Sodium Feredetate 190mg/5ml Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Feredetate 190mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml dose contains Sodium Feredetate 190mg (equivalent to 27.5mg of elemental iron/5ml)
Also contains the following excipients with known effect Ponceau 4R lake (E124) 0.08mg/5ml
Methyl hydroxybenzoate (E218) 5.0mg/5ml
Propyl hydroxybenzoate (E216) 1.0mg/5ml Sorbitol liquid (E420) 1500mg/5ml
Ethanol 0.014ml/5ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
Red coloured liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Iron deficiency anaemia, notably in paediatrics.
In pregnancy when other forms of oral iron may not be well tolerated.
Anaemias secondary to rheumatoid arthritis.
4.2 Posology and method of administration
For oral administration:
Treatment:
Children:
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.
Adults: 5ml increasing gradually to 10ml three times daily.
Elderly (over 65 years): As for adults.
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
4.3
Contraindications
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.
4.4 Special warnings and precautions for use
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.
This medicinal product contains the following:
- Sorbitol; patients with rare hereditary problems of fructose intolerance should not take this medicine. Sorbitol may also cause mild laxative effects.
- Methyl hydroxybenzoate (E218)) and Propyl hydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
- Ponceau 4R (E124) which may cause allergic reactions.
- Small amounts of ethanol (alcohol), less than 100mg per ml.
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.
4.5 Interaction with other medicinal products and other forms of interaction
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.
4.6 Fertility, pregnancy and lactation
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.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
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: www.mhra.gov.uk/yellowcard.
4.9 Overdose
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 >142pmol/l, children >90pmol/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).
Serum iron levels should be monitored throughout.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic properties
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 Sodium Feredetate 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.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate (E216)
Saccharin Sodium Glycerol
Sorbitol liquid (E420)
Ethanol
Black cherry flavour Ponceau 4R (E124)
Citric acid monohydrate Water
6.2 Incompatibilities
None known
6.3 Shelf life
Unopened: 24 months
Opened: 3 months from date of opening
6.4 Special precautions for storage
Store in the original package in order to protect from light.
6.5 Nature and contents of container
Amber glass bottle with a white child resistant tamper evident plastic cap. Each bottle contains 500ml of Sodium Feredetate oral solution.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
NRIM Limited Unit 15 Moorcroft Harlington Road Hillingdon UB8 3HD United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 41830/0037
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/09/2015
10 DATE OF REVISION OF THE TEXT
09/09/2015