Epsom Salts BP

1. Name Of The Medicinal Product

Magnesium Sulphate Heptahydrate BP.

Epsom Salts BP

2. Qualitative And Quantitative Composition

Magnesium Sulphate Heptahydrate BP 100% W/W.

3. Pharmaceutical Form

Crystals or Crystalline Powder.

Brilliant colourless crystals or a white crystalline powder.

4. Clinical Particulars

4.1 Therapeutic Indications

1. For the relief of occasional constipation.

2. For the relief of pain from sprains, bruises and boils.

4.2 Posology And Method Of Administration

1. Oral. As a dilute solution.

2. Cutaneous. As a concentrated solution or paste.

Recommended doses and dosage schedules

Indication 1

Adults and children over 12 years:	5-15g (13 teaspoons) to be taken as required in 250 ml of water, which may be flavoured with citrus juices.
The elderly:	To be used with caution, not exceeding the adult dose.
Children under 12 years:	Not recommended.

Indication 2

As a wet dressing suitable for all ages:

Dissolve one tablespoonful in a small cupful of warm water and apply with lint or cotton wool as required.

4.3 Contraindications

Internal use is contraindicated in cases of intestinal obstruction, and renal impairment, and in children with intestinal parasitic diseases.

Hypersensitivity to magnesium sulphate.

4.4 Special Warnings And Precautions For Use

Keep all medicines away from children.

Avoid prolonged use.

If symptoms persist for longer than 7 days consult your doctor.

Laxatives should not be taken where there is severe abdominal pain.

Osmotic laxatives may produce dehydration so sufficient water should always be taken.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Magnesium salts, taken internally, potentiate the effects of competitive neuromuscular blocking drugs such as tubocurarine.

4.6 Pregnancy And Lactation

Not recommended for internal use during pregnancy and lactation unless under a doctor's instruction.

4.7 Effects On Ability To Drive And Use Machines

No or negligible influence.

4.8 Undesirable Effects

Hypermagnesaemia may occur after prolonged usage of magnesium sulphate as a purgative. May cause colic.

4.9 Overdose

Though magnesium is poorly absorbed following oral administration there may be sufficient accumulation to produce toxic effects if given to a patient with impaired renal function.

Symptoms of poisoning may include extreme thirst, a feeling of heat, hypotension due to vasodilation, drowsiness, nausea, vomiting, flushing, confusion, and muscle weakness, loss of tendon reflexes due to neuromuscular blockade, respiratory depression, cardiac arrhythmias, coma and cardiac arrest.

Hypermagnesaemia may be corrected by the intravenous injection of 10 to 20ml of 10% calcium gluconate. Dialysis and correction of fluid deficit may be of value.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

A06A D04 Osmotically acting laxatives

Magnesium sulphate is a saline purgative.

It can be employed locally in various inflammatory conditions, due to its osmotic action.

5.2 Pharmacokinetic Properties

When a dilute solution of magnesium sulphate is taken by mouth, the absorption of water from the intestine is reduced, and the bulky fluid contents distend the bowel. Active peristalsis is excited and evacuation of the contents of the intestine results.

Magnesium salts cause the secretion of cholecystokinin from the duodenal mucosa, it has been suggested that cholecystokinin - mediated pancreatic secretion and increased secretion and motility of the small intestine and colon may contribute to the cathartic effect

Magnesium sulphate causes bowel evacuation normally within 2-4 hours.

5.3 Preclinical Safety Data

No data of relevance which is additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

None.

6.2 Incompatibilities

Magnesium sulphate is incompatible with polymyxin B sulphate, with sodium and potassium tartrates, with soluble phosphates and arsenates and with alkali carbonates and bicarbonates in concentrated solution

6.3 Shelf Life

150gm: (securitainer)	36 months unopened.
300gm: (securitainer)	36 months unopened
500gm: (securitainer):	36 months unopened.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

150gm:	Polypropylene securitainer with LDPE/HDPE white cap.
300gm:	Ploypropylene securitainer with LDPE/HDPE white cap.
500gm:	Polypropylene securitainer with LDPE/HDPE white cap.

6.6 Special Precautions For Disposal And Other Handling

None.

ADMINISTRATION DETAILS

7. Marketing Authorisation Holder

L. C. M. Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL: 12965/0023

9. Date Of First Authorisation/Renewal Of The Authorisation

20.08.93

10. Date Of Revision Of The Text

17/11/09