SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Fletchers’ Phosphate Enema

Alternative name: Phosphates Enema BP Formula B

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 128ml enema contains:

Sodium Dihydrogen Phosphate Dihydrate    10% w/v

Disodium Phosphate Dodecahydrate    8% w/v

3 PHARMACEUTICAL FORM

Rectal solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2 Posology and method of administration

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.

4.3 Contraindications

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.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

Pregnancy and lactation

No special warnings.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8    Undesirable effects

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.

4.9    Overdose

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

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Fletchers’ Phosphate Enema is a solution of sodium dihydrogen phosphate dihydrate 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.

5.2 Pharmacokinetic properties

Saline laxatives are poorly and slowly absorbed following rectal administration. Under normal usage only minimal absorption is likely to occur.

5.3 Preclinical safety data

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzalkonium chloride, Disodium Edetate and Purified Water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25 °C.

6.5 Nature and contents of container

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

6.6 Special precautions for disposal

None stated.

7    MARKETING AUTHORISATION HOLDER

CHEMIDEX PHARMA LIMITED

T/A ESSENTIAL GENERICS

CHEMIDEX HOUSE, EGHAM BUSINESS VILLAGE

CRABTREE ROAD

EGHAM

SURREY

TW20 8RB

UNITED KINGDOM

8    MARKETING AUTHORISATION NUMBER(S)

PL 17736/0115

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26/07/2005

10 DATE OF REVISION OF THE TEXT

22/03/2016