Summary of Product Characteristics (SmPC) - Magnesium Trisilicate Compound tablets BP
1 NAME OF THE MEDICINAL PRODUCT
Magnesium Trisilicate Compound Tablets BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Magnesium Trisilicate 250 mg & Hydrated Aluminium Oxide 120 mg.
Excipients with known effect:
Sucrose 500 mg and Lactose 250 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Plain white, uncoated round tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of dyspepsia (heartburn and indigestion), and reflux oesophagitis. Can have a beneficial effect in promoting healing of duodenal ulcers.
4.2 Posology and method of administration
Posology
The tablets should be sucked or chewed before swallowing.
Adults: One or two tablets to be sucked or chewed when required (usually between meals and at bedtime).
Not recommended for use in children.
Method of administration
For oral use.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Acute porphyria or hypophosphataemia.
Renal failure
4.4 Special warnings and precautions for use
Use with caution in cases of renal impairment as it might result in hypermagnesaemia.
Symptoms of hypermagnesaemia may include flushing of the skin, thirst, hypotension due to peripheral vasodilation, drowsiness, confusion, loss of tendon reflexes due to neuromuscular blockade, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest
Frequent or regular use should only be on the advice of a physician.
If symptoms persist for longer than 7 days, consult your doctor.
This product contains sucrose and lactose.
Patients with rare hereditary problems of fructose or galactose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
May reduce the absorption and effect of other medicines, therefore, should not be taken at the same time as other medicines. Examples of other medications which may be affected include, but are not limited to ACE inhibitors, salicylates e.g. aspirin, atazanavir, azithromycin, barbiturates, bile acids, bisphosphonates, cephalosporin antibiotics, fluoroquinolone antibiotics, chloroquine and hydroxychloroquine, deflazacort, digoxin, dipyridamole, eltrombopag, erlotinib, fexofenadine, gabapentin, iron preparations, isoniazid, itraconazole, ketoconazole, lansoprazole, levothyroxine, lithium, methenamine, mycophenolate, nitrofurantoin, penicillamine, phenothiazines, phenytoin, proguanil, pivampicillin, rifampicin, rosuvastatin, sulpiride, diflunisal, most tetracyclines, tipranavir, ulipristal (avoid use with antacids). Concurrent use of antacids reduces the effectiveness of sucralfate and increases the excretion of aspirin, flecainide, mexiletine and quinine.
With quinidine plasma concentrations may be increased.
There is a risk of metabolic alkalosis when oral magnesium salts are given with polystyrene sulfonate resins.
4.6 Fertility, pregnancy and lactation Pregnancy
There is no evidence that orally administered magnesium trisilicate or aluminium hydroxide has adverse effects on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
However, use during early pregnancy should be avoided. Caution should be exercised when prescribing to pregnant women.
Magnesium is not well absorbed and although small amounts may be found in breast milk, they are unlikely to cause problems in breastfed infants although they may cause diarrhoea. Aluminium is unlikely to cause problems in breast fed infants.
4.7 Effects on ability to drive and use machines
Magnesium Trisilicate Tablets has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
No significant side effects but there is a slight possibility of nausea, vomiting, constipation, diarrhoea or belching. In patients with impaired renal function and gastrojejunal stoma, rapid absorption of magnesium may result in hypermagnesaemia, producing symptoms of muscular weakness, hypotension, ECG changes, sedation, confusion and in severe cases, respiratory paralysis and anergic cardiac presystole.
Large doses or even normal doses in patients with low phosphate diets may lead to phosphate depletion accompanied by increased resorption and urinary excretion of calcium with the risk of osteomalacia. Nephrolithiasis may also follow chronic use in patients with impaired renal function.
Long-term, excessive use has been associated with the development of silicabased renal calculi.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Symptoms of overdose include hypophosphataemia, anaemia, exacerbation or
even initiation of osteodystrophy, proximal, myopathy, osteomalacia, encephalopathy, dementia, difficulty in urination or defaecation, depression of
deep tendron reflexes, drowsiness, heart block and respiratory paralysis. Treatment entails administration of 10-20ml of a 10% solution of calcium gluconate which reverses the heart block and respiratory depression induced by magnesium poisoning.
In severe cases intermittent peritoneal dialysis using a fluid free of magnesium may be necessary.
Aluminium toxicity may be treated by removal of aluminium with desferrioxamine.
Other symptomatic measures may be carried out if required.
5.1 Pharmacodynamic properties
A02A D – Combinations and complexes of aluminium, calcium and magnesium compounds
Magnesium Trisilicate and Dried Aluminium Hydroxide Gel are both slow acting antacids and absorption from the gut of breakdown products is very limited.
Antacids react chemically to neutralise or buffer existing quantities of stomach
acid resulting in increased pH of stomach contents thus providing relief of hyperacidity symptoms. They have no direct effect on acid output. Magnesium Trisilicate Compound Tablets BP contain two antacids namely aluminium hydroxide gel and magnesium trisilicate. Magnesium trisilicate is too insoluble and is a relatively weak antacid. Antacid action is exerted slowly therefore it does not provide a rapid symptomatic relief. However the action is prolonged. It is also an effective gastro-intestinal adsorbent. The gelatinous silicon dioxide formed by the reaction of magnesium trisilicate with the gastric content is said to protect ulcerated mucosal surfaces and favour healing. Aluminium hydroxide is also an insoluble antacid. Food in the stomach delays gastric emptying and allows more time for aluminium hydroxide to react.
Alkalinization of gastric content increases gastric motility via gastrin. Aluminium ions relax the smooth muscle of stomach and delay gastric emptying. The relaxant effect is minimised in the presence of magnesium ions. Alkalinization of the gastric content increases lower oesophageal pressure and oesophageal clearance by a mechanism that is independent of gastrin. The use of Magnesium Trisilicate Compound Tablets BP does not significantly effect the motility of the bowel. The constipating effect of aluminium hydroxide is counter balanced by the diarrhoeal effect of magnesium trisilicate.
Aluminium and magnesium containing antacids are not completely absorbed, therefore they do not interfere with the acid-base balance to a great extent.
5.2 Pharmacokinetic properties
The insoluble aluminium compounds that constitute aluminium hydroxide are slowly and incompletely converted to aluminium chloride in the stomach. Some absorption of the aluminium salts occur from the gastro-intestinal tract, with some excretion in urine. Unabsorbed aluminium hydroxide combines with phosphate present in the gut to form insoluble aluminium phosphate and some form carbonates and salts of fatty acids; all these salts are excreted in the faeces. Approximately 0.1 - 0.5 mg of aluminium ions may be absorbed from a standard daily dose of an aluminium containing antacid. In the presence of normal renal function this leads to about doubling of anaverage concentration of aluminium in plasma. However in patients with impaired renal function, higher concentrations occur.
During neutralisation magnesium trisilicate is converted to magnesium chloride and hydrated silica gel. Approximately 5% of the magnesium is absorbed and traces of the liberated silica may be absorbed and excreted in the urine.
5.3 Preclinical safety data
No data of relevance which is additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Lactose
Pregelatinised Maize Starch
Potato Starch
Stearic Acid
Peppermint Oil
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
5 years.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
HDPP tablet containers with LDPE closure. Pack sizes 30, 50, 60, 100 & 500 tablets.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Kent Pharma UK Limited
2nd Floor, Connect 38, 1 Dover Place,
Ashford, Kent, England, TN23 1FB
8 MARKETING AUTHORISATION NUMBER(S)
PL 51463/0130
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/11/2006
10 DATE OF REVISION OF THE TEXT
19/09/2024