Diloxanide Tablets 500mg

A flat, white tablet, scored and with a characteristic engraving E/F on one face.

For the treatment of acute and chronic intestinal amoebiasis.

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.

Hypersensitivity to diloxanide furoate.

Keep all medicines out of the reach of children.

No clinically-significant drug interactions known.

The safety of Furamide during pregnancy and lactation has not been established and use during these periods should therefore be avoided.

No adverse effects known.

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.

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.

Diloxanide furoate is a luminal amoebicide acting principally in the bowel lumen, although its mode of action is not known.

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.

Not applicable.

Maize starch, pregelatinized maize starch, dried maize starch, magnesium stearate, purified water.

None known.

36 months.

None.

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.

Not applicable.

Waymade PLC

Sovereign House

Miles Gray Road

Basildon, Essex, SS14 3FR

United Kingdom

PL 06464/0900

17 November 1999

29 February 2000

POM