Summary of Product Characteristics (SmPC) - Liquid Paraffin B.P.
1 NAME OF THE MEDICINAL PRODUCT
Liquid Paraffin B.P.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid Paraffin 100.0% v/v
3. PHARMACEUTICAL FORM
Oral liquid
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
For the temporary relief of constipation.
4.2. Posology and Method of Administration
Adults, the elderly and children over 12 years
Two to six 5 ml spoonfuls (i.e. 10 to 30 ml) to be taken at bedtime.
Children 5 to 12 years
One to two 5 ml spoonfuls (i.e. 5 to 10 ml) to be taken at bedtime.
Children 3 to 5 years
One half to one 5 ml spoonful (i.e. 2.5 to 5 ml) to be taken at bedtime.
Children under 3 years
Not recommended.
4.3. Contra-Indications
Children under 3 years.
As for other laxatives, it should not be used in patients with undiagnosed abdominal symptoms.
4.4. Special Warnings and Special 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 during lactation.
4.7. Effects on Ability to Drive and Use Machines
None known.
4.8. Undesirable Effects
Anal seepage of paraffin and consequent anal irritation after prolonged use, granulomatous reactions caused by absorption of liquid paraffin, lipoid pneumonia (by accidental inhalation) may occur, therefore caution is required in patients with swallowing difficulties.
4.9. Overdose
If large quantities are ingested withdraw medication; supportive therapy may be required.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
When taken orally Liquid Paraffin B.P. acts as a lubricant and keeps the stools soft; it is useful in the treatment of constipation and in painful conditions of the anus and rectum such as haemorrhoids and anal fissure.
5.2. Pharmacokinetic Properties
Little information is readily available in the literature about the pharmacokinetics of liquid paraffin apart from the fact that it may be absorbed to a slight extent from the gastro-intestinal tract otherwise it passes directly through the body.
5.3. Pre-clinical Safety Data
No relevant data.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
None.
6.2. Incompatibilities
None known.
6.3. Shelf Life
36 months.
6.4. Special Precautions for Storage
Do not store above 25oC. Store in the original container.
6.5. Nature and Content of Container
500 and 2000 ml dispensing packs comprising amber glass bottles with a plastic screw cap with an aluminium foil lined EPE liner.
100 ml OTC pack comprising an amber glass bottle with a plastic “J” cap.
6.6. Instruction for Use, Handling and Disposal
None.
7. MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
Unit 7
Hardicker Street
Manchester
M19 2RB
United Kingdom.
8. MARKETING AUTHORISATION NUMBER
PL 18374/0044
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
14th April 2005
10. DATE OF (PARTIAL) REVISION OF THE TEXT
14/04/2005