Arachis Oil Enema

Pale yellow oil. Single dose disposable retention enema for rectal administration

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.

5.1 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.

6.1 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.