Sodium Feredetate 190mg/5ml Oral Solution SMPC, Taj Pharmaceuticals

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RX SODIUM FEREDETATE ORAL SOLUTION

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:

190MG/5ML

Babies of low birth weight who are solely breast-fed:

1.NAME OF THE MEDICINAL PRODUCT

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.

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) Excipients with known effect: Ponceau 4R lake (E124), Methyl hydroxybenzoate (E218), Propyl hydroxybenzoate (E216), Sorbitol liquid (E420), Ethanol

Other children (elemental iron per day):

For a full list of excipients, see section 6.1.

Age 6 - 11 years: 30 – 60 mg

3. PHARMACEUTICAL FORM

Adolescents: 60 mg

Oral Solution.

Method of administration

Red coloured liquid.

Oral

4. CLINICAL PARTICULARS 4.1 Therapeutic indications

For instructions on dilution of the medicinal product before administration, see section 6.6.

Sodium Feredetate is indicated for Iron deficiency anaemia,

4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

• 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 Posology: Treatment: Children: Treatment of iron-deficiency anaemia in all paediatric age groups is 3-6 mg/kg (max 200

Age 6 - 24 months: 12.5 mg Age 2 - 5 years: 20-30 mg

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.

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Prolonged or excessive use in children may lead to toxic accumulation.

Coffee may be a factor in reducing iron bioavailability.

This medicinal product contains the following:

4.6 Fertility, Pregnancy and lactation

- Sorbitol; patients with rare hereditary problems of fructose intolerance should not take this medicine. Sorbitol may also cause mild laxative effects.

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 sodium feredetate administration during pregnancy and lactation have been reported.

- 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.”

4.7 Effects on ability to drive and use machines None known.

4.8 Undesirable Effects Adverse reactions reported as possibly associated to sodium feredetate 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)

This will appear on the front of the pack within a rectangle in which there is no other information.

Common (>1/100, <1/10)

4.5 Interaction with other medicinal products and other forms of interaction

Rare (>1/10,000, <1/1,000)

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.

Uncommon (>1/1,000, <1/100)

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.

4.9 Overdose

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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.

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. Less severe poisoning: im desferrioxamine should be administered (adults 50mg/kg to a maximum of 4g, children 1g 4 to 6 hourly).

6.1 List of excipients Methyl hydroxybenzoate (E218)

Serum iron levels should be monitored throughout.

Saccharin Sodium

5. PHARMACOLOGICAL PROPERTIES

Glycerol

5.1 Pharmacodynamic properties Pharmacotherapeutic group: Iron preparations 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

Propyl hydroxybenzoate (E216)

Sorbitol liquid (E420) Ethanol Black cherry flavour Ponceau 4R (E124) Citric acid monohydrate Water

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6.2 Incompatibilities None known.

6.3 Shelf life Unopened: 3 years.

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 and other handling None.

7. MANUFACTURER:

Manufactured in India by: TAJ PHARMACEUTICALS LTD. Mumbai, India At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad 438225, Gujarat, INDIA