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Thornton & Ross Ltd

Telephone: +44 (0)1484 842217
Fax: +44 (0)1484 847301
WWW: http://www.thorntonandross.com
Medical Information Direct Line: +44(0)1484 848 251
Medical Information e-mail: phv@thorntonross.co.uk
Customer Care direct line: +44(0)1484 842 217
Medical Information Fax: +44(0)1484 847 301

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Summary of Product Characteristics last updated on the eMC: 21/11/2011
SPC J Collis Browne's Tablets


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1. NAME OF THE MEDICINAL PRODUCT

J Collis Browne's Tablets


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Morphine hydrochloride Ph. Eur.

0.35mg/tablet

Light kaolin BP1980

750mg/tablet

Calcium carbonate, heavy Ph. Eur

200mg/tablet


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3. PHARMACEUTICAL FORM

Uncoated tablet


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the symptomatic relief of occasional diarrhoea.


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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


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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.


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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.


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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.


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4.6 Pregnancy and lactation

No known effects in pregnancy and lactation. However, as with all medicines, use with caution.


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4.7 Effects on ability to drive and use machines

No known effects.


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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.


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4.9 Overdose

Gastric lavage and symptomatic treatment as for morphine hydrochloride is recommended.

Naloxone may be used to counteract central nervous system depression.


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5. PHARMACOLOGICAL PROPERTIES

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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.


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5.2 Pharmacokinetic properties

No pharmacokinetic studies have been carried out.


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5.3 Preclinical safety data

None stated.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Magnesium stearate, sodium polymetaphosphate, sucrose (icing sugar), talc, dispersed pink 11150 (contains E127), liquorice powder 07123937, peppermint flavour extra


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6.2 Incompatibilities

None stated.


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6.3 Shelf life

Three years unopened.


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6.4 Special precautions for storage

None


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6.5 Nature and contents of container

250 micron rigid uPVC 25µ aluminium foil blisters in cardboard cartons in packs of 18 or 36 tablets


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6.6 Special precautions for disposal and other handling

None stated.


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7. MARKETING AUTHORISATION HOLDER

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PL 00240/0092


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15 January 2003


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10. DATE OF REVISION OF THE TEXT


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11 DOSIMETRY

Not Applicable


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12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not Applicable



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/25337/SPC/


Active Ingredients/Generics

 
   calcium carbonate
   kaolin light
   morphine hydrochloride