Summary of Product Characteristics Updated 09-Jun-2023 | Chemidex Pharma Ltd
Fletchers' Arachis Oil Retention Enema
Arachis Oil Enema
Each enema contains arachis oil 130 ml.
Pale yellow oil.
Single dose disposable retention enema for rectal administration
Arachis oil enema is indicated for the treatment of faecal impaction.
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.
Hypersensitivity to the active substance or to peanut or soya.
Inflammatory bowel disease, except under medical advice.
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.
None known.
The use of enemas is not recommended during pregnancy except under medical advice.
This medicine has no or negligible influence on the ability to drive and use machines.
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.
No cases of overdose have been reported.
Pharmacotherapeutic group: Drugs for constipation, Enemas, ATC code: A06AG06.
Arachis oil is used 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 SmPC.
None.
Not applicable.
2 years.
Do not store above 25° C.
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.
No special requirements.
Chemidex Pharma Ltd
T/A Essential Generics
Chemidex House
Egham Business Village
Crabtree Road
Egham
Surrey
TW20 8RB
United Kingdom
PL 17736/0116
Date of first authorisation: 25 July 1988
Date of latest renewal: 24 November 2003
31st May 2023
7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8 RB, UK
+44 (0)1784 471 776
http://www.chemidex.co.uk
+44 (0)1784 477 167
[email protected] info@essentialpharmaceuticals
+44 (0)1784 477167