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Liquid Paraffin Bp

Document: spc-doc_PL 03105-0040 change

SUMMARY OF PRODUCT CHARACTERISTICS

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

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.

5.1    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