Liquid Paraffin
Recommended doses and dosage schedules:
Adults including the elderly: 10-30ml when required. Children over 3 years: 5-20ml when required.
Children under 3 years: not recommended.
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. Interaction 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 with consequent anal irritation after prolonged use. Granulomatous reaction caused by absorption of small quantities of liquid paraffin. Lipoid pneumonia (by accidental inhalation) may occur, therefore caution is required in patients with swallowing difficulty.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
If large doses are ingested withdraw medication. Supportive treatment may be required.
5.
PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Liquid paraffin acts as a lubricant and penetrates and softens the stools.
5.2. Pharmacokinetic Properties
Liquid paraffin is indigestible and is absorbed only to a limited extent following ingestion.
5.3. Pre-clinical Safety Data
None.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
None.
6.2. Incompatibilities
None.
6.3 Shelf life
36 months unopened.
6.4. Special Precautions for Storage
Store below 25°C. Protect from light.
6.5 Nature and contents of container
150ml: Amber glass bottle with plastic cap.
6.6. Instructions for Use, Handling and Disposal
None.
7 MARKETING AUTHORISATION HOLDER
L. C. M. Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH.
8. MARKETING AUTHORISATION NUMBER(S)
PL 12965/0022
9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION
20 August 1993 / 22 October 1998
10 DATE OF REVISION OF THE TEXT
13/04/2015