1. Name Of The Medicinal Product
J Collis Browne's Tablets
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Uncoated tablet
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of occasional diarrhoea.
4.2 Posology And Method Of Administration
Oral.
Adults and the Elderly:
Two or three tablets at once, then two or three tablets every four hours.
Children aged 6 to 10 years
One tablet at once, then one tablet every four hours.
Children under 6 years
Not recommended
4.3 Contraindications
Contraindicated in acute respiratory depression (asthma), acute alcoholism, paralytic ileus, acute ulcerative colitis, raised intra-cranial pressure and head injury. Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
If symptoms persist for more than 48 hours, consult the doctor.
Keep out of the reach of children. Do not exceed the stated dose.
Do not take more than 6 doses in 24 hours. In addition to taking these tablets, it is important to replace body fluids lost during diarrhoea.
Not recommended for children under 6 years of age.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
This product should be given with caution to patients exhibiting the following clinical conditions: hypotension, hypothyroidism, prostatic hypertrophy, renal or hepatic impairment, convulsive disorders, dependence, also if elderly or debilitated.
The depressant effects of opioid analgesics are enhanced by other CNS depressants such as alcohol, anxiolytics, hypnotics, antidepressants including tricyclic antidepressants, anticoagulants such as warfarin, antiepileptics and antipsychotics.
Morphine may interact with monoamine oxidase inhibitors (MAOI's) or within 14 days of stopping such treatment. If opioid analgesics are required they should be given with extreme caution. The effects of morphine in reducing gastrointestinal motility may interfere with the absorption of antiarrhythmics such as mexiletine, and may counteract the stimulatory effect of metoclopramide, domperidone and cisapride.
Cimetidine inhibits the metabolism of some opioids.
4.6 Pregnancy And Lactation
No known effects in pregnancy and lactation. However, as with all medicines, use with caution.
4.7 Effects On Ability To Drive And Use Machines
No known effects.
4.8 Undesirable Effects
Side effects are nausea, vomiting, constipation, drowsiness, difficulty in micturition, ureteric or biliary spasm, dry mouth, sweating, headache, facial flushing, vertigo, bradycardia, tachycardia, palpitations, postural hypotension, hypothermia, hallucinations, dysphoria, mood changes, dependence, miosis, decreased libido or potency, rashes, urticaria and pruritus.
4.9 Overdose
Gastric lavage and symptomatic treatment as for morphine hydrochloride is recommended.
Naloxone may be used to counteract central nervous system depression.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Light kaolin is absorbent and, when given by mouth, absorbs toxic and other substances from the alimentary tract.
Morphine, among other actions, diminishes propulsive peristalsis in the intestinal tract.
It is an effective agent for treating diarrhoea.
Calcium carbonate is an antacid that also has a constipating effect.
5.2 Pharmacokinetic Properties
No pharmacokinetic studies have been carried out.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Magnesium stearate, sodium polymetaphosphate, sucrose (icing sugar), talc, dispersed pink 11150 (contains E127), liquorice powder 07123937, peppermint flavour extra
6.2 Incompatibilities
None stated.
6.3 Shelf Life
Three years unopened.
6.4 Special Precautions For Storage
None
6.5 Nature And Contents Of Container
250 micron rigid uPVC 25ยต aluminium foil blisters in cardboard cartons in packs of 18 or 36 tablets
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
8. Marketing Authorisation Number(S)
PL 00240/0092
9. Date Of First Authorisation/Renewal Of The Authorisation
15 January 2003
10. Date Of Revision Of The Text
11 DOSIMETRY
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not Applicable
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