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KAOLIN MIXTURE B.P.

Active substance(s): LIGHT KAOLIN STERILISED / MAGNESIUM CARBONATE LIGHT / SODIUM BICARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Kaolin Mixture B.P.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Light Kaolin (Sterilised) 1.0 g/5 ml
Light Magnesium Carbonate 0.25 g/5 ml
Sodium Bicarbonate 0.25 g/5 ml
See excipients, see 6.1.

3

PHARMACEUTICAL FORM
Oral suspension.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the symptomatic relief of diarrhoea.

4.2

Posology and method of administration
Adults and the Elderly
10 - 20 ml every four hours.
Children aged 5 - 12 years
5 - 10 ml every four hours.
Children under 5 years

Not recommended.
Route of Administration
Oral.

4.3

Contraindications
Hypersensitivity to any of the ingredients.
Intestinal obstruction, hypocalcaemia and hypochlorhydria. It should be
avoided in metabolic and respiratory alkalosis and by patients on a sodium
restricted diet because of the sodium bicarbonate content. It should not be
used in hypophosphataemia because of the magnesium carbonate content.

4.4

Special warnings and precautions for use
Use with caution in patients with congestive heart failure, hypertension,
cirrhosis of the liver and renal impairment and patients receiving
corticosteroids because of the sodium bicarbonate content.
This preparation should not be used for longer than a few days without
medical advice.
Shake the bottle. Use within 6 months of opening.
Rehydration therapy may be necessary as a consequence of fluid and
electrolyte depletion especially in young children.

4.5

Interaction with other medicinal products and other forms of interaction
The adsorbent effects of kaolin and the antacid effects of light magnesium
carbonate and sodium bicarbonate may reduce or delay the absorption of other
drugs from the gastrointestinal tract when given concomitantly.

4.6

Fertility, pregnancy and lactation
No significant effects have been reported. As with all medicines, the use of
the product during pregnancy or lactation should only be undertaken when the
benefits are considered to outweigh the risks.

4.7

Effects on ability to drive and use machines
No significant effects have been reported.

4.8

Undesirable effects
Sodium bicarbonate and light magnesium carbonate may cause flatulence.
Prolonged use of sodium bicarbonate may lead to metabolic alkalosis.
Hypermagnesaemia may be produced in impaired renal function by light
magnesium carbonate as with other magnesium salts.

4.9

Overdose
Symptoms
In the unlikely event of accidental or inadvertent overdosage if the dosage is
greatly exceeded or large doses are used for a long period, it is theoretically
possible that symptoms of hypermagnesaemia may occur. These occur when
the serum magnesium concentration exceeds 2 mmol/litre and include
flushing, thirst, hypotension, weakness, drowsiness and loss of tendon
reflexes. Respiratory depression, cardiac arrhythmias and ultimately cardiac
arrest may result.
Similarly, metabolic alkalosis may result from overdosage of sodium
bicarbonate. Symptoms include shortness of breath, muscle weakness, mental
disturbances such as restlessness, convulsions and coma. Excessive doses
may lead to sodium overloading and hyperosmolarity.
Emergency Procedures and Antidotes
Hypermagnesaemia may be treated by injection of calcium gluconate to
counteract respiratory depression or heart block. In normal renal function,
adequate fluids should be given to assist magnesium removal but dialysis may
be necessary in renal impairment or severe hypermagnesaemia.
Treatment of metabolic alkalosis and hypernatraemia consists mainly of
appropriate correction of fluid and electrolyte balance.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Kaolin adsorbs toxic and other substances from the gastrointestinal tract and
increases stool bulk.
Light magnesium carbonate is an antacid.
Sodium bicarbonate is an alkalising agent and antacid.

5.2

Pharmacokinetic properties
Kaolin is not absorbed and remains unchanged throughout transit of the
gastrointestinal tract.
Light magnesium carbonate is converted to magnesium chloride and carbon
dioxide in the stomach. Any absorbed magnesium is usually excreted rapidly
in the urine.
Sodium bicarbonate, not used in neutralising gastric acid with the production
of carbon dioxide, is absorbed and in the absence of a deficit of bicarbonate in
the plasma, bicarbonate ions are excreted in the urine together with sodium
ions.

5.3

Preclinical safety data
No relevant data.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Chloroform BP
Peppermint oil BP
Nipastat sodium
Potable water

6.2

Incompatibilities
Sodium bicarbonate is incompatible with acids, acidic salts and many
alkaloidal salts.

6.3

Shelf life
36 months unopened.
6 months opened.

6.4

Special precautions for storage
Do not store above 25oC.
Keep the container tightly closed.

6.5

Nature and contents of container
Dispensing pack
2 litre amber glass bottle with a white plastic screw cap with an aluminium
faced EPE liner.
Patient packs or OTC packs as appropriate
500 ml amber glass bottle with a white plastic screw cap with an aluminium
faced EPE liner.
200 ml and 100 ml amber glass bottle with a white low density polyethylene
Jay cap.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
Unit 7
Hardicker Street
Manchester
M19 2RB
United Kingdom.

8

MARKETING AUTHORISATION NUMBER(S)
PL 18374/0042

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14th April 2005

10

DATE OF REVISION OF THE TEXT
14/04/2005

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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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