Summary of Product Characteristics
last updated on the eMC:
26/09/2007
|
SPC
|
Diloxanide Tablets 500mg (Sovereign Medical)
|
Go to top of the pageGo to top of the page | Active ingredient | Quantity | Diloxanide Furoate | 500 mg |
| |
Go to top of the page | A flat, white tablet, scored and with a characteristic engraving E/F on one face. | |
Go to top of the pageGo to top of the page | For the treatment of acute and chronic intestinal amoebiasis. | |
Go to top of the page | Adults: One tablet three times daily for ten days. Children: 20 mg/kg bodyweight daily in divided doses for ten days. Furamide is not suitable for use in children weighing less than 25 kg. Elderly: There is no need for dosage reduction in the elderly. If required, a second course of treatment may be prescribed. | |
Go to top of the page | Hypersensitivity to diloxanide furoate. | |
Go to top of the page | Keep all medicines out of the reach of children. | |
Go to top of the page | No clinically-significant drug interactions known. | |
Go to top of the page | The safety of Furamide during pregnancy and lactation has not been established and use during these periods should therefore be avoided. | |
Go to top of the page | No adverse effects known. | |
Go to top of the page | No serious side effects have been reported and the bacterial flora of the gut is not upset. Flatulence sometimes occurs but may usually be disregarded. Occasionally, vomiting, pruritus and urticaria may occur. | |
Go to top of the page | Furamide tablets are unlikely to constitute a hazard in overdosage. In severe overdosage, early gastric lavage is recommended. There is no specific antidote. Treatment should be symptomatic and supportive. | |
Go to top of the pageGo to top of the page | Diloxanide furoate is a luminal amoebicide acting principally in the bowel lumen, although its mode of action is not known. | |
Go to top of the page | In the gut, diloxanide furoate is largely, if not wholly, hydrolysed into diloxanide and furoic acid under the combined action of bacterial and gut esterases. After absorption, diloxanide is very rapidly conjugated to form a glucuronide. In circulating blood, it is present to about 99% as a glucuronide and 1% as free diloxanide. Diloxanide is predominantly excreted in the urine. It is believed that the unabsorbed diloxanide is the active anti-amoebic substance, up to 10% remaining in the gut which is subsequently excreted as diloxanide in the faeces. | |
Go to top of the pageGo to top of the pageGo to top of the page | Maize starch, pregelatinized maize starch, dried maize starch, magnesium stearate, purified water. | |
Go to top of the pageGo to top of the pageGo to top of the pageGo to top of the page | A white aluminium tube with a polythene foam disc and a white aluminium screw cap with flowed-in PVC. Pack size: 15 tablets.A white polythene cylindrical bottle and white polypropylene screw cap fitted with a waxed aluminium-faced pulpboard liner. Pack size: 30 tablets.A rectangular amber-glass bottle with a white tin-plate screw cap fitted with a waxed aluminium-faced pulpboard liner. Pack size: 250 tablets.A white polythene cylindrical bottle and white polypropylene screw cap fitted with a waxed aluminium-faced pulpboard liner. Pack size: 250 tablets. | |
Go to top of the pageGo to top of the pageGo to top of the page | Waymade PLC Sovereign House Miles Gray Road Basildon, Essex, SS14 3FR United Kingdom | |
Go to top of the pageGo to top of the pageGo to top of the pageGo to top of the page
More information about this product
Link to this document from your website: http://www.medicines.org.uk/emc/medicine/10787/SPC/
