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ARACHIS OIL ENEMA

Active substance(s): ARACHIS OIL / ARACHIS OIL / ARACHIS OIL

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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.

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
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
25/07/1998

10

/10/12/2003

DATE OF REVISION OF THE TEXT
01/07/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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