Sytron 27.5 mg iron per 5 ml Oral Solution

Each 5 ml of oral solution contains 207.5 mg of sodium feredetate trihydrate equivalent to 27.5 mg of iron.

Excipients with known effect:

Methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), sodium, sorbitol, ethanol and Ponceau 4R (E124) - please refer to section 4.4 for further details.

For the full list of excipients, see section 6.1.

Oral solution

Clear, red syrup, free of particles

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:

 Prophylaxis:

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 100mg in the maximum dose of 10 ml.

At the maximum dose of 10 ml this medicinal product contains approximately 1.04 mmol (24.00 mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

At doses lower than the maximum, this medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.

This medicinal product also contains Sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicine.

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: www.mhra.gov.uk/yellowcard.

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.

Pharmacotherapeutic group: Iron preparations, ATC code: B03A

After absorption, elemental iron is available for haemoglobin regeneration and reversal of anaemia associated with iron-deficient states.

Sodium feredetate is not an iron salt as it contains iron in an un-ionised form. In this compound the iron is “insulated” or “sequestered” with the sodium salt of ethylenediamine tetra-acetic acid (EDTA) to form a chelate. This accounts for the fact that Sytron is not astringent and does not discolour teeth. Studies using radioactive tracers have shown that the iron chelate is split within the gastro-intestinal tract, releasing elemental iron which is absorbed and rendered available for haemoglobin regeneration.

Iron absorption is enhanced in iron-deficiency states. Post-absorption distribution of elemental iron is as follows: 60% to 70% is incorporated into haemoglobin and most of the remainder is present in storage forms, either as ferritin or haemosiderin, in the reticulo-endothelial system and to a lesser extent, hepatocytes. A further 4% is present in myoglobin and haeme-containing enzymes, or bound to transferrin in plasma. Excretion is mainly in the faeces.

EDTA passes through the body unchanged. The compound is poorly absorbed, and that which reaches the bloodstream is eliminated by both glomerular filtration and tubular excretion.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

Methyl hydroxybenzoate (E218)

Propyl hydroxybenzoate (E216)

Citric acid monohydrate

Saccharin sodium

Glycerol

Sorbitol solution

Ethanol 96%

Black cherry flavour

Ponceau 4R (E124)

Potable water

None known

Unopened: 36 months

Opened: 3 months from date of opening

If this product has been diluted with water use within 14 days of preparation.

Store below 30°C

Sytron is supplied in round amber glass bottles with a CRC cap. Each bottle contains either 125ml or 500ml or 2250ml of Sytron.

Not all pack sizes may be marketed.

Water is the recommended diluent for this product.

Kyowa Kirin Limited

Galabank Business Park

Galashiels

TD1 1QH

United Kingdom

PL 16508/0059

13 October 1993/18 February 2004

September 2017