Summary of Product Characteristics (SmPC) - Liquid Paraffin BP
1 NAME OF THE MEDICINAL PRODUCT
Liquid Paraffin BP.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid Paraffin BP 100%
3. PHARMACEUTICAL FORM
Oral Solution
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the temporary relief of constipation.
4.2 Posology and method of administration
Oral
Adults including the elderly
Dose: 10-30 ml when required. Children over 3 years
Dose: 5-20ml when required. Children under 3 years not recommended
4.3 Contraindications
Children under 3 years
4.4 Special warnings and precautions for use
Avoid prolonged use.
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 (alternatively:
safety in human pregnancy has not been established therefore as with other medicines liquid paraffin should not be administered during pregnancy and lactation).
4.7 Effects on ability to drive and use machines
None stated
4.8 Undesirable effects
Anal seepage of paraffin and consequent anal irritation after prolonged use, granulomatous reactions caused by absorption of small quantities of liquid paraffin, lipoid pneumonia (by accidental inhalation) may occur, therefore caution is required in patients with swallowing difficulties.
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 quantities are ingested withdraw medication; supportive treatment may be required.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Laxative : when taken by mouth liquid paraffin keeps the stools soft.
5.2 Pharmacokinetic properties
Liquid paraffin remains unchanged in the system.
5.3 Preclinical safety data
None stated.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None
6.2 Incompatibilities
None known
6.3 Shelf life
60 months in unopened bottle.
6.4 Special precautions for storage
Protect from light. Store below 25°C
6.5 Nature and contents of container
Amber glass bottle with ROPP screw neck. Metal ROPP screw caps with steran or EPE wads. Pack sizes l00ml, 150ml, 500ml, 1000ml and 2000ml.
6.6 Instruction for use, handling and disposal
None
7 MARKETING AUTHORISATION HOLDER
Bell, Sons & Co
Gifford House
Slaidburn Crescent
Southport
Merseyside
PR9 9AL
8. MARKETING AUTHORISATION NUMBER
PL 03105/0040
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/10/2005
10 DATE OF REVISION OF THE TEXT
08/09/2016