J Collis Browne's Tablets

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Discontinued Items:
The preparation being discontinued is:
  • J Collis Browne's tablets (Thornton & Ross Ltd)
The pharmaceutical company has decided to discontinue this product and so it may not be available in the future. This document has been left on the eMC for information purposes.
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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

0.35mg/tablet

Light kaolin

750mg/tablet

Calcium carbonate, heavy

200mg/tablet

For the full list of excipients, see section 6.1.

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3. Pharmaceutical form

Tablet

Flat, circular, mottled pink tablet with bevelled edges with J Collis Browne compressed into one face.

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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 children over 12 years:

Two or three tablets at once, then two or three tablets every four hours.

Elderly and debilitated patients:

Should be used with caution; a reduced dose is recommended.

Children under 12 years

Not recommended.

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4.3 Contraindications

Whilst this product only contains a small amount of morphine, theoretically it should be contraindicated in the same conditions as other morphine-containing preparations. These include acute respiratory depression (avoid during an asthma attack), obstructive airways disease, acute alcoholism, hypercalcaemia, acute hepatic disease, pancreatitis, paralytic ileus or obstructive bowel disorders, acute ulcerative colitis, raised intra-cranial pressure and head injury, pheochromocytoma, coma, convulsive disorders, delayed gastric emptying, acute abdomen; heart failure secondary to chronic lung disease.

Hypersensitivity to any of the ingredients.

Concurrent administration with monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuation of their use.

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4.4 Special warnings and precautions for use

Whilst this product only contains a small amount of morphine, it should (as with other morphine-containing preparations) be used with care in the elderly or in debilitated patients, in patients with prostatic hypertrophy, a history of asthma, shock, myasthenia gravis, diseases of the biliary tract, cardiac arrhythmias, severe cor pulmonale, hypothyroidism, hypotension, renal or heptic impairment and where there is reduced respiratory reserve, and should not be given if paralytic ileus is likely to occur. This product should be given with caution to patients with a history of drug dependence.

Calcium salts should generally be avoided in patients with calcium renal calculi or a history of renal calculi.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine as it contains sucrose.

If symptoms persist for more than 48 hours, consult the doctor.

Keep out of sight and 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 12 years of age.

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4.5 Interaction with other medicinal products and other forms of interaction

The depressant effects of opioid analgesics are enhanced by other CNS depressants such as alcohol, anxiolytics, hypnotics, antidepressants including tricyclic antidepressants, sedating antihistamines, anticoagulants such as warfarin, antiepileptics and antipsychotics.

Possible CNS excitation or depression (hypertension or hypotension) can occur when opioid analgesics are given with antidepressants such as moclobenide and MAOIs (avoid concomitant use and for 2 weeks after stopping MAOIs).

Opioid analgesics can lead to reduced plasma levels of ciprafloxacin when used for surgical prophylaxis, and can enhance the effects of sodium oxybate. Metabolism of opioid analgesics is inhibited by cimetidine leading to increased plasma concentration.

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.

Morphine may increase the plasma concentration of the beta-blocker esmolol, and may increase the bioavailability of the anticonvulsant gabapentin. The plasma concentration of morphine is possibly reduced by the antiviral ritonavir, and the sedative effect of morphine may be increased when given with baclofen.

The absorption of chloroquine, hydroxychloroquine, tetracycline and phenothiazines may be reduced by calcium salts and kaolin. Kaolin may also reduce the absorption of aspirin.

Calcium salts reduce the absorption of ciprofloxacin (and other fluoroquinolone antibiotics), bisphosphonates, fluorides, oral iron, levothyroxine and zinc. There is an increased risk of hypercalcaemia when calcium salts are given with thiazides and related diuretics, and Vitamin D. Calcium-containing products reduce the absorption of numerous drugs including captopril, enalapril, fosinopril, azithromycin, cefaclor, cefpodoxime, isoniazid, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, rifampicin, gabapentin, phenytoin, itraconazole, ketoconazole, fexofenadine, sulpiride, tipranavir, deflazacort, mycophenolate mofetil, rosuvastatin and penicillamine. Calcium-containing products possible reduce the absorption of ACE inhibitors, amprenavir, atazanavir, bile acids, digoxin, dipyridamole and lanzoprazole. Absorption of calcium salts is reduced by corticosteroids.

Kaolin and calcium can affect the absorption of other medicinal products from the gastrointestinal tract, therefore this product should not be taken at the same time as, nor within two to four hours of other medications.

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4.6 Fertility, pregnancy and lactation

This product should not be used in pregnancy or whilst breastfeeding unless recommended by a doctor.

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4.7 Effects on ability to drive and use machines

Although considered unlikely with this product, morphine may cause drowsiness and other central nervous system disorders which may have an effect on the ability to drive or operate machinery. If affected, patients should not drive or operate machinery.

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4.8 Undesirable effects

Opioid analgesics share many side-effects, although qualitative and quantitative differences exist. Side effects which may occur are nausea, vomiting, dyspepsia, anorexia, constipation, paralytic ileus, abdominal pain, exacerbation of pancreatitis, bronchospasm, inhibition of cough reflex, seizures, syncope, drowsiness, dizziness, confusion, sleep disturbances, difficulty in micturition, ureteric or biliary spasm, urinary retention, dry mouth, sweating, headache, raised intracranial pressure, facial flushing, vertigo, bradycardia, tachycardia, palpitations, oedema, hypertension, postural hypotension, hypothermia, hallucinations, euphoria, dysphoria, mood changes, dependence, miosis, visual disturbances, decreased libido or potency, amenorrhoea, rashes, paraesthesia, contact dermatitis, urticaria and pruritus.

Respiratory depression in sensitive patients, muscle rigidity, rhabdomyolysis and hypotension with larger doses.

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4.9 Overdose

Symptoms;

In the unlikely event of overdosage with this product, signs of morphine toxicity and overdosage include pin-point pupils, respiratory depression and hypotension. Circulatory failure and deepening coma may occur in more severe cases. Convulsions may occur, especially in infants and children. Muscle rigidity has been reported in high doses. Rhabdomyolysis progressing to renal failure has been reported following overdose of morphine.

High doses or prolonged use may lead to gastric hypersecretion and acid rebound. Calcium carbonate can cause hypercalcaemia, particularly in patients with renal impairment or after high doses. Alkalosis may also occur as a result of the carbonate anion. There have been reports of the milk-alkali syndrome and tissue calcification. Symptoms of hypercalcaemia include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia, polyuria, nephrocalcinosis, renal calculi, and in severe cases, cardiac arrhythmias and coma.

Treatment;

In acute overdosage, gastric lavage and symptomatic treatment as for morphine hydrochloride is recommended, including assisted respiration if necessary. Naloxone may be used to counteract central nervous system depression.

Mild hypercalcaemia is best corrected by increasing oral fluid intake and treating any identified underlying disease. Severe hypercalcaemia requires prompt treatment to reduce plasma calcium concentrations.

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5. Pharmacological properties
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5.1 Pharmacodynamic properties

A07X – Other antidiarrhoeals

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

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

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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

22/08/2013

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10. Date of revision of the text

22/08/2013

Company information
Thornton & Ross Ltd
Linthwaite, Huddersfield , West Yorks, HD7 5QH
Telephone : +44 (0)1484 842217
Fax : +44 (0)1484 847301
WWW : http://www.thorntonandross.co.uk
Customer Care direct line : +44(0)1484 848200
Medical Information Fax : +44(0)1484 847301
Medical Information e-mail : phv@thorntonross.com
Out of Hours Telephone : 0870 851 0207
More information about this medicine
Legal categories
  • P
Active ingredients/generics
  • calcium carbonate
  • morphine hydrochloride
  • kaolin light
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