MAGNESIUM HYDROXIDE MIXTURE 8%W/W ORAL SUSPENSION
Active substance(s): MAGNESIUM OXIDE / MAGNESIUM OXIDE / MAGNESIUM OXIDE
NAME OF THE MEDICINAL PRODUCT
Magnesium Hydroxide Mixture 8%w/w Oral suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION
Magnesium Hydroxide 8% w/w, equivalent to Magnesium Oxide 5.5% w/v.
For oral use for the relief of mild constipation
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.
Should not be used where there are known or suspected acute gastro-intestinal
conditions, or renal or hepatic impairment.
Special warnings and special precautions for use
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.
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
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.
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.
Effects on ability to drive and use machines
Does not affect ability to drive and use machines.
Can cause colic.
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
Antacid properties in doses of 500-750mg
Laxative properties in larger doses.
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.
Preclinical safety data
List of excipients
Sodium Saccharin 0.08%w/w
Purified Water to 100%
Unopened container 24 months
After opening 1 month
Special precautions for storage
Store below 25°C.
Nature and contents of container
Amber glass bottle with plastic cap containing 150ml, 200 or 500ml.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
14/03/1978 / 12/05/2003
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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