SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Liquid Paraffin and Magnesium Hydroxide Emulsion BP

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Liquid Paraffin BP 25% v/v Magnesium Hydroxide 6%w/w

3.    PHARMACEUTICAL FORM

A white emulsion

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

For oral use for the temporary relief of constipation

4.2    Posology and method of administration

For adults over 12 years (including the elderly) 5 to 20ml orally as required

(maximum daily dose 20ml) For Children 3-12 years of age    5 to 15ml orally as required

(maximum daily dose 15ml)

4.3    Contraindications

Not recommended for children under 3 years of age. Do not use when intestinal obstruction is suspected

4.4    Special warnings and special precautions for use

Avoid prolonged use.

Caution should be exercised in administering this product to the elderly with possible renal impairment.

Keep out of the sight and reach of children.

Store below 25°C Do not freeze.

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

Avoid in early pregnancy or lactation

4.7 Effects on ability to drive and use machines

Does not affect ability to drive and operate machinery.

4.8    Undesirable effects

Anal seepage of paraffin and consequent anal irritation can occur after prolonged use.

Granulomatous reactions caused by absorption of small quantities of liquid paraffin.

Lipoid pneumonia (by accidental inhalation) may occur and 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.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Liquid Paraffin, taken internally, acts as a lubricant and is widely used to alleviate constipation.

Magnesium Hydroxide has antacid properties and also acts as a mild saline laxative.

5.2 Pharmacokinetic properties

There is some evidence that Magnesium salts may cause decreased absorption of the active ingredients of other medications. e.g. Digoxin.

Excessive use of Liquid Paraffin may lead to anal seepage and irritation and may, if emulsified, give rise to granulatomous reactions.

5.3 Preclinical safety data

6.1    List of excipients

Levomenthol    0.02%w/w

Sodium Saccharin    0.08%w/w

Benzalkonium Chloride    0.01%w/w

Purified Water    to 100%

6.2    Incompatibilities

None known.

6.3    Shelf life

Unopened container 3 years After opening 1 month

6.4    Special precautions for storage

Store below 25°C

Nature and contents of container

Amber glass baffles containing 150ml

High density polyethylene opaque bottles containing 500ml and 2000ml

6.6 Instructions for use/handling

Shake well before use.

7 MARKETING AUTHORISATION HOLDER

Ayrton Saunders

9 Arkwright Road

Astmoor Industrial Estate

Runcorn

Cheshire

WA7 1NU

8    MARKETING AUTHORISATION NUMBER(S)

PL 16431/0173

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

6 November 1987 / 25 April 1994

10 DATE OF REVISION OF THE TEXT

21/12/2015