S-Fer

S-Fer syrup is an oral solution for adults, children and babies to treat iron deficiency anemia caused by too little iron in the body. The form of iron used in S-Fer means that it is less likely to cause stomach upsets than other iron-containing medicines, and will not

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S-Fer syrup is an oral solution for adults, children and babies to treat iron deficiency anemia caused by too little iron in the body. The form of iron used in S-Fer means that it is less likely to cause stomach upsets than other iron-containing medicines, and will not discolor teeth. It is indicated for:

Iron Deficiency Anemia (especially in children)

Pregnant women when other forms of oral iron may not be well tolerated

People who have become anemic as a result of having rheumatoid arthritis.

Iron-deficiency anaemia (therapeutic): By mouth using oral solution

Neonate

: Up to 2.5 mL twice daily, smaller doses to be used initially.

• Child 1-11 months
• : Up to 2.5 mL twice daily, smaller doses to be used initially
• Child 1-4 years
• : 2.5 mL 3 times a day
• Child 5-11 years
• : 5 mL 3 times a day
• Child 12-17 years

: 5 mL 3 times a day, increased to 10 mL 3 times a day, dose to be increased gradually

Iron-deficiency anaemia (prophylactic): By mouth using oral solution

Neonate

: 1 mL daily, prophylactic iron supplementation may be required in babies of low birth-weight who are solely breast-fed; supplementation is started 4-6 weeks after birth and continued until mixed feeding is established.

Child 1-11 months

: 1 mL daily, prophylactic iron supplementation may be required in babies of low birth-weight who are solely breast-fed; supplementation is started 4-6 weeks after birth and continued until mixed feeding is established.

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 so it does not discolor teeth. The iron chelate is split within the gastro-intestinal tract and releases elemental iron.

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.

EDTA is poorly absorbed and passes through the body unchanged after reaching the bloodstream.

Allergic reactions: e.g. itchy skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Sodium Feredetate Trihydrate is contraindicated in patients with a history of

Hypersensitivity to the active substance or to any of the excipients.

Haemochromatosis, haemosiderosis and other Iron overload syndromes.

Receiving repeated blood transfusions.

Care should be taken in patients with haemolytic anaemia, iron-storage or iron-absorption diseases or existing gastrointestinal diseases. Iron preparations color 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.

Administration of drugs during the 1st trimester of pregnancy requires careful assessment of potential risks versus benefits to be gained. No adverse events associated with Sodium Feredetate Trihydrate administration during pregnancy and lactation have been reported.

Initial symptoms of iron overdosage include nausea, vomiting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse.Hyperglycaemia and metabolic acidosis may occur.

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.

Store below 25°C. Protect from light. Keep all medicines out of reach of children. Once opened the product should be used within 3 months.