1. Name Of The Medicinal Product
Kaolin Mixture BP
2. Qualitative And Quantitative Composition
|
|
|
|
For full list of excipients see section 6.1
3. Pharmaceutical Form
Oral solution
An off-white suspension which separates on standing to form an off-white sediment and a slightly yellow/brown supernatant liquid.
4. Clinical Particulars
4.1 Therapeutic Indications
For relief of occasional diarrhoea and upset stomachs.
4.2 Posology And Method Of Administration
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.
4.3 Contraindications
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.
4.4 Special Warnings And Precautions For Use
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.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
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.
4.6 Pregnancy And Lactation
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.
4.7 Effects On Ability To Drive And Use Machines
No or negligible influence.
4.8 Undesirable Effects
Sodium hydrogen carbonate may cause stomach cramps and flatulence as a result of excess carbon dioxide production.
4.9 Overdose
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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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.
5.2 Pharmacokinetic Properties
There is no systemic absorption and the orally administered dose is excreted in the faeces.
5.3 Preclinical Safety Data
No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Magnesium carbonate light, peppermint oil, polysorbate 20, chloroform, purified water.
6.2 Incompatibilities
None known.
6.3 Shelf Life
200ml: 12 months unopened, 2 months after first opening.
6.4 Special Precautions For Storage
Store below 25°C.
6.5 Nature And Contents Of Container
200ml: glass bottle with plastic 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
Thornton & Ross Ltd
Linthwaite Laboratories
Huddersfield
HD7 5QH
8. Marketing Authorisation Number(S)
PL 00240/6494R
9. Date Of First Authorisation/Renewal Of The Authorisation
23/1/89, 23/1/94, 23/1/99
10. Date Of Revision Of The Text
11/05/2011
11 DOSIMETRY
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not Applicable
No comments:
Post a Comment