This information is intended for use by health professionals

1. Name of the medicinal product

Fletchers' Arachis Oil Retention Enema

Arachis Oil Enema

2. Qualitative and quantitative composition

The 130ml enema contains:

Arachis Oil BP 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 of a 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.

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

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 and other handling

None stated.

7. Marketing authorisation holder

Chemidex Pharma Ltd

T/A Essential Generics

Chemidex House

Egham Business Village

Crabtree Road

Egham

Surrey

TW20 8RB

8. Marketing authorisation number(s)

PL 17736/0116

9. Date of first authorisation/renewal of the authorisation

25th July 1988 / 24th November 2003

10. Date of revision of the text

1st July 2016