Fletchers' Arachis Oil Retention Enema

Arachis Oil Enema

The 130ml enema contains:

Arachis Oil BP 100%

Single dose disposable retention enema for rectal administration

To soften impacted faeces.

Adults and elderly:

1 enema as required

Children:

In proportion, according to body weight.

Method of administration – rectal administration.

Hypersensitivity to Arachis oil or peanuts.

Inflammatory bowel disease, except under the instruction of a medical practitioner.

Arachis Oil Enema contains Arachis oil (peanut oil) and should not be used by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Arachis Oil Enema.

Not for use in children unless under medical supervision. 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. The enema should be warmed before use by placing in warm water.

None known

The use of enemas is not recommended during pregnancy except under medical advice.

Not applicable.

Like other rectally applied substances, Arachis oil may produce local irritation.

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.

No cases of overdosages have been reported.

Arachis oil is utilised in this product to soften impacted faeces.

Arachis oil is not known to be absorbed and acts purely locally.

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

None

None known

2 years

Store at room temperature (25°C).

Blue PVC bag with clear plastic nozzle and cap

OR

Blue LDPE bottle with clear PVC nozzle and blue overcap

Pack size 130ml

None stated.

Chemidex Pharma Ltd

T/A Essential Generics

Chemidex House

Egham Business Village

Crabtree Road

Egham

Surrey

TW20 8RB

PL 17736/0116

25^th July 1988 / 24^th November 2003

1^st July 2016