Liquid Paraffin Bp/Ep
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