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MAGNESIUM HYDROXIDE MIXTURE 8%W/W ORAL SUSPENSION

Active substance(s): MAGNESIUM OXIDE / MAGNESIUM OXIDE / MAGNESIUM OXIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Magnesium Hydroxide Mixture 8%w/w Oral suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Magnesium Hydroxide 8% w/w, equivalent to Magnesium Oxide 5.5% w/v.

3

PHARMACEUTICAL FORM
Oral suspension

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For oral use for the relief of mild constipation

4.2

Posology and method of administration
For adults (including the elderly)
For children aged 6-12 years
For children aged 1-6 years

25 to 50ml orally as required
(maximum daily dose 50ml)
10 to 25ml orally as required
(maximum daily dose 25ml)
5 to 10ml orally as required
(maximum daily dose 10ml)

Not recommended for children under 1 year of age.
Not recommended in cases of renal impairment of debilitation.
4.3

Contraindications
Should not be used where there are known or suspected acute gastro-intestinal
conditions, or renal or hepatic impairment.

4.4

Special warnings and special precautions for use
Label warnings:

Store below 25°C.
Do not freeze.

Shake well before use.
Keep out of the sight and reach of children.
Chronic use may result in hypermagnesia.
4.5

Interaction with other medicinal products and other forms of interaction
The antacid properties of this preparation can lead to reduced absorption of
diflusinal, azithromycin, ciprofloxacin, isoniazid, norfloxacin, ofloxacin,
pivampicillin, rifampicin and most tetracyclines. Also reduces absorption of
phenytoin,
itraconazole,
ketoconazole,
fosinopril,
chloroquine,
hydroxychloroquine, phenothiazines, biphosphonates and penicillamine. The
use of this product is not advised during dipyridamole therapy. The excretion
of aspirin is increased and quinidine is decreased in alkaline urine which may
occur with use of this product.

4.6

Pregnancy and lactation
There is not or inadequate evidence of safety of use during pregnancy and
lactation but has been used for many years without ill effect. As with all
drugs, use during early pregnancy should be avoided. Can be used during late
pregnancy and during lactation.

4.7

Effects on ability to drive and use machines
Does not affect ability to drive and use machines.

4.8

Undesirable effects
Can cause colic.

4.9

Overdose
Serious symptoms are unlikely following overdose. Discontinue medication
and correct fluid balance if necessary.
Hypermagnesaemia may be treated with intravenous calcium salts but only
under medical supervision

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Antacid properties in doses of 500-750mg
Laxative properties in larger doses.

5.2

Pharmacokinetic properties
The Magnesium Hydroxide acts as a saline laxative in the intestine. Any
absorbed magnesium is rapidly excreted in the urine. It has the benefit over
magnesium carbonate of not causing side effects associated with formation of
carbon dioxide in the stomach.

5.3

Preclinical safety data
None stated

6.1

List of excipients
Levomenthol 0.02%w/w
Sodium Saccharin 0.08%w/w
Phenoxyethanol 0.50%w/w
Purified Water to 100%

6.2

Incompatibilities
None known

6.3

Shelf life
Unopened container 24 months
After opening 1 month

6.4

Special precautions for storage
Store below 25°C.

6.5

Nature and contents of container
Amber glass bottle with plastic cap containing 150ml, 200 or 500ml.

6.6

Special precautions for disposal
None

7

MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU

8

MARKETING AUTHORISATION NUMBER(S)
PL 16431/0174

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/03/1978 / 12/05/2003

10

DATE OF REVISION OF THE TEXT
21/12/2015

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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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