Summary of Product Characteristics (SmPC) - Magnesium Hydroxide Mixture 8%w/w oral suspension
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) 25 to 50ml orally as required
(maximum daily dose 50ml)
For children aged 6-12 years 10 to 25ml orally as required
(maximum daily dose 25ml)
For children aged 1-6 years 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 precautions for use
Label warnings:
Store below 25°C.
Do not freeze.
Shake well before
Keep out of the sight and reach of children.
Chronic use may result in hypermagnesia.
Paediatric population
In young children the use of magnesium hydroxide can produce a hypermagnesemia, especially if they present renal impairment or dehydration.
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.
Urine alkalinisation secondary to administration of magnesium hydroxide may modify excretion of some drugs; thus, increased excretion of salicylates has been seen.
4.6 Fertility, 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.
Gastrointestinal disorders: Abdominal pain (frequency not known)
Metabolism and nutrition disorders: Hypermagnesemia. Observed after prolonged administration of magnesium hydroxide to patients with renal impairment. (frequency very rare).
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 PHARMACEUTICAL PARTICULARS
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
Brown & Burk UK Limited,
Micro House,
Bury Street,
Ruislip,
HA4 7TL
8 MARKETING AUTHORISATION NUMBER(S)
PL 25298/0464
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/03/1978 / 12/05/2003
10 DATE OF REVISION OF THE TEXT
29/09/2026