B
1. Name Of The Medicinal Product
Epsom Salts (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.
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. Pharmacological Properties
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 100g, 150g, 200g, 250g, 300g or 500g.
6.6 Special Precautions For Disposal And Other Handling
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
8. Marketing Authorisation Number(S)
PL 03105/0068
9. Date Of First Authorisation/Renewal Of The Authorisation
12 February 1999
10. Date Of Revision Of The Text
29th November 2010
11 DOSIMETRY
(IF APPLICABLE)
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
(IF APPLICABLE)
Boots Epsom Salts B.P.
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