LIQUID PARAFFIN BP/EP
Active substance(s): PARAFFIN LIQUID
NAME OF THE MEDICINAL PRODUCT
Liquid Paraffin - BP/EP
QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid Paraffin - BP 100% w/w
May be used as a laxative.
Posology and Method of Administration
Adults inclusive of the elderly:
Children over the age of 3:
Children under age of 3:
10- 30 mls as and when required
5-20 mls as and when required
Route of administration: Oral
Children under the age of three.
Special Warnings and Special Precautions for Use
Avoid prolonged use. Do not use repeatedly and consult your doctor if
laxatives are needed every day, if you have persistent abdominal pain or have
a condition which makes swallowing difficult.
4.5. Interactions with other Medicinal Products and other Forms of
There may be interference with the absorption of fat soluble vitamins.
Pregnancy and Lactation
As with all medicines, avoid during early pregnancy and lactation.
Effects on Ability to Drive and Use Machines
Anal seepage of paraffin and consequential anal irritation after prolonged use.
Granulamatouse reaction caused by absorption of small quantities of liquid
paraffin. Lipoid pneumonia (by accidental inhalation) may occur. Caution is
required in patients with swallowing difficulties.
If large quantities are ingested, withdraw medication. Supportive treatment
Liquid paraffin acts as a faecal softener.
If used as directed, it is not normally absorbed; but chronic use may cause
granulamata in the intestinal tract.
Pre-clinical Safety Data
List of excipients
Product is 100% an excipient.
Special Precautions for Storage
At ambient temperatures, under dry conditions and away from direct sun light.
Nature and Content of Container
Up to 20,000 litres bulk, 205 litres barrels, 25 litres drums and 5 litre bottles.
Instructions for Use, Handling and Disposal
No special instructions.
MARKETING AUTHORISATION HOLDER
Fuchs Lubricants (UK) Plc
New Century Street
Stoke on Trent
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
23 July 1984, Renewed 16 April 1998
DATE OF (PARTIAL) REVISION OF THE TEXT