Kaolin Mixture BP

For full list of excipients see section 6.1

Oral solution

An off-white suspension which separates on standing to form an off-white sediment and a slightly yellow/brown supernatant liquid.

For relief of occasional diarrhoea and upset stomachs.

Oral.

Recommended doses and dosage schedules

The dose may be repeated after 4 hours if required.

Not recommended for children under 6 years.

Shake the bottle before use.

Hypersensitivity to light kaolin, sodium hydrogen carbonate or any of the other ingredients.

Contraindicated in renal or hepatic failure, hypocalcaemia, hypochlorhydria, or metabolic or respiratory alkalosis.

Kaolin is contraindicated in intestinal obstruction.

If symptoms persist for longer than 3 days, consult a doctor, especially in children or if other medicines are co-prescribed. Diarrhoea may be a manifestation of a serious underlying disease.

Use extremely cautiously in congestive heart failure, kidney or liver disease, high blood pressure, and in patients receiving corticosteroids.

Kaolin has adsorbent properties and will reduce the intestinal absorption of a number of drugs. These include digoxin and lincomycin.

Antacids may reduce the absorption of a number of drugs including: diflunisal, phenytoin, cimetidine, isoniazid, allopurinol, iron preparations, tetracyclines, phenothiazines, penicillamine, pivampicillin, atenolol, indomethacin, ketoprofen, metronidazole, ketoconazole, itraconazole, prednisolone, ciprofloxacin, ofloxacin, norfloxacin, rifampicin, azithromycin, fosinopril, dipyridamole, hydroxychloroquine, chloroquine, bisphosphonates.

The excretion of quinidine is reduced in alkaline urine and may occasionally increase plasma levels. The excretion of aspirin is increased in alkaline urine. Antacids should be avoided with dipyridamole.

The safety of kaolin mixture has not been established in these conditions. However, as with all other medicines, use during early pregnancy should be avoided.

No or negligible influence.

Sodium hydrogen carbonate may cause stomach cramps and flatulence as a result of excess carbon dioxide production.

Constipation may occur. Treatment is observation, and if necessary, any symptomatic and supportive measures.

Excessive administration of sodium hydrogen carbonate may lead to hypokalaemia and metabolic alkalosis, especially in patients with impaired renal function. Excessive doses of sodium salts may lead to sodium overloading and hyperosmolarity. Treatment of metabolic alkalosis and hypernatraemia consists of appropriate correction of fluid and electrolyte balance.

A07B C02 - Intestinal adsorbants, other intestinal adsorbants.

Kaolin is adsorbent and when given orally, it adsorbs toxic and other substances from the alimentary tract and increases the bulk of the faeces.

There is no systemic absorption and the orally administered dose is excreted in the faeces.

No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.

Magnesium carbonate light, peppermint oil, polysorbate 20, chloroform, purified water.

None known.

200ml: 12 months unopened, 2 months after first opening.

Store below 25°C.

200ml: glass bottle with plastic cap or white 28mm cap with Tamper Evident band and EPE/Saranex Liner.

None.

Thornton & Ross Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

PL 00240/6494R

23/1/89, 23/1/94, 23/1/99

11/05/2011

Not Applicable

Not Applicable