Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sodium feredetate trihydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Sytron is an oral solution for adults, children and babies to treat iron deficiency anaemia caused by too little iron in the body. The form of iron used in this product means that it is less likely to cause stomach upsets than other iron-containing medicines, and will not discolour teeth. It is taken by: • People with iron deficiency anaemia (especially children) • Pregnant women when other forms of oral iron may not be well tolerated • People who have become anaemic as a result of having rheumatoid arthritis. 2.
e Sytron
DO NOT TAKE Sytron if you: • are allergic to sodium feredetate trihydrate or any of the other ingredients of this medicine (listed in section 6, please also see end of section 2: "Sytron contains" for important information about some of the ingredients). • have a history of sensitivity to iron-containing preparations. • have a disorder in which there is excessive absorption and storage of iron such as haemochromatosis or haemosiderosis. • have repeated blood transfusions or have had them in the past. • are currently having iron injections. Warnings and precautions Talk to your doctor or pharmacist before taking Sytron: • if you have haemolytic anaemia • if you have an iron storage or absorption disease • if you have gastrointestinal disease • if you are having tests on your stools as iron preparations colour the faeces black and can interfere with test results
Children and young people Talk to your doctor or pharmacist if a child has been taking Sytron for a long time or at high doses as this can lead to toxic accumulation in the body Other medicines and Sytron Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take Sytron if you: • are currently having iron injections Tell your doctor if you are taking any of the following: • dimercaprol (for metal poisoning) • iron-containing medicines or tonics • chloramphenicol, fluoroquinolones or tetracyclines (to treat infections) • penicillamine (for rheumatoid arthritis) • methyldopa (for high blood pressure) • mycophenolate (to prevent organ transplant rejection) • levodopa, carbidopa or entacapone (for Parkinson's disease) • bisphosphonates (for osteoporosis) • thyroxine (for thyroid problems) • trientine (for Wilson's Disease) • cholestyramine (for high cholesterol) • proton-pump-inhibitors e.g. omeprazole (for stomach ulcers) • bicarbonates, carbonates, calcium, magnesium, zinc and other mineral supplements (indigestion and antacid remedies) Sytron with food and drink Tea, coffee, eggs, milk, ascorbic acid (vitamin c) and citric acid, may interfere with Sytron. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before taking this medicine. Driving and using machines Sytron is not expected to have an effect on your ability to drive or operate machinery. Sytron contains: • Methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), ponceau 4R (E124) may cause allergic reactions (possibly delayed). • Sorbitol (sugar) – this medicine contains 1400 mg sorbitol in each dosage unit (5 ml) which is equivalent to 280 mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. • Ethanol (alcohol) – this medicinal product contains small amounts of ethanol (alcohol), less than 100 mg in the maximum dose of 10 ml. • Sodium (salt) – this medicine contains approximately 23 mg sodium (main component of cooking/table salt) in the maximum dose of 10 ml (2 x 5 ml spoonfuls). This is equivalent to 1.2% of the recommended daily dietary intake of sodium for an adult. However, if you are taking smaller doses e.g. 1 x 5 ml spoonful at a time or less then it contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium free'.
3.
Sytron
The liquid is to be taken by mouth. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Treatment of Anaemia: Adults and Elderly (over 65 years) 1 or 2 x 5 ml spoonfuls 3 times a day Children Depends on weight – 3 to 6 mg/kg (max 200 mg) of elemental iron* as given by your healthcare professional in 2-3 divided doses Prevention of Anaemia: Babies of low-birth weight who are solely breast-fed 5 mg of elemental iron* (0.9 ml given in a 1ml syringe) daily as given by your healthcare professional. A higher dose – depending on weight – up to 2 mg/kg of elemental iron* daily as given by your healthcare professional may be required for exclusively breast-fed babies. Babies (6 to 24 months) 1 x 2.5 ml spoonful daily Children (2 to 5 years) 1 x 5 ml spoonful daily Children (6 to 11 years) 1-2 x 5ml spoonfuls daily Adolescents 2 x 5 ml spoonfuls daily *Elemental iron is iron your body can absorb. If you take more Sytron than you should If you accidentally take too much Sytron or give too much to a child, tell your doctor immediately or contact your hospital. Take this leaflet, the container and any remaining Sytron with you, if you can. An overdose may cause: • sickness (this may have some blood in it) or make you feel sick • stomach pains • diarrhoea • blood in your stools • tiredness • cold and sweaty skin • fast heart beat • high blood sugar • high blood acidity (metabolic acidosis). If you have any further questions on the use of this product, ask your doctor or pharmacist. If you forget to take Sytron If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions: e.g. itchy skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing. If you experience any of the above, stop taking this medicine and see a doctor immediately. You may feel sick or have mild diarrhoea in the early stages of treatment. These effects should quickly disappear if you stop taking Sytron for a short time. When treatment is restarted, a lower dose of your medicine should be taken. If your doctor tells you to take Sytron at doses higher than is stated in this leaflet, you may experience mild diarrhoea. Talk to your doctor or pharmacist if a child has been taking the medicine for a long time or at high doses as this can lead to toxic accumulation in the body. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
Sytron
Keep this medicine out of the sight and reach of children. Do not store above 25oC. Do not use this medicine after the expiry date which is stated on the label after EXP. Once opened the product should be used within 3 months (there is a space on the label to record the date it was first opened). If the product shows any signs of deterioration please return it to your pharmacist. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
What Sytron contains The active substance is: sodium feredetate trihydrate (also known as sodium iron edetate) 207.5 mg/5 ml (equivalent to 27.5 mg/5 ml of elemental iron). The other ingredients are: methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), citric acid monohydrate, saccharin sodium, glycerol, sorbitol, ethanol, ponceau 4R (E124), black cherry flavouring, water (please see end of section 2: "Sytron contains" for important information about some of the ingredients).
What Sytron looks like and contents of the pack Sytron is a red, sugar free, cherry-flavoured liquid supplied in amber coloured glass bottles containing 125 ml, 500 ml or 2250 ml of oral solution (not all pack sizes may be marketed). Marketing Authorisation Holder Grünenthal Ltd. TOR Building, Saint Cloud Way, Maidenhead, Berkshire, SL6 8BN United Kingdom. Manufacturer Laleham Health and Beauty Limited, Fairfield, Bradshaw Lane, Greenhalgh, Kirkham, Preston, Lancashire, PR4 3JA, United Kingdom. The package leaflet for this medicine is also available on the Electronic Medicines Compendium website: https://www.medicines.org.uk/emc/ The leaflet was last revised: May 2025
Sytron 27.5 mg iron per 5 ml Oral Solution comes as oral solution containing 27.5mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Sytron 27.5 mg iron per 5 ml Oral Solution is sodium feredetate trihydrate.
This leaflet reproduces the patient information leaflet approved for Sytron 27.5 mg iron per 5 ml Oral Solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Sytron is indicated in adults, children and infants for iron deficiency anaemia:
• Notably in paediatrics;
• In pregnancy when other forms of oral iron may not be well tolerated;
• In anaemias secondary to rheumatoid arthritis.
Posology
Treatment:
Adults and the elderly
(over 65 years):
5 ml increasing gradually to 10 ml three times daily.
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.
Prophylaxis:
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
Method of administration
Oral
For instructions on dilution of the medicinal product before administration, see section 6.6.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Iron preparations are contraindicated in patients with haemochromatosis and haemosiderosis.
Iron is contraindicated in patients receiving repeated blood transfusions or in patients receiving parenteral iron therapy.
Care should be taken in patients with haemolytic anaemia, iron-storage or iron-absorption diseases or existing gastrointestinal diseases.
Iron preparations colour the faeces black, which may interfere with tests used for detection of occult blood in the stools.
Prolonged or excessive use in children may lead to toxic accumulation.
Contains Methyl hydroxybenzoate (E218), Ponceau 4R (E124) and Propyl hydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg in the maximum dose of 10 ml.
This medicine contains approximately 23 mg sodium in the maximum dose of 10 ml, equivalent to 1.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
At doses lower than the maximum, this medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
This medicine contains 1400 mg sorbitol in each dosage unit (5 ml) which is equivalent to 280 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sorbitol may cause gastrointestinal discomfort and mild laxative effect when taken orally at levels equal to, or over, 140 mg/kg/day. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietery intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
The label will state:
“Important warning: Contains iron. Keep out of the sight and reach of children, as overdose may be fatal.”
This will appear on the front of the pack within a rectangle in which there is no other information.
Avoid concomitant administration of oral iron with dimercaprol (formation of toxic compounds).
Iron reduces the absorption of penicillamine, mycophenolate, fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates.
Administration of oral iron may reduce the hypotensive effect of methyldopa.
Iron and tetracyclines reduce the absorption of each other.
Iron and zinc reduce the absorption of each other.
Oral chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Absorption of iron is reduced with entacapone, proton pump inhibitors, bicarbonates, carbonates, calcium, zinc, magnesium and other mineral supplements, trientine, antacids, cholestyramine, tea, eggs and/or milk, but may be increased by ascorbic acid and/or citric acid.
Coffee may be a factor in reducing iron bioavailability.
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.
None known
Adverse reactions reported as possibly associated to Sytron are presented in the following table by MedDRA System Organ Class (SOC), Preferred Term and frequency. The following frequency categories are used:
Very common (>1/10)
Common (>1/100, <1/10)
Uncommon (>1/1,000, <1/100)
Rare (>1/10,000, <1/1,000)
Very rare (<1/10,000)
Post-marketing adverse reactions are reported voluntarily from a population with an unknown rate of exposure. Therefore it is not possible to estimate the true incidence of adverse reactions and the frequency is “unknown”.
Tabulated summary of adverse reactions
SYSTEM ORGAN CLASS (SOC)
FREQUENCY
ADVERSE REACTION
Immune system disorders
Unknown
Hypersensitivity
Gastrointestinal disorders
Unknown
Nausea, mild diarrhoea
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycaemia and metabolic acidosis may occur.
Treatment of overdosage
1. Administer an emetic.
2. Emesis should be followed by gastric lavage with desferrioxamine solution (2g/l). Desferrioxamine 5g in 50ml to 100ml water should be introduced into the stomach following gastric emptying.
3. Keep the patient under constant surveillance to detect possible aspiration of vomitus. Maintain suction apparatus and standby emergency oxygen in case of need.
4. In adults, a drink of mannitol or sorbitol should be given to induce small bowel emptying. Inducing diarrhoea in children may be dangerous and should not be undertaken in young children.
5. Severe poisoning: in the presence of shock and/or coma with high serum iron levels (adults >142μmol/l, children >90μmol/l), immediate supportive measures should be introduced. Desferrioxamine should be given by slow iv infusion (adults 5mg/kg/h, children 15mg/kg/h). The maximum dose is 80mg/kg/24h. Warning: hypotension may occur if the infusion rate is too rapid.
6. Less severe poisoning: im desferrioxamine should be administered (adults 50mg/kg to a maximum of 4g, children 1g 4 to 6 hourly).
7. Serum iron levels should be monitored throughout.
Ask anything about Sytron 27.5 mg iron per 5 ml Oral Solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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