Magnesium Trisilicate Mixture BP

1. Name Of The Medicinal Product

Magnesium Trisilicate Mixture BP or Indigestion Mixture.

2. Qualitative And Quantitative Composition

Magnesium carbonate light	250mg/5ml
Magnesium trisilicate	250mg/5ml
Sodium hydrogen carbonate	250mg/5ml

For full list of excipients see section 6.1

3. Pharmaceutical Form

Mixture

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of the symptoms of indigestion, heartburn and dyspepsia.

4.2 Posology And Method Of Administration

Oral.

RECOMMENDED DOSE

Adults and children over 12 years: two to four 5ml spoonfuls.

Children 5 to 12 years: one to two 5ml spoonfuls.

Directions for use: shake the bottle.

Take in a little water.

DOSAGE SCHEDULE

To be taken three times a day or as required.

4.3 Contraindications

Contraindicated in severe renal failure and hypophosphataemia.

Should not be administered to patients with metabolic or respiratory alkalosis, hypocalcaemia or hypochlorhydria.

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The product should be used with caution in patients with fluid retention. In view of the sodium hydrogen carbonate content the product should also be administered extremely cautiously to patients with congestive heart failure, renal impairment, cirrhosis of the liver, hypertension and to patients receiving corticosteroids.

If renal function is impaired hypermagnesaemia may result giving the symptoms described under (9) overdose.

The following warnings and precautions appear on the labels:

Keep all medicines away from children

Discard any unused mixture one month after opening.

If symptoms persist consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Antacids may interact with a number of other drugs by altering their absorption and, sometimes, their elimination. Examples include diflunisal, phenytoin, cimetidine, mexiletine, chlorpromazine, isoniazid, allopurinol, iron preparations, tetracyclines, phenothiazines, penicillamine, pivampicillin, atenolol, diclofenac, digitoxin, ibuprofen, indomethacin, ketoprofen, levodopa, metoprolol, metronidazole, ketoconazole, itraconazole, prednisolone, quinidine, tolfenamic acid, ciprofloxacin, ofloxacin, norfloxacin, rifampicin, azithromycin aspirin, fosinopril, dipyridamole, hydroxychloroquine, chloroquine, diazepam, bisphosphonates, warfarin and lithium.

4.6 Pregnancy And Lactation

Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal development (see section 5.3). The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Magnesium salts may cause diarrhoea in some patients. Magnesium carbonate and sodium hydrogen carbonate may cause stomach cramps and flatulence as a result of excess carbon dioxide production.

4.9 Overdose

Overdose, or excessive or prolonged intake of magnesium containing antacids may give rise to hypermagnesaemia, and excessive administration of sodium hydrogen carbonate may lead to hypokalaemia and metabolic alkalosis, especially in patients with renal insufficiency.

Symptoms of hypermagnesaemia include nausea, vomiting, flushing of the skin, thirst, drowsiness, hypotension, confusion, muscle weakness, CNS and respiratory depression, hyporeflexia, peripheral vasodilatation, bradycardia, cardiac arrhythmias, coma and cardiac arrest. Treatment of mild hypermagnesaemia is usually limited to restricting magnesium intake. In severe hypermagnesaemia, ventilatory and circulatory support may be required.

Treatment should consist of the intravenous administration of calcium gluconate injection 100% at a dose of 10 – 20ml, to counteract respiratory depression or heart block. If renal function is normal, adequate fluids should be given to assist magnesium removal from the body. Haemodialysis may be necessary in patients with renal impairment or for whom other methods prove ineffective. Metabolic alkalosis and hypernatraemia can be treated by appropriate correction of fluid and electrolyte balance.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Magnesium trisilicate mixture is an antacid with slow neutralising action and mild laxative action.

5.2 Pharmacokinetic Properties

Magnesium chloride and hydrated silica gel are formed during the neutralisation. About 5% of magnesium is absorbed and traces of liberated silica may be absorbed and excreted in the urine.

Any sodium hydrogen carbonate not neutralised in the stomach is absorbed and excreted as bicarbonate and sodium ions in the urine in the absence of a plasma deficit.

5.3 Preclinical Safety Data

None known.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium nipasept, peppermint oil, chloroform, polysorbate 20, purified water.

6.2 Incompatibilities

None.

6.3 Shelf Life

200ml: 18 months unopened, 1 month after first opening.

500ml: 18 months unopened, 1 month after first opening.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

200ml: amber glass bottle with polypropylene cap or white 28mm cap with tamper evident band and EPE/Saranex liner.

500ml: amber glass bottle with plastic lined cap or white 28mm cap with tamper evident band and EPE/Saranex liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L.C.M. Ltd

Linthwaite laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL 12965/0025

9. Date Of First Authorisation/Renewal Of The Authorisation

10^th May 1994 / 10^th May 1999

10. Date Of Revision Of The Text

10/10/2011