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LIQUID PARAFFIN BP/EP

Active substance(s): PARAFFIN LIQUID

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Liquid Paraffin - BP/EP

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid Paraffin - BP 100% w/w

3.

PHARMACEUTICAL FORM
Liquid

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
May be used as a laxative.

4.2.

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
Not recommended

Route of administration: Oral

4.3

Contra-Indications
Children under the age of three.

4.4.

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
Interaction
There may be interference with the absorption of fat soluble vitamins.

4.6.

Pregnancy and Lactation
As with all medicines, avoid during early pregnancy and lactation.

4.7.

Effects on Ability to Drive and Use Machines
None.

4.8.

Undesirable Effects
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.

4.9.

Overdose
If large quantities are ingested, withdraw medication. Supportive treatment
required.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Liquid paraffin acts as a faecal softener.
5.2.

Pharmacokinetic Properties
If used as directed, it is not normally absorbed; but chronic use may cause
granulamata in the intestinal tract.

5.3.

Pre-clinical Safety Data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Product is 100% an excipient.

6.2.

Incompatibilities
None.

6.3.

Shelf-Life
24 months.

6.4.

Special Precautions for Storage
At ambient temperatures, under dry conditions and away from direct sun light.

6.5.

Nature and Content of Container
Up to 20,000 litres bulk, 205 litres barrels, 25 litres drums and 5 litre bottles.

6.6.

Instructions for Use, Handling and Disposal
No special instructions.

7

MARKETING AUTHORISATION HOLDER
Fuchs Lubricants (UK) Plc
New Century Street
Hanley
Stoke on Trent
ST1 5HU

8.

MARKETING AUTHORISATION NUMBER(S)
PL 02021/5003R

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23 July 1984, Renewed 16 April 1998

10.

DATE OF (PARTIAL) REVISION OF THE TEXT
February 1998

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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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