This information is intended for use by health professionals
Each 5ml dose contains:
| Aluminium Hydroxide Gel BP
Magnesium Hydroxide BP
Antacid suspension for oral administration.
Antacid therapy in gastric and duodenal ulcer, gastritis, heartburn, gastric hyperacidity. Treatment of indigestion. Relief of symptoms of heartburn and dyspepsia associated with gastric reflux in hiatus hernia, reflux oesophagitis and similar conditions.
Adults, elderly and children over 12 years of age:
10-20ml three times daily 20 minutes to one hour after meals, and at bedtime, or as required.
Children under 12 years of age:
Should not be used in patients who are severely debilitated or suffering from kidney failure.
In young children the use of magnesium hydroxide can produce a hypermagnesemia, especially if they present renal impairment or dehydration.
Antacids inhibit the absorption of tetracyclines and vitamins and should not be taken concomitantly.
Urine alkalinisation secondary to administration of magnesium hydroxide may modify excretion of some drugs; thus, increased excretion of salicylates has been seen.
For Mucogel Suspension no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Caution should be exercised when prescribing to pregnant women.
Gastrointestinal side-effects are uncommon. This formulation minimises the problems of diarrhoea and constipation.
Frequency not known:
Frequency very rare:
Hypermagnesemia. Observed after prolonged administration of magnesium hydroxide to patients with renal impairment.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Serious symptoms are unlikely to follow overdosage.
The product contains two established antacids, magnesium and aluminium hydroxides with an acid neutralising capacity in excess of 25ml of 0.1N HC1 consumed, per gram of suspension.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Sorbitol Solution 70%
Simethicone Emulsion 30%
Hydrogen Peroxide 35% Solution
Strong Sodium Hypochlorite Solution.
Unopened - 2 years
Opened - 28 days
Do not freeze. Store below 25°C.
High density polyethylene bottle with a high density polyethylene closure fitted with a tamper evident ring.
Pack sizes: 100ml, 300ml and 500ml
CHEMIDEX PHARMA LIMITED
CHEMIDEX HOUSE, EGHAM BUSINESS VILLAGE
December 1997 / 15th