KAOLIN MIXTURE B.P.
Active substance: 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
4.1
CLINICAL PARTICULARS
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
5.1
PHARMACOLOGICAL PROPERTIES
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
6.1
PHARMACEUTICAL PARTICULARS
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
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
4.1
CLINICAL PARTICULARS
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
5.1
PHARMACOLOGICAL PROPERTIES
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
6.1
PHARMACEUTICAL PARTICULARS
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
Source: Medicines and Healthcare Products Regulatory Agency
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