SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Fletchers’ Arachis Oil Enema Arachis Oil Enema

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

The 130ml enema contains: Arachis Oil 100%

3    PHARMACEUTICAL FORM

Single dose disposable retention enema for rectal administration

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

To soften impacted faeces

4.2    Posology and method of administration

Adults and elderly:

1 enema as required Children:

In proportion, according to body weight. Method of administration -rectal administration.

4.3 Contraindications

Hypersensitivity to Arachis oil or peanuts. Inflammatory bowel disease, except under the instruction ofa medical practitioner.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Pregnancy and lactation

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

4.7 Effects on ability to drive and use machines

Not applicable

4.8 Undesirable effects

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

4.9 Overdose

No cases of overdosages have been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

5.2    Pharmacokinetic properties

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

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

None

6.2    Incompatibilities

None known

6.3 Shelf life

2 years

6.4 Special precautions for storage

Store at room temperature (25°C).

6.5 Nature and contents of container

Blue PVC bag with clear plastic nozzle and cap.

OR

Blue LDPE bottle with clear PVC nozzle and blue overcap. Pack size 130ml.

6.6 Special precautions for disposal

None stated.

7 MARKETING AUTHORISATION HOLDER

CHEMIDEX PHARMA LIMITED

CHEMIDEX HOUSE, UNIT 7 EGHAM BUS VILLAGE

CRABTREE ROAD

EGHAM

SURREY

TW20 8RB

UNITED KINGDOM

8    MARKETING AUTHORISATION NUMBER(S)

PL 17736/0116

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

25^th July 1988 / 24^th November 2003

10 DATE OF REVISION OF THE TEXT

17/04/2008