SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Epsom Salts (Magnesium Sulphate BP)

Numark Epsom Salts BP (Magnesium Sulphate BP)

Boots Epsom Salts B.P.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Magnesium Sulphate 100%

3    PHARMACEUTICAL FORM

Powder for oral solution

4    CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of occasional constipation.

4.2 Posology and method of administration

Adults and children over 12 years: 1 to 4g to be taken in warm water, once daily.

Children under 12 years: Not recommended.

4.3 Contraindications

Intestinal obstruction.

4.4 Special warnings and precautions for use

To be used with caution in elderly or debilitated patients and in those with renal insufficiency.

4.5 Interaction with other medicinal products and other forms of interaction

This product may interact with tetracyclines, digoxin, vitamins and iron and may potentiate tubocurarine during anaesthesia.

4.6 Pregnancy and lactation

The use of magnesium containing salts in the first trimester of pregnancy should be avoided. They should only be used after medical advice if the benefits exceed potentially unknown risks of foetal exposure to magnesium. No adverse effects are anticipated in breast fed infants.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Prolonged excessive use of this product may cause alkalosis and hypermagnesaemia. 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.yellowcard.mhra.gov.uk.

4.9 Overdose

Excessive amounts of this medicine may cause diarrhoea and dehydration. Hypermagnesaemia and hypercalcaemia may also occur, particularly if there is impaired renal function. Treatment consists of supportive and symptomatic measures with appropriate correction of fluid and electrolyte balance.

5.1    Pharmacodynamic properties

Not applicable.

5.2    Pharmacokinetic properties

Not applicable.

5.3    Preclinical safety data

Never undertaken by Abdine Limited. This product was granted a 'Licence as of Right' some 25 years ago.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

None.

6.2 Incompatibilities

None are recognised.

6.3    Shelf life

As packaged for sale: Three years As reconstituted for use: One day After first opening the container: One month

6.4    Special precautions for storage

Do not store above 25 °C.

6.5 Nature and contents of container

A spirally wound, varnished, cardboard tub with a press-fit lid or polypropylene jar and cap containing 100 g,150g, 200 g, 250g, 300g or 500 g.

6.6 Special precautions for disposal

Take from 1 to 4g in warm water.

7    MARKETING AUTHORISATION HOLDER

Bell Sons & Co (Druggists) Ltd

Gifford House

Slaidburn Crescent

Southport

Merseyside

PR9 9AL

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 03105/0068

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12/02/1999 / 21/10/2003

10 DATE OF REVISION OF THE TEXT

15/12/2010