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Liquid Paraffin B.P.

SUMMARY OF PRODUCT CHARACTERISTICS

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 ā€œJā€ 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