Epsom Salts BP (Boots Company plc)

1. Name Of The Medicinal Product

Epsom Salts B.P.

2. Qualitative And Quantitative Composition

Magnesium sulphate Ph Eur 100%w/w

3. Pharmaceutical Form

Crystalline powder

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of occasional constipation.

For oral administration.

4.2 Posology And Method Of Administration

Adults and children over 12 years: One to two teaspoonfuls.

Children 5 to 12 years: Half to one teaspoonful.

Children under 5 years: Not recommended.

To be taken, preferably before breakfast, either with a cup of tea or in half to one tumbler of water.

There is no need for dosage reduction in the elderly.

4.3 Contraindications

Should not be taken where there is severe abdominal pain, nausea or vomiting or for prolonged periods.

4.4 Special Warnings And Precautions For Use

Use of magnesium sulphate is inadvisable in patients with renal impairment. Laxatives should not be taken where there is severe abdominal pain or used regularly for prolonged periods, except on medical advice.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions known.

4.6 Pregnancy And Lactation

The safety of Epsom Salts during pregnancy and lactation

has not been established, it is therefore best avoided during the first trimester of pregnancy and during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Ingestion of magnesium salts may cause gastro-intestinal irritation, colic and watery diarrhoea. Prolonged use may result in hypermagnesaemia, particularly in patients with renal impairment, symptoms of which include nausea and vomiting.

4.9 Overdose

Overdosage may lead to hypermagnesaemia, symptoms of which may include, flushing, thirst, hypotension, drowsiness, hyporeflexia, respiratory depression, cardiac arrhythmias, coma and cardiac arrest.

Emergency treatment should include intravenous injection of calcium gluconate, fluid replacement and if necessary, dialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Magnesium sulphate is a saline purgative. In dilute solution it produces an osmotic reduction in the water absorbed from the intestine with the result that the intestinal contents distend the bowel and stimulate peristalsis.

5.2 Pharmacokinetic Properties

Magnesium sulphate is absorbed from the gastrointestinal tract. In plasma 25-30% of magnesium is protein bound. Magnesium salts are excreted mainly in the urine, over 90% of filtered magnesium being reabsorbed. Small amounts are excreted in breast milk, faeces and saliva. Magnesium sulphate also crosses the placenta.

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 stated.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

A cardboard carton with a paper/polythene liner.

Pack sizes: 200g and 500g.

A cardboard jcarton containing a metallised PET laminate bag.

Pack sizes: 200g and 500g.

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)

PL0014/5552R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 30 March 1984

Date of Last Renewal: 17 October 1994

10. Date Of Revision Of The Text

October 1999