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NUMARK EPSOM SALTS (MAGNESIUM SULPHATE BP)

Active substance(s): MAGNESIUM SULPHATE

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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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
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 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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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