Arachis Oil Enema

Summary of Product Characteristics Updated 09-Jun-2023 | Chemidex Pharma Ltd

1. Name of the medicinal product

Fletchers' Arachis Oil Retention Enema

Arachis Oil Enema

2. Qualitative and quantitative composition

Each enema contains arachis oil 130 ml.

3. Pharmaceutical form

Pale yellow oil.

Single dose disposable retention enema for rectal administration

4. Clinical particulars
4.1 Therapeutic indications

Arachis oil enema is indicated for the treatment of faecal impaction.

4.2 Posology and method of administration

Posology

Adults and elderly

1 enema as required.

Paediatric population

In proportion, according to body weight.

Method of administration

For single rectal use.

The enema should be warmed before use by placing in warm water.

4.3 Contraindications

Hypersensitivity to the active substance or to peanut or soya.

Inflammatory bowel disease, except under medical advice.

4.4 Special warnings and precautions for use

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, 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

This medicine has no or negligible influence on the ability to drive and use machines.

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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

No cases of overdose have been reported.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for constipation, Enemas, ATC code: A06AG06.

Arachis oil is used 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 SmPC.

6. Pharmaceutical particulars
6.1 List of excipients

None.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 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 LDPE overcap.

Pack size 130 ml.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Chemidex Pharma Ltd

T/A Essential Generics

Chemidex House

Egham Business 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

Date of first authorisation: 25 July 1988

Date of latest renewal: 24 November 2003

10. Date of revision of the text

31st May 2023

Company Contact Details
Chemidex Pharma Ltd
Address

7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8 RB, UK

Telephone

+44 (0)1784 477 167

Medical Information Direct Line

+44 (0)1784 477167

WWW

http://www.chemidex.co.uk

Fax

+44 (0)1784 471 776

Medical Information e-mail

[email protected] info@essentialpharmaceuticals