SYTRON Oral solution Ref.[27557] Active ingredients: Sodium feredetate

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:

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.

None known.