MAGNESIUM TRISILICATE MIXTURE BP

Active substance: SODIUM HYDROGEN CARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Magnesium Trisilicate Mixture BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Magnesium Carbonate Light
Magnesium Trisilicate
Sodium Hydrogen Carbonate

250mg/5ml
250mg/5ml
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, hypophosphataemia and in patients
who must control sodium intake e.g. congestive heart failure, hypertension,
cirrhosis of the liver.
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 renal impairment, to
patients receiving corticosteroids or patients with respiratory acidosis,
eclampsia, or aldosteronism.
Magnesium trisilicate mixture has a sodium content of 6 mmol equivalent to
69.4 mg/5 ml or 139 mg/10 ml dose. This must be taken into consideration for
patients on a controlled sodium diet.
This product contains sodium methyl, sodium ethyl and sodium propyl
parahydroxybenzoates (E219, E215 and E217 respectively) which may cause
allergic reactions (possibly delayed).
If renal function is impaired hypermagnesaemia may result giving the
symptoms described under (4.9) overdose.
The following warnings and precautions appear on the labels:
Keep out of the reach and sight of children.
Do not give to children under 5 years old unless your doctor tells you to.
Once opened use within 28 days.
If symptoms persist consult your doctor.
This product contains 6 mmol (or 139 mg) sodium per 10 ml dose. To be taken
into consideration by patients on a controlled sodium diet.
It also contains sodium methyl, sodium ethyl and sodium propyl
parahydroxybenzoates (E219, E215 and E217) which may cause allergic
reactions (possibly delayed).

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, thereby reducing their
effectiveness. Antacids may also damage enteric coatings designed to prevent
dissolution in the stomach. In order to minimise the risk of interactions, this
product should not be taken within two to four hours of other medications
(allow at least 4 hours before or 2 hours after erlotinib).
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, rifampicin, rosuvastatin,
sulpiride, tetracyclines, tipranavir, ulipristal (avoid use with antacids).
There is a risk of metabolic alkalosis when oral magnesium salts are given
with polystyrene sulphonate resins.

4.6

Fertility, 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. As there is no specific
data for this product, it is recommended that Magnesium Trisilicate Mixture
only be used in pregnancy on the advice of a doctor.
Caution should be exercised when prescribing to pregnant women as this
product contains sodium (see Section 4.4).

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.
Long-term, excessive use has been associated with the development of silicabased renal calculi.

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.
Symptoms of hypokalaemia and metabolic alkalosis include mood changes,
tiredness, shortness of breath, muscle weakness and irregular heart beat.
Muscle hypertonicity, twitching and tetany may develop, especially in
hypocalcaemic patients. Excessive doses of sodium salts may lead to sodium
overloading and hyperosmolality.
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 10% 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. Replacement of calcium, chloride, and potassium ions
may be of particular importance.

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
18 months unopened, 1 month after first opening.

6.4

Special precautions for storage
Store below 25ºC.

6.5

Nature and contents of container
200 ml: Amber glass bottle with white 28mm Child-resistant cap with Tamper
Evident band and EPE/Saranex Liner.

6.6

Instructions for use/handling
None.

7.

MARKETING AUTHORISATION HOLDER
L.C.M. Ltd
Linthwaite laboratories
Huddersfield
HD7 5QH

8.

MARKETING AUTHORISATION NUMBER
PL 12965/0025

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10th May 1994 / 10th May 1999

10

DATE OF REVISION OF THE TEXT
18/12/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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