory information can differ by country and manufacturing period. The locally approved package leaflet should therefore be checked for the specific product being used.
22. References
- Electronic Medicines Compendium (emc). Sytron 27.5 mg iron per 5 ml Oral Solution — Summary of Product Characteristics. Last updated 19 May 2025.
- Medicines and Healthcare products Regulatory Agency (MHRA). Sytron 27.5 mg iron per 5 ml Oral Solution — approved product information / SmPC. Revision dated 1 May 2025.
- Electronic Medicines Compendium (emc). Sytron — Package Leaflet for the User, including composition, excipients, pregnancy information and pack details. Revised May 2025.
- North East and North Cumbria Integrated Care System Formulary. Oral iron preparations; sodium feredetate (sodium iron edetate), Sytron, 27.5 mg elemental iron/5 ml.
- Public Egyptian medicine-directory listings. Sytron 27.5 mg/5 ml syrup, 125 ml; current listings identifying the Egyptian-market product and its listed manufacturer information. These sources are useful for market identification but are not substitutes for an official Egyptian regulatory record.