Furamide Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Furamide 500 mg Tablets Diloxanide 500 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of diloxanide furoate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
A flat, white tablet scored and with a characteristic engraving E/F on one face.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Diloxanide Tablets are indicated in adults and children weighing over 25 kg for the treatment of acute and chronic intestinal amoebiasis.
4.2. Posology and method of administration
Posology
Adults
One tablet three times daily for ten days.
Paediatric population
20 mg/kg bodyweight daily in divided doses for ten days. Diloxanide Tablets are 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
Method of administration Oral
4.3 Contraindications
Hypersensitivity to the active substance diloxanide furoate or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically-significant drug interactions known.
4.6 Fertility, pregnancy and lactation
Pregnancy
The safety of diloxanide furoate during pregnancy has not been established and use in pregnancy should therefore be avoided.
Breast-feeding
The safety of diloxanide furoate during lactation has not been established and use when breast-feeding should therefore be avoided.
4.7 Effects on ability to drive and use machines
Diloxanide furoate may have a minor influence on the ability to drive and use machines. Dizziness including headache may occur following administration of diloxanide furoate ( See section 4.8)
4.8 Undesirable effects
The following adverse reactions have been reported with erythromycin. The adverse reactions are listed according to their frequency:
Very common (> 1/10)
Common (> 1/100 - <1/10)
Uncommon (> 1/1000 - <1/100)
Rare (> 1/10000 - <1/1000)
Very rare (<1/10000)
not known (frequency cannot be estimated from the available data)
The bacterial flora of the gut is not upset.
Metabolism and nutrition disorders not known: Anorexia
Nervous system disorders not known: Headache, dizziness
Gastrointestinal disorders not known :Flatulence, vomiting, nausea, diarrhoea, abdominal cramps
not known:Pruritus, urticaria
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, website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Diloxanide 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.
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: dichloroacetamide derivatives ATC code: P01AC01
Diloxanide furoate is a luminal amoebicide acting principally in the bowel lumen, although its mode of action is not known.
5.2 Pharmacokinetic properties
Biotransformation
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.
Elimination
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.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize starch, pregelatinized maize starch, dried maize starch, magnesium stearate, purified water.
6.2 Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
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.
Special precautions for disposal
6.6
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Amdipharm UK Limited
Capital House, 85 King William Street,
London EC4N 7BL, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20072/0225
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17th November 1999
10 DATE OF REVISION OF THE TEXT
31/03/2015