Medine.co.uk

Liquid Paraffin

Document: spc-doc_PL 02021-5003R change

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:    10- 30 mls as and when required

Children over the age of 3:    5-20 mls as and when required

Children under age of 3:    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.

Instructions for Use, Handling and Disposal

6.6.


No special instructions.

7 MARKETING AUTHORISATION HOLDER

Fuchs Lubricants (UK) Plc New Century Street Hanley

Stoke on Trent ST15HU

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