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CASTOR OIL B.P.

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Castor Oil B.P.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Castor Oil B.P. 100.0% v/v

3

PHARMACEUTICAL FORM
Oil

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
To be taken orally as a laxative.

4.2

Posology and method of administration
Children:
Up to one year:
Ten drops.
1 to 12 years:
Ten drops to two 5ml spoonfuls according to age.
Adults (including the elderly):
One to four 5ml spoonfuls to be taken in milk or lemon juice one hour before
breakfast or on an empty stomach.

4.3

Contraindications
None stated.

4.4

Special warnings and precautions for use
Store out of reach of children.
May increase intestinal motility.
May cause abdominal cramps.
Should be avoided in the presence of abdominal obstruction.
Prolonged use may percipitate the onset of an atonic non-functioning colon
and hypokalaemia.

4.5

Interaction with other medicinal products and other forms of interaction
None stated.

4.6

Fertility, pregnancy and lactation
Not recommended for use during pregnancy; seek medical advice.

4.7

Effects on ability to drive and use machines
None stated.

4.8

Undesirable effects
None stated.

4.9

Overdose

May produce nausea, vomiting, colic and severe purgation. The effects
subside naturally without treatment, but fluids should be given if large
volumes of fluid are lost.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Castor Oil is a mild purgative, its action being exerted as a result of
saponification in the intestine, with fermentation of the irritant alkali
ricinoleate.

5.2

Pharmacokinetic properties
The laxative action of Castor Oil takes effect in four to eight hours and causes
little to no griping.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
None.

6.2

Incompatibilities
None stated.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
None stated.

6.5

Nature and contents of container
Amber glass bottles with a plastic screw cap — 50ml and 100ml.
Plastic Jerry-can ex Smiths container with a plastic cap - 2000ml

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0046

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28.09.1989

10

DATE OF REVISION OF THE TEXT
14/12/2011

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