Fletchers' Phosphate Enema

Alternative name: Phosphates Enema BP Formula B

Each 128ml enema contains:

Sodium Dihydrogen Phosphate Dihydrate 10% w/v Disodium

Phosphate Dodecahydrate 8% w/v

Rectal solution

Routine treatment of constipation. Pre- and post-operative cleansing of the bowel, in obstetrics and prior to proctoscopy, sigmoidoscopy or X-ray examination.

Adults including the elderly:

1 enema as required.

Children over 3 years of age:

Reduce adult dosage in proportion to body weight.

Children under 3 years of age:

Not recommended.

For rectal administration only. The enema may be administered at room temperature or warmed in water before use.

Hypersensitivity to any of the constituents. Use in patients with inflammatory or ulcerative conditions of the large bowel, in those with increased colonic absorptive capacity eg Hirschsprung's disease and in those with acute gastrointestinal conditions.

Prolonged use may lead to irritation of the anal canal. Use with caution in patients requiring a reduced sodium intake and electrolyte balance should be maintained during extended use. Use with caution in patients with intestinal obstruction. Care should be taken not to use undue force in administration of the enema especially in the elderly or debilitated patients or those with neurological disorders.

None known.

No special warnings.

Not applicable.

Local irritation.

There have been occasional reports of apparent vasovagal attacks occurring in elderly patients following administration of phosphate enemata.

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 at: www.mhra.gov.uk/yellowcard.

There have been no cases of overdosage. In the event of overdosage, electrolyte levels should be monitored and balance restored where appropriate.

Fletchers' Phosphate Enema is a solution of sodium dihydrogen phosphate dehydrate and disodium phosphate dodecahydrate. The formulation is equivalent to Phosphates Enema BP Formula B. Following rectal administration the active ingredients exert their laxative effect via their osmotic properties. The resulting fluid retention in the bowel encourages evacuation.

Saline laxatives are poorly and slowly absorbed following rectal administration.

Under normal usage only minimal absorption is likely to occur.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Benzalkonium chloride, Disodium Edetate and Purified Water.

Not applicable.

3 years

Do not store above 25°C.

Translucent LDPE bottle with rubber non-return valve, plastic nozzle and nozzle plug containing 128ml solution packed singly in a cardboard carton, or alternatively longtube version with separate applicator with extension tube for attachment before use.

None stated.

CHEMIDEX PHARMA LIMITED

T/A ESSENTIAL GENERICS

CHEMIDEX HOUSE, EGHAM BUSINESS VILLAGE

CRABTREE ROAD

EGHAM

SURREY

TW20 8RB

UNITED KINGDOM

PL 17736/0115

26/07/2005

22/03/2016