Liquid Paraffin BP (Boots Company plc)

1. Name Of The Medicinal Product

Liquid Paraffin B.P.

2. Qualitative And Quantitative Composition

Liquid paraffin Ph Eur

100%v/v

3. Pharmaceutical Form

Liquid

4. Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of constipation.

4.2 Posology And Method Of Administration

Unless otherwise directed by the doctor.

Adults and children over 12 years:

10 - 30ml daily in divided doses preferably before breakfast and at bedtime.

Children 5 - 12 years

5 - 10ml at bedtime.

Children 3 - 5 years

2.5 - 5ml at bedtime.

Children under 3 years

Not recommended.

Elderly

There is no need for dosage reduction in the elderly.

For oral administration.

4.3 Contraindications

Hypersensitivity to liquid paraffin. It should not be used when abdominal pain, nausea or vomiting is present. 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. Do not use repeatedly.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Liquid paraffin decreases the absorption of fat soluble vitamins in the diet. Decreased absorption of vitamin K

enhances the effect of oral anticoagulants.

4.6 Pregnancy And Lactation

The safety of liquid paraffin during pregnancy and lactation has not been established and should not therefore be used during these periods.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

May cause anal seepage and irritation. Liquid paraffin is absorbed to a slight extent and may give rise to granulomatous reactions. Lipoid pneumonia may occur, therefore caution is required by patients with swallowing difficulties.

4.9 Overdose

Symptoms of overdosage may include excessive purgation, watery diarrhoea with excessive loss of fluid and electrolytes. Gastric lavage is not necessary and emesis

is contraindicated.

Treatment should be symptomatic and supportive.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Liquid paraffin acts as a lubricant laxative.

5.2 Pharmacokinetic Properties

Absorption following oral administration is minimal. The liquid paraffin which is absorbed is distributed into the mesenteric lymph nodes, intestinal mucosa, liver and spleen.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

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

None

6.5 Nature And Contents Of Container

An amber glass bottle having a tinplate or thermoset plastic cap with a stearan BK faced pulpboard liner or an aluminium roll-on pilfer-proof cap with a flowed-in liner or a triseal (LDPE/EP/LDPE) liner or a wadless polypropylene tamper evident cap.

Pack sizes: 100ml, 150ml, 200ml and 2000ml.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL0014/5464R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 6 April 1984

Date of Last Renewal: 26 September 1999

10. Date Of Revision Of The Text

May 2004